bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Appropriate Weight Gain Pregnant Women
Condition: Pregnancy
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and
      an interactive physical activity monitoring system can help pregnant women gain an
      appropriate amount of weight during pregnancy.
    


Intervention name(s): Intervention; Intervention 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.; Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gestational weight gain; Physical activity
Caudal Epidural Block and DPNB in Hypospadias
Condition: Hypospadias; Postoperative Pain
MeSH terms: Hypospadias; Pain, Postoperative
Study type: Observational

Summary: 
      Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of
      the penis and is defined as the urethral meatus being located in the ventral part of the
      penis instead of its normal place. The surgery of this anomaly is very painful in the
      postoperative period and requires long-term analgesia. Regional anesthesia methods combined
      with general anesthesia play an important role in providing effective and long-term
      postoperative pain control in pediatric penile surgery. These methods also reduce
      postoperative morbidity, enable early mobilization and significantly decrease the need for
      narcotic analgesics.

      The investigator's hypothesis is peripheral nerve blocks are superior to neuraxial blocks as
      the blocks provide longer-term analgesia and have fewer side effects.
    

Detailed description: 
      The surgery of hypospadias is very painful in the postoperative period and requires long-term
      analgesia. A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly
      used regional anesthesia techniques for postoperative pain control.

      Aims: The primary aim of the current study was to use the duration until the first
      postoperative analgesic requirement after two different block techniques to compare the
      analgesic effect. The secondary aims were to compare the two methods for postoperative
      Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental
      satisfaction scores.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted with children who underwent hypospadias surgery at a training and
        research hospital in Istanbul, Turkey.
      
Keywords: dorsal penile nerve block; caudal epidural block; postoperative pain; analgesia; hypospadias; ultrasound
Treatment for Improvement of Cellulite Appearance Using Form Applicator
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with
      masked evaluation.
    

Detailed description: 
      Eligible patients will receive 2 treatments (4 ± 2 weeks apart) on either one side (right or
      left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System
      with the Form applicator ('2X').

      Treatment may be administered after the enrollment and screening at the first visit, or it
      may occur later following the enrollment and screening activities based on site scheduling
      availabilities.

      All patients will return to the clinic for one follow up visit at 3 months ± 1 week post last
      treatment (FU1).

      Methodology described in the protocol to evaluate efficacy and safety of treatments will be
      carried out at each visit at the clinic.
    

Intervention name(s): Sofwave
Intervention type(s): Device
Intervention description(s): The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
Other Names:
SUPERB
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: upper thigh; buttock; skin laxity
Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)
Condition: Obesity; Time Restricted Feeding; Weight Loss; Calorie Restriction
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that
      involves eating a daily period of 8 hours or less. This is a randomized controlled trial to
      evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk
      factors in obese adults over 12 months compared to continuous energy restriction (CER).
    


Intervention name(s): Time restricted feeding; Continuous Energy Restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).; Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing Spondylitis
Condition: Anti - TNF Therapy; Ankylosing Spondylitis; Neuropathy
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      Patients with ankylosing spondylitis were divided into 2 groups as anti-TNF and conventional
      therapy according to the treatments they were using for the last 5 years. Nerve conduction
      studies in the upper and lower extremities of the patients were compared.
    

Detailed description: 
      Demyelinating lesions in central nervous system after anti-TNF agents were reported
      previously. There are limited studies investigating the effects of anti-TNF treatments on the
      peripheral nervous system. The aim of this study is to investigate whether peripheral nerves
      are affected due to long-term use of anti-TNF agents.

      Patients with a diagnosis of ankylosing spondylitis who received conventional or anti-TNF
      therapy for five years at Istanbul Physical Therapy and Rehabilitation Training and Research
      Hospital were included in the study. The patients were divided into two groups as
      conventional group and anti-TNF group according to the treatment they received. All patients
      were evaluated in a single section. Sociodemographic characteristics of the patients and Bath
      Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis
      Functionality Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) scores
      were recorded. Median-ulnar motor and sensory conduction studies and tibial-peroneal motor
      and sural nerve sensory conduction studies were performed in both upper extremities of all
      patients. Median, ulnar, and tibial nerve F-response studies were also performed.
    

Intervention name(s): Anti-TNF agents; Conventional therapy users for the last 5 years
Intervention type(s): Drug; Drug
Intervention description(s): Group of patients using anti-TNF for the last 5 years.; Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years
Other intervention name(s): Anti-TNF agents users for the last 5 years.; Conventional therapy (non steroid anti inflammatory drugs and/or salazopyrin)
Intervention MeSH terms: Sulfasalazine; Anti-Inflammatory Agents
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who had the diagnosis of ankylosing spondylitis and had used conventional or
        anti-TNF therapy at least 5 years.
A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the
      treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to
      evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer
      gastrointestinal ulcers compared to patients treated with naproxen and placebo.
    


Intervention name(s): CJ-023,423; placebo; naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg BID; placebo; naproxen
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
Condition: Muscle Injury; Muscle Soreness; Exercise Induced Muscle Damage
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the current study is to investigate the therapeutic effect and especially the mode
      of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on
      exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium
      proficiency level compared to placebo.
    


Intervention name(s): Wobenzym® plus; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Wobenzym
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle soreness; Exercise induced muscle damage; Inflammation; Proteolytic enzymes; Muscle strength Dynamometer
Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))
Condition: Parkinson Disease; Fluctuating Mood Symptoms
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in
      Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of
      non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD.
      The main goal of this project is to validate the NF-scale in french language in a multicenter
      approach.
    

Detailed description: 
      Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the
      off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral
      addictions, mania, and psychosis might occur during the on-medication condition. Early
      diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often
      under-recognized by patients or misdiagnosed by physicians due to the lack of specific
      assessment tools. The NFS is composed of 20 items among which ten measure the "ON
      neuropsychological state" and ten, the "OFF neuropsychological state". It provides two
      sub-scores (one ON and one OFF) with a maximal total score of 30.
    

Intervention name(s): FN scale auto-questionnaire
Intervention type(s): Other
Intervention description(s): Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Interaction of Salivary Proteins and Polyphenols
Condition: Diet Habit; Diet Modification; Taste, Altered; Saliva Altered
MeSH terms: Dysgeusia
Study type: Interventional

Summary: 
      Participants will be chosen through an initial sensory test to find high and low-perceivers
      of astringency. Selected participants will drink a chocolate milk or milk substitute beverage
      for one week each with washout weeks in between. At the end of each week participants will
      taste and rate multiple beverages for their astringency and other sensory properties.
      Participants will provide saliva samples weekly for proteomic analysis and (potentially)
      analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall
      once per week. Data will be analyzed to determine if there is a relationship between
      polyphenol exposure, astringency ratings, and salivary protein composition.
    


Intervention name(s): Chocolate Milk; Chocolate milk substitute; Chocolate milk substitute with gelatin
Intervention type(s): Other; Other; Other
Intervention description(s): Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.; Chocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.; Chocolate milk substitute with gelatin added will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study Of Celecoxib In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the
      incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.
    


Intervention name(s): Celecoxib; Loxoprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib 100mg tablet twice a day with meal for 2 weeks; Loxoprofen 60mg tablet three times a day with meal for 2 weeks; Placebo tablet three times a day with meal for 2 weeks
Intervention MeSH terms: Celecoxib; Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endoscopy
Gluconeogenesis Rates and Its Precursors in Pediatric Sepsis
Condition: Sepsis; Hyperglycemia; Critical Illness
MeSH terms: Sepsis; Hyperglycemia; Critical Illness
Study type: Observational

Summary: 
      Critically ill children have abnormal utilization of nutrients such as glucose, lipids and
      protein. Often sick children have increased glucose concentrations in blood. However, the
      origin of the high glucose has not been determined in these populations. There is a close
      interrelationship between protein and energy metabolism. An increase in the energy supply
      will not promote nitrogen retention unless the amino acid supply is adequate, and conversely,
      an increased amino acid supply will be useless if energy is limiting, hence the importance of
      adequate protein and energy intake. Our study aims to investigate the protein-energy
      interactions in critically ill septic children and adolescents with the objective to
      eventually provide the best nutritional support for these patients.
    

Detailed description: 
      This is an observational study, aimed at exploring:

      i) gluconeogenesis rates ii) sources of gluconeogenesis and pyruvate cycling, and iii)
      protein kinetics in critically ill children and adolescents, and its differences by age
      group, as well as in comparison to healthy adolescents. The study size will include 45
      critically ill septic, pediatric patients (22 children at 5-12 years of age and 23
      adolescents' at 13-19 years of age), male and females admitted to the pediatric intensive
      care unit (PICU) at Children's Medical Center, Dallas. The minimal subject's weight will be
      17kg. Additionally, 30 healthy adolescents matched by age, gender, BMI and Tanner stage will
      be studied at the Clinical Translational Research Center at Zale Lipshy Hospital, to serve as
      healthy adolescent controls. The number of subjects includes an expected drop out rate of
      about 20%, in order to obtain 18 patients with complete data in each group. Patients will
      receive nutritional support as per standard care. This study will yield important knowledge
      and may lead in the future to changes in the current practice on the management of critically
      ill pediatric patients in the PICU.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Septic pediatric subjects: A total of 45 critically ill children age 5-19 years with
        diagnosis of sepsis, as defined by the International Sepsis Consensus Conference.

        Healthy subjects: A total of 30 healthy adolescents 13-19 years matched for age, gender,
        Tanner and BMI to serve as controls. A Dexa scan will be obtained to determine lean body
        mass.
      
Biospecimen description: 
      Blood and urine samples.
    
Keywords: Gluconeogenesis; Glycogenolysis; Pyruvate cycling; Glucose production rates; Mitochondria; Acylcarnitines
Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
Condition: Colorectal Cancer; Colon Polyps; Adenomatous Polyp of Colon
MeSH terms: Colorectal Neoplasms; Adenoma; Adenomatous Polyps; Polyps; Colonic Polyps
Study type: Observational

Summary: 
      Conflicting guideline recommendations for screening colonoscopy result due to scant data upon
      which to develop appropriate recommendations. No previous study has compared the prevalence
      of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first
      degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk
      individuals with no family history of CRC. The purpose of this study is to determine the
      prevalence of colon adenomas in 40-49 year old individuals and identify risk factors
      associated with the presence of advanced adenomas. This data will provide evidence to
      determine appropriate colon cancer screening guidelines in 40-49 year old persons with a
      family history of colon polyps or colorectal cancer.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are recruited from the endoscopy units of the participating study sites prior
        to their colonoscopy procedure.
      
Keywords: Colorectal Cancer
Understanding Brain Reward Responses in Individuals With Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      This study will examine brain responses associated with reinforcement and reward tasks in
      individuals with major depressive disorder (MDD).
    

Detailed description: 
      Major depressive disorder (MDD) is a severe form of depression that can significantly
      interfere with an individual's thoughts, behavior, mood, and physical health. People who
      suffer from MDD may experience anhedonia, or the inability to gain pleasure from normally
      pleasurable experiences. Such individuals do not respond to motivational rewards in the same
      way as do individuals who are not depressed. Anhedonia has been recognized as a core symptom
      of depression and it is not always remedied with antidepressant medication. Abnormal brain
      activity and processing may be the underlying cause of depression and specifically anhedonia.
      A better understanding of the brain mechanisms of depression may lead to the development of
      new effective medications or psychological treatments.

      Event-related potential (ERP), which measures electrical activity in the brain, and
      functional magnetic resonance imaging (fMRI), which uses scanned images to illustrate changes
      in brain activity, are two techniques that can identify abnormal areas of brain processing.
      The purpose of this study is to use ERP and fMRI to compare brain activity that is related to
      reward processing in individuals with MDD versus individuals without MDD.

      This study will consist of 3 study visits; visits will be scheduled as close together as
      possible. At the first study visit, potential participants will be assessed with the SCID
      (Structured Clinical Interview for DSM-IV), which will identify individuals with the
      diagnostic criteria for MDD. A control group of non-depressed individuals will also be
      enrolled in the study. During the second and third study visits, participants will take part
      in a monetary reinforcement reward task followed by a signal detection reward task. Brain
      activity of all participants will be monitored during both tasks. During the second study
      visit, ERP will be used; during the third study visit, fMRI will be used. Demographic
      information will also be collected, and participants will complete several standardized
      questionnaires to assess mood. Some participants will be asked to return after eight weeks to
      complete the fMRI and EEG sessions again. Those who do complete all five sessions will be
      awarded a bonus.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Control participants, Participants with MDD
      
Keywords: Reward Processing; Anhedonia; Major Depressive Disorder; Depression
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of AZD2516
      following administration of a single dose to Japanese healthy subjects.
    


Intervention name(s): AZD2516; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered once orally. Specific dose depends on dose panel.; Capsule administered once orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; tolerability; AZD2516; pain; Japanese
Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859
      compared with placebo and an active control (ibuprofen) in subjects with acute dental pain
      after third molar extraction.
    


Intervention name(s): Placebo; ADL5859 30 mg; ADL5859 100 mg; ADL5859 200 mg; ibuprofen 400 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose; single dose; single dose; single dose; single dose
Other intervention name(s): Advil
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: delta opioid agonist; dental pain