bioihbjkbjnl/mcl2 huggingface dataset:
Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress
Condition: Anxiety; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy
      intervention delivered using a smartphone application for reducing anxiety and stress within
      college students.
    

Detailed description: 
      The objective of this project is to understand the potential effectiveness of a 4 week
      Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for
      reducing anxiety and stress within college students. Although in-person mindfulness-based
      cognitive therapy approaches have been found effective for reducing anxiety and stress; given
      the pervasiveness of anxiety and stress in this population, there is a need to provide
      alternative and accessible interventions to improve students' mental health. One such
      approach may be by leveraging existing tools such Sanvello - a free mindfulness-based
      cognitive therapy smartphone application - which could more easily be deployed across a
      broader population. Accordingly, using a cluster-randomized controlled design, this
      intervention will assess the extent to which 4-weeks of using the Sanvello application was
      effective for reducing anxiety and stress within college students.
    

Intervention name(s): Mindfulness Practice
Intervention type(s): Behavioral
Intervention description(s): Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness-Based Cognitive Therapy
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of Brivaracetam to support the submission
      file in the indication of adjunctive treatment in adolescents and adults with partial onset
      seizures.
    


Intervention name(s): Placebo; Brivaracetam; Brivaracetam; Brivaracetam
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures
Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453
Condition: Hypertension; Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single
      oral doses
    

Detailed description: 
      Single centre, randomised, double-blind, placebo-controlled study of single ascending doses
      in 10 sequential groups of 8 healthy young male volunteers. Within each group (n=8), 6
      volunteers were randomised to receive BIA 5-453 and the remaining 2 volunteers were
      randomised to receive placebo. A volunteer participated only in a single period.
    

Intervention name(s): BIA 5-453; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIA 5-453 Gelatine capsule for oral administration (1, 10 or 20 mg). Single oral doses of BIA 4-543 2 mg, 10 mg, 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg were administered to subjects in fasting conditions.; Placebo Gelatine capsule for oral administration. The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient (API).
Other intervention name(s): Etamicastat; Placebo Gelatine capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia?
Condition: Pre-Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to test the hypothesis that a short course of atorvastatin can
      improve vascular function in women with a history of preeclampsia, compared to placebo.
    

Detailed description: 
      Women with a history of preeclampsia (high blood pressure/protein in the urine during
      pregnancy) are at increased risk of developing high blood pressure and heart problems in the
      10-15 years after their baby is born. At present we do not know how to reduce this risk.
      Lowering blood pressure and blood lipid (fats) levels are common strategies for primary
      prevention of cardiovascular problems. However, most women with a history of preeclampsia in
      the 5-10 years after pregnancy, will have normal blood pressure readings, blood sugar and
      cholesterol levels.

      Atorvastatin, a type of "statin", is widely used in lowering lipids and preventing
      cardiovascular disease. This drug has beneficial actions other than lipid-lowering, that may
      also help prevent cardiovascular problems, including improving function in the lining of
      blood vessels. We know that impairment in blood vessel function is evident in women in the
      years after a preeclamptic pregnancy and may contribute to the risk of women after
      preeclampsia going on to develop cardiovascular disease.

      We would like to know if giving a short course of atorvastatin to women with a history of
      preeclampsia improves their blood vessel function. To do this, ex-preeclamptic women will be
      invited to take either a atorvastatin or placebo ("dummy") tablet daily for 4 weeks, then no
      tablets for 4 weeks, then "crossover" to receive the alternative tablet (placebo or
      atorvastatin) daily for 4 weeks. Blood vessel function would be measured using specialised
      noninvasive scans and taking a blood test at the beginning and end of each treatment period.
      The study will be jointly run by the Departments of Cardiovascular Medicine and Obstetrics &
      Gynaecology at the John Radcliffe Hospital, Oxford.

      We anticipate this study will provide valuable data to support larger clinical trials to
      determine whether improving blood vessel function ultimately reduces the risk of developing
      early-onset cardiovascular disease after preeclampsia.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 4 week treatment, 20mg/day taken orally in tablet form
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: endothelial function; cardiovascular
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with
      levodopa in the treatment of patients with RLS.
    


Intervention name(s): cabergoline; levodopa
Intervention type(s): Drug; Drug
Intervention description(s): Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events; Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
Intervention MeSH terms: Levodopa; Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Insulin- and Glucose Metabolism in Pulmonary Arterial Hypertension
Condition: Insulin Resistance
MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Insulin Resistance
Study type: Observational

Summary: 
      Insulin resistance is a key mechanism in metabolic disorders, which has also been implicated
      in the development of pulmonary hypertension. In this pilot study, the investigators´ goal is
      to directly determine insulin sensitivity in idiopathic pulmonary arterial hypertension
      patients and to compare the results with data from healthy controls.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls, or patients with idiopathic or hereditary pulmonary hypertension
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
Condition: RSV Infection; Bronchiolitis
MeSH terms: Infections; Bronchiolitis; Respiratory Syncytial Virus Infections
Study type: Observational

Summary: 
      The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway
      inflammation. Some research experiments have demonstrated stimulation of nitric oxide
      production in respiratory epithelial cells infected with RSV.

      The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is
      elevated in hospitalized pediatric patients with viral lower respiratory illness and to
      determine if there is a difference in feNO level between RSV and non-RSV infection.

      NO may play a role in the association between RSV, airway reactivity, and airway
      inflammation.

      This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years
      of age admitted to Winthrop University Hospital, as well as controls (children in the same
      age range without respiratory conditions and who are well enough to perform the test).
      Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) & DFA) and via direct
      fluorescent antigen technique (DFA) for influenza A & B, parainfluenza, human metapneumovirus
      and adenovirus.

      Method of feNO measurement will utilize the offline options for preschool children & infants
      appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society
      & the European Respiratory Society when discussing tidal breathing techniques with
      uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask
      connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert
      reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an
      NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.

      The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.
    


Intervention name(s): Collection of exhaled breath
Intervention type(s): Other
Intervention description(s): balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The parents of children admitted to WUH with a diagnosis of lower respiratory tract viral
        illness (LRTVI) will be offered the opportunity to participate
Safety Study of ORG 34517 for Major Depression With Psychotic Features
Condition: Major Depressive Disorder; Psychotic Disorders
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients suffering from Major Depressive Disorder with Psychotic features who have received
      no changes in their medications in the previous two weeks will receive "usual" treatment of
      antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517.
      The patient will be hospitalized for up to two weeks to monitor their medications and
      progress and will return to the site for periodic assessments.
    


Intervention name(s): ORG 34517
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
Condition: HPV 16 Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy,
      immunogenicity, and safety.
    


Intervention name(s): Comparator: HPV 16 L1 Vaccine; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6; A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6
Other intervention name(s): V501
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects
Condition: Gingival Recession, Localized
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate, whether use of the modified free gingival graft
      (mod-FGG) technique improves treatment outcomes after surgical root coverage at mandibular
      incisors with gingival recession defects.
    

Detailed description: 
      Gingival recession defects (GRD), defined as displacement of the gingival margin apical to
      the cemento-enamel junction, are frequent clinical findings in the general population.

      The major indications for root coverage procedures are improved esthetics, reduction of root
      hypersensitivity and the increase of the dimensions of keratinized tissue in order to
      facilitate infection control and prevent further progression of gingival recession defects.
      Numerous surgical techniques for root coverage have been suggested, with different degrees of
      success as assessed by the proportion of complete root coverage. The scientific evidence has
      revealed that mandibular incisors were associated with the least favourable outcomes when
      compared to other teeth. The lower success rate and lower predictability of root coverage
      procedures at lower incisors, teeth with the highest frequency of GRDs, may be related to the
      unfavorable anatomic conditions including marginal frenum attachment, high muscle pull and a
      shallow vestibule. These features are frequently encountered in the anterior area of the
      mandible, while they are rare in the maxillary anterior region.

      The so-called "Free Gingival Graft" (FGG) was shown to be the most effective procedure for
      gingival augmentation at sites with minimal amount of keratinized tissue. Great variability
      in terms of proportion of root coverage (range: 11% to 87%; mean: 63%) has been reported when
      applying this technique, however. One of the challenges may be the inadequate blood supply to
      the portion of the FGG placed on the exposed root surface. A modified version of the FGG
      technique (mod-FGG) has been proposed, aiming to improve the vascularity of the recipient
      site over the denuded root surface. However, there is to date no scientific evidence whether
      the mod-FGG provides better clinical results than the conventional FGG.

      The hypothesis of the study is that the mod-FGG will improve predictability and treatment
      outcomes for root coverage at mandibular incisors.
    

Intervention name(s): Mucogingival surgery
Intervention type(s): Procedure
Intervention description(s): The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization
Condition: Normal Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo- and positive-controlled (moxifloxacin), 3-period, 3-way
      crossover thorough QT study, which includes a Screening Period, Treatment Periods (1 through
      3), and a Follow-up Visit. Subjects will be confined to the investigational site for 4
      nights/3 days during Period 1 and for 3 nights/2 days during Periods 2 and 3. There will be a
      minimum of a 14 day washout between treatments.
    

Detailed description: 
      Each of the following treatments will be evaluated on Day 1 of each period in a crossover
      fashion. The IV eravacycline (TP-434) and IV placebo will be double-blinded.

        -  Treatment A: Eravacycline (TP-434) 1.5 mg/kg administered intravenously over 60 minutes
           and one placebo oral tablet;

        -  Treatment B: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes
           and one moxifloxacin 400 mg oral tablet; and

        -  Treatment C: Placebo (0.9% sodium chloride) administered intravenously over 60 minutes
           and one placebo oral tablet.

      Subjects will be randomized to a treatment sequence according to a pre-generated treatment
      scheme. Subjects will receive a different treatment during each of the 3 periods.
    

Intervention name(s): Eravacyline, Moxifloxacin, and placebo
Intervention type(s): Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and
      desflurane at equal minimum alveolar concentrations using power spectral analysis of the
      electroencephalogram.
    

Detailed description: 
      Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated
      that equi-minimum alveolar concentration of various volatile anesthetic agents may produce
      different spectral entropy or bispectral index values. However, there were no studies that
      demonstrate the difference of hypnotic potency using power spectral analysis of
      electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of
      each bandage). The purpose of this clinical trial is to compare hypnotic effect of
      sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral
      analysis of the electroencephalogram.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.; Anesthesia was maintained with desflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
Other intervention name(s): SEVO; DES
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Education in Therapy of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) has considerable impact on motor, psychological and social
      activities and significantly affects the quality of life of patients and their families. To
      improve the medical care of PD patients, the investigator have developed an educational
      program specific to PD.

      The principal aim of this study is to evaluate the therapeutic education Program, comparing
      the quality of life of PD patients with or without the educational program after six month
      and one year follow-up.

      The secondary aims are to evaluate the evolution of motor and psychological states in these 2
      groups of patients and to compare the medical costs.

      This is a monocentric, comparative, prospective randomised study. The investigators will
      evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients
      with a traditional medical care. Quality of life of PD patients is evaluated using a specific
      scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological
      states were assessed with UPDRS and HAD Scales. The educational program consisted of both
      individual and collective educational consultations.

      The investigators supposed that the therapeutic education program will improve the quality of
      life of PD patients. The supposition that this improvement will correlate with the motor and
      psychological states.
    


Intervention name(s): therapeutic education program
Intervention type(s): Behavioral
Intervention description(s): The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: therapeutic education; Parkinson's disease; quality of life