bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy
Condition: EGFR Inhibitor-Induced Skin Rash
MeSH terms: Exanthema
Study type: Interventional
Phase: Phase 2

Summary: 
      Epidermal growth factor receptor inhibitor (EGFRI) therapy for cancer is associated with
      potentially severe face and trunk skin acneiform rash. Severe or persistent side effects may
      lead to decreased dose, interruption or discontinuation of EGFRI treatment. Inflammation is
      believed to play an important role in EGFRI-induced skin toxicity as a number of
      proinflammatory cytokines induced by EGFRI are released from epidermal cells, resulting in
      activation and recruitment of immune cells such as neutrophils and lymphocytes, and
      subsequent development of skin reaction associated with keratinocyte apoptosis. AC-701 has
      been reported its antibiotic and anti-inflammatory activities in literature, and further
      demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated
      with EGFR inhibition. This study is to evaluate the prophylactic efficacy of topical AC-701
      in subjects with skin rash associated with EGFRI therapy.
    


Intervention name(s): AC-701 Topical Gel 0.3%; Placebo Gel
Intervention type(s): Drug; Other
Intervention description(s): AC-701 Topical Gel 0.3%, BID; Placebo Gel, BID
Other intervention name(s): AC-701; Placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of LY3192767 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to investigate the side effects related to LY3192767 when
      given as an injection under the skin to healthy participants. Blood tests will be done to
      check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to
      get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and
      Part B. Each participant will enroll in one part. For each participant, Part A will last up
      to about 32 days after last dose and Part B will last up to about 49 days after last dose.
      Screening must be completed prior to study start.
    


Intervention name(s): LY3192767; Basal Insulin Peglispro; Insulin Glargine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered SC.; Administered SC.
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Condition: Pregnant Women
Study type: Interventional
Phase: Phase 2

Summary: 
      Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly
      used for spinal injection in cesarean section. Nevertheless, its use often results in a long
      duration of motor nerve block and a haemodynamical instability. Recently developped, the
      Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for
      hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for
      intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the
      effect of the local anesthetics while decreasing their dose-related side effects, the aim of
      this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled
      cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
    


Intervention name(s): HB Prilocaine 2% (varying dose); HB Prilocaine 2%; Sufentanil; Morphine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl; 2.5µg sufentanyl; 100 µg Morphine
Other intervention name(s): Tachipri; Tachipri
Intervention MeSH terms: Sufentanil; Morphine; Prilocaine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scheduled cesarean delivery; spinal anesthesia; local anesthesia
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine
      fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in
      patients with generalized anxiety disorder (GAD).

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate; Paroxetine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anxiety; GAD
Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying
      out of proportion. Other terms used to describe this condition include emotional lability,
      emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and
      pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the
      reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923
      in the treatment of MS patients suffering from pseudobulbar affect.
    


Intervention name(s): AVP-923
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pseudobulbar Affect; Uncontrolled; Laughing; Crying
n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone
      and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm
      after electrical conversion in patients with persistent Atrial fibrillation (AF).
    

Detailed description: 
      Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing
      burden on the healthcare system. Treatment of AF remains controversial. In patients on
      antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44%
      to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus
      rhythm.Over the last few years, a growing amount of evidences has supported the protective
      effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden
      cardiac death. Furthermore, in the last years, the interest for their possible beneficial
      role in AF prevention has been increasing.We hypothesized that the administration of n-3
      PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in
      patients with persistent AF. Therefore the present study aims to evaluate the role of n-3
      PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS
      blockers therapy in patients with persistent AF.
    

Intervention name(s): n-3 PUFAs; Placebo; RASS inhibitors and/or RAS blockers; Amiodarone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day; 1.0 g of olive oil,one capsule twice a day; Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.; Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.
Other intervention name(s): OMACOR; renin-angiotensin-aldosterone system inhibitor
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: PUFA atrial fibrillation
Anxiety Levels in Adolescents Undergoing Endoscopy
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The aim of our study was to evaluate the pre-procedure state and trait anxiety levels of
      adolescents patients hospitalized for the purpose of gastrointestinal endoscopy performed
      under sedation.
    

Detailed description: 
      Although anxiety is known to be a disorder that is much more relevant for adults, it is seen
      at a frequency of approximately 6.5% in the childhood and adolescence. Anxiety is usually
      examined in two different forms, state anxiety and trait anxiety. A total of 180 pediatric
      patients who underwent GIS endoscopy in our hospital were included in our study. Demographic
      data (age, gender, height, weight, educational status, school and grade), additional diseases
      and diagnoses were recorded. Our aim was to evaluate the anxiety and trait anxiety levels of
      adolescents scheduled for gastrointestinal system (GIS) endoscopy under sedation, after being
      admitted as a single-day inpatient and before the procedure. A form evaluating state and
      trait anxiety levels (Spielberger's state and trait anxiety scale) and another form
      consisting of demographic data were given to the patients. We requested that the forms be
      filled by the children themselves. After monitoring in the endoscopy unit, sedation was
      applied with IV anesthetic drugs routinely.Oxygenation was provided with nasal O2 in all
      patients. Heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2) were
      monitored. Also complications (bradycardia, tachycardia, arrhythmia, hypotension,
      hypertension, bronchospasm, decrease in SpO2, apnea) were recorded.
    

Intervention name(s): state and trait anxiety scale levels
Intervention type(s): Behavioral
Intervention description(s): While the STAI-I anxiety level is scored as "(1) never, (2) somewhat, (3) frequently, and (4) almost always", the scoring options in STAI-II are "(1) almost never, (2) sometimes, (3) most of the time, and (4) almost always".
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        180 pediatric patients
      
Keywords: Adolescent; anxiety; endoscopy; anesthesia
Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was an open-label, randomized, 2-way crossover to compare the
      single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)
      200 mg fluconazole tablets under fasting conditions.
    

Detailed description: 
      Detailed Description : The study was conducted as an open-label, randomized, single-dose,
      2-way crossover, relative bioavailability study performed on 18 healthy adult male
      volunteers. A total of 17 subjects completed the clinical phase of the study. In each period,
      subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral
      200 mg doses were separated by a washout period of 21 days.
    

Intervention name(s): Fluconazole; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Fluconazole Tablets, 200 mg; Fluconazole 200 mg tablets
Other intervention name(s): Dr. Reddy's Laboratories; Diflucan (Pfizer)
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Fluconazole; Crossover
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in
      the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will
      be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and
      calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target
      sample size is 100-500 individuals.
    


Intervention name(s): Placebo; ibandronate
Intervention type(s): Drug; Drug
Intervention description(s): po monthly for 12 months; 150mg po monthly for 12 months
Other intervention name(s): Bonviva/Boniva
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Pandemic on Children With Cerebral Palsy
Condition: Cerebral Palsy; Covid19
MeSH terms: COVID-19; Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood
      and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17
      million worldwide.

      Social isolation, economic conditions, interruption of treatments, etc. may cause physical,
      mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing
      regular physiotherapy can worsen functional skills and cause complications in children with
      cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments
      of children with cerebral palsy during the pandemic period, their physical and psychosocial
      effects, and the relationship between their parents' fear of covid-19.
    


Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        -Parents of children under the age of 18 with cerebral palsy who applied to our hospital
        between 01.01.2014-31.01.2021
      
Keywords: Cerebral Palsy; Covid19; Pandemics
Tardive Dyskinesia and Cognitive Function
Condition: Tardive Dyskinesia; Neurocognitive Function
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Previous researchers indicate that impaired cognitive flexibility was the primary factor
      distinguishing patients with from those without tardive dyskinesia (TD)1, and cognitive
      dysfunction correlates positively with the severity of TD2. Longitudinal data raised the
      possibility that the association between cognitive dysfunction and TD may reflect not organic
      vulnerability to but rather a state marker for this movement disorder as "tardive dementia"3.
      Atypical antipsychotic had been reported to alleviate the severity of TD4 and improved
      neurocognitive function separately5. But no researchers ever investigated the correlation of
      the two effects simultaneously. This randomized, single-blind and controlled study compared
      the effect of atypical antipsychotic on TD, neurocognitive function and associated factors
      for these changes.
    

Detailed description: 
      Eighty chronic schizophrenia inpatients who received conventional antipsychotics for more
      than one year, and met Schooler and Kane's criteria for persistent TD were enrolled in the
      study. The subjects were randomized to three groups: the olanzapine, amisulpride and FGA
      (first generation antipsychotic) controlled groups. Neurocognitive function were assessed
      using Wisconsin Card Sorting Test (WSCT) and Continuous Performance test (CPT) at baseline,
      12th week and 24th week. Clinical successive ratings were performed with Brief psychiatric
      Rating Scale (BPRS), AIMS (Abnormal Involuntary Movement Rating Scale), Simpson-Angus Rating
      Scale (SAS), Udvalg for Kliniske Undersogelser side effect ratings (UKU) and Barnes akathesia
      scale (BAS).To evaluate the influences of prognostic factors on tardive dyskinesia and
      neurocognitive function and to control for all potential confounding variables, longitudinal
      analyses on the repeated measures data were conducted using generalized estimating equation
      models (GEE).
    

Intervention name(s): amisulpride; Olanzapine; Conventional antipsychotics
Intervention type(s): Drug; Drug; Drug
Intervention description(s): amisulpride tablet 100-1200mg/day for 24 months; Olanzapine tablet 2.5 to 30 mg/day for 24 months; the subjects were randomized to the conventional antipsychotic group to maintain their original conventional antipsychotics
Other intervention name(s): solian; zyprexa; conventional antipsychotic
Intervention MeSH terms: Olanzapine; Antipsychotic Agents; Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tardive dyskinesia; neurocognitive function
Online Versus Real Time Dental Education
Condition: Educational Problems
Study type: Interventional

Summary: 
      Through covid period the concept of distant, online and hybrid learning evolved in reaction
      to lockdown. This hindered the capability of students to receive and practice on patients as
      they should do. The current study compared data of two classes that had different education
      systems because of COVID-19. Class 2020 had nearly a complete online teaching of theoretical
      part, practical and minimal patient interaction. Class 2021 had the opportunity to try both
      systems because of partial lockdown in 2020 and complete return to work in 2021.
    

Detailed description: 
      Methodology

      Evaluation of the quality of teaching of oral surgery curriculum during the COVID 19 lock
      down.

      The Objective Achieving high quality teaching in similar future situations. The Standards
      used for evaluation. The course report published by the faculty student's affair section and
      the students survey.

      ETHICS & ENGAGEMENT This data was collected from the course report published by the faculty
      student's affair section. All students shared in the survey consented that their data can be
      used and presented for research and audit purposes. All adjunctive research presented in this
      audit got ethical clearance from the Faculty Ethical Committee.

      sample Fourth year students studying oral surgery had online teaching and forty students had
      real time teaching.

      Survey Questions A short five-question survey was used to assess the students overall and was
      given to 40 students from each class to assess the student's satisfaction with the quality of
      the education.

      The survey questions:

        1. Technical skills taught during the academic year were valuable or not.

        2. real patients provide higher skills compared to dummies and models

        3. Teaching in real classroom is better than teaching through online portal

        4. do you prefer introudction of dummies before real time patients

        5. Regarding the overall satisfaction by the education system The survey portal had a
           percentage satisfactory meter. Responses over 50% or equal 50% were considered yes and
           responses below 50% were considered no.

      Statistical assessment:

      Chi-square test was used to assess the statistical significance between the results using
      SPSS software.
    

Intervention name(s): online teaching; In class teaching
Intervention type(s): Other; Other
Intervention description(s): teaching of subject was done using online system only; subjects were explained in normal class room
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two group survey 40 students had online teaching 40 students had real time teaching
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
The Impact of Non-pulsatile Blood Flow on CO2-Reactivity
Condition: Cerebrovascular Circulation
Study type: Interventional

Summary: 
      The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by
      systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were
      enrolled in this prospective case control study. Blood flow velocity in the middle cerebral
      artery as well as regional cerebral oxygenation was determined during step changes of PaCO2
      between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during
      non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood
      flow.
    


Intervention name(s): alteration of PaCO2 level
Intervention type(s): Procedure
Intervention description(s): step changes between 30, 40 and 50 mmHg
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each patient served as his own control.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to establish the relative bioavailability (BA) of two
      different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over
      the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation
      following oral single dose administration in fasting healthy male volunteers
    


Intervention name(s): Ranitidine hydrochloride ODT; Ranitidine hydrochloride ODT RM; Ranitidine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint); Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)
Other intervention name(s): Maximum Strength ZANTAC 150®
Intervention MeSH terms: Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment