bioihbjkbjnl/mcl2 huggingface dataset:
18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
Condition: Alzheimer's Disease; Cortical Basal Syndrome; Frontotemporal Dementia; Progressive Supranuclear Palsy; Vascular Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Supranuclear Palsy, Progressive; Tauopathies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label study to evaluate the performance of a novel tau imaging ligand in up
      to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV). Subjects will be recruited from
      the patient population and healthy volunteers of Taiwan residents. This study protocol
      requires each subject to complete the following components: screening evaluation, brain MRI
      and 18F-PM-PBB3 PET imaging up to two sessions. The screening procedures will include
      neuropsychological assessments, vital signs, ECG, physical examinations and laboratory tests.
      In addition, 18F-AV-45 PET imaging result will be as a part of inclusion criteria to confirm
      presence of amyloid deposition in patients with clinically diagnosed probable AD or absence
      of amyloid deposition in FTD, VCI and HV subjects. Furthermore, 18F-AV-133 PET imaging data
      will also be as a part of inclusion criteria to confirm the diagnosis of PSP and CBS. All
      subjects will complete clinical assessments and clinical safety tests to ensure the subject
      is medically stable to complete the study protocol. The screening procedures will occur
      within 30 days prior to 18F-PMPBB3 PET imaging.
    


Intervention name(s): F-18
Intervention type(s): Drug
Intervention description(s): This is an open-label study to evaluate the performance of a novel tau imaging ligand in up to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV).
Other intervention name(s): F-18 PMPBB3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      From the profiles of antibiotic susceptibility data following eradication therapy,
      tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the
      rescue treatment.
    

Detailed description: 
      The H pylori-infected adult patients with failure of standard triple therapy and H
      pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly
      assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin
      regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for
      10 days. Repeated endoscopy with rapid urease test, histological examination and culture or
      urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
    

Intervention name(s): 10d TL quadruple therapy; 10d AL quadruple therapy
Intervention type(s): Drug; Drug
Intervention description(s): esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.; esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
Other intervention name(s): esomeprazole 40 mg; tripotassium dicitrate bismuthate 300mg; tetracycline 500 mg; levofloxacin 500 mg; esomeprazole 40 mg; tripotassium dicitrate bismuthate 300mg; amoxicillin 500 mg; levofloxacin 500 mg
Intervention MeSH terms: Amoxicillin; Levofloxacin; Ofloxacin; Tetracycline; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate; Rescue treatment
Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the safety of hydrocodone extended-release
      tablets when used over a 12-month period in patients with chronic pain, as assessed by
      adverse events, clinical laboratory results, vital signs measurements, electrocardiogram
      results, physical examination findings, pure tone audiometry, and concomitant medication
      usage.
    

Detailed description: 
      This was a Phase 3, open-label, nonrandomized study that consisted of a screening period, an
      open label titration period, and a 52 week, long term, open-label treatment period in
      patients with chronic pain. Patients were eligible to participate in this study if they had
      completed study C33237/3079 (NCT01240863) (these patients are hereafter referred to as
      rollover patients) or if they had not participated in study 3079 (these patients are
      hereafter referred to as either new opioid naïve or new opioid experienced patients).
    

Intervention name(s): Hydrocodone ER
Intervention type(s): Drug
Intervention description(s): Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.
Other intervention name(s): CEP-33237; Hydrocodone bitartrate extended-release
Intervention MeSH terms: Hydrocodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: moderate to severe pain; diabetic peripheral neuropathy; postherpetic neuralgia; traumatic injury; complex regional pain syndrome; back pain; neck pain; osteoarthritis; rheumatoid arthritis
3D Versus 4K Laparoscopic Cholecystectomy
Condition: Cholecystitis; Gallstones
MeSH terms: Cholecystitis; Gallstones
Study type: Interventional

Summary: 
      Introduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to
      reduce the time required to complete tasks in laboratory settings. This benefit derives from
      the addition of binocular depth perception cues when compared to two-dimensional (2D)
      systems. This year a '4K' laparoscopic system has become commercially available, so-named as
      it provides a high resolution 2D image with four times the number of pixels of 2D full high
      definition. The improved visualisation is likely to provide additional non-binocular depth
      cues. It is currently unclear to what degree improving the resolution of 2D systems can
      compensate for binocular depth cues.

      Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides
      benefits during laparoscopic cholecystectomy when compared to the monocular vision provided
      by high-resolution 4K systems.

      Methods: A randomised controlled trial of 3D HD versus 4K laparoscopic systems will be
      performed, comparing the time to complete laparoscopic cholecystectomy, and error scores.

      Impact: This study is a unique, first-of-its-kind investigation into two new surgical
      technologies, and is the first study to involve a 4K system. The uptake of three-dimensional
      systems has been curbed by financial cost and the limitations of early 3D technologies. This
      study aims to determine which system may be the safest, quickest and most cost- effective, in
      order to guide future investment and technological development towards either 3D or 2D
      systems. In addition, these systems may also aid in the learning curve of trainee surgeons.
    


Intervention name(s): 3D laparoscopy; 4K laparoscopy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt)
      versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human Volunteers Under
      Fasting Condition.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Heterosofir; Sovaldi
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir
Other intervention name(s): Sovaldi
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol
      problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more
      effective for helping with drinking in a Family Medicine clinic.
    

Detailed description: 
      Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote
      abstinence, with few reported side effects. A limitation of these studies, however, has been
      their lack of generalizability due to restrictive inclusion and exclusion criteria.
      Furthermore, most of the previous studies of acamprosate have been conducted in Europe, in a
      different treatment setting from the typical American Family Medicine center, where alcohol
      dependent patients are most likely to be first identified in the U.S.

      The present study is designed to determine the efficacy of acamprosatefor alcohol dependence
      in a Family Medicine setting using minimal psychotherapeutic interventions-as would also
      likely occur in a primary care setting. The study will be a 12-week, double-blind,
      placebo-controlled, randomized trial comparing 666 mg acamprosate t.i.d. to placebo in
      patients at the UNC Family Medicine Center with alcohol dependence. Subjects will be seen by
      Family Medicine physicians and receive brief motivational interventions. Primary efficacy
      will be determined by measuring % days abstinent and secondary outcomes include rates of
      complete abstinence, % heavy drinking days, CGI and GGT in the acamprosate group compared to
      the placebo group.
    

Intervention name(s): Acamprosate (Campral)
Intervention type(s): Drug
Intervention description(s): The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Other intervention name(s): Acamprosate, campral, alcohol dependence medication
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Family Medicine Setting; University of North Carolina at Chapel Hill
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The
      purpose is to evaluate the relationship between the dose of lebrikizumab and the response in
      terms of the efficacy, safety, and tolerability in patients with asthma who are not on
      inhaled steroids.
    


Intervention name(s): lebrikizumab (MILR1444A); lebrikizumab (MILR1444A); lebrikizumab (MILR1444A); placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous repeating dose; Subcutaneous repeating dose; Subcutaneous repeating dose; Subcutaneous repeating dose
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MILR1444A
Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Condition: Bone and Body Composition; Obesity; Metabolic Syndrome; Physical Function; Quality of Life
MeSH terms: Metabolic Syndrome; Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in
      carbohydrate combined with low intensity exercise to favorably impact body composition, bone
      health, physical function, metabolic disease and quality of life compared to a conventional
      higher carbohydrate diet in overweight women over age 60.
    


Intervention name(s): Whey protein isolate; Maltodextrin powder supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50g/day (two 25 g doses taken at breakfast and afternoon snack mixed with food or beverage); Loss of 10% baseline weight over 6 months, with whey protein isolate supplemented at 50 g / day (two 25 g doses at breakfast and afternoon snack mixed with food or beverage)
Other intervention name(s): carbohydrate, starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis
Condition: Rectus Abdominus; Diastasis, Complicating Delivery
MeSH terms: Diastasis, Muscle
Study type: Interventional

Summary: 
      There is insufficient evidence regarding the benefit from surgical reconstruction of
      post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the
      abdominal trunk function preoperatively and postoperatively in a group of women undergoing
      surgery for abdominal rectus muscle diastasis.
    

Detailed description: 
      There is little evidence regarding the various treatment options of abdominal rectus muscle
      diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by
      the lack of uniform criteria for assessing the trunk function and how the trunk function
      affects the ability to perform daily activities. To be able to evaluate the condition with
      symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.

      In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a
      multimodal examination test was developed with the purpose to be able to evaluate the full
      picture of the condition.

      The purpose of this study was to evaluate the effect of surgical reconstruction of
      post-partum abdominal rectus muscle diastasis in women with insufficient improvement after
      adequate physical training using a novel multimodal evaluation tool.
    

Intervention name(s): Surgical repair of the diastasis
Intervention type(s): Procedure
Intervention description(s): Repair of the diastasis with a double row plication using absorbable Quill suture
Intervention model: Single Group Assignment
Intervention model description: Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
Condition: Infection, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a
      single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate
      vaccine
    


Intervention name(s): EuNmCV-5; Menveo
Intervention type(s): Biological; Biological
Intervention description(s): 0.5mL single intramuscular dose on Day 0; 0.5mL single intramuscular dose on Day 0
Other intervention name(s): Meningococcal(Groups A, C, W-135, X, and Y) Conjugate Vaccine; Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Motivational Interviewing and Neuroimaging With Adolescents
Condition: Alcohol Use, Unspecified
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This is a randomized controlled trial to examine the impact of two brief interventions on
      adolescent and young adult alcohol use behaviors and related brain response. The
      interventions being compared are motivational interviewing (MI) and brief adolescent
      mindfulness (BAM).
    


Intervention name(s): Motivational Interviewing (MI); Brief Adolescent Mindfulness (BAM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change.; Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Relative Bioavailability Food Effect Study of LY03005
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective if this study is to assess the relative bio-availability of single oral doses
      of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions
      in a 2-period, crossover trial.
    

Detailed description: 
      Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled
      and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed
      state) at a 1:1 ratio.
    

Intervention name(s): LY03005
Intervention type(s): Drug
Intervention description(s): 80 mg oral tablet single dose
Other intervention name(s): Desvenlafaxine
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders; Desvenlafaxine Succinate; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Antidepressive Agents; Psychotropic Drugs
Surgery Or Lifestyle Intervention for Type 2 Diabetes (SOLID)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study will investigate the safety and effectiveness of weight loss surgery for
      overweight persons with type 2 diabetes. Eligible patients will undergo one of 2 types of
      weight loss surgery, Roux-en-Y gastric bypass, or laparoscopic adjustable gastric banding, or
      an intensive lifestyle modification. Participants will be closely followed for one year to
      compare the effects of these treatments on diabetes remission.
    


Intervention name(s): Roux-en-Y Gastric Bypass surgery; Laparoscopic Adjustable Gastric Banding surgery; Intensive Lifestyle Modification
Intervention type(s): Procedure; Procedure; Behavioral
Intervention description(s): Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.; Surgical intervention for weight loss. This is a one-year study and participants will attend five study visits.; Intensive lifestyle modification program for weight loss. Participants randomized to this condition will receive an weekly individual treatment of 30 minutes for the first 6 months and every-other-week sessions from months 7 to 12. Treatment will be provided by a behavioral psychologist or registered dietitian following a structured curriculum used in our prior studies. During the first 4 months, participants will be prescribed a 1000-1200 kcal/d diet that provides four daily servings of meal replacement products (liquid shakes, cereals, meal bars, etc), combined with an evening dinner entree. Each serving of the meal replacement (HMR 170; Boston, MA) will provide 170 calories, with 16 g of protein, 22 g of carbohydrate, and 2 g of fat. Dinner entrees (containing at least 20 g of protein and approximately 220-260 kcal) will be consumed with a garden salad and a serving of fruit (and other vegetables allowed ad libitum throughout the day).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Bariatric Surgery; Roux-en-Y Gastric Bypass; Gastric Banding; Obesity; Weight loss; Insulin sensitivity; GLP-1; Meal Challenge; Euglycemic Clamp