bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm
Condition: Coronary Vasospasm
MeSH terms: Coronary Vasospasm
Study type: Interventional
Phase: Phase 4

Summary: 
      The correlation between endothelial dysfunction and the risk of coronary heart disease is
      well known through previous studies. The degradation of the function of nitric oxide acting
      on the endothelium of blood vessels is mainly explained by reduction of synthesis, loss due
      to oxidative stress, and decreased sensitivity to vascular dilatation action. In particular,
      patients with high blood pressure have been known to have impaired vascular endothelial
      function through animal experiments and several clinical studies, mainly due to increased
      biomechanical friction in the blood vessels and decreased biological availability of nitric
      oxide, which in turn causes incongruity in the production of nitric monoxide and changes in
      normal vascular dilatation. There have also been reports recently that early diagnosis and
      treatment may improve endothelial dysfunction and prevent the progression of coronary artery
      disease. However, the reality is that the drugs available in vasospastic angina patients with
      endothelial dysfunction are very limited. Until recently, beta-blockers were reported to
      inhibit vascular dilatation of adrenaline stimuli, a drug corresponding to relative
      contraindications in vasospastic angina patients, with one study reporting that propranolol
      cannot, but rather exacerbates, vasospastic angina. However, a series of reports on the
      vascular dilatation of the recently developed third-generation beta-blockers have reinvented
      the role of beta-blockers in vasospastic angina, especially nebivolol (selective, continuous
      beta-blockers) is known to act on β-1 adrenaline receptor blockings and endothelium to create
      vascular dilatation, and also to stimulate β-3 adrenaline receptors to cause nitric oxide
      generation and antioxidant effects in the endothelium of blood vessels. Therefore, this
      clinical trial seeks to find whether nebivolol will inhibit vascular contraction in
      hypertensive patients and will work in angiospastic angina patients.
    


Intervention name(s): Nebivolol; Diltiazem; Nebivolol+Diltiazem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.; Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.; Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.
Intervention MeSH terms: Nebivolol; Diltiazem
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Nebivolol group Group 2: Diltiazem group Group 2: Nebivolol + Diltiazem group
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nebivolol
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents and
      patients will provide their Informed Consent to upload their data for population-based
      analyses and optionally to adhere to a patient adherence support program "AUMENTA" designed
      to improve their adherence and, ultimately, clinical outcomes. Adherence data will be
      primarily derived from the easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and explore the hypothesis that patient adherence support
      programs improve adherence and subsequent clinical outcomes. Collected data will be also
      analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      -To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To asses the impact of adherence on IGF1 (i.e. above, below or within normal ranges)

        -  To assess/describe the impact of Mexico patient support program "AUMENTA"
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome
Condition: Low Anterior Resection Syndrome; Sacral Neuromodulation - Interstim Therapy; Rectal Cancer
MeSH terms: Low Anterior Resection Syndrome; Syndrome
Study type: Interventional

Summary: 
      Low anterior resection syndrome (LARS) is a complex disorder suffered by patients who undergo
      rectal resection mainly due to rectal cancer. It is characterized by fecal incontinence,
      fragmented defecation, constipation, defecatory urgency among others, which induce an
      impairment in quality of life.

      LARS treatment armamentarium is scarce and with no long-term relief, being a difficult
      challenge for surgeons. There is evidence showing that sacral neuromodulation (SNM) improves
      patients' symptoms and quality of life. However, no prospective randomized studies have
      supported this improvement.

      This is a prospective randomized cross-over study which evaluates the effectiveness of SNM in
      LARS, specifically analyzing intestinal, urinary, sexual symptoms as well as quality of life.
    


Intervention name(s): Sacral neuromodulation
Intervention type(s): Device
Intervention description(s): After the definitive implantation, stimulators are placed in position OFF for the first arm and in position ON for the second arm during 4 weeks.
Then all the stimulators are switched OFF (both first and second arms) for 2 weeks.
Finally stimulators are maintained in position ON for the first arm and switched OFF for the second arm during 4 weeks.
Since this is a cross-over study, patients can be randomly assigned to any arm first, but they will go to the other arm since the patient is its own control. 50% of randomized patients will go through ON-OFF and the other 50% OFF-ON.
After this cross-over phase, ALL stimulators will be in ON position until the end of the study period.
Other intervention name(s): InterStim Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over of two sequences (2x2: AB / BA)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Respiratory Physiotherapy in the Management of Infectious Pleural Effusion
Condition: Pleural Diseases; Infection
MeSH terms: Pleural Effusion; Pleural Diseases
Study type: Interventional

Summary: 
      Chest physiotherapy (CP) facilitates the absorption of fluid in the pleural cavity and
      reduces the formation of fibrous adhesions in patients with pleural infection, allowing a
      faster clinical, functional and radiological improve. The aim of the study is to determine if
      the CP associated with conventional medical treatment (CT) improves functional sequelae
      secondary to pleural infectious.
    

Detailed description: 
      This is a multicenter, prospective and randomized trial. Objective: To determine if the Chest
      physiotherapy (CP) associated with conventional medical treatment (CT) improves functional
      sequelae secondary to pleural infectious disease, defined as an increased of 15% in Vital
      Functional Capacity (VFC). Adult patients with diagnosis of pleural infection will be
      included and randomized into two branches: control group - only CT and interventional one -
      CT plus CP.
    

Intervention name(s): Chest physiotherapy
Intervention type(s): Other
Intervention description(s): Depending on the location of the pleural effusion different techniques are performed: 1. Postural control techniques; 2. Secretions drainage techniques; 3. Thoracic expansion techniques; 4. Diaphragmatic mobility techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pleural disease; infecTion; chest physiotherapy
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
Condition: Amputation
Study type: Interventional

Summary: 
      The purpose of this research is to evaluate benefits of a microprocessor controlled
      prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon
      fiber prosthetic ankle-foot device.
    

Detailed description: 
      Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed
      additional functionality for the lower limb amputee, but research into the effectiveness of
      microprocessor controlled ankle-foot systems has been limited.

      In this research study, differences in perceived mobility, functional capabilities and gait
      parameters between energy storing and returning and microprocessor controlled ankle-foot
      mechanisms will be identified where they exist. Also a comparison of the initial function
      with a new system compared to the function after a four week accommodation period will
      provide insight into the time it takes for the prosthesis user to experience a benefit from a
      microprocessor ankle-foot.
    

Intervention name(s): Kinnex; Pacifica LP
Intervention type(s): Device; Device
Intervention description(s): The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).; The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microprocessor Controlled Ankle; Transtibial Amputee; Pacifica LP; Kinnex
CUIDA-TE, an APP for the Emotional Management
Condition: Emotional Distress; Burnout, Professional; Emotional Stress
MeSH terms: Burnout, Professional
Study type: Interventional

Summary: 
      The aim of this study is to develop and validate an Ecological Momentary Intervention APP for
      healthcare workers, in order to face of work-related stresses generated by the COVID-19
      pandemic.
    

Detailed description: 
      The COVID-19 pandemic has had a very high emotional impact on healthcare workers. Ecological
      momentary interventions (EMI) can offer an intervention in real time, when the emotion
      arises. CUIDA-TE is an EMI APP based on principles of different transdiagnostic cognitive
      behavioral interventions focused on emotion regulation. The effectiveness of CUIDA-TE will be
      investigated in the current study. A two-arms randomized controlled trial (RCT) will be
      conducted. At least 182 healthcare workers will be randomly assigned to a 2-month immediate
      intervention group (CUIDA-TE APP, n= 91), or a control group (no assessment or intervention,
      n=91). The CUIDA-TE consists of an app-based EMI that estimates and intervenes based on
      ecological momentary assessment data of five emotional states: joy, fatigue, sadness,
      anxiety, anger, as well as sleep quality, sleep quantity, burnout, perceived stress, and
      self-perception of coping skills. The primary outcome is the PHQ-9. Secondary outcomes
      include ERQ, DERS, OASIS, BRS, SUS, and ProQOL questionnaires. Primary and secondary outcomes
      will be obtained at pre- and post-intervention measurements, and at 3-month follow-up
      measurement.
    

Intervention name(s): Experimental: Intervention group
Intervention type(s): Behavioral
Intervention description(s): During 2 months participants will be able to asses their mood and practice in real time their emotional regulation skills with an ecological momentary interventions APP.
Other intervention name(s): CUIDA-TE APP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Perioperative Dexmedetomidine Administration on Immune Suppression and Outcomes in Patients With Uterine Cancer Undergoing Radical Resection
Condition: Uterine Cancer
MeSH terms: Uterine Neoplasms
Study type: Interventional

Summary: 
      Surgical stress and anesthesia may cause immunosuppression in immunocompromised cancer
      patients. The natural killer (NK) cell is a critical part of anti-tumor immunity.
      Dexmedetomidine has sympatholytic effect and preserves NK cell function. This study
      investigate the effect of dexmedetomidine on immune suppression and postoperative outcomes in
      patients undergoing uterine cancer resection.
    


Intervention name(s): Dexmedetomidine group; Control group
Intervention type(s): Drug; Drug
Intervention description(s): dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery; 0.9% saline infusion
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Memory and Mental Health in Aging
Condition: Memory
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of memory training with and without donepezil.
    

Detailed description: 
      Study 1:

      Investigators evaluated the short-term and longer-term efficacy and effectiveness of a
      pharmacologic augmentation strategy for a nonpharmacologic treatment to improve memory
      performance in nondemented older adults. Investigators used a randomized controlled trial
      with parallel groups design that compares two Treatments: DONEPEZIL + COGNITIVE TRAINING
      versus PLACEBO + COGNITIVE TRAINING.

      Study 2:

      The second study looked more closely at dosage. Investigators hoped to determine the best
      dosage of the drug donepezil for enhancing the effects of the memory training program.
    

Intervention name(s): Donepezil; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Participants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14; Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
Participants also received 2 weeks of memory training at weeks 13-14
Other intervention name(s): Aricept; Control
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of SMS in Diabetes Control
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Introduction: The Spanish Society of Family and Community Medicine, started the Program of
      Preventive Activities and Health Promotion, which generates periodic recommendations of
      preventive methods based on scientific evidence. In the last update it has become evident the
      need of modifications to adapt the program to modern times and focuses on improving
      accessibility and offering more flexible responses to users of the program. In this sense,
      the mobile phone technology could be useful, specifically the messaging service to remind
      patients their appointments and increase attendance rates. Main objective Compare the
      percentage of patients in the intervention group compared with the control group who achieved
      a figure of HbA1c <7% in 2013.Design: single blind Randomized Clinical Trial. Study
      population: Patients with diabetes with or without hypertension or lipid metabolism disorder,
      over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting
      the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a
      difference of 16% in the percentage of patients with HbA1c lower than 7% between groups:
      Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps.
      Control group: Routine clinical practice. Statistical analysis: The relationship between the
      intervention received and the main variable (compliance with preventive activities at 12
      months) were analyzed using a logistic regression model.
    


Intervention name(s): SMS MESSAGING
Intervention type(s): Behavioral
Intervention description(s): SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: diabetes; management; glycated hemoglobin; preventive activities
A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to determine whether an investigational medication (SEP363856) changes how
      long it takes for food to move through the stomach into the small intestine in patients with
      schizophrenia. This study is accepting both male and female subjects. It will be conducted in
      approximately 6 study sites in the United States. The duration of participation will be
      approximtely 10 weeks.
    

Detailed description: 
      This is a randomized, open-label, single dose two-period crossover study with two treatment
      sequences. For each treatment sequence, subjects will receive a single-dose of SEP-363856 and
      prior antipsychotic (PA) standard of care (PA) in random order. Up to 3 separate cohorts of
      subjects will be randomized to determine the final dose of SEP-363856.
    

Intervention name(s): SEP-363856; Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Intervention type(s): Drug; Drug
Intervention description(s): SEP-363856 will be supplied by 25 mg and 50 mg tablets. Multiple tablets may be required to achieve a single dose.; PA will be prepared by the pharmacy staff according to the patient's prescribed treatment and will be orally administered. Multiple tablets or capsules may be required to achieve a single dose.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Antipsychotic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fasted Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.
      Dosing periods were separated by a washout period during fasted study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Montelukast Sodium Tablets 10 mg
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To compare the health economic parameter and clinical outcome of Phacoemulsification with
      small incision cataract surgery (SICS)
    


Intervention name(s): Phacoemulsification cataract extraction surgery; Small incision cataract surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF); Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cataract
Primary Hyperaldosteronism and Ischemia-reperfusion Injury
Condition: Primary Hyperaldosteronism
MeSH terms: Reperfusion Injury; Hyperaldosteronism; Ischemia
Study type: Interventional

Summary: 
      Patients with primary hyperaldosteronism experience more cardiovascular events compared to
      patients with primary hypertension, independent of the blood pressure level.

      In this research we hypothesize that patients with primary hyperaldosteronism are more
      susceptible to ischemia-reperfusion injury.
    

Detailed description: 
      Patients with PHA have an increased risk of cardiovascular events, independent of blood
      pressure level. Also in patients suffering a myocardial infarction, circulating aldosterone
      levels are associated with increased mortality. In animal models of myocardial infarction,
      the administration of exogenous aldosterone increased infarct size, although other studies
      did not report this effect. In similar models, antagonists of the mineralocorticoid receptor
      (MR) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (CD73, the
      enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and
      adenosine receptor knock-out mice. Therefore, we hypothesize that patients with PHA have an
      increased susceptibility for ischemia-reperfusion (IR)-injury due to down-regulation of the
      enzyme CD73. We will use the reduction in brachial flow-mediated dilation (FMD) by forearm IR
      as a well-validated endpoint for (endothelial) IR-injury.
    

Intervention name(s): forearm ischemia and reperfusion
Intervention type(s): Procedure
Intervention description(s): both arms will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: primary hyperaldosteronism; primary hypertension; forearm ischemia-reperfusion; (reduction) in brachial artery FMD; endothelial ischemia-reperfusion injury