bioihbjkbjnl/mcl2 huggingface dataset:
Acute Biliary Pancreatitis - Optimal Time for Cholecystectomy
Condition: Acute Biliary Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      In patients with mild gallstone pancreatitis, early cholecystectomy within 48 hours might
      reduce the risk of recurrent gallstone-related complications, compared with the more commonly
      used strategy in our locality of conservative management and delayed cholecystectomy.
      However, evidence to support early cholecystectomy is poor, and concerns exist about an
      increased risk of cholecystectomy-related complications with this approach. In this study, we
      aimed to compare the benefits and harms of early versus delayed cholecystectomy in patients
      with mild biliary pancreatitis.
    

Detailed description: 
      Inclusion criteria

        1. Patient diagnosed with a first attack of mild biliary pancreatitis

        2. Age ≥ 18 years

        3. American Society of Anesthesiologists (ASA) grade I, II or III

        4. a serum C-reactive protein (CRP) concentration less than 100 mg/L,

        5. no need for opioid analgesics,

        6. normal oral diet tolerance Exclusion criteria

      1. chronic pancreatitis 2. alcohol abuse 3. pregnancy The number of patients needed was
      calculated. Considering a power of 80% and reliability of 0.05, we found that 53 patients
      should be present in each group. Eligible patients will be randomly divided into two equal
      groups (Group 1: early cholecystectomy, Group 2: delayed cholecystectomy) according to a
      computer-generated random numbers.

      Procedure Early cholecystectomy was done within 48 after admission. Delayed cholecystectomy
      was done after 30 days after randomization. All cholecystectomies were done by, or under the
      direct supervision of, a surgeon who had undertaken at least 100 cholecystectomies in the
      past 5 years.
    

Intervention name(s): early cholecystectomy; delayed cholecystectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): cholecystectomy was done within 48 after admission; cholecystectomy was done after 30 days after randomization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
NextStep:Study to Evaluate Safety,Efficacy & Tolerability of Rivastigmine Patch in Mild to Moderate Alzheimer's Patients.
Condition: Mild to Moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function
      measured as change from baseline to week 24 in the total score of Mini-Mental State
      Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to
      benefit from other cholinesterase inhibitors (ChEIs).
    


Intervention name(s): Rivastigmine Patch
Intervention type(s): Drug
Intervention description(s): Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and will be up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
Other intervention name(s): rivastigmine
Intervention MeSH terms: Rivastigmine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease
Active Prevention of MSDs (Musculoskeletal Disorders, Upper and Spine Members) in the Context of Computer Screen Work
Condition: Symptomatic Musculoskeletal Diseases; Latent Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the benefit of an intervention by a computer program comprising active breaks, in
      the form of a personalized self-program on functional impairment and / or pain, among
      employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in
      connection with the computer work environment.
    

Detailed description: 
      The benefit of the intervention will be assessed among four groups of subjects: symptomatic
      and asymptomatic subjects randomized in control or experimental group.

      Subjects of the experimental group will have to follow an intervention for one month,
      consisting in active breaks from computer work. Control group patients had no intervention.

      Symptoms of MSD will be assessed via questionnaire before and after intervention, in all
      groups.
    

Intervention name(s): Computer program
Intervention type(s): Behavioral
Intervention description(s): Intervention consists in a computer program suggesting workers to take active breaks at given times of their working day, during one month.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: musculoskeletal diseases; eyestrain; occupational diseases; computer work; muscle stretching exercise; computer software application; MSDs
A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone
Condition: Multiple Myeloma; Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hematopoietic stem cells (HSC) are used to support the administration of high dose
      chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5
      million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs
      such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream.
      HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of
      patients fail to mobilize the minimum HSC dose required for safe transplantation, and this
      trial is investigating a way to enhance mobilization to overcome this problem. This trial
      aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when
      used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will
      be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells
      will be collected. A comparison group of patients will be given G-CSF alone for both
      mobilizations. Stem cells collected from patients in this trial will be frozen and stored
      until they are required for transplantation into that patient. At that time, patients will be
      monitored for how well they recover from their high dose chemotherapy and HSC
      transplantation.
    


Intervention name(s): VTP195183
Intervention type(s): Drug
Intervention description(s): VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Lymphoma
Laryngeal Mask Insertion Conditions And Hemodynamic Effects
Condition: Laryngeal Masks
Study type: Interventional

Summary: 
      This interventional double-blind, randomized trial has included120 children of American
      Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either
      sex, scheduled for outpatient minor surgery under general anesthesia.This study examined
      whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion
      conditions and preserve hemodynamic state in patients.
    

Detailed description: 
      This study aims to compare two anesthesia protocols: propofol induction with or without a
      prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or
      unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of
      blood pressure and heart rate).

      The conditions of LMA insertion have been assessed in each study group by an experimented
      anesthesiologist, who was unaware of the treatment group assignment. Conditions were
      considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed,
      there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When
      the investigators save at least one unacceptable of these criteria, conditions were
      considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose
      of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of
      attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed
      attempts of LMA insertion, and then patient was excluded.
    

Intervention name(s): Ketamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group; The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group
Other intervention name(s): sevoflurane, nitrous oxide (N2O); sevoflurane, N2O
Intervention MeSH terms: Ketamine; Nitrous Oxide; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled and double blind assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ketamine; Propofol; laryngeal masks; anesthesia; child
Laboratory Smoking of Marijuana "Blunts"
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind within-subjects clinical laboratory study comparing the product appeal
      and abuse liability-related subjective effects of different flavored cigar wrappers for
      marijuana blunts.
    


Intervention name(s): Marijuana
Intervention type(s): Drug
Intervention description(s): Marijuana smoked via blunts with different cigar wrappers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis
Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children
Condition: Diarrhea, Infantile
MeSH terms: Diarrhea; Diarrhea, Infantile
Study type: Interventional

Summary: 
      Randomized double blinded clinical trial comparing amino acid based oral rehydration
      solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in
      pediatric population
    


Intervention name(s): VS002A; WHO-ORS
Intervention type(s): Other; Other
Intervention description(s): Amino acid based ORS/Medical food; WHO Oral rehydration solution, which is glucose based
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blinded
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Smokeless Tobacco on Anterior Segment
Condition: Eye Manifestations; Tobacco; Use, Harmful; Tobacco Chewing Toxicity
MeSH terms: Eye Manifestations
Study type: Observational [Patient Registry]

Summary: 
      Observational, comparative, cross-sectional study
    

Detailed description: 
      To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment
      parameters using optical biometry. Observational, comparative, cross-sectional study Place
      and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University.

      The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes
      of 54 healthy subjects without ST (control group). Following a full ophthalmological
      examination, baseline measurements were taken with optical biometry and these measurements
      were repeated at 5, 30 and 60 mins after using ST.
    

Intervention name(s): optical biometry measurement
Intervention type(s): Device
Intervention description(s): The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All the study subjects underwent a full ophthalmological examination.The anterior segment
        parameter measurements were taken with optical biometry.

        Each subject was questioned in respect of how many years and how many times a day they used
        ST. Before taking the optical biometry measurements, the subjects were questioned as to
        whether they had used ST, drunk anything containing caffeine or smoked cigarettes in the
        previous 12 hours, and those who had were excluded from the study.

        Each subject was given 1mg ST and the optical biometry measurements were repeated after 5,
        30 and 60 mins. A single measurement was performed with optical biometry in the control
        group. To avoid diurnal variations, the measurements were taken in the morning between
        09.00 and 12.00 hours.
      
Keywords: Optical biometry; pupillar diameter; smokeless tobacco
Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth
Condition: Deep Caries Lesion of Primary Teeth
Study type: Interventional

Summary: 
      In front of a lack of evidence to determine the best treatment for deep cavitated carious
      lesions, the search for an effective restorative technique, which results in a least possible
      discomfort to patients, and reduce the time needed for the restorative treatment, if becomes
      relevant. The objective of this randomized clinical trial to evaluate the efficacy of high
      viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium
      hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for
      treatment of deep lesions in primary molars, as well as the impact of treatment in the
      criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4
      to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera
      of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium
      hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be
      evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The
      efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related
      to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3)
      cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival
      and the long-rank test. Cox regression is performed the assessment of the influence of some
      other variable results. For all analyzes, the significance level is set at 5%.
    


Intervention name(s): HVGIC; Indirect pulp capping
Intervention type(s): Other; Other
Intervention description(s): In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.; In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Condition: Safety Issues; Immunogenicity
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed
      typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
    

Detailed description: 
      Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed
      typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.

      Involved participants aged 6 months old to 60 years old.
    

Intervention name(s): Vi-DT Typhoid Conjugate Vaccine; PQed Typhoid Conjugate Vaccine; Vi Polysaccharide Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 dose of Investigational Product; 1 dose of Active Comparator; 1 dose of Active Comparator
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine.
Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Typhoid Conjugate Vaccine
Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients
Condition: Neurocysticercosis
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a short course of increased corticosteroid
      dosing with tapered dosing decreases seizure frequency as compared to standard corticosteroid
      dosing in patients with neurocysticercosis (NCC).
    

Detailed description: 
      NCC is the most common parasitic infection of the central nervous system (CNS). It is caused
      by ingestion of eggs from a tapeworm of genus Taenia. Inflammation, seizures, or neurologic
      problems may occur in a patient with NCC. Corticosteroids are the current standard of care
      for NCC patients, but corticosteroids have many side effects. Albendazole is used to treat
      infections caused by worms; however, it is unclear if its use with the corticosteroid
      dexamethasone will decrease seizure frequency in NCC patients. The purpose of this study is
      to evaluate the efficacy of reducing seizure frequency with a short course of dexamethasone
      with tapered dosing when given with albendazole, as compared to standard dexamethasone and
      albendazole treatment, in NCC patients.

      In this open label study, patients will be randomly assigned to one of two arms. Group I will
      receive 6 mg dexamethasone daily for 10 days only. Group II will receive 6 mg dexamethasone
      daily for 10 days, then 8 mg dexamethasone daily for 4 weeks with a 2-week taper. Both groups
      will also receive albendazole and omeprazole (a medicine that helps prevent gastroesophageal
      disease [GERD], a side effect of corticosteroid use). There will be 13 study visits over a
      360-day period. Blood collection will occur at most visits. Group II will also undergo sputum
      smears and rapid culture testing on Days 14, 28, and 42. Patients will undergo magnetic
      resonance imaging (MRI) at screening and on Day 180 and computed tomography (CT) scanning on
      Day 360.
    

Intervention name(s): Albendazole; Dexamethasone; Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg tablet taken orally twice daily; 6mg or 8mg taken daily; 20 mg tablet taken orally daily
Intervention MeSH terms: Albendazole; Dexamethasone; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Taenia; Seizures; Tapeworm; Parasite
App Based Dexterity Training in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and
      the most common cause of non-traumatic disability in young adults (Kamm et al. 2014;
      Vanbellingen & Kamm, 2016). It is a heterogeneous disease, which is associated with long-term
      disability, leading to reduced quality of life (QoL). Disease-modifying pharmacological
      therapies (DMT) decrease activity and progression of the disease, and symptomatic
      pharmacological treatments reduce complaints to a certain extent, however MS patients often
      still suffer from various neurological deficits during the course of their disease (Kamm et
      al. 2014). Consequently, specific non-pharmacological therapies are needed in order to
      further reduce disability, eventually resulting in better QoL (Lamers et al. 2016;
      Vanbellingen & Kamm, 2016).

      Impaired dexterity is a frequently observed impairment, affecting up to 76% of patients with
      MS (Johannson et al. 2007). The different neurological deficits caused by MS, such as ataxia,
      spasticity, sensory-motor deficits, and apraxia may be alone or in combination, impair manual
      dexterity (Kamm et al. 2012; Heldner, Vanbellingen et al. 2014). MS patients experience
      impairments in the performance of several activities of daily living (ADL), such as grooming,
      cooking, etc. Sometimes these problems are even associated with loss of work, and lack of
      social integration (Chruzander et al. 2013).

      The effectiveness of the app based exercises still needs to be proven. With respect to
      dexterity, a first new app has been developed called "Finger Zirkus", by a team of experts
      including an occupational therapist, graphic designer, and IT expert. The app is already
      available to be downloaded from google play store or apple store (see for more details:
      www.fingers-in-motion.de).
    


Intervention name(s): App Dexterity; Theraband
Intervention type(s): Behavioral; Behavioral
Intervention description(s): App based dexterity training by means of Finger Zirkus (see for more details: www.fingers-in-motion.de); Active control being five traditional hand strengthening (Thera-band) exercises, which we published in our previous RCT, being feasible and effective in improving dexterity (for more details see for Kamm et al. 2015).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment