bioihbjkbjnl/mcl2 huggingface dataset:
Energy Intake, Exercise and Energy Replacement
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effect of an exercise alone versus. An
      exercise followed by the ingestion of an energy replacement snack on the following energy
      intake, food reward and appetite feelings in adolescents with obesity.
    

Detailed description: 
      The present study will compare the nutritional response to the realisation of an acute
      exercise with and without an energy replacement snack on the following energy intake in
      adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete
      three experimental sessions: i) one control session (rest); ii) one session with an acute
      exercise realized during the morning; iii) one session with the same exercise followed by a
      snack covering the exercise-induced energy expenditure. Their ad libitum energy intake will
      be assessed at the following meal as well as at dinner time. Appetite feelings will be
      assessed at regular intervals and their food reward in response to the lunch will also be
      assessed.
    

Intervention name(s): CON . control condition without exercise / rest condition; EX. Condition with an acute exercise set in the middle of the morning; EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): CON . Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals; EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appetite control; obesity; Adolescents; exercise; Energy replacement
Rosiglitazone and Exercise in Patients With Type 2 Diabetes Mellitus
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to investigate the influence of systemic exercise,
      rosiglitazone administration and combined pharmaceutical and lifestyle intervention on
      cardiovascular risk factors
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rosiglitazone,exercise,cardiovascular risk factors
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer
Condition: Carcinoma of the Appendix; Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the
      tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.

      PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who
      have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic
      perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or
      appendix cancer .
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine time to progression from surgery in patients who have undergone cytoreductive
           surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or
           adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant
           thalidomide.

      Secondary

        -  Estimate progression-free survival probability of patients treated with this regimen.

        -  Obtain toxicity data for patients receiving long-term oral thalidomide therapy.

      OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every
      28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for up to 12 months.
    

Intervention name(s): thalidomide; surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.; Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
Intervention MeSH terms: Thalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carcinoma of the appendix; stage II colon cancer; stage III colon cancer; stage IV colon cancer; recurrent colon cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent rectal cancer
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and
      placebo, as measured by the number of binge days (defined as days during which at least 1
      binge episode occurs) per week as assessed by clinical interview based on subject diary and
      Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by
      the end of the Open-label Treatment Phase.
    


Intervention name(s): Lisdexamfetamine dimesylate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods); Placebo capsule once per day (double-blind period)
Other intervention name(s): SPD489; LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of single ascending doses of
      UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
    


Intervention name(s): UCB7665 Intravenous 1; UCB7665 Intravenous 2; UCB7665 Intravenous 3; UCB7665 Intravenous 4; UCB7665 Intravenous 5; UCB7665 Subcutaneous 1; UCB7665 Subcutaneous 2; Intravenous Placebo; Subcutaneous Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: subcutaneous infusion; Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: subcutaneous infusion; Active substance: Placebo
Pharmaceutical form: solution
Concentration: 0.9 % saline
Route of Administration: intravenous infusion; Active substance: Placebo
Pharmaceutical form: solution
Concentration: 0.9 % saline
Route of Administration: subcutaneous infusion
Intervention MeSH terms: Rozanolixizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Monoclonal antibody; subjects; First in human
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
Condition: Small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w
      in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in
      subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized
      monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective
      Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).

      The study is composed of two parts. Part 1 of the study will determine the safety and
      tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The
      second phase of treatment was carried out by selecting one group of administration mode and
      the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of
      SHR-1210 in combination with Apatinib in 39 subjects.
    

Detailed description: 
      Subjects will be 1:1:1 randomly assigned to receive

        -  SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD, or

        -  SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）, or

        -  SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off） treatment
           until disease progression, unacceptable toxicity, or death.
    

Intervention name(s): SHR-1210; Apatinib
Intervention type(s): Drug; Drug
Intervention description(s): A humanized anti-PD-1 monoclonal antibody; A tyrosine kinase inhibitor selectively targeting VEGFR-2
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
Condition: Hypercholesterolemia; Atherosclerosis
MeSH terms: Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to assess whether co-administration of ezetimibe 10 mg with
      atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with
      atorvastatin 10 mg alone for reducing LDL-concentrations.
    


Intervention name(s): Ezetimibe + Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks; oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
Other intervention name(s): SCH 58235; Zetia; Lipitor; Lipitor
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stereotactic Directional Vacuum-Assisted Breast Biopsy
Condition: Breast Cancer; Stereotactic Directional Vacuum-assisted Breast Biopsy; Female; Adult Patients
Study type: Observational

Summary: 
      Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy
      procedure for suspicious findings on mammograms in Western countries for more than 10 years
      [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike
      and was reported to feature a high sensitivity, very low delayed false-negative rate (less
      than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and
      less morbidity compared with needle localization excisional biopsy [6,7]. However, its
      sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian
      women have different breast parenchyma pattern, different breast cancer prevalence.
      Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving
      either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an
      effective alternative to NLOC excisional biopsy in our country.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        asymptomatic women with mammographic screening, and with suspicious findings on
        mammography.
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label extension study will permit patients with Systemic Juvenile Idiopathic
      Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab
      treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg
      s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or
      when study CACZ885G2402 is in place at their study center or around March 2013, whichever
      occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2
      mg/kg s.c. every 4 weeks.
    


Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention description(s): Canakinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Flare; arthritis; IL-1beta antagonist; systemic juvenile idiopathic arthritis; CHAQ; steroids; ACR pediatric response; Systemic juvenile idiopathic arthritis with active flare
Digital Voice Analysis in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      There is a differences in voice frequency of schizophrenic patients compared to patients with
      other mental diseases and compared to mentally healthy people.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Schizophrenic patients

          -  Other mental disease patients

          -  Healthy people
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the
      main method of correcting this deformity. Rods are attached to the spine to make it strait.
      There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle
      screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead
      placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the
      bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think
      screws correct scoliosis better than hooks. The current literature agrees that screws are
      better for deformity correction in the lumbar spine and patients with severe deformity. There
      is disagreement in the literature regarding which works better in the thoracic spine in less
      severe deformity. There are no randomized, controlled trials in the literature that examine
      whether constructs that use hooks in the thoracic spine and screws in the lumbar spine
      (called hybrid constructs) work as well as all-screw constructs. This clinical study is a
      randomized controlled trial being conducted to evaluate treatment outcomes in patients with
      scoliosis undergoing surgical correction for their curves using either all-screw or hybrid
      constructs as fixation devices. The study population is limited to those with less severe
      deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable
      as screws in terms of correction.
    


Intervention name(s): Pedicle screws; Laminar Hooks
Intervention type(s): Device; Device
Intervention description(s): Screws that are placed into the pedicle of vertebral body.; Hooks are placed over the lamina of the vertebral body
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized; controlled; hooks; screws
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Condition: Second-degree Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      The evidence is insufficient to determine whether the types of dressings containing silver
      differ in time / proportion for complete wound healing and pain. We will analyze the
      cost-effectiveness of these dressings in outpatients, considering the service provided by the
      Brazilian National Public Health System.
    

Detailed description: 
      Randomized, single-center, single-blinded, controlled clinical trial. Adult patients (age
      between 18 and 65 years), regardless of sex, with second degree burns treated in outpatient
      regimen will be randomized (1:1) into two groups: 1% silver sulfadiazine and nanocrystalline
      silver.

      Primary outcome:

      - Proportion of lesions completely epithelialized within 15 days.

      Secondary outcomes:

        -  Time in days for complete epithelialization of the burned areas;

        -  Number of dressing changes;

        -  Level of pain associated with the application and removal of the dressings;

        -  Direct medical and non-medical costs;

        -  Need for surgery;

        -  Incidence of infection;

        -  Presence of local adverse reactions.
    

Intervention name(s): Nanocrystalline silver; Silver Sulfadiazine
Intervention type(s): Drug; Drug
Intervention description(s): Flexible polyester low-grip coated nano-crystalline silver layer. The level of silver is 1.64 mg/ cm². This dressing enables the sustained release of silver in humid conditions dynamically and reached a higher plateau than 60 mg / L in less than 2 hours, and maintains a uniform level by 72 hours.; This is at Standard treatment. The cream silver sulphadiazine at 1% was applied on the burn aseptically in a thick layer, approximately 3 to 5 mm, ie 5 g per 80 cm2
Other intervention name(s): Acticoat; Silvazine
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: burns; dressings; silver sulfadiazine; silver compounds; cost
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the overall clinical comfort performance of
      enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.
    

Detailed description: 
      This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon
      A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in
      one eye and the control lens in the other eye.
    

Intervention name(s): enfilcon A; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): Test lens; Control lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Evaluating the Use of Two Different Needles in Subjects With Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare two needle types when
      used with a disposable insulin injection pen in the everyday life setting of an insulin
      treated patient with diabetes.
    


Intervention name(s): NovoFine® needle 6 mm; NovoFine® needle 8 mm
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Norovirus Bivalent-Vaccine Efficacy Study
Condition: Prevention From Norovirus Infection
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether the norovirus vaccine is effective in
      preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge
      dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the
      vaccine.
    


Intervention name(s): Norovirus Bivalent Vaccine; Saline Comparator
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses IM 28 days apart; 2 doses IM 28 days apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention