bioihbjkbjnl/mcl2 huggingface dataset:
Loperamide Grapefruit Juice Interaction PK Trial
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium)
      affects the body and how the body affects loperamide.
    

Detailed description: 
      An open-label, randomized, single-dose, fixed-sequence crossover drug interaction study of
      loperamide HCl with grapefruit juice. About 33 healthy subjects, about equal numbers of men
      and women, 18 through 59 years of age, will be enrolled into this 10 day trial. Subjects will
      be divided into three cohorts of about 11 subjects each. Each cohort will receive red, white
      or pink grapefruit juice. Subjects will take 4 mg of loperamide on Day 1. They will ingest 8
      ounces of grapefruit juice and then 4 mg of loperamide on Day 3. They will ingest 8 ounces of
      grapefruit juice in the morning and in the evening on Days 5, 6 and 7. On Day 8, subjects
      will ingest 8 ounces of juice and then 4 mg of loperamide. Blood samples will be collected at
      at predose (0) and 0.5, 1, 1.5, 32, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36 and 46 hours after
      dosing on Day 1, Day 3 and Day 8. Pupillometry assessments will be performed at pre-dose (0)
      and 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8. Subjects will collect
      their urine from about 8 PM to about 6 AM prior to dosing on Day 1, Day 3 and Day 8.
    

Intervention name(s): Loperamide / Red Grapefruit Juice; Loperamide/ White Grapefruit Juice; Loperamide / Pink Grapefruit Juice
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fixed sequence of loperamide 4 mg with and without red grapefruit juice; Fixed sequence of loperamide 4 mg with and without white grapefruit juice; Fixed sequence of loperamide 4 mg with and without pink grapefruit juice
Other intervention name(s): Imodium; Imodium; Imodium
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation
      around eye in dry eye disease patients who are scheduled for LASEK surgery.
    

Detailed description: 
      Duration of study period (per participant): Screening period (0-14 days), Intervention period
      (12 weeks), F/U period (2 weeks) Patient needs to visit site at least 9 times (Screening,
      baseline, V1, V2, V3, Tele-visit, V4, V5, F/U Tele-visit). Baseline visit will be done on the
      day of surgery. Visit 1, 2, 3, Tele-visit, 4, 5, F/U Tele-visit is 1 day, 3 days, 1 weeks, 2
      weeks, 4 weeks, 12 weeks and 16weeks after baseline visit.
    

Intervention name(s): Real Pulse Electrical Stimulation (NuEyne 01); Sham Pulse Electrical Stimulation
Intervention type(s): Device; Device
Intervention description(s): Patients wear our clinical trial device 15~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.; Patients wear our clinical trial device 15~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effect of pre-operative oral pregabalin on post operative
      morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
    

Detailed description: 
      The participants are randomized into two groups by computer randomization. The patient
      undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine
      is initiate in the post-anesthetic care unit. We compare post operative morphine consumption
      in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.
    

Intervention name(s): placebo; Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.; Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregabalin; postoperative pain; abdominal hysterectomy
Impact of Cerebellar Mass Resection on Pain Processing
Condition: Cerebellar Neoplasm
MeSH terms: Cerebellar Neoplasms
Study type: Observational

Summary: 
      The purpose of the study is to evaluate how cerebellar resection surgery may affect pain
      sensation and the way the brain "reads" pain signals. By measuring brain activity in children
      and adolescents following surgery, the investigators hope to gain valuable information about
      pain processing in the brain.
    

Detailed description: 
      This study is designed to test whether cerebellar resection surgery affects pain pathways in
      the brain. To participate a participant must (A) have had a cerebellar mass surgically
      removed, or (B) are a healthy volunteer with no history of pain disorders or mental illness.
      The study will involve sensory testing and brain imaging using magnetic resonance imaging
      (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact
      thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic
      fields and radio waves to give pictures of the brain without using radiation.
    

Intervention name(s): Medoc Advanced Medical Systems PATHWAY Model ATS; Cold water bath; MRI scanner; Questionnaires
Intervention type(s): Device; Procedure; Device; Other
Intervention description(s): 30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.; The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.; An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.; The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cerebellar resection and healthy volunteers.
      
Keywords: Cerebellar tumor; Non-malignant low-grade cerebellar astrocytomas
Impact of Catch-up HPV Vaccination
Condition: HPV; HPV Vaccination; Vaccine Preventable Disease; Cervical Lesion; Cervical Cancer
MeSH terms: Vaccine-Preventable Diseases
Study type: Observational

Summary: 
      Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The
      vaccinal cover stays insufficient since less than 30% of the french population is vaccinated.
      Therefore french studies about vaccine efficacy and especially about the catch-up vaccine
      (done after 15years old) are needed.

      HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the
      catch-up HPV vaccination.

      Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to
      do their regular cervical smear. At this time, a survey will be given to know their vaccinal
      status.

      The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the
      cervical smears results and by comparing the vaccinated group with the not-vaccinated group.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 25 and 38 years old in 2022 coming for a HPV or smear test during the study
        period.
Oxygen Level and Safe Emergence From Anesthesia
Condition: Focus of Study is Postoperative Pulmonary Atelectacis
Study type: Interventional

Summary: 
      Using a protective ventilation strategy during general anesthesia from pre-oxygenation to
      emergence and selecting patients without risk of a difficult airway or intubation, a lower
      fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the
      postoperative area of atelectasis without desaturations becoming more common.
    


Intervention name(s): 30% oxygen; 100% oxygen
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label trial to evaluate the safety and immunogenicity of INO 5150
      alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by
      electroporation (EP) in men with biochemically relapsed prostate cancer.
    

Detailed description: 
      Phase I, open label study of INO-5150 (DNA plasmids encoding prostate specific antigen (PSA)
      and prostate specific membrane antigen (PSMA)) alone or co-administered with INO-9012 (IL-12
      plasmid) delivered intramuscularly followed by EP using the CELLECTRA®-5P device in adult
      males with biochemically relapsed prostate cancer following definitive local therapy (e.g.
      prostatectomy, external beam radiation, or brachytherapy). Four injections will be
      administered to approximately 60 eligible subjects who consent to participate in the study.
      Subjects will be monitored for safety and immunogenicity through Week 72.
    

Intervention name(s): 2mg INO-5150 and electroporation device CELLECTRA®-5P; 8.5mg INO-5150 and electroporation device CELLECTRA®-5P; 2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P; 8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P; Electroporation using CELLECTRA®-5P
Intervention type(s): Biological; Biological; Biological; Biological; Device
Intervention description(s): 2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P; 8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P; 2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P; 8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P; Electroporation device CELLECTRA®-5P
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PSA
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary
      chemotherapy in patients with inoperable or recurrent breast cancer.
    

Detailed description: 
      The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with
      breast cancer in 2001, making it the leading cause of cancer among women since 1995.
      Statistical database in Exel format/outline of health welfare statistics from the Ministry of
      Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in
      2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast
      cancer patients, detection and treatment at an earlier stage can lead to higher survival
      rates. However, the recurrence rate increases as the disease progresses. In addition, about
      thirty percent of all breast cancer patients are believed to have recurrent disease. Thus,
      developing treatments against recurrence may be an important task.

      The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including
      anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B
      recommendation) breast cancer. In a second-line therapy recommended for metastatic or
      recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu
      derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is
      superior to docetaxel alone for improving survival. This regimen is recommended for patients
      with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation).
      However, data are lacking to support capecitabine as a standard regimen as a second-line
      therapy; its efficacy needs verification and further study. Accordingly, this study is
      designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride, to
      which an indication of "inoperable or recurrent breast cancer" was added, as a first-line
      therapy in patients with inoperable or recurrent breast cancer by comparing it with
      Capecitabine alone, which is already approved of the same indication.
    

Intervention name(s): Capecitabine; S-1
Intervention type(s): Drug; Drug
Intervention description(s): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.; 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
Other intervention name(s): Xeloda; TS-1
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Neoplasms; Drug Therapy
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures
Condition: Tuberous Sclerosis Complex-associated Refractory Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the efficacy and safety of two trough-ranges of everolimus given as
      adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory
      partial-onset seizures.

      The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1)
      to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week
      18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had
      completed the core phase] and Post Extension phase [from end of Extension phase to end of
      study].
    


Intervention name(s): RAD001; Placebo; Antiepileptic drug (1 to 3 only); open label RAD001 (only used for post-extension phase)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.; Placebo tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.; no more than any 3 of the listed antiepileptic drugs could be taken with the study drug or placebo. List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin; everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister backs in boxes with open label design and were taken during the Post-Extension phase, where all the participants, including those who were previously on placebo, took the 2mg tablets.
Other intervention name(s): everolimus; open label everolimus
Intervention MeSH terms: Everolimus; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TSC seizures; TSC epilepsy; mTOR inhibitor; RAD001; Everolimus
Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      This study aimed to examine the impact of surgical masks on maximal and submaximal exercise
      in both athlete and non-athlete individuals.
    

Detailed description: 
      All participants will be informed about the procedure and, will sign an informed consent
      form. They will undergone a detailed physical examination before enrollment in the study. The
      study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary
      exercise tests (CPET) are going to be performed with and without a surgical mask with 48
      hours in between.
    

Intervention name(s): CPET without mask; CPET with mask
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Regular cardiopulmonary exercise tests were applied to all participants in phase 1.; A 3-layer surgical mask was placed on CPET device's mask and was fixed with a CPET tribune. In phase 2, as using this combined (surgical mask and device's mask) masks, CPETs were performed in all participants again, after 48 hours.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: A prospective, crossover designed study was conducted in 2 phases. Cardiopulmonary exercise test was performed with and without surgical mask in all participants in between 48 hours. The participant group was further divided into two groups as athlete and non-athlete. In first step, parameters were compared between the CPET tests performed with and without surgical masks. In second step, athletes' and non-athletes' parameters were compared during CPET tests performed with surgical mask.
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: surgical mask; Cardiopulmonary exercise test; COVID-19 (coronovirus-19 disease); exercise
Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to
      explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science
      positron emission tomography (PET) sleep imaging. This study will allow us to gain insight
      into the differences in sleep and waking brain mechanisms between veterans with PTSD and
      those without PTSD.
    


Intervention name(s): Sleep data recording; PET scan - waking; PET scan - REM Sleep
Intervention type(s): Other; Other; Other
Intervention description(s): After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.; After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.; After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF),
        ages 18-50, with combat experience, who are not on medication.
      
Keywords: Post Traumatic Stress Disorder; PTSD; Brain; Imaging; PET; Neural; Sleep; REM Sleep
The Comparison Of Nerve Blocks In Cesarean Delivery
Condition: Anesthesia, Obstetrical
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of different kinds of popular
      peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed,
      compared with traditional epidual analgesia.
    

Detailed description: 
      Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.
    

Intervention name(s): QLB; Intravenous patient controlled analgesia (PCA)
Intervention type(s): Procedure; Procedure
Intervention description(s): QLB, quadratus lumborum block.; Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: quadratus lumborum block; anesthesia; pain, postoperative