bioihbjkbjnl/mcl2 huggingface dataset:
Stress Reduction & CVD Morbidity and Mortality in Blacks
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effects of two stress reduction techniques, Transcendental Meditation (TM) and
      Progressive Muscle Relaxation (PMR), on the control of mild hypertension in elderly Blacks
      with hypertension.
    

Detailed description: 
      BACKGROUND:

      Life expectancy for Black Americans is about 10 percent less than for whites. The leading
      cause of excessive mortality in older Blacks is cardiovascular disease which may be largely
      due to disproportionately high rates of hypertension in older Blacks. Conventional
      antihypertensive drug therapies are frequently associated with adverse effects on
      quality-of-life (QL) and low compliance rates, especially in elderly minority populations.

      The present study is an extension of a pilot study on a comparable sample of 80 Black
      elderly. The previous study, which was the first of its kind, yielded results which indicated
      that both TM and PMR produced moderate reductions in systolic and diastolic blood pressure,
      with TM producing the most significant improvements in blood pressure and in quality-of-life.
      Dr. Schneider hypothesized from this and related evidence that TM should prove to be an
      effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly
      Blacks, and should prove even more effective in fostering compliance and in improving overall
      quality-of-life without any of the unpleasant side effects of anti-hypertensive medications.

      DESIGN NARRATIVE:

      Randomized. Over an 18-month period, 213 people were screened for inclusion in the study. Of
      these, 127 with initial diastolic blood pressure of 90 to 109 mm Hg, systolic blood pressure
      of 189 mm Hg or less, and final baseline blood pressure of 179/104 or less mm Hg were
      randomized to treatment. Of the 127 participants, 16 did not complete follow-up blood
      pressure measurements. Thus, 111 subjects completed the study. All subjects were pretested
      over a four session baseline period on clinic blood pressure, ambulatory blood pressure,
      cardiovascular and emotional reactivity, and quality-of-life measures. Subjects were then
      randomly assigned, 36 to TM, 37 to PMR, and 38 to lifestyle modification education control
      and followed monthly with major post-tests at three months and eighteen months on these
      variables. The primary outcome variables were changes in clinic systolic and diastolic blood
      pressure values measured blindly. The secondary outcomes were changes in self-monitored home
      blood pressure and compliance.

      The study was extended through July, 2007 for an additional 5 years of followup of the
      cohort.
    

Intervention name(s): meditation; relaxation
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Prevention
Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
Condition: Analgesia
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of
      elderly people. The aim of the present study was to compare the analgesic effect of
      intra-articular bupivacaine and morphine in patients with knee osteoarthritis.

      DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São
      Paulo Federal University.

      METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3
      on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine
      diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml)
      0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee
      flexion and extension angles were measured after administration of the drugs at rest and
      during movement. The total amount of analgesic complementation with 500 mg paracetamol was
      also determined.
    

Detailed description: 
      Among the 39 patients selected, two patients from group 1 and five from group 2 were excluded
      from some of the analyses because they did not return on the day of assessment or because
      they used a complementary analgesic different from that standardized in the study
    

Intervention name(s): morphine
Intervention type(s): Drug
Intervention description(s): 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and 25 mg (10 ml) 0.25% bupivacaine without epinephrine.
Other intervention name(s): dimorf
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Analgesia; Morphine; Bupivacaine; Osteoarthritis; Knee
Effect of Food on Opicapone
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of food on the
      catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC,
      development code BIA 9-1067) in healthy subjects and to characterize the effects of food on
      the pharmacokinetics (PK) and tolerability of OPC after repeated doses.
    

Detailed description: 
      Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a
      single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC
      was orally administered in the evening (reference hour for all other administrations) after a
      minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC
      once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally
      administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally
      administered in the evening, thirty minutes after the start of a moderate meal (with a
      previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening
      administration after 2 hours fast).
    

Intervention name(s): Opicapone (OPC)
Intervention type(s): Drug
Intervention description(s): 50 mg OPC capsules; oral route
Other intervention name(s): Ongentys; BIA 9-1067
Intervention MeSH terms: Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Incidence of Cystitis in Women Consuming a Mixture of Cranberry, Cinnamon, Probiotics
Condition: Cystitis; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Cystitis
Study type: Observational

Summary: 
      Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of
      bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of
      cranberries, its mechanism of action has been several times proposed by the scientific
      community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete
      disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell
      body. Cinnamon and microbiotic strains could enhance this synergy.

      This study aims to evaluate the effectiveness of a food supplement based on cranberry,
      cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary
      discomfort and the number of cystitis reported by women.
    

Detailed description: 
      Women who use or not the cranberry, cinnamon, and microbiotic blend are encouraged to
      complete a 6-month diary in which they report any urinary tract disorders they encounter.
    

Intervention name(s): Feminabiane CBU
Intervention type(s): Dietary Supplement
Intervention description(s): EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The first 80 women of the CEN Nutriment (Clinical Investigation Center) volunteer panel
        corresponding to the selection criteria and wishing to participate in the study.
Preoperative Radiation Therapy for High Risk Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I dose-escalation study of moderate dose radiation therapy prior to radical
      prostatectomy for patients with high-risk localized disease. Its hypothesis is that such
      treatment will be well tolerated with similar side effect profile as surgery alone. Patients
      in Groups 1 and 2 will receive 39.6 Gy and 45 Gy (at 1.8 Gy/fx), respectively, to the whole
      pelvis. Patients in Groups 3 and 4 will receive 45 Gy to the whole pelvis, followed by a
      boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 Gy,
      respectively. The patient will then undergo radical prostatectomy between 4-8 weeks after
      completion of radiation.
    


Intervention name(s): Radiation; Radical Prostatectomy
Intervention type(s): Radiation; Procedure
Intervention description(s): Pre-operative Radiation to Prostate, SV, and Pelvic Lymph Nodes; Patients will undergo evaluation by a surgeon for consideration of resection after completion of radiation therapy. If a surgical resection is possible, it is recommended that patients undergo surgery four to eight weeks after completion of radiation therapy. This surgical procedure will be performed by one of the standard accepted approaches.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostatectomy; radiation; neoadjuvant
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
Condition: HIV-infection/AIDS
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and
      without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy
      subjects.
    

Detailed description: 
      Primary Objectives

        -  To evaluate the steady-state PK of CVC administered with and without DTG .

        -  To evaluate the steady-state PK of DTG administered with and without CVC .

        -  To evaluate the PK of a single dose of Midazolam administered with and without steady
           state CVC when both are administered orally.

      Secondary Objectives

        -  To evaluate the safety and tolerability of CVC administered with and without DTG.

        -  To evaluate the safety and tolerability of CVC administered with and without Midazolam.
    

Intervention name(s): Cenicriviroc; Dolutegravir; Midazolam
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): CVC; DTG; Dormicum; Hypnovel; Versed
Intervention MeSH terms: Dolutegravir; Cenicriviroc; Midazolam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HIV/AIDS; Cenicriviroc (CVC); Dolutegravir (DTG); Midazolam; Healthy Subjects
Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This study is the first to quantify the level of NF-kB translocation in lymphocyte
      populations in children and adolescents with psoriasis of varying severity.
    

Detailed description: 
      This is a diagnostic study aimed at finding immunological predictors of the effectiveness of
      therapy in children and adolescents with psoriasis.

      The study included 90 patients from 1 to 18 years old with psoriasis vulgaris, mild /
      moderate and severe. The comparison group consisted of 30 healthy children.

      The study took into account the PASI (Psoriasis Area Severity Index); the BSA (Body Surface
      Area); including patient age; duration of the disease; type of therapy; duration of therapy.
      Depending on the type of therapy, all psoriatic children were divided into 3 groups: Group 1
      (n = 24) - patients receiving basic and external therapy; Group 2 (n = 20) - patients
      receiving systemic therapy with methotrexate; and Group 3 (n = 46) - patients receiving
      therapy with genetically engineered biological drugs (Adalimumab, Etanercept, Ustekinumab).

      The analysis of the NF-κB translocation level in lymphocytes was performed by flow cytometry
      with imaging (Image Stream Mark II - AMNIS) using the Amnis NF-κB Translocation Kit.
    

Intervention name(s): Peripheral blood samples were obtained following the standard procedures.
Intervention type(s): Diagnostic Test
Intervention description(s): Taking 4 ml of peripheral blood from patients on an empty stomach.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: NF-κB translocation; Lymphocytes; Flow cytometry with imaging (Amnis); Biological drugs; Сhildren and adolescents
Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Condition: Rumination
MeSH terms: Rumination Syndrome; Feeding and Eating Disorders of Childhood
Study type: Interventional

Summary: 
      This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and
      active tDCS provides better rumination attenuation than the combination of VR and tDCS
      placebo 2) the acceptability and experiential experience of combining these two well known
      medical devices.
    

Detailed description: 
      Inclusion visit:

        -  Confirmation of eligibility criteria

        -  Written informed consent

      Visit 1 and 2 (or end of study visit) :

      Before first ruminations induction :

        -  Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI),
           Inventory, Visual Analogic Scale (VAS), Ruminative Response Scale - Short Form (RRS-SF),
           Beck depression Inventory (BDI)

        -  EEG recording

      Then Procedure for inducing ruminations using a pre-recorded voice listened to in an audio
      headset alternating statements promoting a positive, neutral and negative introspection and
      self-judgment attitude (the latter are heard at the end to initiate the rumination process)
      over 8 minutes

      Then

        -  Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale
           (VAS), Beck depression Inventory (BDI),

        -  EEG recording

        -  Pulse and blood pressure measurements

      Then immersion in a relaxing virtual environment for 20 minutes with active or sham placebo.

      • Cutaneous conductance measurement and eye-tracking during immersion

      At the end of immersion :

        -  Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale
           (VAS), Beck depression Inventory (BDI), IGroup presence questionnaire (IPQ)

        -  Pulse and blood pressure measurements

      Then again procedure for inducing ruminations .

      At the end of ruminations induction :

        -  Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI),
           Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), tolerance
           questionnaires

        -  Debriefing
    

Intervention name(s): VR + active brain stimulation; VR +sham brain stimulation
Intervention type(s): Device; Device
Intervention description(s): Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes); Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: virtual reality; brain stimulation; tDCS; phenomenology
Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects.
Condition: Intrabony Periodontal Defect
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study was to evaluate the bone formation potential of 400µg
      alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.
    

Detailed description: 
      The aim of the present study was to evaluate the bone formation potential of 400µg
      alendronate(ALN) delivered in β-TCP in the treatment of periodontal intra-osseous defects.

      Materials and Methods: Thirty patients with periodontal defects were randomly assigned to
      400µg ALN + β-TCP + saline (test) group and β-TCP + saline (active-control) group. Clinical
      parameters like clinical attachment level (CAL) gain, probing depth (PD) reduction,
      post-operative gingival recession (GR) were assessed from the baseline, 3 months and 6 months
      recordings. Radiographic parameters like linear bone growth (LBG), percentage bone fill
      (%BF), change in alveolar crest height (ACH) were assessed from baseline and 6 months
      radiographs.
    

Intervention name(s): Alendronate sodium; beta-tricalcium phosphate bone substitute
Intervention type(s): Drug; Biological
Intervention description(s): 400µg of alendronate sodium is combined with beta-tricalcium phosphate bone graft and implanted in periodontal intra-osseous defects as a single, local dose.; beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.
Other intervention name(s): fossamax, osteofos; cerasorb, sorbone
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal regeneration
Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches
Condition: Impacted Tooth With Abnormal Positioning
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The time required for orthodontic traction of impacted canines after surgical exposure is a
      particularly troubling clinical problem because it prolongs the orthodontic treatment
      duration. During traction process, several complications could result in alveolar bone loss,
      root resorption of the adjacent teeth, ankylosis, discoloration, loss or vitality and
      gingival recession. Accordingly, and due to the lack of studies concerned with accelerating
      the traction movement of the impacted canines, we conducted this study to evaluate the
      effectiveness of some surgical interventions (corticotomy and Piezocision) in increasing the
      rate of orthodontic traction movement. We also aimed to evaluate dentoalveolar changes
      associated with the use of such accelerating procedures compared with the conventional
      traction method.
    

Detailed description: 
      Adult patients with unilateral palatally impacted canines will be included in this study. One
      of patient groups will be treated using fixed orthodontic appliances in combination with some
      accelerated surgical interventions, while the second patient group will be treated using the
      traditional treatment method. The velocity of traction movement will be assessed in the two
      groups. The differences between the two groups in terms of the total treatment duration and
      the traction duration will be evaluated.

      Dentoalveolar changes associated with the use of such accelerating procedures will be
      assessed by several variables studied on cone-beam computed tomography (CBCT) images. In this
      study, two groups are going to be evaluated: (1) patients treated in the traditional manner,
      (2) patients will undergo corticotomy-assisted traction of the impacted canines.
    

Intervention name(s): Corticotomy; Traditional traction of the impacted canine without corticotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): A corticotomy procedure will be applied with some osteoperforations during the surgical exposure of the impacted canine. Then this will be followed after 8 weeks with another surgical stimulation using piezosurgery.; In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Canine impaction; Acceleration of tooth movement; Corticotomy; Minimally invasive acceleration; Maxillary canine impaction; Withdrawal of an impacted canine; Piezosurgery
Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label, randomized, parallel group single dose intravenous
      (i.v.) administration study. The subjects will be randomized to receive a single dose of
      OxyNorm® 2.5, 5, and 10mg.
    

Detailed description: 
      After up to 7 days screening period, Eligible Patients will be randomized to 1 of 3 groups,
      and begin treatment with single dose of OxyNorm® 2.5,5, and 10mg.
    

Intervention name(s): Oxycodone (OxyNorm®) Injection
Intervention type(s): Drug
Intervention description(s): The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.The plasma concentration will be analyzed to determine the following pharmacokinetic parameters:AUC0-t:ug•hr/L-Area under the plasma concentration-time curve frame: predose,0,2min,5min,10min,15min,30min,45min,1hr,1.5hr,2hr,3hr,4hr,6hr,8hr,12hr, 24hr post-dose.AUC0-inf:ug•hr/L-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: ug/L-Maximum observed plasma concentration of oxycodone and noroxycodone.Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of oxycodone elimination.
Other intervention name(s): OxyNorm®
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment