bioihbjkbjnl/mcl2 huggingface dataset:
Autonomic Modulation Recovery After Acute Resistance Exercise
Condition: Resistance Training
Study type: Interventional

Summary: 
      To analyze the autonomic behavior in recovery post-acute resistance exercise performed in
      different intensities and body segments.
    

Detailed description: 
      Resistance training (RT) is recommended to people with different health condition. RT is
      recognized as safe and effective method of increasing muscle strength, physical fitness,
      muscle mass, and overall cardiovascular health. The magnitude of the RT effects is associated
      with the structure of the training program. Understanding these aspects may provide guidance
      for the RT prescription while reducing potential risk of cardiovascular events associated
      with the recovery period after exercise. The objective of the study is to compare the acute
      responses of the Autonomic Nervous System post RT performed with different intensities
      (endurance and strength) in different body segments (UL and LL). Our hypothesis is that
      different intensities and body segments influence the acute responses of the ANS in the post
      RT recovery period.
    

Intervention name(s): Resistance Training - UL endurance protocol; Resistance Training - UL strength protocol; Resistance Training - LL endurance protocol; Resistance Training - LL strength protocol
Intervention type(s): Other; Other; Other; Other
Intervention description(s): UL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).; UL strength protocol - 2 series of 8 repetitions, elbow flexion at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).; LL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test strength of 1 maximum repetition, (recovery 1 minutes between sets).; LL strength protocol - 2 series of 8 repetitions, knee extension at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a cross-over clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistance training; autonomic modulation; heart rate; exercise
Observational Study of Correlation Between Recurrent Basal Cell Carcinoma and Localisation
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Observational

Summary: 
      .During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier
      University Hospital Anatomopathology unit were included in this study. Localisation and
      histological characteristics were collected. All the recurrences of BCC were searched from
      the medical records (or histopathology request form).

      From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with
      recurrent BCC were contacted to obtain agreement and more informations about the first
      resection and some clinical informations like sun exposure and phototype.

      The statistical analysis focused on the localisation of recurrent BCC (with a complete first
      resection) compared to localisations of primary BCC in this population. The goal was to
      identified localisations with an increased risk of recurrences.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort :

        All the resected BCC during one year in Montpellier University Hospital and Millau Hospital
        (both analyzed in anatomopathology unit in Montpellier University Hospital).

        Cases :

        All the cases of recurrent BCC, found after research in medical records or histopathology
        request form.
      
Keywords: Resection of BCC (Basal Cell Carcinoma); Recurrence of BCC (Basal Cell Carcinoma); Localisation
In Vitro Detection of Tissue Abnormality
Condition: Breast Cancer Female
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to
      image the excised tissue surgical margins. The study is designed to demonstrate reduction in
      the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an
      adjunct imaging device to the standard of care.
    

Detailed description: 
      Intraoperative real-time margin assessment of breast conserving surgeries can reduce the need
      for repeat operations due to cancer involved margins. Repeat operations result in excessive
      removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic
      results. In the current standard of care, the status of the margins is determined by
      pathology only several days after surgery. An intraoperative assessment of the margins
      enables complete tumor excision in a single surgery.

      The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge
      imaging device to the Standard of Care (SoC) of margins assessment in breast conserving
      surgeries. The study will assess whether there is an improvement in the detection of cancer
      involved margins by measuring whether removal at the time of primary surgical treatment can
      reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

      ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used
      in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons
      successfully used the device to identify cancer involved margins and that it can reduce the
      need for repeat surgeries by meeting the margins depth criteria to require repeat operations.
      European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was
      clinically evaluated by several hospitals.
    

Intervention name(s): Testing a new device (LS BioPath TOUCH) on excised tissue
Intervention type(s): Device
Intervention description(s): Measurements are obtained with test device on excised tissue.
Intervention model: Single Group Assignment
Intervention model description: 2 phase study: Phase 1 - Validation of safety and accuracy when used ex-vivo to image excised breast surgery specimens Phase 2 - To guide surgeon's decision to re-excise additional margins during primary operation
Masking: None (Open Label)
Primary purpose: Treatment
Dysport in Post-Surgical Neuralgia
Condition: Chronic Scar Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to determine whether a currently licensed version of botulinum toxin
      (Dysport®) is effective for the treatment of pain that has developed and/or persisted for
      months or years around the scar of a previous surgical site, and whether this condition could
      be suitable for the testing of similar new medicines. The study will compare three different
      doses of Dysport® to see if there is benefit and/or a best dose for treating persistent
      post-surgery scar pain.
    


Intervention name(s): Lidocaine; Botulinum toxin type A; Placebo; Placebo
Intervention type(s): Drug; Biological; Drug; Drug
Intervention description(s): 0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points).; 0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).; Part A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points).; Part B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum).
Other intervention name(s): AbobotulinumtoxinA (Dysport®); Saline solution
Intervention MeSH terms: Lidocaine; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in
      24-week treatment in patients with remission status after Abilify with Depakote in the 6-week
      study of acute mania in patients with bipolar disorder
    

Detailed description: 
      Further study details as provided by Korea OIAA
    

Intervention name(s): Abilify(aripiprazole); Depakote (divalproate)
Intervention type(s): Drug; Drug
Intervention description(s): Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder; Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
Intervention MeSH terms: Valproic Acid; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer
Condition: Dendritic Cells; Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed
      dendritic cell Immunotherapy for the patients with pancreatic cancer
    

Detailed description: 
      The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients
      with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard
      protocol.

      Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with
      unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

      The dendritic cells are them matured and injected subcutaneous (all patients) and
      intratumorally (when possible).
    

Intervention name(s): Dendritic cells pulsed with tumor lysate; Dendritic cells pulsed with MUC-1/WT-1 peptides
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dendritic cells, pancreatic cancer, immunotherapy
Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine
Condition: Renal Insufficiency; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency
      on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to
      establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired
      patients
    


Intervention name(s): Nevirapine
Intervention type(s): Drug
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Longitudinal Use of Protective Behavioral Strategies
Condition: Alcohol Use, Unspecified
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study tested a deviance regulation theory intervention in a sample of university
      freshman. The aims were to (a) increase use of protective behavioral strategies, (b) decrease
      alcohol use, and (c) decrease alcohol-related consequences.
    

Detailed description: 
      College student freshmen were invited to participate in a study on the use of alcohol
      protective behavioral strategies. They were randomly assigned to receive a positive message
      about individuals that used protective strategies, a negative message about individuals that
      did not use protective strategies, or an assessment control. They were then followed for the
      next 12 months. Assessments were completed at weeks 0, 1, 2, 3, 4, 5, 12, 26, and 52.
    

Intervention name(s): Deviance Regulation Theory
Intervention type(s): Behavioral
Intervention description(s): In the negative message condition, participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. In the positive message condition, participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to 1 of 3 parallel conditions. After assignment, they received a brief intervention and were then followed for the next 12 months.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Deviance Regulation Theory; Alcohol Use; Alcohol Consequences; Protective Behavioral Strategies; College Freshman
Preoperative Ionized Magnesium Assessment
Condition: Magnesium Deficiency
MeSH terms: Magnesium Deficiency
Study type: Observational

Summary: 
      The reported incidence of hypomagnesemia is approximately 2% in the general population.
      Hypomagnesemia is a common problem, occurring in nearly 10%of general hospitalized patients
      and 17% of hospitalized cancer patients. A higher incidence, up to 60% to 65%, has been found
      among intensive care unit patients. Hypomagnesemia can potentially cause fatal complications
      including ventricular arrhythmia, coronary artery spasm, and sudden death. It also associates
      with increased mortality and prolonged hospitalization.

      Magnesium exists in three different forms in the body. In serum, 5-14% of the magnesium is
      reported to be complexed with anions such as phosphate, bicarbonate, and citrate, 19-33% is
      reported to be protein-bound (mainly to albumin), and 55-67% is found in the free ionized
      fraction. Because the amount of bound or complexed Mg can vary significantly, especially in
      illness, the ionized magnesium can vary in an unpredictable way. Conventional laboratory
      testing typically only measures total serum magnesium, which is often not reflective of
      ionized magnesium. Unlike ionized calcium, which is commonly measured and is also readily
      calculated from the total calcium and albumin levels, ionized magnesium is neither commonly
      measured nor easily calculated. One study reported that the level of ionized magnesium cannot
      be predicted by analysis of total magnesium and that the levels of ionized magnesium vary
      upon different pathophysiological conditions and between individuals. Furthermore,
      measurement of ionized magnesium in serum might be of great impact in patients for whom
      magnesium status is required, and the correlation of ionized magnesium and total magnesium is
      weak in patients for whom magnesium status is required as a whole, and this is the reason why
      the ionized magnesium should be measured directly.

      To date, most of the clinical studies were evaluate the effect of hypomagnesemia on the
      outcome after surgery using the levels of total serum magnesium. However, the portion of
      extracellular magnesium that is physiologically active is in the various process is ionized
      magnesium. So, it is important to evaluate the level of ionized magnesium in surgical
      patients to predict the outcomes after surgery. Unfortunately, clinical trial regarding the
      effect of the concentrations of ionized magnesium on the surgical patients is limited.
    


Intervention name(s): Ionized magnesium
Intervention type(s): Diagnostic Test
Intervention description(s): Assessment of ionized magnesium level
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10
      mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg
      alone when administered to Japanese participants with hypercholesterolemia. The primary
      hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior
      to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is
      superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein
      cholesterol (LDL-C) after 12 weeks of treatment.
    


Intervention name(s): Ezetimibe 10 mg; Atorvastatin 10 mg; Placebo for Ezetimibe 10 mg tablet; Placebo for Atorvastatin 10 mg capsule; Diet control/Daily Exercise
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral
Intervention description(s): Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Curcumin Bioavailability
Condition: Safety After Oral Intake; Pharmacokinetics After Oral Intake
Study type: Interventional

Summary: 
      The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the
      rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based
      on its natural low bioavailability and the number of its effects on human health, several
      approaches such as increasing its water solubility or inhibiting its metabolism were taken to
      improve its bioavailability. Pharmacokinetics of curcumin from various supplements using
      those different mechanisms have been compared to the one of native curcumin. The
      investigator's study here will compare the bioavailability of curcumin from eight different
      curcumin formulations with native curcumin and between themselves. The study will folllow a
      single dose (in form of curcumin formulations, normalized to 207 mg curcumin),
      placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week
      washout periods. Plasma samples will be collected at intervals up to 24 hours after intake.
      Investigators will compare the pharmacokinetics between the different curcumin formulations
      and to native curcumin.
    


Intervention name(s): Native turmeric extract; Native turmeric extract with 7-9% volatile turmeric oils; Turmeric extract plus mixture of phytochemicals; Cyclodextrin complex of curcuminoids; Turmeric oleoresin; Liposomal curcumin; Phytosomal curcumin; Micellar turmeric extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 207 mg curcumin; 207 mg curcumin; 207 mg curcumin; 207 mg curcumin; 207 mg curcumin; 207 mg curcumin; 207 mg curcumin; 207 mg curcumin
Intervention MeSH terms: Curcumin; Turmeric extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; Curcumin; Demethoxycurcumin; Bisdemethoxycurcumin
School-Based Treatment for Early Childhood Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This pilot will be used for academic research, in hopes of developing effective treatments
      for early childhood anxiety. The intervention is an adaptation of Parent-Child Interaction
      Therapy (PCIT). PCIT is an evidence-based intervention, rooted in attachment and social
      learning theory. In recent years, researchers have successfully adapted PCIT to address
      anxiety in a clinical setting (PCIT-CALM). In this pilot study, we will be applying the
      PCIT-CALM intervention in the school setting, emphasizing teachers as a therapeutic agent of
      change.

      PCIT is unique because the child's caregiver is trained on how to use therapeutic techniques,
      and then receives live coaching via a "bug in the ear" as they learn to implement the new
      skills. In this pilot study, both parents and teachers will be taught skills to create a
      therapeutic relationship and address anxiety. After these teaching sessions, the child's
      teacher will receive coaching in the classroom to implement the skills. The intervention will
      last approximately 12 weeks.
    


Intervention name(s): TCIT-CALM (Teacher-Child Interaction Training-CALM)
Intervention type(s): Behavioral
Intervention description(s): This intervention is designed to treat early childhood anxiety. It is an adaptation of parent-child interaction therapy (PCIT), in which teachers rather than parents are targeted as the therapeutic agent of change. The intervention follows the procedures of the CALM protocol, in which caregivers are taught play therapy skills to support and address anxious behaviors and avoidance.
Intervention model: Single Group Assignment
Intervention model description: This is a pilot study in which all individuals will be enrolled in the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parent-Child Interaction Therapy (PCIT); CALM Protocol; Teacher-Child Interaction Training (TCIT)
Cognitive, Emotional and Behavioural Impairments in Patients After Sars-Cov2 Infection
Condition: COVID-19; Sars-CoV-2 Infection
MeSH terms: Infections; COVID-19
Study type: Observational

Summary: 
      Recent studies suggest cognitive, emotional and behavioural impairments occur in patients
      after SARS-CoV-2 infection. Problems with memory, attention, information processing and
      executive functions are particularly prevalent in these patients, probably due to
      hypothesised sensitivity of the hippocampus to the virus. Cognitive impairment is also
      present in patients with no neurological, neuropsychological and neuropsychiatric history.
      Therefore, the aim of the present study is to describe neuropsychological and
      neuropsychiatric features in patients recovered from moderate to severe forms of Covid-19
      some weeks after hospital dismission.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who were hospitalized in the Covid ward and recovered from the acute phase of
        Covid-19 with no need of ICU admission. All patients had SARS-Cov-2 infection confirmed by
        positive PCR from nasopharyngeal swab. Neuropsychological study was performed on average 20
        days after hospital discharge to have the most recent possible cognitive profile related to
        the infection. We enrolled 29 healthy controls (Covid-) who did not have SARS COV 2
        infections with a 1:1 match by age, education and gender.
      
Keywords: Covid-19; Cognition; Teleneuropsychology; Memory; Executive Functions