bioihbjkbjnl/mcl2 huggingface dataset:
Implication of Left veNtricle Vortex Flow Guided aNticOagulation Therapy for preVenting Apical Thrombus Formation In Patients With Acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION Study
Condition: Apical Thrombus Formation; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Thrombosis; Infarction
Study type: Observational

Summary: 
      Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting
      Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter
      Prospective Randomized Clinical Trial; INNOVATION study
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with acute anterior wall myocardial infarction showing akinetic or dyskinetic
        apical wall motion abnormalities on an initial transthoracic echocardiogram
      
Keywords: Vortex; Thrombus; Contrast echocardiography; Prediction and prevention of apical thrombus formation in acute myocardial infarction patient by using Vortex parameters.
PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      The investigators hypothesized that migraine without patients with many genetic loci
      associated with migraine (high genetic load) would be more sensitive and get provoked more
      migraine attacks by PACAP compared to patients with few genetic loci associated with migraine
      (low genetic load).
    

Detailed description: 
      Migraine is a very prevalent neurological disorder with a strong genetic factor. The common
      forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics
      research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic
      loci have been identified to be associated with migraine with (MA) and without aura (MA) in
      four large genome-wide association studies (GWAS). The functional consequences of this
      genetic variant in humans are yet unknown.

      PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is
      present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via
      an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that
      intracellular accumulation of cAMP is crucial for the induction of migraine attacks.

      The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of
      the 12 genetic susceptibility loci that have been identified.
    

Intervention name(s): PACAP
Intervention type(s): Drug
Intervention description(s): Pituitary adenylate cyclase-activating polypeptide (PACAP)
Other intervention name(s): Pituitary adenylate cyclase-activating polypeptide
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 3

Summary: 
      HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the
      Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single
      subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with
      Hereditary Angioedema (HAE) during an initial acute attack.
    

Detailed description: 
      Study HGT-FIR-086 will enroll 30 subjects from 2 to less than 18 years of age, divided into 2
      groups: prepubertal and pubertal/postpubertal. At least 10 prepubertal children and at least
      20 adolescents (including 10 treated during a HAE attack) must be enrolled in the study.

      After a qualifying screening period, the PK, safety/tolerability, and efficacy of treatment
      with SC icatibant will be evaluated in at least 20 subjects (10 prepubertal and 10
      pubertal/postpubertal subjects) who present with cutaneous, abdominal, or laryngeal symptoms
      of an acute attack of HAE. The PK and safety/tolerability of SC icatibant will be evaluated
      in at least 10 additional pubertal/postpubertal subjects who meet screening criteria and
      receive treatment with SC icatibant in the absence of a current acute HAE attack.

      The planned duration of active participation for subjects who present with an initial attack
      of acute HAE will consist of treatment with a single subcutaneous injection of icatibant on
      Day 1 through follow up at day 90.

      After having received initial treatment with icatibant, either during or in the absence of an
      attack, at least 10 pubertal/postpubertal subjects who subsequently experience an acute HAE
      attack may continue to receive treatment with icatibant as a single SC administration per
      attack for a total of 3 eligible icatibant-treated attacks.

      The period of active participation in the study for prepubertal subjects will be
      approximately 90 days, while that for pubertal/postpubertal subjects could be a maximum of
      approximately 270 or 360 days (3 separate active periods of approximately 90 days for those
      treated with icatibant during an attack; 4 separate active periods for those treated without
      an attack), with each active period separated by periods of inactive participation of
      variable duration.
    

Intervention name(s): icatibant
Intervention type(s): Drug
Intervention description(s): Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
Other intervention name(s): Firazyr
Intervention MeSH terms: Icatibant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Hereditary angioedema; HAE; Pediatric; Children; Pharmacokinetics; Safety; Firazyr; icatibant
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of
      selexipag on time to first morbidity or mortality event in patients with pulmonary arterial
      hypertension.
    


Intervention name(s): Selexipag; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Selexipag 200 µg tablets; Placebo tablets matching selexipag
Other intervention name(s): ACT-293987
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulmonary arterial hypertension; PAH
Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation
      with Barostim NeoTM compared to usual care in patients with resistant hypertension
      (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long
      modeling.
    


Intervention name(s): Baroreceptor stimulation with Barostim Neo TM
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; baroreceptor stimulation; Hypertension resistant
Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study is to determine and compare the effects of static and PNF hamstring
      stretching exercises on joint pain, hamstring flexibility and functional status in patients
      with knee osteoarthritis.
    

Detailed description: 
      A total of 36 patients between the ages of 40 and 75 who were diagnosed with
      Kellgren-Lawrence Stage II and III knee OA by the physician were included in the study.
      Participants were divided into two groups as static stretching group (n = 18) or PNF
      stretching group (n = 18). Patients' demographic and clinical information was recorded. Pain
      intensity was evaluated with visual pain scale, hamstring flexibility with Active Knee
      Extension Test, functional status with Western Ontario and McMasters University
      Osteoarthritis Index and Timed Get Up and Go Test. In addition to the standard physiotherapy
      program, the subjects praticed stretching exercises for 15 sessions according to the groups
      that they've been separated. Evaluations were repeated in the end of the treatment (4th week)
      and in the 3rd month after the treatment.
    

Intervention name(s): Static Stretching; PNF Stretching
Intervention type(s): Other; Other
Intervention description(s): Static hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist; PNF hold-relax stretching technique that consists of 10 seconds isometric contraction, 30 seconds hamstring stretching and 10 repetitions under the supervision of the physiotherapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Hamstring; Stretching
Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
Condition: Cardiovascular Diseases; Elderly Patients; Tooth Extraction
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This study intends to investigate the relevant risk factors of perioperation complications or
      mortality in older patients with cardiac diseases undergoing teeth extraction surgery and
      this study aims to quantify the risk factors and then to establish the predictive scoring
      systems.

      Hypothesis:Preoperative parameters could predict postoperative complications.
    

Detailed description: 
      This study intends to investigate the relevant risk factors of perioperative complications or
      mortality in older patients with cardiac diseases undergoing teeth extraction surgery and
      this study aims to quantify the risk factors and then to establish the predictive scoring
      systems.

      We hope that the benefits will include less patients becoming seriously postoperative
      complications and mortality after teeth extraction surgery.We also hope the information will
      help doctors understand the preoperative risks better and therefore make better informed
      decisions.This may also reduce the overall cost of surgery for patients and hospitals.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population are all older patients with cardiac diseases undergoing teeth extraction
        surgery.
      
Keywords: Cardiovascular diseases; Prediction model; Dental extraction; Elderly patients
Assess Safety, Tolerability and PK of AZD3199 in Japanese
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to investigate the safety and tolerability of single
      and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler
      inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse
      events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP),
      pulse rate, lung function parameters, body temperature and laboratory variables (clinical
      chemistry, haematology and urinalysis). The secondary objectives of the study are to
      investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by
      assessment of the degree of accumulation, dose proportionality and time linearity in healthy
      Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single
      and multiple ascending doses of AZD3199 by assessment of potassium and lactate
      concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and
      FEV1.
    


Intervention name(s): AZD3199 Turbuhaler®; Placebo Turbuhaler®
Intervention type(s): Drug; Drug
Intervention description(s): 240, 720 and 2160 μ g, single and multiple (o.d. for 12 days); single and multiple (o.d. for 12 days)
Intervention MeSH terms: AZD-3199
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD3199; Japanese Healthy Volunteers; Phase I study; Single and Multiple Ascending Dose; safety; tolerability; PK
Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      To determine whether oral or intravenous ibuprofen has a better or same efficacy and
      tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm
      infants.
    

Detailed description: 
      To determine whether oral or intravenous ibuprofen has a better or same efficacy and
      tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm
      infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this
      prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at
      an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

      One of the following echocardiographic criteria of a duct size >1.5 mm, a left
      atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood
      flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis
      determined the need of ibuprofen treatment.
    

Intervention name(s): oral ibuprofen
Intervention type(s): Drug
Intervention description(s): oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patent ductus arteriosis; İbuprofen; Extremely Low Birth Weigh infant
Drug Treatment for Pathologic Gambling Disorder
Condition: Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will establish the best dose of the drug naltrexone to treat patients with
      Pathological Gambling Disorder (PGD) and severe urge symptoms.
    

Detailed description: 
      PGD is a prominent and growing social problem. Unfortunately, there is no established drug
      treatment for this disorder. Preliminary investigations demonstrate that naltrexone in doses
      up to 250 mg/day is well tolerated and safe during an 11-week period and may be a viable
      treatment option for PGD patients with severe urges. The implications of this study extend
      from PGD to other impulse control disorders, including compulsive shopping, kleptomania, and
      possibly alcoholism.

      Participants are randomly assigned to receive either naltrexone or placebo for 16 weeks. The
      responses of men and women are compared to determine whether efficacy is distributed in a
      male:female ratio analogous to that of the PGD population in the United States. A Clinical
      Global Impression and a Gambling Symptom Scale are used to assess participants.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For subjects who were randomly assigned to naltrexone 50mg/day, 100mg/day, or 150mg/day.; For subjects who were randomly assigned to placebo.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impulse Control Disorders
Videoocular Assessment of Eye Movement Activity in an Ataxia Telangiectasia
Condition: Ataxia Telangiectasia; Dysmetria
MeSH terms: Ataxia; Cerebellar Ataxia; Ataxia Telangiectasia; Telangiectasis
Study type: Observational

Summary: 
      Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T
      mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural
      degeneration, immunodeficiency, and progressive ocular motor dysfunction. In previous
      studies, the quantitative description of the ocular motor deficits from clinical examination
      was limited to various defects in saccade and gaze control, dysmetric saccades, impairments
      of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow
      phases, and cancellation of the vestibulo-ocular reflex. The aim of our research is to add
      existing findings with quantitative description of oculomotor patterns in A-T patients using
      videooculography (VOG).
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The young citizens of Russia suffered from ataxia telangiectasia.
      
Keywords: Eye movements; Saccades; Unstable gaze holding; Rehabilitation
Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the
      full thickness palatal graft donor site healing acceleration and in the patient's morbidity
      reduction. Eighty patients, with at least one gingival recession will be treated by a flap
      with connective tissue graft(CTG). In the test group (20 patients) and in the control group 2
      a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the
      control groups 2-4 patients will be treated by an absorbable gelatin sponge. Patients will be
      monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the
      palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the
      post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic
      scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed
      bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.
    

Detailed description: 
      In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the
      full thickness palatal graft donor site healing acceleration and in the patient's morbidity
      reduction. Eighty patients, with at least one gingival recession will be treated by a
      coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the
      de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple
      layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups
      patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2,
      3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE),
      the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D),
      and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation.
      Furthermore, the analgesics consumption and the existence of delayed bleeding from the
      palatal wound (DWB) during the first post-operative week will be assessed.
    

Intervention name(s): Palatal wound bandage with PRF; Palatal wound bandage with Gelatine Sponge
Intervention type(s): Procedure; Procedure
Intervention description(s): palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes; palatal wound will be protected by gelatine sponge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison Between Efficacy of Music Therapy and Intravenous Midazolam 0.02 mg/kgBW in Reducing Preoperative Anxiety
Condition: Cancer
Study type: Interventional

Summary: 
      This study aimed to compare the efficacy of music therapy and midazolam 0,02 mg/kgBW in
      reducing preoperative anxiety on patients undergoing brachytherapy with spinal anesthesia
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Intravenous (IV) cannula had been set and The Amsterdam Preoperative Anxiety and Information
      (APAIS) score questionnaire was filled by the subject. Blood pressure, pulse rate, and mean
      arterial pressure were recorded. Subjects were then randomized into two groups (music therapy
      and midazolam). In music therapy group, subjects listened to music using headphone attached
      to music player for 30 minutes. Music player has been filled with variety of slow beat songs
      (60 - 80 BPM), including instrumental, pop, jazz, classical, and so forth. In midazolam
      group, subjects was given intravenous midazolam 0,02 mg/kgBW injection without listening to
      music. After injection, subjects are allowed to rest or sleep for 30 minutes. After
      intervention, APAIS score was filled by subjects with blood pressure, pulse rate, and mean
      arterial pressure recorded again. Subjects then were moved to brachytherapy room.
    

Intervention name(s): Music therapy; Midazolam
Intervention type(s): Other; Drug
Intervention description(s): Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia; Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care