bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Double-blind study (OMK1 vs. Placebo) A total of 90 patients, 30 per center, will be the
      study sample. The study will include patients with Primary Open angle Glaucoma (glaucoma or
      pseudoexfoliation) with a loss of visual field with MD between -2 dB and -15 decibel.

      Patients will be randomized into 2 treatment groups, both treated with hypotonic ocular drug
      therapy: one part of the patients will be treated with the OMK1 Medical Device containing
      topical citicoline for 3 years; the remaining part will receive a placebo.

      All patients will be followed with quarterly visits which will check, in addition to the
      intraocular pressure (IOP), the structure of the optic nerve and visual function (standard
      visual field).

      The primary objective is to evaluate a reduction of the perimetric progression in the group
      that receives the topical citicoline compared to the group treated with placebo. The
      reduction of the progression will be evaluated with Spectral Domain Optic coherence
      tomography and with standard perimetry (SAP).

      The secondary objective is to assess the tolerability and safety of OMK1 eye drops.
    


Intervention name(s): Citicoline eye drops (OMK1); Placebo Comparator: hypromellose based ocular lubricant
Intervention type(s): Device; Other
Intervention description(s): (OMK1) will be prescribed in the dosage of 1 drop 3 times a day; will be prescribed in the dosage of 1 drop 3 times a day
Intervention MeSH terms: Cytidine Diphosphate Choline; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glaucoma; Glaucoma Open Angle; Pseudoexfoliation Glaucoma
Biomarkers In Retinitis Pigmentosa (BIRP)
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Observational

Summary: 
      In this study, markers of oxidative stress will be measured in the aqueous humour and plasma
      of RP patients compared to controls.
    

Detailed description: 
      People with Retinitis Pigmentosa have loss of night vision followed by loss of central vision
      due to damage and death of photoreceptors. One of the mechanisms causing damage is high
      levels of oxygen in the eye. This damage produces specific biomarkers which can be measured.
      In this study, these biomarkers will be assessed in people with Retinitis Pigmentosa and
      compared to controls.
    

Intervention name(s): Anterior Chamber (AC) tap
Intervention type(s): Other
Intervention description(s): Aqueous Samples will be collected for measurement of biomarkers
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Retinitis Pigmentosa patients and Controls
      
Biospecimen description: 
      Anterior Chamber fluid from the eye
    
Keywords: RP
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
Condition: Chronic Periodontitis, Generalized
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic
      patients with chronic periodontitis?
    

Detailed description: 
      The aim of the present study was to monitor the clinical outcomes and the metabolic response
      of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled
      type 2 diabetes.

      Regarding clinical and metabolic parameters at baseline, no differences were displayed
      between two groups. However, at 3-months follow-up period the patients within a test group
      were demonstrated better clinical outcomes than patients in a control group
    

Intervention name(s): amoxicillin 500mg and metronidazole 400mg
Intervention type(s): Combination Product
Intervention description(s): metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
Other intervention name(s): Amoxil and Flagyl
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the
      effects of morning surgery with afternoon surgery on early postoperative sleep function and
      postoperative recovery under general anesthesia.
    

Detailed description: 
      The circadian rhythm is an intrinsic timing mechanism generated by endogenous systems to
      adapt to the external environment, which is closely related to the human sleep-wake cycle.
      Patients after major surgery are prone to changes in sleep structure and sleep quality,
      called postoperative sleep disturbances (POSD), which are characterized by the total sleep
      time reduced, rapid eye movement sleep absent, slow wave sleep shortened, and shallow sleep
      phase increased, times of wakefulness increased, and highly fragmented sleep. Some studies
      have shown that POSD can aggravate postoperative pain and fatigue, increase postoperative
      delirium, cardiovascular adverse events, and even cause accidental death of patients. The
      investigators don't know whether the early postoperative sleep function and postoperative
      recovery quality of patients undergoing general anesthesia are affected by surgery in the
      morning or in the afternoon. The present study was conducted in laparoscopic hysteromyoma
      patients, aiming to compare the effects of morning surgery with afternoon surgery on early
      postoperative sleep function and postoperative recovery under general anesthesia.
    

Intervention name(s): morning surgery; afternoon surgery
Intervention type(s): Other; Other
Intervention description(s): 31 patients will be operated on between 8:00 and 12:00 in the morning.; 31 patients will be operated on between 14:00 and 18:00 in the afternoon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Postoperative sleep disturbances; Postoperative recovery; General anesthesia; Early postoperative sleep; Procedure started in the morning and afternoon
Effect of a Multi-component Education Program on Salt Reduction in Adults
Condition: Blood Pressure; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Excess salt intake is a major contributor to high blood pressure, the leading individual risk
      factor for cardiovascular events, such as stroke, myocardial infarction and heart failure.
      According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than
      recommended by the international health organisations, indicating the need for effective
      implementation of salt reduction interventions. In Portugal the main source of daily salt
      intake is added salt during cooking, and salt content in bread, cheese and processed meat.

      The objective of this study is to determine the effectiveness of a dietary education program
      tailored for salt reduction. To assess the effectiveness of the salt reduction program the
      investigator's will measure changes in salt consumption levels, by evaluating the 24 h
      urinary sodium excretion.

      This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed
      to assess the effectiveness of a salt reduction program versus generic healthy lifestyle
      program in the Lisbon Metropolitan Area.
    


Intervention name(s): Salt reduction program; Healthy lifestyle program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.; Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Research has shown that music engages the brain bilaterally throughout cortical and
      subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This
      research explores the hypothesis that use of these shared neural networks allows neurologic
      music therapy interventions targeting upper extremity motor control to promote plasticity and
      functional improvements in persons recovering from a cerebrovascular accident. The potential
      therapeutic benefits of these interventions on attentional processes and affective responding
      will also be examined.
    

Detailed description: 
      More individuals are surviving and living with the effects of stroke, a trend that is
      expected to continue. Upper extremity limitations present a common, persistent challenge for
      stroke survivors, impacting quality of life. In addition, links have been found between
      physical impairment and depression, and depression and stroke-induced cognitive impairment.
      Music has been shown to exert multimodal effects on individuals and may be used as a
      mediating stimulus to promote therapeutic change. Furthermore, motor imagery may enhance the
      effectiveness of upper extremity interventions by engaging the same brain areas that are
      active in physical movement. The purpose of this study is to investigate the effects of
      therapeutic instrumental music performance and sensory-enhanced motor imagery on upper limb
      movement, affect and cognition following a stroke. Participants will be assessed at two
      baselines, and randomly assigned to one of three intervention groups: therapeutic
      instrumental music performance, therapeutic instrumental music performance and
      sensory-enhanced motor imagery, or therapeutic instrumental music performance and motor
      imagery without sensory enhancement.
    

Intervention name(s): Therapeutic Instrumental Music Performance; Therapeutic Performance with Sensory-Enhanced Motor Imagery; Therapeutic Performance with Motor Imagery
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.; Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.; Participants will engage in motor imagery of previously practised movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium
      Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate
      and atorvastatin calcium) tablets 10mg/80mg of Pfizer Ireland Pharmaceuticals Dublin, Ireland
      in healthy, adult,human subjects under Fed conditions.
    

Detailed description: 
      Open label, randomized, two-treatment, two-period, two-sequence, oral bioequivalence study of
      Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg under Fed conditions.
    

Intervention name(s): Amlodipine besylate/Atorvastatin calcium
Intervention type(s): Drug
Intervention description(s): Amlodipine besylate/Atorvastatin calcium 10/80 mg
Other intervention name(s): Caduet
Intervention MeSH terms: Amlodipine; Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females
Condition: Pharmacokinetics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aimed to compare age and gender differences for increasing doses of mirabegron when
      given to healthy young and elderly males and healthy young and elderly females.
    

Detailed description: 
      Each subject will receive a single dose of mirabegron OCAS-M or placebo on Day 2, followed by
      multiple dosing (qd) for 10 days (Day 5-14).

      Young subjects will be divided into 4 groups and elderly subjects into 2 groups. Dosage will
      be different among groups.
    

Intervention name(s): mirabegron OCAS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM178 OCAS
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Pharmacokinetics; Mirabegron; Phase 1; Dose-Escalation
Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
Condition: Adrenal Pheochromocytoma; Hemodynamic
MeSH terms: Pheochromocytoma
Study type: Interventional

Summary: 
      Study of the relationship between hemodynamic stability and preoperative intravenous
      rehydration in patients with pheochromocytoma
    

Detailed description: 
      All patients were subclassified into either the hemodynamic stability group (HS group) or the
      hemodynamic instability group (HU group) according to whether intraoperative hemodynamic
      instability occurred. Differences in data between the two groups were examined, and the risk
      factors for intraoperative hemodynamic instability were analyzed using logistic regression.
    

Intervention name(s): Abandonment of intravenous volume expansion during preoperative preparation in patients with pheochromocytoma
Intervention type(s): Drug
Intervention description(s): Abandonment of intravenous volume expansion with alpha-blockers during preoperative preparation in patients with pheochromocytoma
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Smartphone-based Application Post-myocardial Infarction to Manage Cardiovascular Disease Risk
Condition: Percutaneous Coronary Intervention
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators aim to evaluate Wellframe, a patient engagement platform that includes a
      mobile phone application for patients, for its impact on supporting patients who have
      undergone a percutaneous coronary intervention. The patient mobile app has articles about
      cardiovascular disease and other health related topics, patient-reported outcomes surveys,
      physical activity tracking, reminders for medications and upcoming appointments, and two-way
      communication with a Wellframe Health Advocate. The Wellframe Health Advocate encourages
      patients to achieve their health goals and stay engaged in their health. The feasibility of
      onboarding patients to the app and the clinical efficacy of the platform will be evaluated.
    


Intervention name(s): Wellframe
Intervention type(s): Other
Intervention description(s): Wellframe mobile phone app
Intervention model: Single Group Assignment
Intervention model description: Enroll and onboard 150 patients with the Wellframe application
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine
      will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and
      immunological responses in chronic hepatitis B (CHB) patients.
    


Intervention name(s): DV-601; Entecavir
Intervention type(s): Drug; Drug
Intervention description(s): Six injections of DV-601 administered over a period of 12 weeks.; Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
Other intervention name(s): Baraclude
Intervention MeSH terms: Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DV-601; hepatitis B; entecavir; therapeutic vaccine
Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this project is to investigate the effect of Raloxifene 120mg in men with
      schizophrenia. This trial will adopt a 12 week randomised controlled model.

      Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM)
      will have a significantly greater reduction in psychosis symptoms over the course of the
      study than men receiving adjunctive placebo.

      Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater
      improvement in cognitive function than men receiving adjunctive placebo
    

Detailed description: 
      With the recent advent of selective estrogen receptor modulators (SERMS), such as raloxifene
      hydrochloride, there is the potential to harness the positive estrogenic effect on central
      nervous system (CNS) neurotransmitter systems. While the CNS effects of raloxifene have not
      been fully studied, its actions are mediated through binding to estrogen receptors and can
      thereby regulate gene expression that is ligand, tissue or gene specific. By inference then,
      raloxifene would be expected to impact on dopamine and serotonin pathways in a similar
      fashion to unconjugated estrogen.

      This study aims to examine the impact of adjunctive SERM (120mg oral Raloxifene daily)
      treatment on the psychopathology and cognition of men with schizophrenia and related
      disorders
    

Intervention name(s): Raloxifene Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 120mg daily - 1 capsule daily for 12 week trial; 1 capsule daily for 12 week trial
Other intervention name(s): Evista; Raloxifene; Lactose
Intervention MeSH terms: Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Mental Illness; SERM; Raloxifene
A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics
      (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects
      with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate
      (MTX).
    


Intervention name(s): NNC0215-0384; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.; Placebo administered corresponding to NNC0215-0384 treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Is Levocetirizine Less Sedating Than Cetirizine?
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine
      (xyzal), and placebo differ in the degree of sedation they produce and their relief of
      allergy symptoms.
    

Detailed description: 
      Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative
      to placebo than was cetirizine in separate trials. We plan to examine whether patients who
      did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study
      will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine,
      cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will
      receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their
      own control.
    

Intervention name(s): Cetirizine; Levocetirizine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cetirizine 10 mg tab daily x 7 days; 5 mg tab daily x 7 days; Placebo tablet daily x 7 days
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic Rhinitis