bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
Condition: Fulminant Hepatic Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver
      Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver
      transplant or bridge to native liver recovery.
    

Detailed description: 
      Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity
      and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity
      to be bridged to transplant or to avoid transplantation and to have their native liver
      recover.
    

Intervention name(s): ELAD; Standard of care (Control)
Intervention type(s): Biological; Other
Other intervention name(s): Extracorporeal Liver Assist Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fulminant Hepatic Failure
A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects
Condition: Obese; Overweight; Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple
      ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy
      overweight and obese subjects
    

Detailed description: 
      The study was conducted in 2 parts:

      Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6),
      enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food.

      Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7),
      enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and
      Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once
      daily for 28 days with LB54640 or placebo.
    

Intervention name(s): LB64640; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.; Placebo is provided as a matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a randomized, double-blind, placebo-controlled study conducted in two parts. Study Part 1 had a SAD design to investigate the safety, tolerability, and PK of LB54640 administered orally in healthy overweight and obese subjects. Study Part 1 included a cohort (Cohort S3) to assess the effect of food on LB54640, which was conducted with a blinded, placebo-controlled, two-way crossover design. Study Part 2 had a MAD design to investigate the safety, tolerability, PK, and PD of LB54640 administered orally in healthy overweight and obese subjects
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)
Condition: Diabetes Mellitus Type 2; Hypertension; Metabolic Syndrome
MeSH terms: Hypertension; Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether MC-1 alone and in combination with an ACE
      inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with
      diabetes
    

Detailed description: 
      Hypertension is an extremely common co-morbid condition in diabetics, affecting up to 11
      million patients, depending on obesity, ethnicity and age. Hypertension substantially
      increases the risk of both macrovascular and microvascular complications including stroke,
      coronary artery disease, peripheral vascular disease, retinopathy, nephropathy and possibly
      neuropathy.

      In recent years, adequate data from well-designed randomized clinical trials have
      demonstrated the effectiveness of aggressive treatment of hypertension in reducing diabetic
      complications. In the epidemiological UK Prospective Diabetes Study (UKPDS), each 10 mmHg
      decrease in mean systolic blood pressure was associated with reductions in risk of 12% for
      any complication related to diabetes, 15% for deaths related to diabetes, 11% for myocardial
      infarction and 13% for microvascular complications. Currently the consensus guidelines
      recommend a blood pressure target of <130/80 mmHg in diabetic patients with hypertension,
      even though they recognize many people will require three or more drugs to reach this goal.

      MC-1 is a naturally occurring metabolite of vitamin B6, and thus has very low toxicity.
      Evidence from pre-clinical studies suggests that MC-1 has beneficial effects on hypertension
      and metabolic dysfunction. This trial will assess the effects of MC-1 alone and MC-1 in
      combination with an ACE inhibitor compared to placebo on hypertension and parameters of
      metabolic function in type 2 diabetic patients.
    

Intervention name(s): pyridoxal-5'-phosphate with and without ACE inhibitor
Intervention type(s): Drug
Intervention MeSH terms: Pyridoxal; Pyridoxal Phosphate; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension; antihypertensive agents; diabetes mellitus type 2; metabolic syndrome
Pilot Study of Multi-wavelength Laser for Tattoo Removal
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of an investigational version of the Cutera enLighten
      laser that offers muliple wavelengths for tattoo removal.
    

Detailed description: 
      Currently, the enLighten laser offers two wavelengths: 532nm and 1064nm. The version of the
      laser under investigation allows the user to choose a wavelength between 640nm to 800nm.

      This is a multi-center prospective, open-label, uncontrolled pilot study in up to 75 male or
      female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single
      or multi-color ink. Subjects will receive laser treatments and will be followed at 6 weeks.
    

Intervention name(s): Cutera enLighten laser
Intervention type(s): Device
Intervention description(s): Subjects will receive laser treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers
Condition: Subcutaneous Adipose Tissue Reduction
Study type: Interventional
Phase: Phase 1

Summary: 
      An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.
    


Intervention name(s): LIPO-102
Intervention type(s): Drug
Intervention description(s): LIPO-102
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
Condition: HiV1- Positive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety, tolerability, and antivira activity of
      Epzicom in virologically controlled HIV subjects.
    

Detailed description: 
      Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare
      the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4-
      cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV
      infected, HLA*B5701 begative subjects who were initially suppressed on a HAART regiment that
      includes TDF/FTC QD.
    

Intervention name(s): Abacavir/Lamivudine
Intervention type(s): Drug
Intervention description(s): one tablet once a day
Other intervention name(s): ABC/3TC
Intervention MeSH terms: Lamivudine; Abacavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
Condition: Post-surgical Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

Summary: 
      GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol
      1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic
      efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The
      duration of the entire study will be approximately 18 weeks. Each subject will have to come
      to the clinic for three visits (Screening, Treatment and Follow up visits).
    


Intervention name(s): Paracetamol 1000 mg; Paracetamol 650 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Paracetamol 1000mg; Paracetamol 650 mg; Placebo
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dental pain; paracetamol; Post-surgical dental pain
Physiotherapy Techniques in Adult Neck Pain
Condition: Neckache
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      To compare the effectiveness of thoracic manipulation and MET on chronic mechanical neckache
    

Detailed description: 
      it is a randomized control clinical trail to compare the effectiveness of physical exercises
      for the management of chronical mechanical neckache .so we employed thoracic manipulation for
      experimental group and MET (muscle energy technique) for control group
    

Intervention name(s): thoracic manipulation; muscle enegy technique
Intervention type(s): Other; Other
Intervention description(s): thoracic manipulation for unlocking of facet joints; to release muscle spasm of cervical musces
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups , geoup A named as control group and group B named as experimental group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neckache
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This work aims at the analysis of ocular aberrations induced by wave front optimized ablation
      profiles WFO using I-Trace aberrometer (Ray -Tracing)
    

Detailed description: 
      The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal
      topography with a ray tracing aberrometer to measure quality of vision in a patient. This
      work aims at the analysis of ocular aberrations induced by wave front optimized ablation
      profiles WFO using I-Trace aberrometer (Ray -Tracing)
    

Intervention name(s): LASIK
Intervention type(s): Device
Intervention description(s): All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.
Intervention model: Single Group Assignment
Intervention model description: A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Masking: None (Open Label)
Primary purpose: Treatment
A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)
Condition: Healthy Smokers; Smoking Cessation
Study type: Observational

Summary: 
      The study's major aim is to investigate the ability of a commercial Electronic Nicotine
      Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking
      reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes
      in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette
      and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in
      withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria"
      electronic cigarette) using initially for 6 weeks "ORIGINAL" 7.4 mg nicotine cartridges
      followed by a further 6 weeks of "CATEGORIA" 5.2 mg nicotine cartridges. The primary
      hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows
      smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and
      cravings.
    

Detailed description: 
      The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed
      for the purpose of nicotine delivery to the respiratory system where nor tobacco nor
      combustion are necessary for its operation. For these reasons, it is possible that this
      product may be safer than cigarettes. Marketing claims also include that they can be useful
      smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to
      that of tobacco cigarettes and reproduces the gesture component associated with tobacco
      smoking, very little is known about the effect of E-Cigarette on the smoking habits of
      regular tobacco smokers. Therefore, we designed a prospective observational study consisting
      of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final
      visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well
      characterized regular smokers experimenting the e-cigarette focusing on long-term smoking
      reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events.
      Specifically, 100 smokers will be given "Categoria" electronic cigarette initially loaded
      with "ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg
      nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24
      weeks.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Regular smokers from Catania in Italy recruited following the placement of an advertisement
        in a local newspaper.
      
Keywords: electronic cigarette; nicotine; smoking cessation; smoking reduction
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
    

Detailed description: 
      This is a single and multiple ascending dose study to assess the safety, tolerability and
      pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The
      study will be conducted under double blind conditions.

      The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral
      administration of single or multiple ascending doses and estimate the maximum tolerated dose
      of SUVN-D4010,if possible.

      The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics
      following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy
      male subjects.
    

Intervention name(s): SUVN-D4010; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SUVN-D4010; serotonin 4 (5-HT4) receptor; first in human; safety; pharmacokinetics; tolerability; single dose; repeat dose
A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional

Summary: 
      Objective: The study of medication adherence in depression (MAPDep study) aims to evaluate
      the effectiveness and cost-effectiveness of a multi-component strategy to enhance
      patient-centered care to improve adherence toward medications in patients with depression,
      formed by an educational intervention to psychiatrists and/or a collaborative care
      intervention group to patients and relatives plus a reminder system through the use of a
      mobile APP.

      Methods: The objective will be assessed under an open multicenter, clinical controlled trial
      with random allocation by clusters to one of three interventions or to usual care (control
      arm). In group 1 only patients and family members receive intervention, in group 2 only
      psychiatrists receive intervention, and group 3 is a combined intervention for patients and
      psychiatrists. The main measure will be the change in medication adherence rate. Secondary
      endpoints are depression, emotional distress, health-related quality of life, physical
      functioning, patients' knowledge about their medications, provider beliefs regarding
      patient-centeredness, and healthcare resource utilization.
    


Intervention name(s): Intervention to Patients; Intervention to Psychiatrists; Control
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Multifaceted intervention consisting of:
A collaborative care management intervention, including depression education, medication management and behavioral activation.
Use of a medication reminder mobile app.; Educational intervention consisting of theoretical and practical sessions to to improve communication and negotiation abilities, and to develop skills to promote patient-centered care and shared decision-making.; Other: Usual care Usual care for depressive disorder received in mental health units
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Depression; Medication adherence; Multicomponent intervention
Use of Functional Magnetic Resonance Imaging (fMRI) to Study Brain Activation in Children With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of the study is to map regions of brain activation following rectal stimulation
      in children with irritable bowel syndrome (IBS) and healthy controls.
    

Detailed description: 
      Our first aim is to compare the brain areas activated rectal stimulation in boys and girls
      with IBS and healthy children. Our second aim is to compare the anatomic regions of the brain
      activated during rectal stimulation in pre and post-pubertal male and female subjects between
      10-18 yrs of age.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children will be selected from the Gastroenterology Clinic at Children's Hospital of
        Wisconsin.
      
Keywords: fMRI; IBS; Brain Activation
Clinical Evaluation of a New Reduced Volume Bowel Preparation
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
    

Detailed description: 
      Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic
      efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.

      Thirty patients admitted to the hospital (inpatients) planned to undergo a complete
      colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake
      mode.
    

Intervention name(s): macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
Intervention type(s): Drug
Intervention MeSH terms: Ascorbic Acid; Polyethylene glycol 3350
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon cleansing
Magnesium Sulfate in Pregnancy and Postpartum
Condition: Severe Pre-eclampsia With Postnatal Complication
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies
      demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take
      into account the use of magnesium sulphate before delivery. Termination of pregnancy is the
      best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know
      the minimum effective dose.The investigators believe that if the patient has received less
      than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for
      6 hours is as effective as keeping it for 24 hours.
    

Detailed description: 
      The definitive treatment known for pre-eclampsia is the interruption of pregnancy. While the
      definitive treatment is the pregnancy interruption, management includes other measures that
      have proven effective, including the administration of antihypertensive drugs for severe
      hypertension and that the use of anticonvulsant such as the magnesium sulfate.

      There are multiple studies that prove the effectiveness of magnesium sulfate to prevent
      eclampsia in patients with severe / serious disorder. Unfortunately these studies used the
      drug before birth and continue after birth. Therefore the investigators can not conclude
      whether the administration just before pregnancy is sufficient to prevent seizure. That is,
      if the cure or definitive treatment of pre-eclampsia is the interruption, did not seem
      necessary to justify the administration of anticonvulsant drugs after birth. Obvious post
      delivery management sulfate arises from the large number of postpartum eclampsia reported in
      many studies. It is unknown if the administration of magnesium sulfate for a minimum period
      not yet determined before birth and delivery requires even keep the drug after
      discontinuation.

      For all these reasons the investigators propose the following: A randomized trial where all
      those patients who received magnesium sulfate for less that 8 hours before birth will be
      randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-Continue
      magnesium sulfate for 6 hours postpartum.
    

Intervention name(s): Magnesium Sulfate
Intervention type(s): Drug
Intervention description(s): Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
Other intervention name(s): anticonvulsivant
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment