bioihbjkbjnl/mcl2 huggingface dataset:
Tracking CF Lung Disease Through the Early Years: Utility of the LCI
Condition: Observational
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis
      and healthy controls for a period of two years. This study will include monitoring the
      subjects lung clearance index (by performing a breathing test called the multiple breath
      washout), as well as spirometry and their respiratory symptoms every three months as well as
      during a pulmonary exacerbation and after their recovery.
    

Detailed description: 
      This is a prospective observational cohort study. During the 3 year study period, each
      participant will be followed for a period of 2 years. The study will include quarterly
      measurements of the lung clearance index (LCI), as well as spirometry, for CF patients at
      their routine clinic visits. Parents of patients with CF will be asked to call the study
      nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to
      the clinic for assessment of lung function. CF patients will then be assessed by a CF
      physician to assess whether they require antibiotic treatment based on a clinicians decisions
      to treat with antibiotics. The treatment decision will be left to the discretion of the
      patient's responsible physician, who will be blinded to the MBW results. All patients who
      meet the symptom based definition of a pulmonary exacerbation, regardless of treatment
      decision, will have MBW measured after 4 weeks. Following these visits at the time of an
      exacerbation, patients will have their MBW measured at their next clinic visit (usually
      within 3 months), and every 3 months thereafter until the end of the 2 year observation
      period, or the repeat onset of symptoms.This study will capture a maximum of two
      exacerbations per patient over the 2 year study period.
    

Intervention name(s): This is an observational study, no intervention used.
Intervention type(s): Other
Intervention description(s): No intervention is being used in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There were 139 subjects recruited in the original preschool longitudinal study, and all
        participants from this original study will be invited to participate in this follow up
        study. We would like to recruit an additional 40 CF patients at the Hospital for Sick
        Children to increase our cohort size.
Treating Smokers With Mental Illness
Condition: Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar II Disorder; Mental Illness
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a smoking cessation study that will enroll smokers who have been diagnosed with a
      severe mental illness. The study will use a combination of intensive tobacco treatment
      counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting
      smoking over the course of six months.
    

Detailed description: 
      At the baseline measurement visit, participants will be asked to complete a survey and an
      interview. They will be randomly assigned to either the intervention or control group. Both
      groups will receive a smoking cessation manual and list of resources. The intervention group
      will also receive smoking cessation counseling and nicotine replacement therapy. Both groups
      will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
    

Intervention name(s): Nicotine patch; Nicotine lozenge; Therapy; Information
Intervention type(s): Drug; Drug; Behavioral; Other
Intervention description(s): Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use; In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase; Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mental illness; tobacco treatment
A Study of IBI311 in Subjects With Active Thyroid Eye Disease
Condition: Thyroid Eye Disease
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, double-masked, placebo-controlled Phase II/III study in
      subjects with active thyroid eye disease. Approximately 114 subjects meeting study
      eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1
      ratio stratified by smoking status
    


Intervention name(s): IBI311; placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10 mg/kg on Day 1 followed by 20 mg/kg q3W for the remaining 7 infusions for phase II/III.; 4 does of placebo for phase II; 8 does of placebo for phase III.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison Between Intrathecal and Intravenous Dexmedetomidine
Condition: Postoperative Analgesia
Study type: Interventional

Summary: 
      A prospective, randomized, comparative controlled clinical trial, aiming to compare the use
      of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request
      to analgesia. The secondary end-points were the total postoperative analgesic consumption as
      well as the VAS.
    

Detailed description: 
      Seventy patients undergoing lower limb surgeries were included in this study. Using a random
      number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of
      dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of
      0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V
      receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight
      dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free
      normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine
      in group T. An independent investigator prepared the drug solutions and provided the coded
      drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic
      administrator, patients, outcome assessors, and data analysts were blinded to the allocation.
      Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before
      anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using
      a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and
      clear cerebrospinal fluid, the drug was administered and the patients were then placed in the
      supine neutral position.

      Assessment: The primary end-point of this study was the first request to analgesia. The
      secondary end-points were the total postoperative analgesic consumption as well as the VAS.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): INTRATHECAL AND INTRAVENOUS
Other intervention name(s): precidex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
Condition: Hepatocellular Carcinoma; Portal Vein Tumor Thrombus
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is working to evaluate the surgical comprehensive treatment for different types of
      tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a
      standardized, unified, effective therapeutic program.
    

Detailed description: 
      Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly,
      results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that
      can worsen the prognosis of patients with PLC.

      In clinical, various treatments have been applied to improve this short-term prognosis, but
      there was no identical indication for treatment of PLC patients with different PVTT.

      The objective of this study is to evaluate the surgical comprehensive treatment for different
      types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish
      a standardized, unified, effective therapeutic program.
    

Intervention name(s): chemotherapy with endostar; treatment with CBP and 5-FU; treatment with endostar, CBP and 5-FU
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15mg/d×14d; CBP 300mg/d×2d，5-FU 1000mg/d×5d; CBP 300mg/d×2d，5-FU 1000mg/d×5d ，Endostar 15mg/d×14d
Other intervention name(s): chemotherapy with endostar group; treatment with CBP and 5-FU group; endostar, CBP and 5-FU group
Intervention MeSH terms: Fluorouracil; Endostar protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; portal vein tumor thrombus; surgical comprehensive treatment
Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this randomized clinical trial study is to compare safety profile undiluted
      intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims
      to answer is whether moxifloxacin and levofloxacin have similar safety profile.

      Participant will be randomized into two treatment arms. All participant will receive
      standardized treatment before, during, and after surgery and will be followed up at one day,
      one week, and one month after surgery.
    

Detailed description: 
      This study aims to observe the safety profile in patient receiving cataract surgery who
      receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile
      defined as visual acuity, intraocular pressure, corneal endothelial cell density, central
      corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are
      obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are
      randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery;
      (2) receiving undiluted levofloxacin 0.1 cc during surgery.
    

Intervention name(s): Moxifloxacin Ophthalmic Solution; Levofloxacin Ophthalmic
Intervention type(s): Drug; Drug
Intervention description(s): Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery; Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
Other intervention name(s): Molcin(R); Cravit(R)
Intervention MeSH terms: Moxifloxacin; Levofloxacin; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moxifloxacin; Levofloxacin; Cataract surgery
The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children
Condition: Stunting; Environmental Enteric Dysfunction
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine
      colostrum or a control flour along with a multiple micronutrient powder to the diets of
      healthy Malawian children 9 months of age. This supplement provides additional essential
      amino acids, choline and immunoactive colostrum. Children will be receive either the
      supplement or control for 12 weeks. Children will have regular follow-up where anthropometry
      is measured. At enrollment and after 12 weeks, stool will be collected and a urinary
      lactulose permeability test conducted. Children will be measured at enrollment and at weeks
      2, 4, 8, 12, 20, 32 after enrollment.
    


Intervention name(s): BC/ egg; Control; multiple micronutrient
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4.3 egg powder + 5.7 g bovine colostrum; 15 grams corn-soya blend; multiple micronutrient sprinkle powder
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects
Condition: Healthy
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of
      the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with
      co-administration of active rabies vaccine in healthy subjects.
    

Detailed description: 
      Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at
      Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility
      check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment
      (BPL HRIG + vaccine or Comparator HRIG + vaccine) on Day 0. Further assessments will be
      conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140. Vaccine
      will be administered on Day 0, 3, 7, 14 and 28.
    

Intervention name(s): HRIG; HyperRAB; RabAvert
Intervention type(s): Drug; Drug; Biological
Intervention description(s): A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.; A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.; A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
Other intervention name(s): HRIG; active rabies vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccine
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Kidney Failure, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney
      expansion as well as worsening of renal function in patients with ADPKD and whether the
      application of 5 mg/day everolimus as monotherapy is safe and well tolerated.
    


Intervention name(s): Placebo; Everolimus
Intervention type(s): Drug; Drug
Intervention description(s): placebo comparator; experimental
Other intervention name(s): certican
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: end-stage renal disease, ESRD, autosomal dominant polycystic kidney disease, ADPKD, everolimus
A Biomarker Study of Solanezumab in Patients With and Without Alzheimer's
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to compare the average change in the amount of amyloid beta
      species in blood after an infusion of solanezumab.
    


Intervention name(s): solanezumab
Intervention type(s): Drug
Intervention description(s): 400mg administered once intravenously
Other intervention name(s): LY2062430; A Beta Antibody
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the glycemic control, as measured by HbA1C, between insulin glargine and
      rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and
      metformin
    


Intervention name(s): insulin glargine; rosiglitazone; metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Insulin Glargine; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving ACL Reconstruction Outcomes: CBPT
Condition: ACL Injury; ACL - Anterior Cruciate Ligament Rupture; ACL Sprain; ACL Tear
MeSH terms: Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The overall objective of this study is to conduct a two-group randomized trial to examine the
      efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function,
      return to sport, and quality of life outcomes in patients following ACL reconstruction
      (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral
      based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central
      hypothesis is that the CBPT-ACLR participants relative to the Education group will
      demonstrate significantly greater improvement in postoperative outcomes at 12 months
      following surgery.
    


Intervention name(s): CBPT-ACLR; Education
Intervention type(s): Behavioral; Other
Intervention description(s): The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.; The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Gingival recessions are often successfully treated by coronally advanced flap technique (CAF)
      associated with subepithelial connective tissue grafts (SCTG). Currently the xenogeneic
      collagen matrix (CM) has been used as a substitute for SCTG associated with CAF technique for
      root coverage. CAF technique was not developed for use with CM and has shown limited results
      when applied to the CM. The aim of this study was to compare and show the benefits of the
      extended flap technique (EFT) compared to CAF technique using CM for root coverage.
    


Intervention name(s): root coverage comparing two techniques
Intervention type(s): Device
Intervention description(s): The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
Other intervention name(s): Mucograft; porcine collagen matrix; extended flap technique; coronal advanced flap technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: root coverage; gingival recession; periodontal surgery