bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Honey on Xerostomia and Oral Mucositis
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis; Xerostomia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the use of pure honey will help in the
      treatment of radiation induced xerostomia and oral mucositis (symptom management)
    

Detailed description: 
      Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure
      of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation
      epithelitis towards the second and third weeks of conventional fractionated radiotherapy.
      Likewise, salivary flow may decrease by approximately 50% during the first week of
      radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced
      xerostomia is associated with inflammatory reaction. The study will include an intervention
      and a control group, one receiving honey prior and after the radiotherapy and the other group
      not receiving honey at all.
    

Intervention name(s): Honey mouthwash; Normal Saline
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The patients in the intervention group will receive honey mouthwash 15 minutes before the radiotherapy session, 15 minutes after and 6 hours after the radiotherapy session; Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: head and neck cancer; radiotherapy induced xerostomia; radiotherapy induced oral mucositis; RCT; symptom management
Effect of Variable PSV in Acute Lung Injury: Part I and Part II
Condition: Acute Lung Injury (ALI); Acute Distress Respiratory Syndrome (ARDS)
MeSH terms: Lung Injury; Acute Lung Injury; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Wounds and Injuries
Study type: Interventional

Summary: 
      Noisy Pressure Support Ventilation (noisy-PSV) would lead to improved lung function, while
      preserving respiratory muscle unloading. Basically, noisy PSV differs from other assisted
      mechanical ventilation modes that may also increase the variability of the respiratory
      pattern (e.g. proportional assist ventilation) by the fact that the variability does not
      depend on changes in the patient's inspiratory efforts.

      The aim of this study is to evaluate the optimal variability for noisy PSV in patients with
      ALI based on its effects on respiratory mechanics, breathing comfort, gas exchange, and
      hemodynamics. The investigators hypothesize that noise in pressure support leads to
      variations in VT that are able to improve lung function and that physiologic variables
      respond differently to the degree of variability in pressure support
    


Intervention name(s): Noisy-PSV 1; Noisy-PSV 2
Intervention type(s): Other; Other
Intervention description(s): Noisy-PSV 1: different levels of variable pressure support (PS) will be randomized: a) PS variability equal to 0%, b) PS variability equal to 45%, c) PS variability equal to 90%.; Noisy-PSV 2 : different levels of variable Pressure Support (PS) will be randomized: a) PS equal to Baseline and variability 0%; b) PS equal to Baseline and variability set in order achieve an increase or decrease of pressure of 5 cmH2O; c) PS equal to Baseline - 5 cmH2O and variability 0%; d) PS equal to Baseline - 5 cmH2O and set in order achieve an increase or decrease of pressure of 5 cmH2O.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALI; ARDS; Noisy pressure support ventilation
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
Condition: Bioequivalence Study in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5
      mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg
      flupentixol, administered as single doses
    

Detailed description: 
      All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours
      post-dose) for each dosing period. First and second dosing will be separated by a washout
      period of at least 21 days
    

Intervention name(s): 0.5 mg Flupentixol film-coated tablet (test treatment); 1 mg Flupentixol film-coated tablet (test treatment); 5 mg Flupentixol film-coated tablet (test treatment); 0.5 mg Flupentixol coated tablet (reference treatment); 1 mg Flupentixol coated tablet (reference treatment); 5 mg Flupentixol coated tablet (reference treatment)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single oral dose, fasted state, day 1 in period 1 or 2; single oral dose, fasted state, day 1 in period 1 or 2; single oral dose, fasted state, day 1 in period 1 or 2; single oral dose, fasted state, day 1 in period 1 or 2; single oral dose, fasted state, day 1 in period 1 or 2; single oral dose, fasted state, day 1 in period 1 or 2
Other intervention name(s): Fluanxol®; Fluanxol®; Fluanxol®
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Retinal Nerve Fibre Layer by Optical Coherence Tomography in Uveitis Patients With Papilloedema
Condition: Uveitis; Glaucoma
MeSH terms: Papilledema; Glaucoma; Uveitis
Study type: Observational

Summary: 
      Assessment of optic disc morphology can be difficult in patients with uveitis and
      papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning
      techniques may help to detect damage to the retinal nerve fibre layer.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients with anterior or intermediate uveitis and papillooedema in fluoreszein
        angiography.
      
Keywords: anterior and intermediate uveitis; papilloedema
VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
Condition: Stroke; Upper Limb Deficits
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The primary study objectives are to assess the safety and feasibility of the therapy,
      including the surgical intervention and stimulation, as well as to provide information on the
      appropriateness of the study test measures (assessments) and to provide a basis for sample
      size calculations for a larger, pivotal study.
    


Intervention name(s): Vagus Nerve Stimulation (VNS)
Intervention type(s): Device
Other intervention name(s): VNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Adding Metformin to the Treatment of Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Insulin resistance is known to adversely effect viral response to treatment in hepatitis C
      patients

      We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of
      hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized
      controlled trial
    

Detailed description: 
      Subjects with hepatitis C will be randomized to receive standard treatment with or without
      metformin. The results will be compared.
    

Intervention name(s): Metformin; pegylated interferon; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg oral three times a day for 6 months; 180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype; 800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Intervention MeSH terms: Metformin; Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; metformin; Insulin Resistance
Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the relative bioavailability of the test
      formulation of sertraline 100 mg tablets with an already marketed reference formulation
      Zoloft® 100 mg tablets (Pfizer), under fasted conditions in healthy male and female adult
      subjects.
    

Detailed description: 
      This randomized, single-dose, two-way, crossover study was conducted to compare the relative
      bioavailability of two formulations of 100 mg sertraline hydrochloride tablets under fasting
      conditions. The study was conducted with 36 (30 completing) healthy adults in accordance with
      protocol No.

      10540323(Revision 0). In each study period, a single 100 mg dose was administered to the
      subjects following an overnight fast of at least 10 hours. The test formulation was Ranbaxy
      Research Laboratories's Sertraline Hydrochloride 100 mg Tablets and the reference formulation
      was ZOLOFT® (sertraline hydrochloride) 100 mg Tablets Manufactured by Roerig (Division of
      Pfizer). The subjects received the test product in one study period and the reference product
      in the other period; the order of administration was according to the dosing randomization
      schedule. There was a 14-day interval between treatments.

      Blood samples were collected pre-dose and at intervals over 144 hours after each dose. The
      plasma samples for all subjects completing both periods of the study were sent to Helen
      Fassoulas, B.Sc., Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul
      Industriel, Laval, Quebec, H7LAS3 Canada, Telephone: 450-663-6724, ext. 438, FAX:
      450-975-8111 for determination of sertraline plasma concentration.

      Statistical analysis was performed by Yetta I. Wilbur, Biostatistician, Novum Pharmaceutical
      Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206, USA, Telephone: 412-363-3300, Fax:
      412-362-5783 to evaluate the relative bioavailability of the test formulation to that of the
      reference product.

      A total of 36 healthy adult subjects.
    

Intervention name(s): sertraline 100 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence sertraline 100 mg tablets fasting conditions
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of aerosolized
      surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses
      to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous
      positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to
      neonates receiving nCPAP alone.
    


Intervention name(s): Lucinactant for Inhalation; nCPAP alone
Intervention type(s): Drug; Device
Intervention description(s): Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product); nCPAP therapy
Other intervention name(s): Aerosurf; nasal continuous positive airway pressure
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential escalating dosing groups, each group contained an active and control arm of equal size.
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery
Condition: Tracheal Reconstruction
Study type: Interventional

Summary: 
      Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with
      tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common
      indication for (TRR).The immediate postoperative period can be anxiety provoking for some
      reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which
      inadequately treated.

      Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia
      technique for its feasibility and efficacy. The use of regional anesthesia in combination
      with general anesthesia may lighten the level of general anesthesia required , provide
      prolonged postoperative analgesia and reduce the requirements for opioid analgesics

      Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic
      receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects.
      Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine
      enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical
      studies.

      Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer
      alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be
      equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.

      Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia
      techniques both after bolus administration and continuous post-operative infusion.
    

Detailed description: 
      The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine
      versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper
      tracheal resection and reconstruction surgery.
    

Intervention name(s): Levobupivacaine; Levobupivacaine-Dexmedetomidine; General Anaesthesia
Intervention type(s): Drug; Drug; Other
Intervention description(s): Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine; Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine; Using propofol, fentanyl and atracurium
Intervention MeSH terms: Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated
      estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated
      estrogens tablets produced using a new manufacturing process
    


Intervention name(s): bazedoxifene/conjugated estrogens
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Functions on Coronary Surgery
Condition: Neurocognitive Disorders
MeSH terms: Neurocognitive Disorders
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of different but safe levels of arterial
      oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. It is
      also to investigate the effect on cognitive functions in the postoperative period. For our
      study the investigators will conduct a randomized control trial. Patients will be randomly
      assigned to one of two possible study groups according to the arterial oxygen levels.If there
      is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be
      made by doctors.
    

Detailed description: 
      In most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level
      for safety purposes against the risk of tissue hypoxia that may develop during surgery due to
      CPB use. At the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage
      increases with the follow-up of CABG surgery, microcirculation is impaired and tissue
      oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. Recent research
      has focused on evaluating optimal oxygen levels in CPB during cardiac surgery. However, the
      potential of tightly regulated intraoperative normoxia to improve POCD following cardiac
      surgery has not been studied prospectively.

      The purpose of this study is to determine whether patients who underwent CPB and CABG, which
      were preserved under normoxic conditions during the intraoperative period, would have a lower
      incidence of early and late POCD than those exposed to hyperoxia.
    

Intervention name(s): procedure: cerebral oxygenation intervention
Intervention type(s): Procedure
Intervention description(s): During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cardiovascular surgery; cerebral oxymetre; neurocognitive assessment
The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of long-term dosing with
      ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
    


Intervention name(s): Patisiran
Intervention type(s): Drug
Intervention description(s): Patisiran was administered IV.
Other intervention name(s): ALN-TTR02
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All the participants received only patisiran but divided into 3 arm groups based on administration in the parent study (placebo or patisiran in 003 [NCT01961921] or 004 [NCT01960348] studies).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
Cardiac Magnetic Resonance in Children With Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Dystrophies, Limb-Girdle
Study type: Observational

Summary: 
      This protocol will exploit novel state of the art cardiovascular magnetic resonance
      techniques to examine important changes in the heart in children with muscular dystrophy. The
      purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected
      cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children
      with Muscular Dystrophy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the parallel protocol: PITT1109 Cardiac Outcome
        Measures in Children with Muscular Dystrophy
      
Keywords: cardiac; muscle; pediatric; dystrophy
Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival
Condition: Cancer, Rectum
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      This study was conducted to compare the significance of lymph node ratio and absolute count
      of positive lymph node count on overall survival in patients with rectal cancer who underwent
      resection with curative intent
    

Detailed description: 
      Retrospective cohort study carried on 229 patients with non-metastatic rectal cancer,
      admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical
      resection surgery with curative intent.

      Exclusion criteria included patients with familial adenomatous polyposis, multiple
      synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3
      months. Demographic, histopathological, follow up and outcome data were collected.

      Demographics included age, gender, family history, and chief complaint at presentation.
      Histopathological data included tumor site, grade, vascular-perineural invasion, total number
      of lymph nodes removed, and positive lymph nodes.

      Lymph node ratio was defined as the ratio of positive lymph nodes to the total number of
      retrieved lymph nodes in histopathology specimen. Survival was calculated for each patient
      based on time of surgery to time of death

      Statistical analysis will be used to evaluate the effect of lymph node ratio on overall
      survival.
    

Intervention name(s): Surgical resection for cancer rectum
Intervention type(s): Other
Intervention description(s): Curative resection for cancer recum
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with rectal cancer that were admitted in tertiary hospitals and underwent curative
        rectal resection. Patients' files were reviewed, and the data were collected and tabulated.
      
Keywords: Cancer Rectum; Lymph node ratio; Overall Survival; Prognosis
Sonography Guided Transcervical Ablation of Uterine Fibroids
Condition: Menorrhagia
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia
Study type: Interventional

Summary: 
      The objective of this study is to establish the safety and effectiveness of the Sonata®
      System in the treatment of symptomatic uterine fibroids.
    

Detailed description: 
      In this single-arm study, subjects who have symptomatic uterine fibroids will have
      transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using
      the Gynesonics Sonata System.
    

Intervention name(s): Intrauterine Ultrasound-Guided Radiofreq. Ablation System
Intervention type(s): Device
Intervention description(s): The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).
Other intervention name(s): Gynesonics Sonata System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abnormal Uterine Bleeding associated with fibroids; AUB-L; Fibroids; Heavy menstrual bleeding; HMB; Myoma; Menorrhagia