bioihbjkbjnl/mcl2 huggingface dataset:
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
Condition: Colorectal Cancer; Precancerous Condition
MeSH terms: Colorectal Neoplasms; Adenomatous Polyposis Coli; Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
      of celecoxib may keep polyps and colorectal cancer from forming in patients with familial
      adenomatous polyposis.

      PURPOSE: This randomized phase I trial is studying the side effects and best dose of
      celecoxib in treating young patients with a genetic predisposition for familial adenomatous
      polyposis.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and toxicity of celecoxib in pediatric patients with
           genotype-positive familial adenomatous polyposis.

      Secondary

        -  Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of
           these patients.

        -  Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic
           techniques, tolerability of procedure).

        -  Compare sedation strategies based on local standards (monitored anesthesia care vs
           conscious sedation).

        -  Validate the ACF scoring technique.

        -  Establish the short-term (3 month) impact of celecoxib on ACF count in order to
           determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral celecoxib twice daily for 3 months in the absence of
           disease progression or unacceptable toxicity.

        -  Arm II: Patients receive oral placebo twice daily for 3 months in the absence of disease
           progression or unacceptable toxicity.

      Patients undergo colonoscopy at baseline and at 3 months. Patients also complete psychosocial
      questionnaires at baseline.

      Blood samples are collected at baseline to assess the influence of polymorphisms (CYP2C9,
      uridine diphosphate (UDP)-glucuronosyl transferase, A6, glutathione S-transferase [GST] M1,
      and Glutathione S-transferase (GST) theta 1 (GSTT1)) on age of onset of phenotype or number
      of colorectal polyps. Plasma drug trough levels are assessed at baseline, 1 month, and 3
      months.

      After completion of study treatment, patients are followed periodically for up to 2 months.
    

Intervention name(s): celecoxib; placebo
Intervention type(s): Drug; Other
Intervention description(s): Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.; Orally, twice daily for 3 months
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer; familial adenomatous polyposis
Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients
Condition: Condition Requiring Rapid Transfusion During Liver Transplantation Surgery
Study type: Observational

Summary: 
      Rapid infusion of red blood cells is known to result in hyperkalemia in the body. However,
      potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in
      the reservoir of rapid infusion system and its effect on the plasma potassium change during
      rapid transfusion are unknown. This study is designed to investigate these changes while
      massive transfusion is performed during liver transplantation surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult liver transplantation recipients
      
Keywords: transfusion; liver transplantation; potassium
Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery
Condition: Tonsillitis; Herniorrhaphies; Surgery; Children; Parents
MeSH terms: Tonsillitis
Study type: Interventional

Summary: 
      This research aims to evaluate the effectiveness of web-based mobile intervention (Icory
      -Solution) developed to pediatric patients and their parents in the pathway of outpatient
      surgery treatment in pre-intra- and postoperative setting: (1) Examine the effectiveness of
      the intervention on children's preoperative anxiety and fear, and postoperative pain (2)
      examine the effectiveness of the intervention on parental anxiety and satisfaction in
      children´s care path and (3) examine the experiences of the gamification in children in the
      intervention group.
    

Detailed description: 
      Children and their families are entitled to know what is going to happen to them before
      undergoing day surgery and information must be based on the child's age and understanding. It
      is important to help children to cope with any upcoming surgery because the more anxious and
      fear they are, the more pain they experience after the day surgery. Digital gaming solutions
      could help families and children to be better oriented to the coming treatment. Icory
      -solution is a digital pathway for children and family and it contains a virtual tour to
      hospital and distraction games for children. The information on the application is aligned
      with the patient's individual needs based on the type of surgery and requirements.
    

Intervention name(s): IcorySolution
Intervention type(s): Device
Intervention description(s): The ICory-solution programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery. The healthcare professional have received face-to-face training on how to use the BuddyCare dashboard and BuddyCare has been in the hospital in earlier studies.The Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support, games and distraction to children and a virtual tour to the hospital before children´s operation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis (NASH); Type2 Diabetes Mellitus
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with
      NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo
      run-in, treatment phase and end-of-study phase.
    

Detailed description: 
      This exploratory study will first enroll 10 patients with NASH and type 2 DM, to evaluate the
      safety of oral insulin and to measure the change in liver fat content.

      At the completion of their 4-week follow-up period, results will be presented to the Helsinki
      Committee. Following approval, an additional 20 patients will be enrolled. The size of the
      study population was determined by the investigator (with literature review) to be sufficient
      to show trends of reducing liver fat content by analysis of MRI PDFF (MRI-Proton Density Fat
      Fraction) images, the FibroMax™ Test and Fibroscan® including Controlled Attenuation
      Parameter (CAP™). CAP™ is a measure of the ultrasound attenuation to quantify steatosis in
      the liver.
    

Intervention name(s): Oral Insulin
Intervention type(s): Biological
Intervention description(s): all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.
Condition: Alveolar Bone Loss; Alveolar Bone Resorption
MeSH terms: Bone Resorption; Alveolar Bone Loss
Study type: Interventional

Summary: 
      the aim of the present study was to evaluate the dimensional variation and osseointegration
      of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a
      collagen membrane.
    

Detailed description: 
      The Schneiderian mucosa will be elevated and the created space will be filled with a natural
      bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients
      randomly selected (control sties), a native collagen membrane made of porcine dermis
      (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten
      patients of the test group, the antrostomy will be left without the membrane. The flaps will
      be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients.
      The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with
      different surface will be installed and retrieved after further 3 months for
      histomorphometric evaluations.

      CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor
      augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations
      over time of soft and hard tissues will be performed.
    

Intervention name(s): Maxillary sinus augmentation
Intervention type(s): Procedure
Intervention description(s): Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.
Other intervention name(s): maxillary sinus lift, maxillary sinus elevation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: test and control group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antrostomy; Maxillary sinus augmentation; collagen membrane; biomaterial
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Cross-sectional Study
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Observational

Summary: 
      In Denmark and the western world, there is an increasing prevalence of obesity probably due
      to a combination of inadequate daily physical activity and a high energy intake. One approach
      to achieve weight loss and change life style is to participate in an intensive supervised
      prolonged life style modification course. The immediate effect is often positive, but over
      time the overall effect is limited as the majority will not maintain weight loss and a
      changed life style.

      The purpose of this study is therefore to characterize the physiological factors that
      determine/influence the capacity to maintain weight loss and a healthy lifestyle after a
      prolonged lifestyle intervention.

      The investigators have the following research questions:

        1. Are there physiological traits and characteristics that mediate better adherence to
           lifestyle changes and weight loss?

        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict
           success in maintaining weight loss and lifestyle changes?

        3. How does gender and age influence the capacity to maintain the lifestyle induced
           adaptation in muscle and adipose tissue and maintaining weight loss?

      The study design is cross-sectional and will be based on a lifestyle intervention, as it is
      practiced in a real life setting at Ubberup folk high school. The investigators will recruit
      former participants of this lifestyle style intervention. 50 % who maintained a weight loss
      and a healthy life style and 50 % who did not.
    


Intervention name(s): Intensive Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): The included subjects has previously participated in the Intensive Lifestyle Intervention intervention at Ubberup Folk High School. This intervention includes daily exercise and a hypocaloric diet (app. -700KCal/day) for 10-14 weeks. Furthermore theoretical and practical education within e.g. Nutrition, exercise and motivational psychology.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Former participants of Ubberup Folk High School will be included in this study. Ubberup
        Folk High School is a privately hold externate that teaches lifestyle intervention courses
        with focus on weight loss. A stay at Ubberup has a duration of 10-14 weeks and is primarily
        self-financed. The study population will consist of men and women of two different age
        Groups (18-35 and 35-65yr). We will recruit participants who succeeded in maintaining the
        weight loss and participants who regained in weight.
      
Biospecimen description: 
      Whole blood, muscle and fat tissue.
    
Keywords: Weight loss maintenance; Body composition; Physical activity; Lifestyle intervention
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
Condition: Low Back Pain Due to Spinal Nerve Compression
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      To evaluate the effects of skin compression with an indicator at the needle entry point on
      radiation exposure time of fluoroscopically guided transforaminal epidural block in obese
      patients
    


Intervention name(s): skin compression
Intervention type(s): Procedure
Intervention description(s): skin compression with an indicator for determination of needle entry point
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of
Condition: Sore Throat; Cough
MeSH terms: Pharyngitis; Cough; Hoarseness; Dysphonia
Study type: Interventional
Phase: Phase 3

Summary: 
      ABSTRACT:

      The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly
      (over tracheal tube cuff) compared with distilled water on the post intubation syndrome
      incidence. This study has not been carried out in Iran.

      99 patients of either sex undergoing elective surgery were recruited in a single blind
      randomized study. The patients, using randomization table, were divided into three groups.
      Anesthetics and medications used during surgery were similar for all the patients.

      For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the
      voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of
      medications were obtained.
    


Intervention name(s): betamethasone gel; lidocaine jelly; distilled water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.; the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.; The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Intervention MeSH terms: Betamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Syndrome incidence after intubation; Betamethasone gel; lidocaine jelly; sore throat; cough; hoarseness of voice
Emla-Cream as Pain Relief During Pneumococcal Vaccination
Condition: Children; Pain
Study type: Interventional

Summary: 
      The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief
      or no pain relief in connection to the first pneumococcal vaccination at the age of three
      months in Child health care.

      Primary objective

      1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at
      the age of three months to lower pain scores in the use of FLACC as a pain measurement
      instrument?
    

Detailed description: 
      The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief
      or no pain relief in connection to the first pneumococcal vaccination at the age of three
      months in Child health care.

      Primary objective

        1. Leads Emla cream as pain relief to children in connection with pneumococcal vaccination
           at the age of three months to lower pain scores in the use of FLACC as a pain
           measurement instrument?

           Secondary objectives

        2. Leads Emla cream as pain relief in connection with pneumococcal vaccination to any
           difference in the child's heart rate response and saturation?

        3. Leads Emla cream as pain relief that it takes longer before the baby starts crying and
           does the child cry for a shorter time in connection with vaccination?

      Method: The study is randomised and singleblind. The study involves 72 children who are 3
      months old. 36 children will receive Emla-cream and 36 children will receive placebo-cream.

      This study will lead to new knowledge about Emla cream and pneumococcal vaccination. The
      study will give new knowledge how painful pneumococcal vaccination is for the children. If
      the study shows that Emla cream don´t give enough pain relief during pneumococcal vaccination
      more studies should be done with other pain relief.
    

Intervention name(s): Emla-cream; Miniderm cream
Intervention type(s): Drug; Drug
Intervention description(s): Topical anaesthetic; Topical
Other intervention name(s): Studied drug: Emla-Cream, lidocaine and prilocaine; Placebo:Miniderm, glycerin cream, non-pharmacological agent
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Children; Pain; Vaccination; Emla; Pneumococcal; Painscale
Growth and Safety Clinical Trial on a New Infant Formula
Condition: Weight Gain
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant
      formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be
      randomized to one of two infant formulas: a standard, commercially-available infant formula
      for term infants or the new infant formula for term infants for 16 weeks. A reference group
      of human milk-fed infants will also be enrolled. This study is designed in accordance with
      Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations,
      21CFR106.96. This study allows caregivers to participate completely from the comfort of their
      own home.
    


Intervention name(s): New Infant Formula; Commercial Infant Formula
Intervention type(s): Other; Other
Intervention description(s): New infant formula fed daily ad libitum; Commercially available infant formula fed daily ad libitum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: infant; formula; in-home
Effects of Self-administered Acupressure in Psychiatric Patients With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to evaluate the effects of self-administered acupressure therapy for
      psychiatric in-patients with constipation

      Two main research questions include:

        1. What are the effects of the standardized self-administered acupressure program on
           reducing those adult psychiatric patients' symptoms of constipation?

        2. What are the psychiatric patients' (participants') perceived benefits and limitations of
           self-administered acupressure on management of their constipation?

      In this study, the participants who met the study criteria and completed the baseline
      measurement would be randomly assigned into either the self-administered acupressure program,
      or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of
      this study are:

        1. There is no significant difference between the acupressure and sham group immediately
           and/or two weeks after the completion of intervention on patients' symptom severity of
           constipation; and

        2. There is no significant difference between the acupressure and sham group on patients'
           perceived quality of life at immediately and two weeks after treatment completion.
    

Detailed description: 
      Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient
      Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic
      and clinical data collected by a trained assessor who was blind to the intervention
      assignment of the participants. These data would be measured at recruitment (baseline) and
      immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day
      intervention. Qualitative focus group interview data would be collected after Post-test 2 .
    

Intervention name(s): Self-administered acupressure; Sham control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Self-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision .; Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
Other intervention name(s): Self-help acupressure therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupressure; Self-administration; Psychiatric in-patients; Constipation; Self-administered acupressure program; Sham control group