bioihbjkbjnl/mcl2 huggingface dataset:
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to
      detect the spread of mouth and throat cancer to lymph nodes in the neck.

      PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and
      sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have
      mouth or throat cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the sensitivity of lymphoscintigraphy and isosulfan blue in localization of
           sentinel lymph nodes in patients with previously untreated squamous cell carcinoma of
           the oral cavity or oropharynx.

        -  Determine evidence of micrometastases in histologically normal sentinel lymph nodes
           resected from these patients.

        -  Assess the clinical significance of micrometastases in lymph nodes resected from these
           patients.

      OUTLINE: Patients undergo preoperative lymphoscintigraphy utilizing technetium Tc 99m sulfur
      colloid followed by intraoperative injections of isosulfan blue at 3-4 locations into the
      primary tumor periphery. Once the afferent lymphatic channel and sentinel node have been
      identified, patients undergo cervical lymphadenectomy followed by resection of the primary
      tumor.

      Resected primary tumor, radioactive lymph nodes, and blue-stained sentinel nodes are then
      subjected to molecular (polymerase chain reaction) and histocytochemical
      (immunohistochemistry for cytokeratin and micrometastases, light microscopy) analyses.

      Patients are followed at 1, 3, 6, 12, 18, and 24 months.

      PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
    

Intervention name(s): isosulfan blue; polymerase chain reaction; immunohistochemistry staining method; lymphangiography; radionuclide imaging; sentinel lymph node biopsy; technetium Tc 99m sulfur colloid
Intervention type(s): Drug; Genetic; Other; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Primary purpose: Diagnostic
Keywords: stage 0 oropharyngeal cancer; stage 0 lip and oral cavity cancer; stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx
Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?
Condition: Healthy; Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      With aging the amount of slow wave sleep decreases drastically and this disruption is
      markedly exaggerated in older adults suffering from mild cognitive impairment and Alzheimer's
      disease. Critically, the disruption of slow wave sleep and cognitive decline seem
      bidirectionally linked forming a vicious cycle. In the long run, improving slow wave sleep
      might be a useful intervention tool to delay the onset of cognitive decline. The present
      study aims at improving slow wave sleep and memory functions through a closed-loop acoustic
      stimulation approach. A closed-loop algorithm is used that detects slow waves in the
      electroencephalogram and is programmed to present short tones (50 ms) in the rhythm of these
      waves. This procedure has shown to boost both slow wave sleep as well as memory performance,
      mainly in young adults and when applied for one night. Here, the investigators apply tones
      via multiple consecutive nights and assess memory performance during this 3-night
      intervention.
    


Intervention name(s): Closed loop acoustic stimulation; Sham acoustic stimulation
Intervention type(s): Other; Other
Intervention description(s): The intervention consists of three consecutive nights of closed loop acoustic stimulation during slow wave sleep. An established closed-loop algorithm is utilized that detects slow oscillations in the electroencephalogram and is programmed to present short tones (50 ms) into their up-states. Tones will be presented via a headband with integrated speakers. The procedure does not wake participants; Sham acoustic stimulation: participants wear the headband but no stimuli are delivered during slow wave sleep. This ensures that in both the control and the intervention group the conscious experiences are the same.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
Condition: Dyslipidemia; Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of different doses of
      CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will
      evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with
      moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in
      patients with hypercholesterolemia who are on a statin.
    


Intervention name(s): CAT-2003; Placebo; Statin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Structuring Financial Incentives to Increase Physical Activity
Condition: Physical Activity; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of different structures of long
      term financial incentives on increasing physical activity performed by subjects, as measured
      by the number of steps walked per day.

      Investigators are interested in studying whether physical activity increases during an
      intervention period (with incentives) and a post-intervention period (with no incentives).
    

Detailed description: 
      The proposed study is a field experiment. Adults within the ages of 25 and 60 years of age,
      and with a body mass index of 22 or higher will be eligible to participate.

      The study will consist of (1) a two-week baseline period, (2) a 36-week intervention period,
      and (3) a 12-week follow-up period.

      At the beginning of the study, subjects will be given a wearable fitness device and their
      daily step count will be monitored for two weeks; this is the baseline period. After the
      two-week baseline period, the subjects will be randomly assigned to one of the five different
      conditions (Control, Gain, Loss, Gain Streak, or Loss Streak) and will be given the goal to
      increase their baseline step counts by 2,500 steps.

      =====

      HYPOTHESES -- Investigators expect the following:

        1. Loss Aversion: Subjects in the Loss treatment will achieve the goal on a greater number
           of days than subjects in the Gain treatment.

        2. Streak: Subjects in the Gain treatment will achieve the goal on a greater number of days
           than subjects in the Gain Streak treatment.

        3. Loss Streak: Subjects in the Loss treatment will achieve the goal on a greater number of
           days than subjects in the Loss Streak treatment. Whether subjects in the Loss Streak
           treatment will perform better or worse than subjects in the other two treatments will be
           investigated.

      CONTRIBUTION -- Prior research has not examined the effect of a long term financial incentive
      (36 weeks) on individual behavior in achieving a goal. In this study, the investigators also
      examine two additional financial incentive structures: Gain Streak and Loss Streak. If the
      hypotheses are correct, the results have important implications for designing financial
      incentives to encourage good behavior and to encourage good habit formation across domains.
    

Intervention name(s): Financial Incentive
Intervention type(s): Behavioral
Intervention description(s): Giving different structures of long term (36 weeks) financial incentives to increase physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3
Condition: Conduct Disorder; ADHD; Oppositional Defiant Disorder
MeSH terms: Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This study investigates the psychophysiological responses to aversive stimuli in a population
      of 133 children clinically diagnosed with conduct disorder (CD) and/or
      attention-deficit/hyperactivity disorder (ADHD). Participants were administered with either
      omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three
      months: 1) a loud sound, 2) threatening photographs from the International Affective Picture
      System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological
      features of heart rate and galvanic skin conductance were measured and analyzed in relation
      to their omega-3/placebo condition clinical diagnosis.
    


Intervention name(s): Omega-3; Placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Omega-3 supplement is a highly concentrated fish oil brain booster supplement that helps compensate for the neurocognitive and brain dysfunction which acts as a predisposition to antisocial and violent behaviour. Individuals with antisocial personality disorder have been found to show an 11% reduction in gray matter in the prefrontal cortex (Raine et al. 2001), and structural prefrontal impairments are hypothesised to result in disinhibition of limbic subcortical structures that give rise to aggressive behaviour. Omega-3 (specifically DHA) is known to play a key role in neuronal structure and function.; Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with
      low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney
      transplant recipients.
    


Intervention name(s): Everolimus and tacrolimus; mycophenolate mofetil and tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Everolimus:
Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
Dose: 1.5 mg per day
Frequency: 0.75 mg twice daily
Tacrolimus:
Dose adjusted to maintain specific blood levels; Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels
Other intervention name(s): Active Comparator Control)
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplant; renal transplant; immunosuppression; mycophenolate mofetil; tacrolimus; everolimus
Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
Condition: Liver Transplantation
Study type: Interventional

Summary: 
      This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed
      start of the anti-rejection drugs (10 days after liver transplant), compared to the current
      approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2
      days after the liver transplant.
    

Detailed description: 
      Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have
      received transplants, to ensure that the patient's body does not reject the new organ. In
      some cases, while anti-rejection medications protect a newly transplanted liver, they can
      injure the patient's kidneys and cause them not to work as well as they should. The purpose
      of this pilot study is to determine the best way to protect kidney function and to ensure
      that the newly transplanted liver is not rejected. This study will evaluate the use of a drug
      called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days
      after liver transplant), compared to the current approach of starting anti-rejection drugs
      called calcineurin inhibitors or CNI's within 2 days after the liver transplant.
    

Intervention name(s): Thymoglobulin 3mg total; Thymoglobulin 4.5mg total; Mycophenolate mofetil; tacrolimus 3-8; tacrolimus 8-12
Intervention type(s): Biological; Biological; Drug; Drug; Drug
Intervention description(s): 1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg); 1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg); 1000 mg PO/IV BID for up to 6 months; Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180; Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.
Other intervention name(s): CellCept; Prograf; Prograf
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: calcineurin inhibitor delay; Kidney
Influence of Post-thaw Embryo Culture Interval on Assisted Reproduction Success Rates
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The transfer of frozen / thawed embryos has been routinely performed in the last 30 years as
      part of Assisted Reproduction treatment (ART). Currently, more than 50% of couples submitted
      to ART have surplus embryos eligible for freezing followed by transfer in subsequent cycles.
      Therefore the selection criteria for the thawed embryos to be transferred must be rigorous in
      order to maximize pregnancy and of live birth rates. Usually, the evaluation of the embryos
      before transfer can be performed based on blastomeres survival after a short culture period
      between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a
      prolonged period of culture (18h to 24h). Post-thaw embryo culture might have an impact on
      the recovery of mitosis and normal cellular functions. However, until now, there is no
      consensus in the literature on which post-thaw culture interval has a better impact on
      pregnancy and live birth rates. Also, blastocysts formation after freezing/thawing of embryos
      at cleavage stage may bring relevant information about post-thaw culture. Moreover, this
      strategy can be used as an alternative treatment. Therefore, the authors proposed this
      prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture
      on the pregnancy and live birth rates.
    


Intervention name(s): embryo transfer after thaw and culture; embryo transfer with no culture
Intervention type(s): Procedure; Procedure
Intervention description(s): embryos will be kept in culture after thawing for one day before transfer for the uterus; embryos will be transfer with no culture after thaw
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, triple-blinded study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cryopreservation; human embryos; vitrification; embryo culture; embryo transfer; pregnancy rate
Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of BAT2022 in healthy subjects.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation
      clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and
      pharmacodynamics of BAT2022 for Injection in healthy subjects.
    

Intervention name(s): BAT2022
Intervention type(s): Drug
Intervention description(s): Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group.
Other intervention name(s): BAT2022 for Injection (bispecific neutralizing antibody targeting the receptor binding domain (RBD) of spike of SARS-CoV-2)
Intervention MeSH terms: Antibodies, Blocking
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The steady-state pharmacokinetics of Dalfampridine-ER (extended release) 7.5 mg (milligram)
      tablets in healthy adult volunteers and those with mild and moderate renal impairment, and
      examine between group comparisons.
    

Detailed description: 
      Pharmacokinetics in normal, mildly renally impaired, and moderately renally impaired subjects
    

Intervention name(s): Dalfampridine-ER
Intervention type(s): Drug
Intervention description(s): 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
Intervention MeSH terms: 4-Aminopyridine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were
      not satisfied with rizatriptan therapy
    


Intervention name(s): Eletriptan
Intervention type(s): Drug
Intervention description(s): 40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
Intervention MeSH terms: Eletriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning
Condition: Acute Organophosphorus Poisoned Patients
Study type: Interventional
Phase: Early Phase 1

Summary: 
      All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute
      organophosphorus poisoning will be included in the study. The diagnosis of intoxication will
      be based on history of acute exposure , clinical examination and laboratory investigations.
      Patients will be randomly allocated into 2 equal groups.

      Group 1 -. Patients who will receive (conventional treatment of acute organophosphorus
      poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only
    

Detailed description: 
      40 patients with acute organophosphorus poisoning will be randomly assigned as control groups
      and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute
      organophosphorus intoxication will be based on history of acute exposure, clinical
      examination and laboratory investigations. Patients will be randomly allocated into 2 equal
      groups.

      Group 1 - Patients who will receive (conventional treatment of acute organophosphorus
      poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only
    

Intervention name(s): n acetyl cysteine; standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): A patients received NAC 140 mg/Kg IV infusion (as a loading dose), then 70 mg/KgIV infusion every 4 hours up to 17 doses; stabilization and antidotes
Other intervention name(s): atropine and oximes
Intervention MeSH terms: Acetylcysteine; Atropine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment