bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the
      effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ
      pharmacokinetics.
    

Detailed description: 
      Open-label study in two parallel groups of 20 healthy subjects each. Group A assessed the
      effect of CBZ on ESL pharmacokinetics, and Group B assessed the effect of ESL on CBZ
      pharmacokinetics. Each patient participated in the study for approximately 9 weeks. The
      clinical portion of the study was completed in approximately 3 months. Subjects received the
      treatments during 35 days.
    

Intervention name(s): BIA 2-093; Carbamazepine
Intervention type(s): Drug; Drug
Other intervention name(s): Eslicarbazepine acetate; ESL; CBZ
Intervention MeSH terms: Carbamazepine; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
Condition: Diabetic Neuropathies; Neuropathic Pain; Pain, Chronic
MeSH terms: Neuralgia; Diabetic Neuropathies; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic
      neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with
      Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment
      will be random.
    

Detailed description: 
      A multi-centered, randomized, double-blind, placebo-controlled, two-period cross-over study
      to compare the safety and efficacy of Omnitram (30 mg to 120 mg daily) and placebo in
      patients with painful diabetic polyneuropathy. For subjects receiving treatment for
      neuropathic pain prior to study enrollment, their treatment will be tapered and stopped at
      least 2 weeks before they will be enrolled. Approximately fifty subjects will be randomized
      in a double-blind manner to a 4-week treatment period of Omnitram or placebo. After a washout
      of at least one week, patients will cross-over to the other treatment for a second 4 week
      treatment period with Omnitram or placebo.

      During the first two weeks of each treatment period, guided by efficacy and tolerability, the
      dose will be increased from 3 tablets to 12 tablets per day given in three equal doses at
      approximately at 8 am, 2 pm and 8 pm (i.e., if the tablet is Omnitram, 30, 60, 90 or 120
      mg/day). During the final two weeks of the treatment period, the doses will be kept constant
      at the highest tolerated titrated dose. Up to six tablets daily of 500 mg oral acetaminophen
      can be used as rescue medication except on the last 4 days of each treatment segment (Days
      26, 27, 28, and 29).
    

Intervention name(s): Omnitram Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Administered three times daily for 28 consecutive days.; Administered three times daily for 28 consecutive days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia
The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The aim of this clinical investigation is to determine the effect of intraoperative
      ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder
      surgery in the beach chair position (BCP)
    

Detailed description: 
      Recent developments in near-infrared spectroscopy technology now permit rapid assessment of
      cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral
      desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures
      or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation
      of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators
      hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic
      levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects
      hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder
      surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a
      normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously
      throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The
      investigators previously observed an association between CDE in the operating room and
      postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and
      intraoperative SctO2 on clinical recovery will also be determined.
    

Intervention name(s): Hypocapnic group; Normocapnic group
Intervention type(s): Other; Other
Intervention description(s): Patients will be ventilated to an ETCO2 of 30-32 mm Hg.; Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cerebral desaturation events; Cerebral oximetry; Beach chair position
Conservative Treatment of Ingrown Toenail
Condition: Ingrown Nail; Nails, Abnormal
MeSH terms: Nails, Ingrown; Nails, Malformed
Study type: Interventional

Summary: 
      Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for
      consultation in podiatry clinics. In the initial stages of the pathology, conservative
      treatments are the first choice of therapy. The aim was therefore, to analyze and compare the
      efficacy of the technique of nail re-education with gauze bandage and nail remodelling for
      the conservative treatment of onychocryptosis in stage I and IIA, A prospective,
      longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20
      subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part
      of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail
      remodelling group.
    


Intervention name(s): Follow up of the clinical stage
Intervention type(s): Procedure
Intervention description(s): Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ingrown toenail; Conservative treatment; Recurrence; Podiatry; Nail remodelling
Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants
Condition: Pharmacokinetics
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy
      subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when
      administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or
      posaconazole.

      The duration of the study for each individual subject will be approximately 49 days from the
      start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days,
      including 22 overnight stays.
    


Intervention name(s): Milademetan; Itraconazole; Posaconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Milademetan 100 mg capsule for oral administration; Itraconazole (200 mg) oral solution (20 mL of 10 mg/mL); Posaconazole (200 mg) oral suspension (5 mL of 40 mg/mL)
Other intervention name(s): Experimental product; DS-3032; CYP3A4 Substrate; CYP3A4 Inhibitor; CYP3A4 Inhibitor
Intervention MeSH terms: Itraconazole; Posaconazole; Cytochrome P-450 CYP3A Inhibitors
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Prior to dosing on Day 1 of Treatment Period 1, subjects will be assigned to 1 of 2 sequences (sequences AB or AC), according to a pre-generated randomization scheme.
Masking: None (Open Label)
Primary purpose: Basic Science
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
Condition: Japanese Encephalitis; Chickenpox
MeSH terms: Chickenpox; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the occurrence of adverse events and seroconversion
      rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE
      vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine,
      respectively.
    


Intervention name(s): Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine; Live Attenuated Varicella Vaccine; live attenuated JE vaccine
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tau Screening Study in Patients With Early Symptomatic AD
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol is designed to serve as a pre-screening study for subjects who are potentially
      eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for
      inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.
    


Intervention name(s): Flortaucipir F18; Brain PET Scan
Intervention type(s): Drug; Procedure
Intervention description(s): 370 megabecquerel (MBq) IV single-dose; positron emission tomography (PET) scan of the brain
Other intervention name(s): 18F-AV-1451; [F-18]T807
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate
      the safety and efficacy of three dose levels of AZD1722 in subjects with constipation
      predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as
      determined during a two-week screening period. Subjects who qualify and are randomized into
      the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive
      weeks. At the end of this treatment period, subjects will be followed for an additional 4
      weeks.
    


Intervention name(s): AZD1722; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791, Tenapanor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics
      (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses
      of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the
      relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).
    


Intervention name(s): GLPG4399 oral suspension; GLPG4399 capsules; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GLPG4399 for oral administration; GLPG4399 for oral administration; Placebo oral suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: a randomized, double-blind, single ascending dose (SAD), Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation and Part 3 and 4: an open-label, randomized, crossover rBA and food-effect (FE) part.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Detection of Immune Changes as a Result of Surgical Trauma in Human Subject
Condition: Surgical Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Surgical trauma triggers a massive inflammatory response. Over time, both the innate and
      adaptive branches of the immune system are affected by surgical trauma. The purpose of this
      study to characterize the cellular and molecular mechanisms immune response to surgical
      trauma. Additionally, detailed information about patients' recovery profile will be recorded
      over a period of 6 weeks, with the eventual goal of linking immune responses to recovery
      profiles.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing primary hip replacement.
      
Biospecimen description: 
      Whole blood
Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder
Condition: ColoRectal Cancer Screening
MeSH terms: Colorectal Neoplasms; Substance-Related Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC)
      screening patient navigator program for patients with Mental Health (MH) and /or Substance
      Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study
      will involve randomly assigning eligible patients to early intervention or usual care/delayed
      intervention groups. The investigators believe this random assignment is ethical because
      Patient Navigation (PN) is an extremely limited resource, and all patients identified as
      eligible could not be contacted by the navigators in a short period of time. Thus the
      investigators will randomly assign access to PN during the study period, and then allow all
      patients to be navigated and screened after the study period is over. As a result, all
      eligible patients will be referred for PN, but the timing of the referral will be randomly
      assigned.
    


Intervention name(s): patient navigation
Intervention type(s): Behavioral
Intervention description(s): Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Randomized Controlled Trials Comparing Clinical Outcomes of 3D Versus 2D Laparoscopic Surgery for Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to explore the feasibility, safety, and efficacy of 3D
      Laparoscopic Surgery for Gastric Cancer. The patients with gastric adenocarcinoma
      (cT1-4aN0-3M0) were studied.
    

Detailed description: 
      A prospective randomized comparison of 3D and 2D laparoscopic surgery for gastric cancer will
      be performed, to evaluate the clinical value and provide theoretical basis and clinical
      experience for the extensive application of the 3D laparoscopic technique. The evaluation
      parameters are perioperative clinical efficacy, postoperative life quality, immune function
      and 3-year/5-year survival and recurrence rates.
    

Intervention name(s): 3D Laparoscopic Surgery; 2D Laparoscopic Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.; After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, 2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stomach Neoplasms Laparoscopy
Personalized Therapy in Non-small Cell Lung Cancer
Condition: Lung Cancer; Carboplatin Adverse Reaction
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and
      thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to
      platinum agents 、 gemcitabine and pemetrexed respectively.

      Tailored therapy using these molecular determinants suggested patient benefit in a previously
      reported phase 2 trial. Here, we designed a study for an individual patient analysis of
      prospectively accrued patients who were treated with the "personalized therapy" approach
      versus other standard approaches.
    

Detailed description: 
      Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to
      2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on
      sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy
      non-individuation ).

      Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients
      accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS)
      was estimated using the Kaplan-Meier method.
    

Intervention name(s): carboplatin, gemcitabine , pametrexed
Intervention type(s): Drug
Intervention description(s): A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed.
B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression.
Intervention MeSH terms: Carboplatin; Gemcitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; gemcitabine; carboplatin; pemetrexed
Enhancing a High School Based Smoking Cessation Program
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement
      therapy when used in combination with the contingency management (CM) + cognitive behavioral
      therapy intervention. Subjects will be randomly assigned to receive either a nicotine
      transdermal patch or a placebo patch as well as being randomly assigned to receive either CM
      or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that
      subjects receiving both active nicotine patch and CM will have higher rates of abstinence
      from tobacco than subjects in the other groups.
    


Intervention name(s): Cognitive Behavioural Therapy; Contingency Management; Nicotine Transdermal Patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): Weekly CBT for all subjects; incentives given for abstinence based on urine analysis; 14mg ir 21mg doses based on weight and #cigs/day
Other intervention name(s): Habitrol
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: smoking; adolescents; contingency management; nicotine replacement therapy
Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of ambroxol hydrochloride soft pastilles 15
      mg vs. ambroxol hydrochloride (HCL) 15 mg of syrup (15mg/5mL, Reference I) and ambroxol
      hydrochloride 15 mg of syrup (30mg/5mL, Reference II) in a fasted state
    


Intervention name(s): Ambroxol hydrochloride - soft pastille; Ambroxol hydrochloride - syrup - low dose; Ambroxol hydrochloride - syrup - high dose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects
Condition: Atherosclerosis; Diabetes; Restenosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize
      vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI)
      and to accelerate stent endothelialisation.
    

Detailed description: 
      Exenatide LAR will be given as a once-weekly (s.c.) dose of Bydureon (2 mg) add on to Insulin
      in combination with Metformin. If patients are Insulin naïve (both groups) an initial dose of
      10U (s.c.) at bedtime will be started, and further up-titrated to achieve a fP-glucose levels
      at 6 mmol/l. Standard care for post myocardial infarction will be given after PCI.

      Primary objectives:

      To test whether Bydureon, add on to Insulin Neutral Protamine Hagedorn (NPH) + Metformin, is
      superior vs. Insulin NPH + Metformin alone, in covered stent struts

      Secondary objectives:

      To test whether Bydureon, add on to Insulin NPH + Metformin, is superior vs. Insulin NPH +
      Metformin alone: in cardiac and endothelial functions
    

Intervention name(s): Bydureon; Humulin kwickpen; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg Once Weekly; Humulin kwickpen 10U QD at bedtime; Metformin 1g BID
Other intervention name(s): Exenatide; Insulin Aspart; Biguanide
Intervention MeSH terms: Metformin; Insulin Aspart; Exenatide; Biguanides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucagon-like peptide-1; Endothelialization; Cardiac Function; Exenatide; Optical Coherence Tomography