bioihbjkbjnl/mcl2 huggingface dataset:
A Randomised Controlled Trial on LESS Versus Conventional Laparoscopic Appendicectomy.
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 3

Summary: 
      LESS laparoscopic appendectomy is associated with less pain than conventional 3-port
      laparoscopic appendectomy.
    

Detailed description: 
      Since the original description in the 1970's, the laparoscopic approach to management of
      surgical diseases has gained widespread acceptance. It has been shown to be associated with
      decreased wound pain, analgesic requirements, hospital stay and allows improved cosmesis and
      quality of life without significantly increasing the risks of morbidities and mortalities.
      With continued improvements in technology, however, efforts to reduce the number of abdomen
      wounds in an attempt to further decrease pain, improve cosmesis and outcomes are underway.
      Natural Orifices Transluminal Endoscopic Surgery (NOTES) has received widespread attention in
      both the medical field as well as the general public. However, there are still a multitude of
      problems that needs to be solved before the technique can be broadly applied to human
      subjects [7]. On the other hand, a renewed interest in single incision laparoscopic surgeries
      is emerging. The approach has been shown to be safe and feasible in our experience as well as
      the others. It also has the potential to further decrease the surgical trauma induced to the
      patient and to improve cosmesis.

      Since laparoscopic appendicectomy is one of the most basic procedures in laparoscopic
      surgery, it is an appropriate model for initial evaluation of single incision laparoscopic
      surgery. Our unit has already performed 20 cases of single site access laparoscopic
      appendicectomy (SSALA) and so far, the results have been encouraging (data pending
      publication). All the patients in the series had their procedures completed with a single
      incision. None of the patients suffered from adverse events and all had resumption of oral
      diet by day 1 and were discharged on day 2 post-operatively. However, whether the approach is
      more beneficial as compared to conventional three-port laparoscopic appendicectomy is still
      uncertain.

      Hence, the aim of the current study is to compare the approach of SSALA to conventional
      three-port laparoscopic appendicectomy in reducing surgical trauma and improving cosmesis to
      the patient.
    

Intervention name(s): LESS appendectomy; Conventional 3-port laparoscopic appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): See under arms description; See under arms description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Single incision laparoscopic surgery; Single site access laparoscopic surgery; SILS; Single-port access; Laparoendoscopic single site surgery; Appendectomy
A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions
Condition: Parkinson Disease; Huntington Disease; Autistic Spectrum Disorders; Fragile X Syndrome; Alzheimer Disease; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Alzheimer Disease; Huntington Disease; Fragile X Syndrome; Cognitive Dysfunction; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain,
      may be a valuable tool in the early detection, understanding, or evaluation of Parkinson
      disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum
      Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).

      The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as
      a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research
      participants and similarly aged healthy subjects.
    

Detailed description: 
      Informed consent will be obtained for all subjects. All subjects will undergo a screening
      evaluation including baseline clinical laboratory testing, a baseline physical and
      neurological evaluation and baseline cognitive evaluations. All subjects will undergo
      [18F]F-PEB PET imaging. Subjects may also be asked to undergo standard brain MRI to assist in
      the analysis of the PET images obtained.
    

Intervention name(s): [18F]FPEB
Intervention type(s): Drug
Intervention description(s): Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]F-PEB
Other intervention name(s): Fluorine-18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Parkinson; Huntington's; Fragile X; Autistic Spectrum; Alzheimer's; MCI
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic
      efficacy of MK0773 in healthy postmenopausal women.
    


Intervention name(s): MK 0773; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks; Placebo oral tablet b.i.d for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fecal Microbiota Transplantation for Pancreatitis
Condition: Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction; Fecal Microbiota Transplantation
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis
      and protecting the gut against pathogens by competing for nutrients, creating the intestinal
      biological barrier and modulating the host immune system.After the onset of acute
      pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in
      intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and
      endotoxin translocation, which may cause infectious complications which are major causes of
      death in SAP patients.Recently,FMT was shown its efficacy in the treatment of
      gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora
      disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the
      mechanism by which FMT results in cure of diseases has been poorly understood.This study aims
      to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier
      dysfunction.
    

Detailed description: 
      Investigators aims to restore the intestinal bacteria homeostasis through FMT by retention
      enema with fresh bacteria,thus stabilizing intestinal barrier dysfunction,minimizing
      bacterial translocation and preventing infectious complications.The investigators will
      further examine the effect of FMT on inflammatory markers，the predictors of Intestinal
      barrier injury and the incidence of infectious complications.
    

Intervention name(s): Fecal Microbiota Transplantation; normal saline
Intervention type(s): Procedure; Drug
Intervention description(s): FMT via a nasoduodenal tube with fresh bacteria from healthy donor; Normal saline via a nasoduodenal tube.
Other intervention name(s): Fecal Microbiota Therapy; Fecal Transplantation; normal saline 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Severe acute pancreatitis; Fecal Microbiota Transplantation; Intestinal barrier dysfunction; Intestinal flora
Ethaselen for the Treatment of Thioredoxin Reductase High Expression Advanced Non-small Cell Lung Cancers
Condition: Carcinoma, Non-small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed
      that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell
      growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200
      mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately
      50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++
      or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg
      ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In
      pre-clinical research, our group found that, elevated of thioredoxin reductase activity was
      associated with the expression of thioredoxin reductase tested by immunohistochemistry, which
      means high expression of this enzyme may be a favourite predicted factor of ethaselen, the
      specific inhibitor of thioredoxin reductase.
    

Detailed description: 
      This phase 1c study will include patients pathologic diagnosis advanced non-small cell lung
      cancer who had received more than two lines standard treatment, according to NCCN Non-small
      cell lung cancer guideline, there were no standard treatment scheme for these patients.
      Approximately 40 patients will be included in the study, patients will received oral
      ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week
      disease control rate(DCR, CR+PR+SD), secondary endpoints include progression free
      survival(PFS), overall survival(OS), quality of life(QOL) and drug safety.
    

Intervention name(s): ethaselen
Intervention type(s): Drug
Intervention description(s): ethaselen is a specific thioredoxin reductase inhibitor, which has finished phase 1a study in China, phase 1 study of ethaselen showed that 600 mg ethaselen bid could be well tolerated
Other intervention name(s): BBSKE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; thioredoxin reductase
Impact of Physiotherapy Intervention for Children With Ankle Sprains
Condition: Physical Therapy
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      This study will investigate whether adding a physiotherapy intervention to standard Emergency
      Department care will lead to improved recovery following an ankle sprain in the pediatric and
      adolescent population as well as to a decrease recurrence of injuries during the year
      following the initial ankle sprain. Children will be allocated to standard care or to the
      added intervention group. The study hypothesis is that recovery will be better while
      recurrence of injury will be less in those receiving the added physiotherapy intervention.
    


Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Physiotherapy treatment bi-weekly, delivered at the child's home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Nutritional Transition in the Maghreb and Prevention of Obesity and Non-communicable Diseases
Condition: Iron Deficiency,; Anaemia,; Overweight,; Metabolic Syndrome
MeSH terms: Obesity; Overweight; Metabolic Syndrome; Iron Deficiencies; Noncommunicable Diseases
Study type: Observational

Summary: 
      Problematic and state of the art Obesity and its associated non communicable diseases (NCDs)
      are rising rapidly in middle income countries, such as those in the Maghreb (North Africa).
      This progression is related to the context of a nutrition transition (changing food and
      physical activity environment) and profound changes in technological advances and in society.
      These societies and their health systems are insufficiently prepared for this evolution,
      which has enormous health and socioeconomic consequences. In the context of limited
      resources, the priority has been given on an international level to prevention. But several
      problems arise: - these countries are still confronted by undernutrition in terms of
      micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level
      and also individual level. Known as the 'double burden', this coexistence is relatively new
      and has been rarely documented until recently. Educational measures could be ineffective in a
      society where cultural norms do not recognise obesity and where changes in lifestyle are
      possibly not seen as acceptable. As well as information about citizen's knowledge of risk
      factors, data on their perceptions and attitudes are indispensable. Policies that involve
      changing the 'obesogenic' environment that individuals occupy is a priority.

      Objectives of the project Overall aim: to contribute to the development of preventive
      strategies for obesity and chronic NCDs in the context of a nutrition transition.

      Specific objectives: characterise the nature and size of the double burden
      (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of
      biological and behavioural risk factors; characterise the psycho-sociocultural determinants
      of behaviour.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Residents of the region of the capital city
      
Keywords: North Africa; Urban women; Double burden of malnutrition; Iron depletion; Overweight/obesity; Metabolic syndrome; Abdominal obesity; Excess body fat
Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as
      adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.
    

Detailed description: 
      This will be a 2-part multicentre study in approximately 117 patients. Part I of the study
      will consist of a 4-week prospective observational baseline period, a 12-week double-blind
      period (4-week up-titration and 8-week maintenance), and a tapering-off period.

      After the screening visit (V1), patients will enter the baseline period. At the end of the
      baseline period (V2), eligible patients will be randomised in a ratio of 2:1 to receive
      double-blind treatment with Eslicarbazepine acetate or Placebo in addition to concomitant
      therapy with 1 or 2 Anti-Epileptic Drugs (AEDs). Concomitant AED therapy will be kept stable
      during the whole study.

      Initial dose of the study treatment will be 10 mg/kg/day. After 2-weeks on 10 mg/kg/day, the
      dose will be up-titrated to 20 mg/kg/day (maximum 1200 mg/day). After 2 weeks on 20
      mg/kg/day, dose will be up-titrated to 30 mg/kg/day (maximum 1200 mg/day) and patients will
      receive this dose for 8 weeks. If intolerable adverse events (AEs) occur, the patient can be
      down-titrated to the previous dose (only 1 down-titration step will be allowed) or
      discontinued. After the 8-week maintenance period, the study treatment will be tapered off in
      10 mg/kg/day 2 week steps. However, if a patient experiences an increase in seizure frequency
      (e.g. more than 100% increase vs. baseline) during tapering-off, the patient can proceed
      directly to the open-label part of the study (Part II).

      After completion of the last 2-week 10 mg/kg/day step, patients will have the option to enter
      a 1 year open-label treatment (Part II) with Eslicarbazepine acetate (up to 30 mg/kg/day,
      maximum 1200 mg/day), or will have a 4 week observational follow-up period.
    

Intervention name(s): Eslicarbazepine acetate (BIA 2-093); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary.; Treatments will be administered by oral route, once-daily, in the evening.
Other intervention name(s): Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial Epilepsy; eslicarbazepine acetate; Children
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to test the pharmacokinetics, safety, and tolerability
      of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic
      fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the
      drug are found in the sputum.

      Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development
      (OOPD)
    

Detailed description: 
      This is a two center pharmacokinetic and safety dosing study of IV gallium nitrate (Ganite®)
      in cystic fibrosis (CF) patients. Eighteen subjects are planned. Each subject will be
      administered a single 5-day infusion of study medication (one of 2 doses). No placebo is
      used. Each subject will receive 5 days of continuous infusion of the experimental treatment.
      There will be two dosing cohorts (cohort 1: 100 mg/m2/day and cohort 2: 200 mg/m2/day).
      Cohort 2 will begin enrollment only after Data Safety Monitoring Committee (DSMC) safety
      review and approval of cohort 1 data. Study visits occur at baseline (day 1), day 3 (visit
      2), day 6 (visit 3), day 8 (visit 4), day 14 (visit 5), day 28 (visit 6), and day 56 (visit
      7).

      Screening data will be reviewed to determine subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the study.

      The following treatment regimens will be used:

      • Experimental treatment continuous infusion of gallium nitrate at the following doses cohort
      1: 100 mg/m2/day and cohort 2: 200 mg/m2/day All subjects who receive at least one dose of
      study medication will be considered evaluable for safety and efficacy analyses. Incidence of
      adverse events will be monitored during the trial.

      Primary endpoints will be assessment of pharmacokinetic and safety/tolerability data.

      Secondary efficacy assessments will be based on changes in lung function and sputum P.
      aeruginosa density in sputum.

      Total duration of subject participation will be five weeks. Total duration of the study is
      expected to be 20 months.
    

Intervention name(s): 100 mg/m2 dose; 200 mg/m2 dose
Intervention type(s): Drug; Drug
Intervention description(s): 5 day infusion of gallium nitrate (IV Ganite®) at a dose of 100 mg/m2/day; 5 day infusion of gallium nitrate (IV Ganite®) at 200 mg/m2/day
Other intervention name(s): Ganite®; gallium nitrate; Ganite®; gallium nitrate
Intervention MeSH terms: Gallium nitrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: IV Gallium; Gallium; Ganite; Cystic Fibrosis; Gallium Infusion
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064
      patients with myocardial infarction (MI) prior to study entry which aims to demonstrate
      whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces
      a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg
      daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid
      2 mg + vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in
      vascular disease.
    

Detailed description: 
      In observational studies, lower blood cholesterol concentrations are associated with lower
      coronary risk, without any clear threshold below which lower levels are not associated with
      lower risk. Cholesterol reduction with statins reduces such risk but there is uncertainty
      about whether greater reductions with more intensive statin therapy will produce greater
      benefits. Elevated blood homocysteine levels appear to be an independent marker of
      cardiovascular risk, but it is unknown whether taking vitamins to reduce homocysteine
      concentrations will translate into cardiovascular benefit.

      12,064 survivors of myocardial infarction have been randomised in a 2x2 factorial design to
      more intensive versus standard cholesterol-lowering treatment, using 80 mg or 20 mg daily
      simvastatin, and separately to homocysteine-lowering with folic acid plus vitamin B12 or
      matching placebo. Follow-up will continue until there are at least 2800 confirmed major
      vascular events (MVE), defined as non-fatal myocardial infarction, coronary death, stroke or
      arterial revascularisation. The primary outcome is the incidence of first MVE during the
      scheduled treatment period.

      SEARCH should provide reliable evidence of the effectiveness and safety of more intensive
      cholesterol-lowering for the reduction of major vascular events in a high-risk population,
      and of the effects of homocysteine-lowering with folic acid plus vitamin B12.
    

Intervention name(s): Simvastatin 20 mg daily; Folic acid 2 mg + vitamin B12 1 mg daily; Simvastatin 80 mg daily; Placebo
Intervention type(s): Drug; Dietary Supplement; Drug; Drug
Intervention description(s): Simvastatin 20 mg tablet once daily; Folic acid 2 mg + vitamin B12 1 mg tablet once daily; Simvastatin 80 mg tablet once daily; Placebo vitamin B12/folic acid tablet once daily
Intervention MeSH terms: Folic Acid; Vitamin B 12; Hydroxocobalamin; Simvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Myocardial infarction; Coronary heart disease; Cholesterol; Stroke
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and
      safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
    


Intervention name(s): Technetium Tc99m Sestamibi
Intervention type(s): Drug
Intervention description(s): Rest and/or stress SPECT imaging study
Intervention MeSH terms: Technetium Tc 99m Sestamibi
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic