bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with
      preserved or reduced ejection fraction) before and after hospitalization in our internal
      medicine unit (from 2016 to 2017).

      The investigators showed that patients, mainly elderly women with comorbidities, often had
      suboptimal heart failure treatment without an identified cause. The investigators tried,
      whenever possible, to optimize treatment before hospital discharge.

      Our objective is now to analyze the 4-year outcome of these patients, including
      re-hospitalization for heart failure or death.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized for heart failure or with known heart failure in our Internal
        Medecine unit between 2016/01/01 and 2018/01/01.
      
Keywords: Outcomes; Internal medecine; Heart failure treatment; Heart failure guidelines; quality of life
Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study
Condition: Vestibular Schwannoma
MeSH terms: Neurilemmoma; Neuroma, Acoustic
Study type: Interventional

Summary: 
      The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular
      schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the
      hearing is preserved in most patient years after the gamma knife treatment. Recent
      prospective data suggests that radiosurgery could be a hearing preserving treatment for these
      patients.

      The main objective of this study is to evaluate if GKRS can inhibit progression of hearing
      loss in patients with VS. Patients with preserved hearing will be offered to participate in
      the study and randomized ether to GKRS or initial conservative treatment for their vestibular
      schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and
      audiometry and evaluated after one, three and five years after treatment.
    


Intervention name(s): Initial Gamma knife radiosurgery
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vestibular schwannoma; Gamma knife radiosurgery; Hearing preservation
Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each
      subject participated in only one part of the study. In Part A subjects received one dose of
      15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril
      and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the
      other nostril, in a randomized manner. In Part B subjects were randomized to receive a single
      intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into
      one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine
      containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study,
      subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a
      post-study medical was performed prior to discharge.

      The objective of this study was to compare the tolerability of formulations of ketorolac
      tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A
      and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy
      volunteers.
    


Intervention name(s): Ketorolac tromethamine; Ketorolac tromethamine
Intervention type(s): Drug; Drug
Intervention description(s): One dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril; One dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg Ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Alternative Treatments for Premenstrual Dysphoric Disorder
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional

Summary: 
      The primary aim of this study is to examine the effects of co-administered wake therapy
      followed by light treatment on mood, and secondarily on circadian rhythms, to test the
      hypothesis that critically-timed chronotherapy improves mood by correcting phase disturbances
      in melatonin and sleep in women with Premenstrual Dysphoric Disorder.
    

Detailed description: 
      The design is a randomized cross-over contrasting Late Wake Therapy plus morning bright light
      (LWT+Am BWL)vs. Early Wake Therapy plus evening bright light (EWT+PM BWL)administered in the
      luteal phase of two separate menstrual cycles, and preceded by 2 evaluation months. To lessen
      the patient's burden, the 1-night EWT or LWT and the following 7-day BWL interventions will
      be conducted at home, given at a fixed point in each menstrual cycle, from day 1 to 7 after
      the mid-cycle luteinizing hormone(LH) surge (ovulation). We anticipate that LWT+7 days of AM
      BWL (vs. EWT+PM BWL) will produce much greater mood benefits and larger physiological
      responses, than the one-time light pulses used in our earlier phase-shift studies.
    

Intervention name(s): LWT+AM BWL; EWT+PM BWL
Intervention type(s): Other; Other
Intervention description(s): One night of late wake therapy (LWT)(sleep 21:00-01:00 h, followed by wakefulness) plus 7 days of morning bright white light (AM BWL)(light-emitting diode-LED administered for 60 minutes, starting within 30 minutes of habitual wake time); One night of early wake therapy (EWT) (wakefulness until 03:00 h, then sleep 03:00-07:00 h) plus 7 nights of evening bright white light (PM BWL)(light-emitting diode-LED administered 90 minutes before habitual sleep onset, for 60 minutes)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 40 women with Premenstrual Dysphoric Disorder ages 18-45 will be randomized to a cross-over design contrasting one night of Late Wake Therapy followed by 7 days of morning Bright-White Light (LWT+AM BWL) vs. one night of Early Wake Therapy followed by evening Bright-White Light (EWT+PM BWL) administered in the luteal phase of two separate menstrual cycles, with one month of no intervention (washout) between treatments to prevent carry-over effects. Treatment will be preceded by 2 evaluation months to determine diagnosis and collect baseline mood, sleep, actigraphy and endocrine measures. To lessen the patient's burden, the 1-night EWT or LWT and the following 7-day BWL interventions will be conducted at home, given at a fixed point in each menstrual cycle, from the day of mid-cycle LH surge to 7 after the LH surge.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Premenstrual Dysphoric Disorder; Women; Depression; Light therapy; Wake therapy; Phase; Chronobiology
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may
      make the body build an effective immune response to kill tumor cells.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
      with stage I, stage II, or stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the immunologic effects of adjuvant vaccine therapy comprising autologous
           dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in
           patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.

        -  Determine the potential clinical efficacy of this vaccine in these patients.

      OUTLINE: This is an open-label study. Patients are stratified according to type of prior
      primary therapy (surgical vs nonsurgical).

      Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production
      of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells
      to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once
      a month for 2 months in the absence of disease recurrence or unacceptable toxicity.

      Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically
      thereafter.

      PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study
      within 3 years.
    

Intervention name(s): autologous dendritic cell cancer vaccine
Intervention type(s): Biological
Intervention description(s): Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.
Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
Other intervention name(s): DC vaccine; autologous DC vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; bronchoalveolar cell lung cancer
Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia
Condition: Inherited Erythromelalgia
MeSH terms: Erythromelalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of single doses of
      PF-05089771 against placebo in treatment of pain in patients with primary, inherited
      erythromelalgia.
    


Intervention name(s): PF-05089771; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered.; Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
Condition: Atherosclerosis; Diabetes
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The long-term goal of the proposed research is to identify and develop effective
      interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a
      substantial contributor to inflammation, and interactions among stress, inflammation, body
      mass index, and health behaviors have been measured. Mindfulness-based stress reduction
      (MBSR) is effective for stress reduction, has been shown to be effective for inflammation
      reduction in individuals with disease, and is a sustainable practice for individuals across
      the health spectrum. Diet strategies are an effective means of reducing inflammation for some
      individuals, but may not be successful for many people, as evidenced by the steady rise in
      obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR
      compared to an established intervention of a nutrition enhancement (NE) intervention for the
      reduction of inflammation, and 2) test the effectiveness of MBSR compared to a
      non-intervention control conditions (CON) for the reduction of inflammation. Men and women
      25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or
      CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory
      cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles,
      anthropometrics, dietary intake, and all components of the metabolic syndrome will be
      measured pre- and post-intervention to elucidate underlying mechanisms and to determine
      whether health benefits beyond inflammation reduction occur.
    


Intervention name(s): Mindfulness-based stress reduction; Nutrition Enhancement
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stress reduction class and behavioral intervention; Nutrition education class and behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
CAD-CAM PEEK Framework for All-on-4 Implants
Condition: Bone Loss
Study type: Interventional

Summary: 
      This study was conducted to evaluate the clinical peri-implant soft tissue changes during the
      first year after occlusal loading and the ridge base relation after 3 years for mandibular
      computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained
      implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with
      All-on-Four treatment concept.
    

Detailed description: 
      Sixteen completely edentulous patients were rehabilitated by four implants following the
      All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a
      screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to
      polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled
      composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding
      plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion
      (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base
      relation was performed using cone-beam computed tomography CBCT at the time of insertion
      (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable
      All-on-Four framework insertion.
    

Intervention name(s): PEEK framework
Intervention type(s): Device
Intervention description(s): All-on-4 implants with PEEK framework of fixed detachable prosthesis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: All-on-Four implant; CAD-CAM; PEEK framework
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)
Condition: Hypersensitive; Reactive and Intolerant Skin; Redness-prone Skin; Stinger Subjects
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The aim of this study is to assess the dermatological and ophthalmological tolerance of the
      investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice
      daily use on the study areas, under normal conditions of use.

      The aim of this study is also to:

        -  evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.

        -  evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm*, D8 and D22.

        -  evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm*, D8 and D22.

        -  evaluate the cosmetic acceptability by a questionnaire at D22.

      This study is conducted as a national, monocentric, non-randomized open trial. The 33
      subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant
      skin on face. They are stinger subjects, with a dry to very dry skin.

      Timm*: 10 to 30 minutes after first application
    

Detailed description: 
      his study is a national, monocentric, non-randomized open trial, conducted in adults
      presenting hypersensitive, reactive and intolerant skin on the face, with a dry to very dry
      skin.

      The study includes 3 visits, including subjects' selection:

        -  V1: Baseline inclusion

        -  V2: 1 week, intermediate visit

        -  V3: 3 weeks, study end

      The maximal study duration is 25 days.

      The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of
      RV4942A - RY1985 with comparison of each time versus baseline.

      There are twice-daily applications (morning and evening) of the test product on the face.
    

Intervention name(s): Cosmetic product
Intervention type(s): Other
Intervention description(s): RV4942A is a face balm product
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects have been recruited from the panel of the centre. An investigator made a
        dermatological examination of the subjects before inscription in the panel. Data from this
        clinical examination, stored in the computer database with the consent of the subjects, can
        ensure the recruitment; computer software being questioned based on the eligibility
        criteria of the study.
      
Keywords: Hypersensitive skin; Discomfort sensations; Asian skin; Sensitivity reduction
Role of NLRP3 in Periodontitis and Diabetes
Condition: Metabolic Disease; Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Metabolic Diseases
Study type: Observational

Summary: 
      NLRP3 plays a key role in endothelial function and may be a link for the known interaction of
      periodontitis and diabetes. The investigators compared the impact of gingival health,
      periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum
      NLRP3levels.
    

Detailed description: 
      The aim of this study was to evaluate a possible association between NLRP3 and gingival
      health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum
      NLRP3 levels.
    

Intervention name(s): Observation of serum and salivary NLRP3 levels
Intervention type(s): Other
Intervention description(s): Evaluation of serum and salivary NLRP3 levels
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of
        periodontitis + diabetes (n=34)
An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the exposure of sumatriptan after administration of TREXIMA
      (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or
      6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX
      100mg tablet 2 hours later.
    

Detailed description: 
      An open-label, randomized, 3-period crossover study to evaluate sumatriptan pharmacokinetics
      for a TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX®
      (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® and a
      TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using
      the IMITREX STATdose System® compared with an IMITREX Tablet 100mg followed by an IMITREX
      Tablet 100mg.
    

Intervention name(s): TREXIMA™; IMITREX® (4mg); IMITREX® (6mg); IMITREX Tablet 100mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sumatriptan succinate / naproxen sodium tablet; sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System®; sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System®; IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sumatriptan exposure
Impact of Therapeutic Alliance on Dropout in a Naturalistic Sample of Patients With Borderline Pathology Receiving Residential DBT
Condition: Borderline Personality Disorder; Psychotherapy; Dropout
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient
      Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set
      assessing demographic information and pretreatment psychopathology during the days of their
      inpatient stay. Beyond that, changes of therapists were documented.
    


Intervention name(s): Dialectical Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        For this study, all patients aged from 18 to 65, discharged from our personality disorder
        inpatient unit between January 2019 and December 2021, and fulfilling three or more
        criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were
        considered (n = 44).
OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
Condition: Parkinson Disease Dementia
MeSH terms: Parkinson Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety
      and efficacy of daily treatment.
    

Detailed description: 
      This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety
      and efficacy of daily treatment.
    

Intervention name(s): ANAVEX2-73
Intervention type(s): Drug
Intervention description(s): Oral capsules
Other intervention name(s): Blarcamesine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Condition: Massive Ascites
MeSH terms: Ascites
Study type: Interventional

Summary: 
      Massive ascites is usually controlled over several weeks pre-operatively in liver transplant
      recipients with the risk of encephalopathy and peritonitis. We hypothesized that
      intra-operative drainage of ascites will be safe and avoids the inherent risks of
      pre-operative drainage.
    


Intervention name(s): ultrasound guided ascitic fluid drainage; operative drainage of ascites through small skin incision after induction of anesthesia; ultrasound
Intervention type(s): Procedure; Procedure; Device
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention