bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Evaluation of Posterior Direct Restoration in Adolescents
Condition: Composite Resins
Study type: Interventional

Summary: 
      The present study aims to evaluate the performance of direct restorations with bulk fill
      resins in molars with great structural loss, with endodontic treatment. The behavior of class
      II restorations in 68 molars endodontically treated with bulk fill resin and incremental
      technique will be evaluated by means of a randomized clinical trial with a two-year
      follow-up. This project aims to evaluate the performance of this new restorative strategy
      that can greatly contribute to restorations of posterior teeth.
    

Detailed description: 
      Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old,
      mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek
      Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill
      Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and
      24 months by two independent raters using modified United States Public Health Service
      criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman
      non-parametric tests, and Generalized Estimating Equation (GEE) analysis.
    

Intervention name(s): Direct composite resin
Intervention type(s): Procedure
Intervention description(s): For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used
GROUP ACTIVE COMPARATOR
Insert resin-modified glass ionomer cement into the pulp chamber;
Complete the restoration by incremental technique using conventional composite resin in increments of 2mm;
EXPERIMENTAL GROUP
Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm;
Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, single-dose, parallel group study will assess the pharmacokinetics and
      safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic
      hepatic impairment. Patients and healthy volunteers will receive a single oral dose of
      RO4917838.
    


Intervention name(s): RO4917838
Intervention type(s): Drug
Intervention description(s): single oral dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Condition: Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of
      intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine
      for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as
      effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating
      of renal colic.
    


Intervention name(s): Paracetamol+Morphine; Dexketoprofen plus Morphine; Placebo plus Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously; Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously; 100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
Other intervention name(s): Parol; Arveles; SF
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
Condition: Wound Healing
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan
      formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after
      endoscopic sinus surgery.
    


Intervention name(s): 5ml surgishield
Intervention type(s): Device
Intervention description(s): in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site
merocel in the inflated state maintained for 36~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Investigational device (chitosan gel); Wound healing; Endoscopic sinus surgery; SurgiShield
A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
Condition: Moderate to Severe Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, multicenter, randomized, double-blind, active-controlled and
      placebo-controlled study to evaluate the efficacy and safety of 50 units (U) of QM1114-DP for
      the treatment of moderate to severe GL in male and female subjects of Chinese origin. The
      study has been designed to test the superiority of QM1114-DP compared to placebo, and the
      non-inferior efficacy of QM1114-DP compared to onabotulinumtoxinA (BOTOX®), in improving the
      appearance of moderate to severe GL.
    


Intervention name(s): QM1114-DP; OnabotulinumtoxinA; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment phase:

      The purpose of this study is to evaluate the safety and the immune response elicited by a new
      anti-cancer therapy in patients with breast cancer in remission but who are at high risk of
      relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2
      protein combined with an immunostimulant called AS15. The study aims to determine the optimal
      of three different dose levels of dHER2 combined with the same fixed dose of AS15 by
      assessing the safety and the immune response elicited after a series of injections of the
      study product.

      Five-year follow-up phase:

      This part of the study aims to assess any late onset toxicity of the study treatment through
      yearly follow-up visits and to monitor the patients' survival and disease status up to five
      years after the last administration of the study treatment. The patients' immune response is
      also measured to assess the robustness of the immune response elicited by the study
      treatment.
    


Intervention name(s): Immunotherapeutic SB719125 (Primary)
Intervention type(s): Biological
Intervention description(s): Intramuscular injection
Other intervention name(s): dHER2 ASCI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dHER2-AS15 ASCI; Immunotherapeutic; Dose escalation; Breast cancer
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
Condition: Follicle Development; Ovarian Follicle; Follicle Count; Follicle Size; Oral Contraceptive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared
      to two 28-day oral contraceptive regimens containing different synthetic progestins on
      ovarian follicular activity and hormone levels in healthy women.
    


Intervention name(s): Desogestrel/ethinyl estradiol and ethinyl estradiol; 28-day drospirenone oral contraceptive; 28-day levonorgestrel oral contraceptive
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet; Drospirenone/ethinyl estradiol 0.3/0.02 mg; Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Desogestrel; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Alpha Lipoic Acid and Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening
      visit, their insulin resistance will be measured. Subjects will then be given either alpha
      lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be
      repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of
      alpha lipoic acid on insulin sensitivity.
    

Detailed description: 
      We propose to perform a placebo-controlled study of Alpha Lipoic Acid (LA) administration in
      a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of
      180 subjects will be initially estimated by measuring fasting glucose and insulin levels
      (homeostasis model assessment) and oral glucose tolerance test (OGTT). The 60 most insulin
      resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three
      times a day of LA or placebo. To quantitate the ALA-induced improvements, euglycemic
      hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to
      evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling
      pathways, will be performed before and after treatment. We believe these studies will (1)
      confirm the beneficial effect of CR-ALA on insulin sensitivity; (2) further our understanding
      of the molecular mechanisms of LA action; and (3) because these insulin resistant subjects
      are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary
      artery disease (CAD), a demonstration of the beneficial effects of LA on insulin action could
      ultimately have important public health consequences.
    

Intervention name(s): Alpha Lipoic Acid
Intervention type(s): Dietary Supplement
Intervention description(s): Two 400 mg tablets of Alpha Lipic Acid are taken 3 times daily
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Insulin resistance; healthy controls; anti oxidants
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
    

Detailed description: 
      Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to
      placebo in children aged 6-12 with ADHD
    

Intervention name(s): Methylphenidate Transdermal System
Intervention type(s): Drug
Intervention description(s): Placebo
Other intervention name(s): ADHD Patch
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Meditation Effects on Brain Function in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this study is to determine the neural mechanisms supporting meditation-based
      pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA
      patients' use of different meditation practices during noxious thermal stimulation will alter
      neural function in brain areas associated with pain, evaluation, and emotional appraisal. The
      investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20)
      or Intervention B (n=20). At post-intervention, participants will undergo functional MRI
      (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal
      stimulation to determine if the meditation practices differentially alter neural function
      during noxious thermal stimulation.
    


Intervention name(s): Meditation Intervention A; Meditation Intervention B
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.; This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction
Condition: Cholangiocarcinoma; Gallbladder Carcinoma; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Cholangiocarcinoma
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical effectiveness and long-term outcomes
      between patients with malignant hilar biliary obstruction who are treated by unilateral or
      bilateral stenting.
    

Detailed description: 
      Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused
      by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma.
      Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary
      stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.

      Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some
      researchers recommended unilateral stenting for malignant hilar biliary obstruction because
      drainage of 25% of entire liver can achieve the clinical success of biliary drainage.
      However, some researchers recommended bilateral stenting for malignant hilar biliary
      obstruction because some researches demonstrated that bilateral stenting can achieve a longer
      stent patency.In addition, there was no significant difference in post stenting survival
      between patients who were treated by unilateral or bilateral stenting. Therefore, it remains
      under debate whether unilateral or bilateral stenting is better in the treatment of malignant
      hilar biliary obstruction.

      The purpose of this study is to compare the clinical effectiveness and long-term outcomes
      between patients with malignant hilar biliary obstruction who are treated by unilateral or
      bilateral stenting.
    

Intervention name(s): biliary stent
Intervention type(s): Device
Intervention description(s): Self-expandable biliary nitinol alloys stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients
      with essential hypertension. (Trial is not recruiting in the US)
    


Intervention name(s): SPP100
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; angiotensin; renin; aliskiren
Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      Shoulder impingement has been identified as the most common cause of shoulder pain in the
      adult general population. Sometimes therapeutic pushing on the middle part of the back
      (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do
      not known what causes the decreased shoulder pain. It could be that the therapeutic pushing
      makes things move better. It may be that the person getting their back treatment thinks they
      are better or the physical therapist who provides the manual treatment thinks it works.
    

Detailed description: 
      Shoulder impingement has been identified as the most common cause of shoulder pain in the
      adult general population. High-Velocity, Low-Amplitude Thrust Manipulations (HVLATM) of the
      thoracic spine and ribs result in increased shoulder ROM, as well as decreased pain and
      disability in patients suffering shoulder impingement. The quality of the sparse publications
      is low and lacking control or comparison groups regarding the use of HVLATM in the management
      of shoulder impingement. Further higher quality randomized clinical trials are needed.
      Moreover, no research has investigated the effects of the patients beliefs and different
      types of verbal messages conveyed by the clinician to the subjects in regard to the effects
      of HVLATM of the thoracic spine on shoulder pain and function. The purpose of this study is
      to evaluate, in subjects with signs and symptoms of shoulder impingement: (1) the effects of
      a series of the prone thoracic spine High Velocity Low Amplitude Thrust Manipulation (HVLATM)
      as compared to the HVLATM directed at the scapula, on shoulder pain, impingement symptoms,
      and functional outcomes; (2) the effect of the type of message and language used by the
      clinician in regard to thoracic HVLATM on shoulder pain, impingement symptoms, and functional
      outcomes; (3) the effect of subject's expectation of outcome of thoracic and scapula HVLATM
      on shoulder pain, impingement symptoms, and functional outcomes; (4) if these potential
      immediate improvements will be sustained at 6 to 9-day follow up.
    

Intervention name(s): Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM); Scapular High Velocity, Low Amplitude Thrust Maneuver
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Quetiapine in Melancholic Depression
Condition: Depression; Healthy
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      In summary, the investigators propose to integrate fMRI assessments within a clinical trial
      of quetiapine XR in patients with melancholic depression in order to test the predictions
      that:

        1. quetiapine XR treatment will be effective and safe for patients with major depression
           with melancholic features

        2. successful treatment with quetiapine XR will be associated with normalization of limbic
           areas associated with increased salivary cortisol response to a stressful task as well
           as normalization on the emotional faces task differences in the melancholic group
           compared with healthy volunteers.

        3. successful treatment with quetiapine XR will be associated with normalization of the
           salivary cortisol response to the stressful math task (i.e. there will be a diminished
           post-treatment mean AUC for cortisol secretion after the stress task compared to the
           pre-treatment AUC values in the patient group)
    

Detailed description: 
      Patients with major depression (N=20) will be recruited for the 8-week clinical trial of
      quetiapine XR 100 - 300 mg (flexible dosing). Patients who consent to participate will be
      referred for an initial fMRI scanning session prior to the initiation of quetiapine XR.
      Baseline fMRI will be obtained during the index assessment prior to initiating quetiapine XR
      therapy and then will be re-acquired at the final study visit at 8 weeks (the time of
      scheduled visits). Ten demographically matched healthy subjects will receive the same fMRI
      investigations on two occasions in order to provide a healthy baseline comparison to permit
      interpretation of the patient findings (e.g., whether initial and final fMRI measures in
      patients are abnormal and to control for any adaptation to the task that may normally occur).
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): quetiapine XR 100 - 300 mg (flexible dosing)
Other intervention name(s): Open Label Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; healthy
Effects of Diet Interventions on Monocytes in Metabolic Syndrome
Condition: Metabolic Syndrome; Hypertriglyceridemia
MeSH terms: Metabolic Syndrome; Hypertriglyceridemia; Syndrome
Study type: Interventional

Summary: 
      Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive
      diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4
      days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to
      examine lipid levels and circulating monocyte phenotypes.
    

Detailed description: 
      Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive
      diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4
      days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting
      state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid
      levels and circulating monocyte phenotypes.
    

Intervention name(s): diet
Intervention type(s): Other
Intervention description(s): The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, in the same individuals with randomized crossover design.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science