bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Prevention Education After Acute Myocardial Infarction
Condition: Myocardial Infarction, Acute; Anxiety; Education; Quality of Life
MeSH terms: Myocardial Infarction; Infarction; Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of secondary prevention education given to
      individuals after acute myocardial infarction on physiological parameters, anxiety and
      quality of life.
    

Detailed description: 
      The aim of this study is to examine the effect of secondary prevention education given to
      individuals after acute myocardial infarction on physiological parameters, anxiety and
      quality of life.The population of the study will be the individuals hospitalized with the
      diagnosis of acute myocardial infarction in the Coronary Intensive Care Unit of Abant Izzet
      Baysal University Izzet Baysal Training and Research Hospital. The study will be conducted in
      a randomized controlled manner with two groups, 43 in the control group and 43 in the
      secondary prevention education group. CAG (Coronary Angiography) Procedure Training Form,
      Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale,
      Spielberg State and Trait Anxiety Scale and Myocardial Infarction Dimensional Assessment
      Scale will be used to collect data. The data will be collected by face to face interview
      technique. For descriptive statistics, mean and standard deviation or median and
      minimum-maximum values for numerical variables, number and percentage values for categorical
      variables will be given. The Kolmogorov-Smirnov test (p <0.05), skewness and kurtosis
      coefficients (should be ± 1) and X ̅ / SS <4 inequalities will be examined at the same time,
      and the weight in which group will be preferred.
    

Intervention name(s): Secondary prevention training
Intervention type(s): Other
Intervention description(s): Secondary prevention training will be given after acute myocardial infarction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 groups as intervention and control
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: myocardial infarction; anxiety; education; Quality of Life
Platelet-Rich Fibrin in the Healing of Regional and Free Flaps
Condition: Head and Neck Disorder; Free Flap
Study type: Interventional

Summary: 
      Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods
      improves the post-operative management of healing complications from flap donor sites.
    


Intervention name(s): Platelet Rich Fibrin (PRF) Application
Intervention type(s): Procedure
Intervention description(s): Platelet Rich Fibrin application to flap defect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-Rich Fibrin (PRF)
Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly; Insulin Resistance
Study type: Observational

Summary: 
      This study investigates fat distribution in people with acromegaly. The investigator is also
      investigating the change of fat distribution before and after treatment of acromegaly. The
      investigator will compare the results of people with acromegaly to the results of healthy
      volunteers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty-two study subjects will be studied: 1) patients with active acromegaly, and 2)
        healthy controls. Study subjects with acromegaly will be prescribed treatment for
        acromegaly by their healthcare providers, and this study will not interfere in anyway with
        clinical care and will not provide surgery, medications or other forms of clinical care.
      
Biospecimen description: 
      Whole blood, serum
A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety, tolerability, pharmacokinetics,
      pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects
      with mild to moderate Alzheimer's Disease.
    


Intervention name(s): PF-04360365; PF-04360365; PF-04360365; PF-04360365; Placebo; PF-04360365
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Biological
Intervention description(s): Single dose of 0.1 mg/kg IV on Day 1; Single dose of 0.5 mg/kg IV on Day 1; Single dose of 1 mg/kg IV on Day 1; Single dose of 5 mg/kg IV on Day 1; Single dose of placebo IV on Day 1; Single dose of 10 mg/kg IV on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen
      avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the
      advantages of specific treatment with long lasting efficacy, and can modify the course of
      disease. However, use of this treatment is restricted by the high risk of adverse events
      especially in asthmatics. Other, better tolerated, routes of allergen administration than the
      current conventional subcutaneous route (SCIT) have been investigated including sublingual
      (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting
      a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite
      (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The
      first year will be followed by an optional open label extension period. Immunoregulatory
      cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will
      be examined. This project will provide important fundamental knowledge on which to base
      improved and greater application of this potentially curative treatment for allergy. SLIT has
      the potential advantage of home administration and suitability for patients with asthma who
      are currently unable to access many of the allergen desensitising regimens.
    


Intervention name(s): (agent for immunotherapy) Staloral; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Immunotherapy agent for sublingual daily use. First week (vial containing the concentration 10 IR/ml) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
Second week (300 IR/ml) (vial containing the concentration 300 IR/ml) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
Maintenance phase Day 12 to 364 - 8 pressures daily
The first year will be followed by a second year open label period (optional)- 8 pressures daily; Matching placebo for sublingual use. Same schedule used for the intervention ACTIVE group.
First week (vial containing placebo) Day 1 - 1 pressure Day 2 - 2 pressures Day 3 - 4 pressures Day 4 - 6 pressures Day 5 - 8 pressures Day 6 - 10 pressures
Second week (300 IR/ml) (vial containing placebo) Day 7 - 1 pressure Day 8 - 2 pressures Day 9 - 4 pressures Day 10 - 6 pressures Day 11 - 8 pressures
Maintenance phase Day 12 to 364 - 8 pressures daily
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhinitis; asthma; atopy; house dust mite; immunotherapy; SLIT
The Sublimated Mare Milk Supplement in Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      This clinical trial studies the effect of sublimated mare milk supplement on patients with
      hepatitis C.
    

Detailed description: 
      Chronic viral hepatitis C is one of the medical, social and economic public health problems
      throughout the world. In majority of patients with chronic viral hepatitis C, dysbiotic
      changes are detected in the intestinal tract. Disturbances of microbial equilibrium are
      associated with the degree of inflammation, morphological changes in the liver, nature of the
      course and the stage of the disease.

      These dysbiotic changes and and associated immune disorders can significantly aggravate the
      course of immune processes in the liver, converting hepatitis C infection to a chronic
      disease.

      Mare milk is frequently reported for having therapeutic and dietary properties, which are
      initially associated with a specific chemical composition and certain physical properties of
      the product. It contains a total of about 40 biologically active components, the most
      important of them vitamins A, C, B1, B2, B6, B12, amino acids, enzymes and trace elements,
      there are low molecular weight peptides, lactalbumins and globulins.

      The use of mare milk can contribute to the restoration of impaired functions of damaged
      organs and tissues, and play the role of an auxiliary pathogenetic therapy, primarily in
      certain chronic diseases of the digestive system, including chronic viral hepatitis C. Mare
      milk can also be used as a powder supplement through sublimation process.

      In this trial, the effect of this supplement consisting of sublimated mare milk on hepatitis
      C patients will be evaluated. There will be two parallel groups: Interventional (sublimated
      mare milk supplement with standard treatment) and Standard treatment group. Differences in
      laboratory characteristics will be quantitively analyzed between groups.
    

Intervention name(s): Mare milk supplement; Standard therapy
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Supplement consisting of sublimated mare's milk with single-dose 20 mg sachet. The supplement is dissolved in 36-27 degrees of Celsius water and taken 15-20 minutes before meal.; For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and 3: sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Mare milk; Liver function
Comparison of Transfers of Fresh and Thawed Embryos in High Responder Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study tests the hypothesis that controlled ovarian stimulation impairs endometrial
      receptivity in high responders.
    

Detailed description: 
      The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw
      extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in
      patients with expected high response to ovarian stimulation.

      Multiple studies have found altered endometrial histology and gene expression following
      controlled ovarian stimulation.

      PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once
      thawed, the embryos are cultured to the blastocyst stage before transfer.

      In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do
      not actually resume and continue development. PTEC ensures the transfer of embryos that
      resumed development and continued developing at least to the blastocyst stage (4-5 days
      post-thaw).

      The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a
      fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with
      that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian
      stimulation to be assessed.
    

Intervention name(s): Embryo cryopreservation; Fresh blastocyst transfer
Intervention type(s): Procedure; Procedure
Intervention description(s): Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.; Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; in vitro fertilization; blastocyst transfer; endometrial receptivity; embryo cryopreservation
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
Condition: Renal Insufficiency, Chronic
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact
      on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease
      (ESRD).
    

Detailed description: 
      The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization
      in End Stage Renal Disease (ESRD) patients receiving dialysis.
    

Intervention name(s): SANGUINATE
Intervention type(s): Biological
Intervention description(s): Single two-hour infusion of SANGUINATE
Other intervention name(s): (pegylated carboxyhemoglobin bovine)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms
Condition: Parkinson Disease; Dyspepsia
MeSH terms: Parkinson Disease; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe
      for the treatment on health-related quality of life in Parkinson's disease (PD) patients with
      gastrointestinal symptoms.
    

Detailed description: 
      Gastrointestinal (GI) symptoms are frequently complained by PD patients. To improve their
      symptoms, prokinetics are often used in clinics. However, some prokinetics are dopamine
      receptor antagonist which can aggravate motor symptoms of PD patients or develop tardive
      dyskinesia when it affects dopamine receptors of the brain.

      DA-9701 (Motilitone) is recently developed herbal medication which has both 5-HT4 agonism and
      D2 antagonism. Furthermore, it does not cross the blood brain barrier that can be safely used
      in PD patients. Hypothetically it has a potential to be a good choice for the treatment of GI
      symptoms of PD patients. However, there has been no study that evaluates its efficacy and
      safety by randomized clinical trials in PD patients.

      This study will evaluate the efficacy and safety of DA-9701 in the double-blind
      placebo-controlled phase 1 (4 weeks), and the long-term safety of DA-9701 in the open-label
      phase 2 (8 weeks after phase 1).
    

Intervention name(s): DA-9701; DA-9701 placebo
Intervention type(s): Drug; Drug
Intervention description(s): DA-9701 30mg Tablet; Placebo pill manufactured to mask DA-9701 30mg Tablet
Other intervention name(s): Motilitone; Motilitone placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Condition: Head and Neck Cancer; Oral Complications; Radiation Toxicity
MeSH terms: Laryngeal Neoplasms; Mucositis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      sargramostim may protect normal cells from the side effects of radiation therapy.

      PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in
      preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of
           mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.

        -  Determine the effect of GM-CSF on quality of life aspects of these patients as assessed
           by nutritional status, analgesic use, and days in the hospital.

      OUTLINE: This is a randomized study.

      Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated
      to one of two treatment arms before scheduled radiotherapy begins.

        -  Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14
           of the course of radiotherapy.

        -  Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is
           healed, as well as at weeks 2 and 6 following the end of radiotherapy.

      PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.
    

Intervention name(s): sargramostim; quality-of-life assessment; radiation therapy
Intervention type(s): Biological; Procedure; Radiation
Intervention MeSH terms: Sargramostim
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: stage I laryngeal cancer; stage II laryngeal cancer; recurrent laryngeal cancer; oral complications; radiation toxicity
Verbal Stimulation of Orientation on Emergence Agitation
Condition: Emergence Delirium
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether information of the orientation such as
      time, place, and patient's own name can reduce emergence delirium after general anesthesia.
    


Intervention name(s): Giving orientation with headphones; Emergence as usual with headphones
Intervention type(s): Other; Other
Intervention description(s): During emergence, recorded voice of an investigator giving Information of orientation (time, place, patient's own name) is repeatedly played from noise-cancelling headphones; During emergence, recorded voice of an investigator calling the patient's name is repeatedly played from noise-cancelling headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Emergence delirium, Emergence agitation, Orientation
The Effect of Local Anaesthesia Technique on the Recovery After Dental Treatment in General Anaesthesia
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Use of local anaesthesia during full mouth dental rehabilitation under general anaesthesia is
      an everyday practice. It enables better control of the post-extraction bleeding and better
      control of physiological responses. Postoperative numbness and lip and cheek biting can be an
      undesired side effect. With our research, we aim to compare two different types of local
      anaesthesia in relation to postoperative side effects. We also aim to assess the oral
      health-related quality of life after treatment in general anaesthesia to enlighten how full
      mouth rehabilitation affects a child's life.
    

Detailed description: 
      Dental treatment of children under general anaesthesia (GA) is intended for children who, for
      one reason or another, are unable to participate in the outpatient clinic.

      When extracting teeth in GA, local anaesthetics (LA) are regularly applied to control
      bleeding, reduce postoperative sensitivity, and to better control vital functions. The side
      effects of LA can be the patient's irritation due to not understanding the postoperative
      numbness and lip and cheek biting.

      The aim of our study is to determine if there is a difference between the two types of local
      anaesthesia (computer-controlled intraosseous anaesthesia and classical local/conductive
      anaesthesia) in the frequency and extent of the occurrence of side effects postoperatively.

      The research data would help establish a better dental extraction protocol for children under
      GA, which would allow for less postoperative complications.
    

Intervention name(s): Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia
Intervention type(s): Procedure
Intervention description(s): QuickSleeper 5 with DHT needles or carpule with periapical/nerve block needles will be used to administer local anaesthetic before teeth extraction in general anaesthesia.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blinded prospective randomised study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fundus Autofluorescence After Macular Hole Surgery
Condition: Macular Hole
MeSH terms: Retinal Perforations
Study type: Observational

Summary: 
      Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients
      with macular hole. Investigators investigate the association between FAF and visual acuity,
      recovery of foveal microstructure, and FAF in surgically closed macular holes.
    

Detailed description: 
      Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and
      compared with swept source optical coherence tomographic (SS-OCT) images.
    

Intervention name(s): Vitrectomy with internal limiting membrane removal and gas tamponade
Intervention type(s): Procedure
Intervention description(s): Vitrectomy with internal limiting membrane removal and gas tamponade
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Optos ultrawide angle FAF images were taken in 27 eyes before and after MH surgery and
        compared with swept source optical coherence tomographic (SS-OCT) images.
      
Keywords: Macular hole
Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the absorption, metabolism and excretion of BIA 9-1067.
    

Detailed description: 
      Monocentre, open, non-placebo-controlled, single-group, single-dose study
    

Intervention name(s): BIA 9-1067
Intervention type(s): Drug
Intervention description(s): 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
Other intervention name(s): Opicapone
Intervention MeSH terms: Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067