bioihbjkbjnl/mcl2 huggingface dataset:
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      Results from previous studies suggest the association between Osteopathic Manipulative
      Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.

      The primary objective of the present study is to evaluate the effectiveness of sham OMT in
      reducing LOS in a sample of preterm newborns, in order to investigate whether previous
      clinical results could be related to a hypothetical placebo effect.
    


Intervention name(s): Sham Osteopathic Manipulative Treatment; Standard care
Intervention type(s): Other; Other
Intervention description(s): Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.; Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to test clinical strategies that pediatric providers may use to
      prevent misuse and diversion of stimulants by their adolescent patients with ADHD.
    

Detailed description: 
      This study addresses the increase in diversion (selling, sharing, loaning, or trading) of
      prescription stimulant medications by adolescents with Attention-Deficit/Hyperactivity
      Disorder (ADHD). In the absence of any standardized, empirically evaluated clinical
      strategies or interventions to prevent or decrease stimulant diversion, this project will
      test the effect of a brief provider-led intervention for stimulant diversion prevention among
      adolescents being prescribed stimulant medication in pediatric care. The investigators
      hypothesize that adolescents treated in pediatric practices randomized to the intervention
      will report decreased diversion, increased perceived risk of harm, and decreased intentions
      to divert compared to adolescents treated in pediatric practices randomized to
      treatment-as-usual. Secondary analyses will examine the effect of the intervention on
      additional contributing variables (e.g., patient, parent, and provider attitude and behavior
      change).
    

Intervention name(s): Stimulant Diversion Prevention (SDP)
Intervention type(s): Behavioral
Intervention description(s): provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
Intervention MeSH terms: Central Nervous System Stimulants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: ADHD; Stimulant Misuse; Stimulant Diversion
Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens
Condition: Refractive Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This study will serve to evaluate and compare the performance of two new lenses to a marketed
      lens.
    


Intervention name(s): etafilcon A control lens (1DM); etafilcon A with print and PVP for light eyes (EALE); etafilcon A with print and PVP for dark eyes (EADE)
Intervention type(s): Device; Device; Device
Intervention description(s): A marketed daily disposable contact lens; A daily disposable contact lens; A daily disposable contact lens
Other intervention name(s): 1-DAY ACUVUE MOIST Brand Contact Lenses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Local Ketamine Instillation for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into
      the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration
      (I.M. injection of the same dose) with respect to postoperative VAS, first request of
      analgesia, total opioid consumption, and with respect to possible side effects.
    


Intervention name(s): intra-wound instillation of ketamine; intra-wound instillation of normal saline; systemic administration of ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure; intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure; intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.
Other intervention name(s): placebo
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postoperative analgesia; ketamine; total thyroidectomy
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy
Condition: Gait Disorder, Sensorimotor; Diabetes Mellitus, Type 2
MeSH terms: Gait Disorders, Neurologic; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      This study planned to investigate the role of potential explanatory factors effecting the
      speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive
      function, blood pressure, and metabolic measures considering age, sex, and education years in
      diabetic individuals without neuropathy.
    

Detailed description: 
      Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4
      questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below
      4 will be considered for the study.Then aerobic capacity will be measured by a cycle
      ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be
      measured by bioimpedance analysis. Physical activity status will be determined by
      International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini
      Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight
      fasting. Blood pressure will be measured in the sitting position after resting from the left
      arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned
      factors on speed of gait will be studied.
    

Intervention name(s): measurement of gait speed
Intervention type(s): Other
Intervention description(s): Cross sectional, cohort
Other intervention name(s): measurement of aerobic capacity; measurement of muscle mass; measurement of blood glucose and HbA1c; cognitive function testing; physical activity questioning; blood pressure measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type 2 Diabetic individuals without neuropathy
      
Keywords: Mini-Mental State Examination; gait; aerobic capacity; HbA1c; muscle; hypertension; glucose
Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Condition: Cesarean Section
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The purpose of this study was to investigate the incidence of hypotension after spinal
      anesthesia in patients undergoing cesarean section as predicted by preoperative carotid
      artery corrected flow time measured by Doppler ultrasound. Before entering the operation
      room, Two inspectors perform two measurements of carotid artery corrected blood flow time
      respectively, and an average of the four measurements is calculated and analyzed. At this
      time, the patient's posture is supine, and the head is turned about 30 degrees to the left.
      Corrected blood flow time (FTc) is measured using carotid ultrasound as previously described
      by Blehar and colleagues. Corrected blood flow time is calculated by Bazett's formular and
      Wodey's formular by evaluating a single cycle after several successive cycles have reached a
      stable and acceptable quality level.

      The occurrence of hypotension is recorded from the spinal anesthetic injection until the
      fetus is delivered.

      The definition of hypotension after spinal anesthesia is that the systolic blood pressure
      drops to 80 mmHg, less than 75% of the baseline value, or even if it does not meet the former
      criteria, symptoms that are consistent with hypotension (dizziness, dizziness, dyspnea,
      nausea or vomiting).
    


Intervention name(s): Doppler sonographic measurement
Intervention type(s): Diagnostic Test
Intervention description(s): First, place a 4.5-12.0 MHz linear array transducer vertically on the neck with the probe marker facing the patient's head. A long axis B-mode image of the right common carotid artery is obtained at the lower border of the thyroid cartilage. The sample volume is then placed in the center of the lumen located approximately 2 cm proximal to the carotid bifurcation. Next, pulsed wave Doppler tracing is performed in the arterial blood flow. The cycle time using the calliper function in an ultrasonic machine is obtained by measuring the interval between heartbeats at the beginning of the Doppler blood flow upstroke and the Flow time is measured as the time from the beginning of the systolic upstroke to the dicrotic notch.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Uncomplicated singleton full-term parturients undergoing cesarean delivery
Dose-Dependent Effects of Erythritol on Endothelial Function in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is an open-label pilot designed to examine the dose-dependent effects of
      erythritol, a zero calorie sweetener, on endothelial function. Twenty-four subjects with type
      2 diabetes mellitus will make three study visits. At each visit, the will consume an
      orange-flavored beverage containing escalating amounts of erythritol (6, 12, and 18 grams).
      Endothelial function will be assessed before and two hours after beverage consumption.
      Endothelial function will be measured as the change in pulse amplitude in response to
      reactive hyperemia measured in the fingertip by peripheral arterial tonometry. The results
      will be used to plan a randomized, placebo-controlled study.
    


Intervention name(s): Erythritol
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Erythritol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Erythritol; Endothelial function
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
Condition: Scarring
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and local tolerability of two different
      concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a
      day for 21 days to artificially induced dermal wounds in healthy volunteers. In addition, the
      absorption and elimination of profiles of this topically applied product will be determined
      through pharmacokinetic sampling. Assessments for effect of SCX-001 vs. placebo will be done
      but are considered exploratory.
    


Intervention name(s): SCX-001; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nefopam cream formulation; Cream formulation without Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scar; nefopam; cicatrix
Investigation of the Simplify® Cervical Artificial Disc
Condition: Cervical Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study is intended to demonstrate that the Simplify® Disc is at least as safe and
      effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat
      one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as
      intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain
      or myelopathy due to a single-level abnormality localized to the level of the disc space in
      subjects who are unresponsive to conservative management.
    

Detailed description: 
      The objective of this clinical study is to evaluate the safety and effectiveness of the
      Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the
      disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm
      pain and/or a neurological deficit) with or without neck pain or myelopathy due to a
      single-level abnormality localized to the level of the disc space that is unresponsive to
      conservative management.
    

Intervention name(s): Simplify Disc; Anterior Cervical Discectomy & Fusion
Intervention type(s): Device; Device
Intervention description(s): Simplify Disc at one level in the cervical spine.; This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial.
Other intervention name(s): ACDF
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Open-label Placebo to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Placebo pills (pills with no active ingredients) have been shown in research studies to
      somehow produce self-healing processes. The purpose of this study is to determine whether
      people will be willing to enter an open-label non-deceptive placebo treatment for Major
      Depressive Disorder (MDD) and whether open-label placebo can be effective for treating MDD in
      the context of a supportive physician-patient relationship.
    


Intervention name(s): Open-label Placebo
Intervention type(s): Other
Intervention description(s): Participants take open-label placebo pills - two twice daily for four weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: depression; placebo effect; complementary therapies; alternative therapies
Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4
      years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active
      polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab solution for injection for subcutaneous use.
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: juvenile idiopathic arthritis; compassionate use; open label
Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This trial was an obsevational phase IV prospective multicenter study designed to evaluate
      the safety and effectiveness of Cinnomer® in patients with MS in Iran.

      The primary objective of this study was safety assessment of Cinnomer®

      Secondary objectives were:

        -  Effectiveness assessment of Cinnomer®

        -  Assessment of the patients' QoL

        -  Evaluation of the patients' depression status
    

Detailed description: 
      This trial was an observational phase IV prospective multicenter study designed to evaluate
      the safety and effectiveness of Cinnomer® in patients with MS in Iran.

      The primary objective of this study was safety evaluation. To evaluate the safety of
      Cinnomer®, at each visit, the AEs, seriousness of observed AEs, and abnormal laboratory
      findings were recorded.

      To evaluate the effectiveness of Cinnomer® as the secondary objective, the indicative
      parameters of MS activity, including relapse information, MRI findings, and EDSS scores were
      considered. Also, questionnaires assessing the patients' QoL and depression were evaluated.

      The sample size of 368 patients and the 14 months of the study was considered applicable for
      safety and effectiveness evaluation of Cinnomer®, 40 mg/ml, three times per week, in patients
      with relapsing forms of MS.
    

Intervention name(s): Glatiramer Acetate
Intervention type(s): Drug
Intervention description(s): Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.
Other intervention name(s): Cinnomer®
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing forms of MS
      
Keywords: Glatiramer Acetate; Multiple Sclerosis; Quality of Life; Cinnomer; Annualized Relapse Rate; Safety; Relapsing
Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
Condition: Outcome Assessments (Health Care); Comprehension; Language
Study type: Interventional

Summary: 
      Prior to the completion of biomedical research, any person undergoing it must receive a
      readable and intelligible information about this research, in order to give free and informed
      consent. The willingness to inform patients of all risks and constraints related to research
      may be in contradiction with the need to write informative and concise documents that are
      understandable to research participants. As a result, consent forms are long, contain a lot
      of information and are complicated to understand.

      The objective of this study is to evaluate the impact of the readability of the information
      and consent forms on the understanding of the information received by participants in
      clinical trials.
    


Intervention name(s): Questionnaire of understanding
Intervention type(s): Other
Intervention description(s): The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent.
Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Outcome Assessments (Health Care); Volunteers; Informed consent; Comprehension; Language tests
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
Condition: PK of FG-4592; Hepatic Insufficiency; Healthy Subjects
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of moderately diminished liver function on the exposure, safety and tolerability
      of a single dose of FG-4592 is studied in male and female subjects. The results are compared
      to the data gained from subjects with normal liver function.
    

Detailed description: 
      The effect of moderate hepatic impairment on the pharmacokinetics (PK), safety and
      tolerability of a single dose of FG-4592 in male and female subjects is investigated. Data
      obtained from these subjects are compared to data from BMI-, age- and sex-matched subjects
      with normal hepatic function. Both groups consist of 8 subjects.

      Screening takes place from Days -22 to -2 before admission to the clinical unit on Day -1.
      Administration of the trial medication takes place on Day 1 under fasted conditions. Healthy
      subjects are discharged on Day 5 and subjects with moderate hepatic impairment on Day 7, if
      there is no reason to extend the stay. An end-of-study visit (ESV) takes place 5 to 9 days
      after (early) discharge.

      Safety assessments are performed throughout the study.
    

Intervention name(s): FG-4592
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ASP1517,; roxadustat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; FG-4592; Single dose; Moderate hepatic impairment
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study is to rule out a harmful effect of zinc supplementation in
      HIV-1-infected children. The null hypothesis is that zinc supplementation will increase
      plasma HIV RNA levels.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was
      conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected
      children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo
      daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of
      CD4+ T-lymphocytes were established at two study visits prior to randomization, and
      measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1
      viral load and the percentage of CD4+ T-lymphocytes were compared before and after
      supplementation.
    

Intervention name(s): zinc supplementation
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: zinc; HIV; children