bioihbjkbjnl/mcl2 huggingface dataset:
Adult Bipolar Mania
Condition: Acute Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added
      to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in
      treating acute mania and if so, how it compares with placebo (a non-active capsule, like a
      sugar pill, that looks like lithium).
    


Intervention name(s): Quetiapine fumarate XR; Lithium; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.; Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.; Oral treatment twice daily.
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Mania; Mania, Adults; Seroquel; Acute Mania in Adult Patients
InnFocus MicroShunt Versus Trabeculectomy Study
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular
      pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled
      when using maximum tolerated glaucoma medications.
    

Detailed description: 
      This clinical trial is a prospective, randomized, controlled, multicenter, study. After
      informed consent is obtained, patients will be evaluated for eligibility based on glaucoma
      severity, eye health, and visual acuity.

      Clinical follow up will be scheduled over the course of the 24 month study, and examinations
      will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in
      the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual
      follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater
      reduction in IOP from pre-op medicated IOP at 12 months.
    

Intervention name(s): Glaucoma Surgery; InnFocus MicroShunt
Intervention type(s): Procedure; Device
Intervention description(s): An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.; An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: POAG
Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin
Condition: Vertigo, Peripheral
MeSH terms: Vertigo; Dizziness
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate)
           to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of
           treatment;

        -  Evaluation of impact on quality of life in vertigo;

        -  Compare the intensity of daytime sleepiness in the two treatment groups;

        -  Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS;

        -  Compare the duration of treatment in both treatment groups;

        -  Compare Adehence;

        -  Compare the level of satisfaction from each group from the investigators and the
           subjects;

        -  Adverse events;
    

Detailed description: 
      It is a prospective interventional study arms parallel , active -controlled , non-inferiority
      . Participants selected for the study should be of both sexes , aged over 18 years and less
      than 65, which meet all the inclusion criteria and did not fit any exclusion criteria , and
      agree to all the purposes of the study. Participants are divided into two according to the
      randomization treatment groups 1:1.

      The study should take no longer than 30 days to be completed with the amount of 6 visits (7±2
      days): V0 radomization; V1, V2, V3 andV4(FV) are Evaluation visits and One Follow up visit
      7±2 days after the Final Visit.
    

Intervention name(s): Meclizine; Dimenhydrinate
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg, 3 times per day up to 30 days; 50 mg, 3 times per day up to 30 days
Other intervention name(s): Meclin; Dramin
Intervention MeSH terms: Meclizine; Dimenhydrinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vertigo, Meclizine, dimenhydrinate, Peripheral Origin
Liquid Biopsy in Lung Cancer
Condition: Lung Cancer (Diagnosis); Circulating Tumor Cell
MeSH terms: Lung Neoplasms; Neoplastic Cells, Circulating; Neoplasms; Disease
Study type: Observational

Summary: 
      The purpose of this study is to assess clinical utility of combined circulating tumor cell
      (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.
    

Detailed description: 
      The peripheral blood and tumor tissue samples are collected from the participants.CTC and
      ctDNA are analyzed from the blood samples.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects who are referred for the evaluation and management of primary lung cancer in
        the tertiary care center
      
Keywords: Lung cancer; Circulating Tumor Cell; Cell-Free Tumor DNA; Liquid Biopsy
Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population
Condition: Cirrhosis Renal
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: It is important to accurately assess the glomerular filtration rate (GFR) of
      patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs'
      posology.

      Purpose: The frequency of chronic renal failure is underestimated in patients with advanced
      liver disease and the difficulty to assess kidney failure justifies the investigator's study,
      which aims to describe, by means of a population pharmacokinetic model, the evolution of
      plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast
      agent which is used in radiographic procedures, in cirrhotic patients.
    

Detailed description: 
      Cirrhosis is often complicated by kidney failure and the prognostic value of renal function
      (serum creatinine) during cirrhosis is included in the MELD model. In addition, chronic
      kidney disease (15%) after liver transplantation is also an independent mortality factor.

      The most commonly used methods to estimate GFR are based on creatinine, but in patients
      suffering from advanced hepatic disease, such as cirrhosis, this parameter is incorrect, due
      to the low creatinine production and potentially to elevated serum bilirubin and decreased
      albumin levels. Furthermore, ascites can interfere with serum creatinine concentration. In
      this condition, all creatinine-based evaluations of GFR overestimate gold standard-measured
      GFR. Specific eGFR equations for liver disease or new approaches for estimating GFR may be
      necessary.

      The plasma clearance of iohexol is a recognized technique for the measurement of the
      glomerular filtration rate (GFR).
    

Intervention name(s): Iohexol Inj 300 MG/ML
Intervention type(s): Drug
Intervention description(s): After injecting a loading dose of 5ml of iohexol bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis Renal; GFR; renal function; Bayesian model; plasma clearance; iohexol
Trial Evaluating Hedonic vs Cash Incentives
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study aims to determine, using a randomized trial with two parallel arms, whether
      hedonic rewards (Arm 1) can be more effective than their cash equivalent (Arm 2) in
      motivating participants to meet step goals.
    

Detailed description: 
      The evidence is overwhelming that sustained physical activity reduces risks for
      non-communicable diseases, increases longevity, and reduces medical costs. Yet, the rates of
      physical activity have been steadily decreasing such that physical inactivity is now the
      fourth leading cause of death worldwide. In Singapore, 33% of adults are insufficiently
      active despite Singapore being a highly walkable city with numerous subsidized
      community-based physical activity programs. A review of the literature shows that, to date,
      no study has directly compared cash versus hedonic rewards for health behavior change despite
      theory suggesting hedonic rewards may work better. Furthermore, hedonic rewards can often be
      purchased at lower cost than their cash equivalent. This makes hedonic rewards potentially
      more cost-effective if they are proven to be at least as effective at increasing positive
      behavior change compared to giving the same value in cash.

      Thus, we aim to determine, using a randomized trial with two parallel arms, whether hedonic
      rewards (Arm 1) can be more effective than their cash equivalent (Arm 2) in promoting
      increases in physical activity, assessed via step counts measured by a Fitbit physical
      activity tracker, during a 4-calendar month intervention. We hypothesize that the average
      proportion of months meeting the incentivized step target across participants will be greater
      for those in the hedonic incentive arm as compared to those in the cash incentive arm
      (primary outcome).
    

Intervention name(s): Hedonic Reward; Cash Reward; Fitbit
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): A reimbursement credit for hedonic expenses worth up to $50 will be awarded to each participant if they log at least 10,000 daily steps on at least 25 days during the first 28 days of each calendar month on Fitbit activity trackers provided by the study.; A reimbursement credit for $50 in cash will be awarded to each participant if they log at least 10,000 daily steps on at least 25 days during the first 28 days of each calendar month on Fitbit activity trackers provided by the study.; Fitbit devices are wireless pedometers that track the steps of participants, and will be offered in conjunction with a tailored website with customized information for participants.
Other intervention name(s): Fitbit, wireless pedometer, physical activity tracker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Neuromuscular Consequences of Knee Arthroscopy
Condition: Tear of Fibrocartilage of Joint
Study type: Interventional

Summary: 
      To determine changes in quadriceps muscle function following the application of ice and
      compression to the knee.
    

Detailed description: 
      Novel rehabilitation methods, that specifically target decreased muscle activation due to
      joint pathology prior to strength training, have elicited greater improvements in muscle
      function and self-reported disability compared to traditional therapies. Preliminary evidence
      suggests applying cryotherapy to a joint prior to exercise can increase quadriceps
      activation. It is unknown if applying cryotherapy and intermittent pneumatic compression can
      also increase quadriceps force output and voluntary activation. The purpose of this study is
      to determine changes in quadriceps force output and voluntary activation following the
      application of cryotherapy and compression. The investigators hypothesize there will be an
      increase in quadriceps force output and voluntary activation following the application of
      cryotherapy and compression.
    

Intervention name(s): Cryotherapy and compression; Cryotherapy
Intervention type(s): Other; Other
Intervention description(s): Cryotherapy and intermittent pneumatic compression will be applied to the knee joint using a recirculating compression unit and knee sleeve. This unit will recirculate water which is between 1-3° C. Circumferential intermittent pneumatic compression to the knee joint (5 to 50 mm Hg) will be applied in conjunction with cryotherapy. The duration of intervention will be 20 minutes.; Cryotherapy will be applied to the knee joint using a recirculating compression unit and knee sleeve. This unit will recirculate water which is between 1-3° C. The duration of intervention will be 20 minutes.
Other intervention name(s): Cryotherapy and intermittent pneumatic compression; Cryotherapy and vasopneumatic compression; Gameready; Ice; Gameready
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthroscopic partial meniscectomy; meniscus; quadriceps strength; quadriceps voluntary activation; cryotherapy; compression; vasopneumatic compression; intermittent pneumatic compression
Radiochemotherapy With and Without Dose Escalation in Patients Presenting Locally Advanced or Inoperable Carcinoma of the Oesophagus
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Exclusive concomitant radiochemotherapy (RCT) at a dose of 50 Gy delivered over 5 weeks,
      according to the RTOG 85-01 protocol, has led to improved 5-year survival in 25% of patients,
      whereas no patients survived for 5 years using radiotherapy alone for patients with
      esophageal cancer. Surgery, even when combined with preoperative RCT, also gives
      disappointing results for locally advanced tumors, which casts serious doubts on the
      usefulness of preoperative radiotherapy. By varying the fractionation schedule, the length of
      treatment or the radiotherapy volumes, it has become possible to obtain levels of
      loco-regional relapse of around 35 to 45%. After reviewing the results for loco-regional
      relapse according to the dose of radiation and the recommended radiotherapy volumes, we aimed
      to investigate why increasing the dose of radiation has no impact in esophageal cancers.
      Although INT-0123 phase III trial showed no benefit of dose escalation in esophageal cancer,
      some issues remain unclear as most of the patients who died in the experimental arm were
      treated above 50Gy. Moreover, only the tumor was treated up to 64Gy while involved nodes were
      not considered for dose escalation in this trial. In the RTOG 85-01phase III trial, an
      elective nodal irradiation from subclavicular fossa up to the esophagogastric junction was
      performed with a 2D technique, delivering 30Gy which could be considered as not appropriate.

      In this randomized phase II/III trial, we aim to test an exclusive concomitant
      chemoradiotherapy for patients with non resectable esophageal cancer with a dose escalation
      up to 66Gy on the primary tumor as well as the involved nodes using a 3D conformal technique
      combined with a 40 Gy elective nodal irradiation on lymph node stations (as defined by the
      RTOG) with a risk of microscopic involvement ≥ 20%.
    


Intervention name(s): Conformal 3D Radiotherapy with " ENI "-type prophylactic irradiation of the lymph node; Boost; Boost; chemotherapy: FOLFOX 4
Intervention type(s): Radiation; Radiation; Radiation; Drug
Intervention description(s): 40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction); Boost 10 Gy in 5 fr, PTV = +1cm.; Boost 26 Gy in 13 fr, PTV = +1cm.; 6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43) arm B or 3 courses concomitant to radiotherapy (D1, D15, D29) arm A.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unoperated cancers; oesophagus; radiochemotherapy; with and without increased doses
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study is designed to evaluate the risk of cataracts (lens opacities) and describe the
      best corrected distance vision (with glasses/contacts for those who wear them) of pediatric
      patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor
      treatment initiation and are receiving or planning to receive commercially-available
      ivacaftor in the US.
    


Intervention name(s): Ophthalmologic examinations; Ivacaftor Exposed
Intervention type(s): Other; Drug
Intervention description(s): Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.
Intervention MeSH terms: Ivacaftor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with CF who are 11 years of age or younger at the time of initiation of
        treatment with ivacaftor and are receiving or planning to receive commercially-available
        ivacaftor in the United States (US)
      
Keywords: Cystic Fibrosis
The Longitudinal Ovarian Reserve Study
Condition: Effects of Chemotherapy
Study type: Observational

Summary: 
      Postmenarchal female cancer patients scheduled to undergo cancer therapy may enroll in this
      study to assess changes in existing and novel surrogate measures of fertility potential
      before, during and after chemotherapy. Measures of fertility potential to be tested include
      ultrasound imaging for antral follicle counts and ovarian volumes, endocrine evaluation, and
      assessment of oxidative stress.
    

Detailed description: 
      Eligible women are asked to complete a structured interview, questionnaires, a monthly
      menstrual diary, a brief physical examination, a blood test, and an abdominal or pelvic
      ultrasound at baseline and at 3 month intervals following start of chemotherapy through 6
      months post end of treatment.

      Within subject changes in continuous variables (hormones, urinary isoprostane levels, ovarian
      volume, AFC) will be compared using paired t-tests (nonparametric tests as appropriate).
      Non-Gaussian-distributed variables will be logarithmically transformed prior to analysis. In
      general, changes from baseline to every 3 month assessment will be compared individually as
      well as changes from baseline to post treatment. In addition, regression models for repeated
      measures will be used to describe the pattern of change in these outcomes over time.
      Additional models will be constructed to adjust for potential confounding variables including
      age, chemotherapy type, dose and duration of treatment, radiation treatment, gonadotropin
      releasing hormone agonist use, and hormone use. Finally, regression models will be used to
      evaluate the association between changes in urinary isoprostane levels over the study with
      changes in endocrine measures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be referred for this study by their primary oncologists. Eligible
        reproductive-aged girls and women newly diagnosed with cancer or another condition
        requiring chemotherapeutic intervention will be enrolled
      
Biospecimen description: 
      serum
    
Keywords: reproductive hormones; cancer survivors; endocrine function; antral follicle counts; female infertility due to diminished ovarian reserve; perimenopause; premature menopause
Maternal Microcirculation & SDF Imaging
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of pregnant women undergoing a cesarean delivery. It will compare their
      microcirculation before and after the anesthetic. Microcirculation means blood flow to the
      extremely small blood vessels in the body. It will also look at the differences in
      microcirculation of participants who receive an infusion of phenylephrine compared to
      participants who don't. The investigators hypothesize that spinal anesthesia will reduce the
      vascular density and proportion of perfused vessels.
    


Intervention name(s): Initial MicroScan® (Microvision Medical) SDF Measurement; Spinal Anesthesia- Bupivacaine; Comparative MicroScan® (Microvision Medical) SDF Measurement; Bolus Phenylephrine/Ephedrine Treatment; Phenylephrine Infusion
Intervention type(s): Device; Drug; Device; Drug; Drug
Intervention description(s): Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.; The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.; A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.; Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.; Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ephedrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microcirculation; Sidestream Dark Field (SDF) Imaging; Spinal Anesthesia; Phenylephrine