bioihbjkbjnl/mcl2 huggingface dataset:
[11C]-(R)-Rolipram to Measure cAMP Signaling Before and After Ketamine
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Major depressive disorder (MDD) may have many underlying causes. One theory is that brain
      cells with low levels of a molecule called cyclic AMP (cAMP) may cause depression. A drug
      called ketamine may increase the levels of cAMP in a person s brain cells.

      Objective:

      To find out if administering ketamine to people with depression affects cAMP levels in their
      brains.

      Eligibility:

      People aged 18 to 70 with MDD who are enrolled in another NIH study that uses ketamine.

      Design:

      Participants will visit the NIH clinic 5 times in up to 6 weeks. Some of the visits may be
      spread out over more than 1 day.

      Participants will be screened. They will have a physical exam with blood and urine tests.
      They will have a test of their heart function. They will have a psychiatric evaluation. They
      will answer questions about their family history and mental health.

      Participants will have a PET scan. A small amount of a radioactive drug will be injected into
      a vein in their arm. Participants will lie on a bed that slides in and out of a
      doughnut-shaped machine that records images of their brains. They will have their heads in a
      holder to prevent movement. Each scan will last up to 2 hours.

      After their first PET scan, participants will receive ketamine in a different study they are
      enrolled in. Then they will come back for another PET scan with the radioactive drug.

      Participants will also have another scan called an MRI. They will lie on a table that slides
      into a metal tube. They will lie still for up to an hour....
    

Detailed description: 
      Study Description:

      This study will test the effects of ketamine infusion on the cAMP system in human brain to
      determine if ketamine mediates its antidepressant effects at least in part due to modulation
      of cAMP signaling.

      Objectives:

      Primary Objective: To determine if ketamine infusions in depression causes increases in cAMP
      signaling as measured by [11C](R)-rolipram binding.

      Secondary Objectives: To determine if increases in [11C](R)-rolipram correlate with
      symptomatic improvement in major depressive symptoms.

      Endpoints:

      Primary Endpoint: measurement of PDE4 density (volume of distribution VT) in brains of
      individuals with major depressive disorder (MDD) before and after administration of ketamine.

      Secondary Endpoints: Clinical rating scales of depression, including MADRS, HAM-D.
    

Intervention name(s): 11(R)-rolipram
Intervention type(s): Drug
Intervention description(s): Injected IV followed by PET scanning
Intervention MeSH terms: Rolipram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET Imaging; Inflammation; Ketamine; Depression
The Role of a Motion Sensor With Accompanying Web Application on Step Counts, Energy Balance, and Metabolic Markers in Nurses
Condition: Cardiovascular Risk Factor; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this prospective randomized controlled trial is to explore the role of a
      motion sensor with accompany web application on step counts, energy balance, and metabolic
      markers in nurses. Additionally, eating behaviours, behavioural regulation in exercise, and
      mood states that may impact these parameters will also be examined.
    


Intervention name(s): Motion sensor
Intervention type(s): Behavioral
Intervention description(s): To explore the role of a motion sensor with accompanying web application on step counts, energy balance, and metabolic markers in nurses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: cardiovascular disease; motor activity; woman; workplace; Delivery of health care
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and
      safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile
      Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg)
      will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with
      body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks.
      Tocilizumab was administered every 10 days until pre-planned interim analysis was performed
      and changed to Q2W in participants with body weight <30 kg.
    


Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Subcutaneous 162 mg dose QW or Q2W for 52 weeks
Other intervention name(s): RoActemra/Actemra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction
Condition: Tooth Impaction; Tooth Diseases
MeSH terms: Tooth Diseases; Tooth, Impacted
Study type: Interventional

Summary: 
      In this study, the postoperative clinical and microbiologic effects of chlorhexidine
      toothpaste and chlorhexidine-free toothpaste with the same content were compared after
      bilateral mandibular impacted third molar surgery. Similarly positioned fully impacted
      impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients
      were randomly selected. After the operation, the experimental group received Dentasave 0.2%
      chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste
      with the same content but without chlorhexidine. Teeth were extracted by the same dentist at
      14-day intervals. For microbiological analysis, saliva samples were taken before the first
      tooth extraction, before the second tooth extraction 14 days later and on the 28th day and
      sent to the microbiology laboratory. Wound healing, edema and trismus in both extractions
      were evaluated 1 week after tooth extraction. Wound healing was evaluated as good, acceptable
      and poor. VAS (Visual Analog Scale) was used for pain assessment and recorded 14 days after
      tooth extraction.
    


Intervention name(s): Surgery of impacted mandibular wisdom teeth
Intervention type(s): Procedure
Intervention description(s): All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures.
Other intervention name(s): Surgery of impacted mandibular wisdom teeth (the other side)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: chlorhexidine, wisdom teeth, dental surgery
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Different Formulations of Midazolam in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on how
      fast different formulations of midazolam gets into the blood stream and how long it takes the
      body to remove it when administered in healthy participants. The study will also access how
      much endogenous coproporphyrins I and III as biomarkers of OATP1B1 and OATP1B3 is in the
      bloodstream and how the body handles and eliminates them following single and multiple oral
      doses of Pirtobrutinib. Safety and tolerability of Pirtobrutinib will also be evaluated. For
      each participant, the total duration of the study will be 59 days, including screening.
    


Intervention name(s): Midazolam Syrup; Midazolam Solution; Pirtobrutinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered Orally.; Administered IV bolus.; Administered Orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Midazolam; Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Xenical (Orlistat) in Overweight and Obese Adolescents
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or
      overweight adolescents. Patients will be randomised into one of 2 groups; both groups will
      undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also
      receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the
      target sample size is <100 individuals.
    


Intervention name(s): Diet and Exercise; orlistat [Xenical]
Intervention type(s): Behavioral; Drug
Intervention description(s): mildly hypocaloric diet and physical exercise; 120mg po tid
Intervention MeSH terms: Orlistat
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Homeopathic Cold Medicine for Children
Condition: Upper Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a commercially available homeopathic cold remedy
      for children is effective in providing relief from cold symptoms in children 2-5 years old.
      It is postulated that children will have relief of symptoms after receiving a dose of the
      cold remedy
    


Intervention name(s): Hyland's Cold 'n Cough 4 Kids
Intervention type(s): Drug
Intervention description(s): Liquid homeopathic cold remedy, 5 ml by mouth every 4 hours as needed for relief of cold symptoms for up to 10 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: upper respiratory tract infection; children; homeopathic
PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation
Condition: Patients Receiving a Kidney From a Non-Heart-Beating Donor
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double blind, placebo controlled, prospective trial investigating the effect of
      erythropoietin in renal transplantation.

      The investigators postulate that erythropoietin reduces the risk of delayed graft function.
    

Detailed description: 
      Randomized, double blind, placebo controlled, prospective trial in patients, receiving a
      kidney transplantation. Patients will be randomized to receive either Epoetin Beta
      (Neorecormon; Roche) or placebo.

      The primary endpoint will be delayed graft function. The anticipated duration of this trial
      is 2 year and the target sample size is 60 patients per arm.
    

Intervention name(s): Epoetin beta
Intervention type(s): Drug
Intervention description(s): intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Other intervention name(s): Neorecormon
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: erythropoietin; kidney transplantation; delayed graft function
Omega-3 Fatty Acids as Adjunct Treatment for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the study was to determine the effects of 10-week adjunctive
      supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity
      and biochemistry in adolescents with MDD.

      The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently
      increase prefrontal cortical functional activation during sustained attention and increase
      regional biochemical indices of cortical metabolism and integrity concentrations in
      association with reductions in depressive symptoms.
    

Detailed description: 
      This study is a 10-week open-label EPA+DHA treatment trial in adolescent (aged 12-18 years)
      patients with major depressive disorder exhibiting partial response to SSRI medications.
      After a screening visit, patients were randomized (stratified by gender) to open-label fish
      oil supplements at a fixed dose of either 2.4 g/day or 15 g/day (2 tablespoons/day) for 10
      weeks.

      A physical examination, a complete blood count (CBC), and thyroid stimulating hormone (TSH)
      levels were determined at baseline and Week 10, and vital signs (pulse, blood pressure,
      weight, height, body mass index, temperature) were obtained at each visit. At each visit,
      safety and tolerability were assessed using a structured side effect interview, the Side
      Effects Form for Children and Adolescents.

      At baseline and all weekly visits, depression symptom severity was determined with the
      Children's Depression Rating Scale-Revised (CDRS-R), a 17-item observer-rated questionnaire,
      and remission was defined as a CDRS-R score of ≥28. If a patient's depressive symptoms
      worsened over the course of the trial (defined as 30% worsening relative to baseline on two
      consecutive visits using CDRS-R scores), they were withdrawn from the study. In view of the
      potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation,
      manic symptom severity was monitored over the course of the trial with the Young Mania Rating
      Scale (YMRS), an 11-item observer-rated questionnaire.

      fMRI scans were performed at baseline and at 10 weeks.
    

Intervention name(s): Low Dose Fish Oil; High Dose Fish Oil
Intervention type(s): Drug; Drug
Intervention description(s): Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day); Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Other intervention name(s): OmegaRx - Zone Laboratories; OmegaRx - Zone Laboratories
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sadness; Insomnia; Loss of appetite; Fatigue; Trouble thinking
Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders
Condition: Urea Cycle Disorders, Inborn
MeSH terms: Urea Cycle Disorders, Inborn
Study type: Interventional

Summary: 
      The investigators will study and compare how effectively sodium phenylbutyrate, sodium
      benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject
      participation will require three, separate, four-day study periods at least one week apart.
      During one study period (also called a treatment arm), subjects will take sodium
      phenylbutyrate; during another they will take sodium benzoate; during another they will take
      a combination of the two medications.

      We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or
      a combination of the two.
    


Intervention name(s): Sodium Benzoate; Sodium Phenylbutyrate
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.; Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.
Other intervention name(s): Buphenyl (tm)
Intervention MeSH terms: Sodium Benzoate; 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: urea cycle disorders
A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
Condition: Laryngeal Mask Airway
Study type: Interventional

Summary: 
      The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5
      supreme LMA compared to proseal LMA for infants weighing <10kg.
    

Detailed description: 
      This is a randomized prospective study to compare the clinical efficacy and safety for size 1
      and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be
      compared and other parameters such as time to insertion, insertion success rate, fibreoptic
      glottic view and intraoperative complications will be recorded.
    

Intervention name(s): LMA Supreme; LMA Proseal
Intervention type(s): Device; Device
Intervention description(s): The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.; The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension
Condition: Primary Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.
    

Detailed description: 
      To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary
      open-angle glaucoma or ocular hypertension.
    

Intervention name(s): Levobetaxolol eye drops; Betaxolol eye drops
Intervention type(s): Drug; Drug
Intervention description(s): one drop per time; twice daily; one drop per time; twice daily
Intervention MeSH terms: Betaxolol; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Safety; efficacy; Levobetaxolol eye drops; Chinese patients
Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects
Condition: Constipation Drug Induced
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study was being done to study the effect of codeine and Naloxegol for 3 days
      compared to placebo on the movement of food through the colon of healthy individuals. Codeine
      is a commonly used pain-relieving drug that often causes constipation as an unwanted side
      effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation
      induced by Codeine.

      The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and
      colonic transit induced by codeine in healthy participants.
    

Detailed description: 
      This was a single center, randomized, double-blind, placebo-controlled, parallel-group, Phase
      I study of the effects of naloxegol, a novel mu-opioid antagonist, on gastrointestinal and
      colonic transit in the presence or absence of the mu-opiate, codeine. There is a need to
      develop effective medications for the treatment of opiate-induced constipation and other
      motility disorders. Currently available opiates are complicated by addictive potential and
      induction of troublesome constipation.
    

Intervention name(s): Naloxegol; Codeine; codeine placebo; naloxegol placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25mg daily; 30mg 4 times daily; 4 times daily (placebo will be made to match the codeine); placebo will match naloxegol, given daily
Other intervention name(s): MOVANTIK
Intervention MeSH terms: Codeine; Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the effect of an encapsulated juice
      powder concentrate on the number of days with at least moderate common cold symptoms over
      winter time.
    

Detailed description: 
      Common cold is the most frequent acute illness in industrialised societies. Though it is
      usually benign, it is a leading cause of absence from work and doctor visits, causing an
      enormous economic burden including lost productivity and treatment costs.

      Common cold is caused by a variety of viruses, with rhinoviruses and corona viruses as the
      most common. There is currently no treatment for common cold, thus therapy is focussed on
      symptom relief only. Prevention strategies for common cold include lifestyle measures such as
      avoiding infected people and regular hand washing during cold season. Dietary supplements
      including herbs and vitamins have been suggested as preventive strategies for common cold.

      Juice Plus+® is a dietary supplement composed primarily of juice powder concentrate and pulp
      from fruits and vegetables. It contains several antioxidants including vitamin C, vitamin E,
      beta-carotene and folate. One randomized study reported reduction in work days lost to
      illness in the Juice Plus+® group compared to the placebo group. However, the clinical
      benefit for preventing common cold symptoms has not yet been tested in a large adult
      population.
    

Intervention name(s): Juice Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Juice Plus+® is a dietary supplement from concentrated fruits (apple, orange, pineapple,cranberry, cherry (acerola), papaya and peach) and vegetables (carrot, parsley, beet, broccoli, kale, cabbage, spinach, and tomato).
Subjects will take four capsules of Juice Plus+® daily.; Four capsules of placebo daily.
Other intervention name(s): Juice Plus+®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Common cold; prevention; dietary supplement