bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor
      Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.

      The investigators hypothesize that no statistical difference will exist in the efficacy
      between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription
      devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be
      most cost-effective than Atopiclair or EpiCeram.
    

Detailed description: 
      The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair
      Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate
      atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these
      products. A significant difference exists in the cost of these products; therefore, if our
      hypothesis is proved correct - that Aquaphor will be just as efficacious as the more
      expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the
      overall cost of treating atopic dermatitis.

      This is a single center, investigator blinded, randomized, prospective controlled study of
      subjects with mild to moderate atopic dermatitis. The study is intended to compare the
      efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin
      Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All
      subjects will receive active study medication and will return to study center for efficacy
      and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order
      to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to
      receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables.
      Efficacy will be measured through Investigator's Global Assessment, BSA involvement,
      Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt
      Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of
      Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be
      calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.
    

Intervention name(s): Atopiclair Nonsteroidal Cream; Aquaphor Healing Ointment; EpiCeram
Intervention type(s): Drug; Other; Drug
Other intervention name(s): MAS063DP; BRC-Cer
Intervention MeSH terms: Decanoic acid; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Wake Forest; Dermatology; Skin; Over-the-counter; Moisturizer; Children
Effects of a Rehabilitation Program on Physical Performance and Disease Self-management in Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a group-based exercise and
      educational program for people with Rheumatoid Arthritis (RA) on physical performance and
      disease-self-management.
    

Detailed description: 
      Currently, the effectiveness of a program consisting of education to improve disease
      self-management combined with intensive exercises is not clear. In the present study the
      investigators developed a group-based program for people with RA consisting of physical
      exercise to increase physical performance (i.e. aerobic capacity and muscle strength)
      combined with an educational program to improve disease self-management (self-reported health
      status and self-efficacy). The investigators called it the 'FIT program'. The aim of the
      present randomized controlled trial (RCT) was to examine the effects of the FIT program on
      aerobic capacity, muscle strength, self-reported health status and self-efficacy, in a
      population of people with RA. The investigators hypothesized that the FIT-program would have
      beneficial effects on physical performance (ie. aerobic capacity and muscle strength) and
      disease self-management (i.e. perceived health status and self-efficacy components) compared
      to a waiting list control group (WLCgroup).
    

Intervention name(s): experimental Fit-program; no intervention
Intervention type(s): Other; Other
Intervention description(s): Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part consisted of a muscle exercise circuit and bicycle training,sport and aqua jogging. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level. Further information was given about body sensations, sports, food and energy, pain, fatigue, emotional changes, sleeping disturbance and daily routine.; waiting list control group with no intervention
Other intervention name(s): rehabilitation; rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise; education; self-management; rehabilitation
Lifestyleintervention for the Treatment of Severe Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1
      year) term effects on body composition and psychological health after a 10 to 14-weeks
      comprehensive lifestyle modification program for the treatment of severe obesity.

      The aims of the PhD project are to investigate whether an intensive lifestyle intervention
      leads to acute and short term (< 1 year) changes in:

        1. The BMI/Weight

        2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and
           visceral fat area)

        3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and
           health-related quality of life
    

Detailed description: 
      The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity
      Clinic, which is an inpatient program to address morbid obesity in adults. The study is a
      non-randomized clinical trial comparing the acute and long-term effects on physical and
      psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification
      program for the treatment of morbidly obese patients.

      In between the inpatient stay, the patients are followed up either by telephone, occasional
      mail and/or structured / weekly email.

      In this project we prospectively follow two groups of patient included in the treatment
      programme in September 2010 and January 2011, respectively. In addition a control group with
      waiting-list patients is also included in the study, and they were recruited in
      October-November 2011
    

Intervention name(s): Intensive lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lifestyle; Physical activity
Physical Activity, Sleep and Age
Condition: Aging; Movement Efficiency; Sleep
Study type: Interventional

Summary: 
      Ageing is associated with a reduction of physical activity, movement efficiency, and quality
      of sleep. This leads to reduced health and well being in elderly subjects. Exercise training
      can increase movement efficiency and quality of sleep.

      Objectives:

        1. Laboratory validation test of body acceleration based indexes for movement efficiency
           and quality of sleep;

        2. Cross-sectional analysis to assess relations between these indexes and age;

        3. Intervention study to assess the effect of exercise training on daily life movement
           efficiency and quality of sleep in ageing subjects

      45 healthy human volunteers, age 50-83 yr, BMI 20-30 kg/m2 are divided in control or
      intervention group. Subjects that will have practiced fitness activities in the previous
      year, as well as pregnant or lactating women, will be excluded.
    


Intervention name(s): One year fitness training
Intervention type(s): Behavioral
Intervention description(s): Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in
      treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive
      chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180
      micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a
      24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12
      months, and the target sample size is less than 100 participants.
    


Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): 180 mcg subcutaneously once per week for 48 weeks.
Other intervention name(s): Pegasys®
Intervention MeSH terms: Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Condition: Nondependent Opioid Abuse, Episodic
MeSH terms: Opioid-Related Disorders; Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the abuse potential of EMBEDA compared to
      controlled release morphine when crushed and taken orally by non-dependent recreational
      opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA
      relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with
      crushed controlled-release morphine and crushed placebo.
    


Intervention name(s): Placebo; MS Contin (morphine sulfate, controlled release); EMBEDA (morphine sulfate / naltrexone hydrochloride)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage; Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage; Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Intervention MeSH terms: Naltrexone; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: abuse potential; abuse liability; recreational opioid use; morphine
Effect of an Exercise Bout in Plasma and Fecal Profile
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this project is to study the effect of a bout of exercise on the metabolomic
      profile of plasma and feces as well as its influence on the intestinal microbiota.
    

Detailed description: 
      The practice of physical exercise has numerous health benefits, preventing the appearance and
      development of cardiovascular diseases and various types of cancer. Exercise causes changes
      in the vascular, muscular and pulmonary systems, etc. One of the benefits that can result
      from exercise modification of the intestinal microbiota and its metabolic profile. In order
      to identify the potential changes that exercise has on the intestinal microbiota and its
      metabolic profile, the purpose of this study is to identify changes in the plasma and fecal
      metabolome and in fecal microbiota associated with a bout of exercise
    

Intervention name(s): Prolonged Exercise session
Intervention type(s): Other
Intervention description(s): After a standardized warm-up of 10 minutes of continuous running on a treadmill at 60% of their maximum heart rate (HRmax), subjects will perform a maximum oxygen consumption test (VO2max) with a gas analyzer (UltimaTM Series, MGC Diagnostic Corporation, St. Paul, MN, USA. The protocol will start with a slope of 1% at a speed of 10 km/h, with increments of 0.3 km/h every 30 s until volitional exhaustion. Finally, ten minutes after the treadmill test, volunteers will run 1 kilometer (t1km) as fast as possible and the time needed to cover the distance will be recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm
Condition: Older Adults
Study type: Interventional

Summary: 
      Research has shown that reducing the time spent sitting can reduce the risk of many diseases,
      such as diabetes and heart disease, and improve health. It is estimated that many older
      adults typically spend 70% of their waking day sitting, but little is known about whether
      reducing sitting promotes health and well-being in this age group. The aim of this research
      is to investigate the health effects of reducing sitting time by replacing it with short
      periods of standing or walking in adults over the age of 65.
    


Intervention name(s): Sitting; Standing; Walking
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System
Condition: Gynecologic Surgeries
Study type: Interventional

Summary: 
      During laparoscopy, trocars are essential: they allow the passage of instruments through the
      wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and
      forceps) and 10 to 12mm are used (especially for optics).

      Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain,
      infections or postoperative hernias, or aesthetic sequelae, and should be chosen with
      caution: most complications of laparoscopy are essentially due to their placement, and the
      complications at the introduction of the first trocar are the most frequent.

      The MiniLap® system developed by Teleflex does not require trocars in the case of a single
      forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance®
      system). The aim of the latter is to make minimally invasive surgery even less invasive,
      thanks to a reduction in the number of trocars used (in many cases, elimination of two
      trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus
      reducing the complications
    


Intervention name(s): laparoscopic gynecologic surgery with the MiniLap System.; laparoscopic gynecologic surgery with the conventional single-use trocars.
Intervention type(s): Device; Device
Intervention description(s): Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care, but using the MiniLap System instead of the conventional single-use trocars used usually.; Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Laparoscopy; Trocar; MiniLap; surgery; gynecology; pain, scars; scars
Evaluation of the Re-volumizing Performance of Aliaxin (New Trademark)
Condition: Malar and Sub-malar Volume Deficiency
Study type: Interventional

Summary: 
      Aim of the study is to evaluate the re-volumizing performance and the duration effect of the
      product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to
      aging mechanism.
    


Intervention name(s): Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.)
Intervention type(s): Device
Intervention description(s): First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure.
0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm).
A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Urinary Biomarkers of Folate Status
Condition: Healthy
Study type: Interventional

Summary: 
      The major objective of the proposed study is to demonstrate the suitability of new markers
      for folate status in humans, which avoid blood sampling, as required for the established
      marker RBC folate concentration, but can be obtained from spot urine samples. For this reason
      urine and blood will be collected from volunteers, twice at baseline and in a subgroup after
      6 and 12 weeks of intake of a folic acid supplement

      Specific hypotheses to be tested:

      Correlation study:

        -  The 24 h urinary excretion of total p-ABG, as extrapolated via urinary creatinine
           concentration from the total p-ABG concentration in a spot sample is significantly
           correlated to RBC and plasma folate levels in the studied subjects

        -  The 24 h urinary excretion of FIGLU, as extrapolated via urinary creatinine
           concentration form the FIGLU concentration in a spot sample is significantly correlated
           to RBC and plasma folate levels in the studied subjects

      Intervention study:

      Changes in folate status (RBC folate) after supplementary intake of folate result in
      increased urinary excretion of total p-ABG and FIGLU in subjects identified with a low folate
      status and in subjects identified with a high folate status among the study participants of
      the correlation study
    


Intervention name(s): folic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 0.4 mg of folic acid per day
Intervention MeSH terms: Folic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: folic acid; folate; p-aminobenzoylglutamate; formiminoglutamate; homocysteine; experimental validation of a new biomarker
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
Condition: Drug Safety and Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will have one stage consisting of multiple treatment visits. The study is designed
      to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy
      volunteers in various formulation. The study is also designed to assess the reproducibility
      of pharmacokinetic profiles with various formulations.
    


Intervention name(s): Teriparatide; Oral PTH (1-34)
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous standard injection; Different optimization of API
Other intervention name(s): Teriparatide
Intervention MeSH terms: Teriparatide; Parathyroid Hormone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood and Plasma Collection For Use in Future Clinical Trials
Condition: Influenza A Virus Infection
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Treatment options are limited for the treatment of influenza. This study will collect blood
      from people who have been exposed to the influenza virus or who have received a seasonal
      influenza vaccine. The blood plasma will be used in a future clinical trial to treat people
      hospitalized with influenza.
    

Detailed description: 
      There is a concern that the influenza virus will become resistant to the standard of care,
      oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed
      in people infected with the seasonal influenza virus. Because of the possibility of drug
      resistance, additional treatment options for influenza are needed. The purpose of this study
      is to collect blood from people who have recovered from influenza or who have received a
      seasonal influenza vaccine. The blood will then be processed into Food and Drug
      Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this
      plasma will be used as a treatment for people hospitalized with influenza.

      This study will enroll people who have recovered from influenza or received a seasonal
      influenza vaccine. Participants will donate blood at FDA-licensed blood donor centers up to
      three times during the 240-day study period.
    

Intervention name(s): Collection of Anti-Influenza A Immune Plasma
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include people who have recovered from influenza, received a seasonal
        influenza vaccine, or have both recovered from influenza and received a seasonal influenza
        vaccine.
      
Biospecimen description: 
      Whole blood will be collected from participants.