bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Corrected Carotid Artery Flow Time as a Predictor of Fluid Responsiveness in Spontaneous Breathing Patients
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      It is still challenging to assess intravascular volume status in spontaneously breathing
      patients. Recently, the measurement of corrected flow time in carotid artery was introduced
      as quite useful, simple and noninvasive for the evaluation of circulating blood volume
      change. The aim of this study is to evaluate whether corrected carotid artery flow time as
      determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously
      breathing patients before induction of general anesthesia.
    


Intervention name(s): ultrasonographic measurement of corrected flow time in carotid artery
Intervention type(s): Device
Intervention description(s): Corrected carotid artery flow time is measured using 10-5 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed while the Doppler beams were adjusted to ensure < 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were scheduled to undergo elective neurosurgery for brain tumor
A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of a single oral dose of
      JNJ-88260237 in healthy participants
    


Intervention name(s): JNJ-88260237; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-88260237 will be administered orally.; Matching placebo will be administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Condition: Bleeding; Implants; Breakthrough Bleeding
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective
      method of preventing pregnancy, but it has bleeding side effects that make it unappealing for
      many women. The only study to demonstrate a sustained reduction in bleeding lasting for two
      months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the
      levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary
      data of tamoxifen and ENG implant users, the investigators plan to perform additional studies
      on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.
    

Detailed description: 
      The investigators will perform a 2 phase trial for treatment of women experiencing frequent
      or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist
      of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day
      reference period and the second phase will allow both study arms to receive open-label
      treatment over an additional 90-day reference period. The primary outcome of the study will
      be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first
      treatment (TX1).
    

Intervention name(s): Tamoxifen; Placebo; Tamoxifen (open label)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study; Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study; Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
Other intervention name(s): Nolvadex; Genox; Tamifen; Nolvadex; Genox; Tamifen
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unscheduled bleeding; Long acting contraception
Effect of Yohimbine on Colon Transit
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed
      at which food travels through the stomach, intestines and colon, and if yohimbine affects the
      amount of liquid you can drink in a short period of time. Understanding how yohimbine works
      on the gut may help develop new treatments for patients with constipation. Yohimbine has been
      approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use
      as proposed in this study is considered investigational.
    


Intervention name(s): Yohimbine, oral
Intervention type(s): Drug
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, crossover, open-label study to assess the relative bioavailability,
      pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet,
      softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
    


Intervention name(s): Danicopan - Tablet; Danicopan - Softgel; Danicopan - LFC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet.; Oral softgel capsule.; Oral LFC.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Relative Bioavailability; LFC; Tablet; Softgel Capsule; Food Effect; Pharmacokinetics; Factor D Inhibitor; Safety
Adjunct Minocyline in Treatment-resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the antidepressant efficacy of minocycline as an adjunct to an
      antidepressant standard treatment (AD-ST), for patients with unipolar major depressive
      disorder (MDD).
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized, multicenter proof-of-principle trial
      of adjunctive minocycline for patients with unipolar major depressive disorder (MDD). The
      study tests the antidepressant efficacy of minocycline as an adjunct to an antidepressant
      standard treatment (AD-ST), for patients with unipolar major depressive disorder (MDD). The
      respective AD, for which non-response has been documented, must be on a stable regimen for at
      least 14 days prior to inclusion. AD-ST will then be continued throughout the trial. Trial
      medication is adjunct oral minocycline 200 mg/day or placebo. Response to treatment will be
      measured via the Montgomery-Asberg Depression Rating Scale (MADRS). The total study duration
      for each patient will be 6 weeks.
    

Intervention name(s): Minocycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 weeks 200mg/day Minocycline add-on; 6 weeks Placebo add-on
Other intervention name(s): Solodyn; Minocin; Sugar pills, mimics Minocycline tablet
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: treatment resistant depression; inflammation; microglia; minocycline
A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer
Condition: Solid Tumor; Stage IV Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose
      and recommended dose for phase II trial in patients with advanced solid cancer and explore
      efficacy of DHP107 in patients with gastric cancer
    

Detailed description: 
      1. Primary objective To determine the maximum tolerated dose and the recommended dose for
           phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on
           advanced solid cancer patients

        2. Secondary objectives

             -  To identify the dose limiting toxicity and the safety (toxicity) of DHP107

             -  To evaluate the efficacy (tumor response rate) of DHP107

             -  To assess pharmacokinetic (PK) characteristics of DHP107
    

Intervention name(s): Paclitaxel
Intervention type(s): Drug
Intervention description(s): Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.
Other intervention name(s): DHP107
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 12-Week Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of IBS-C
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center study will
      evaluate the safety and efficacy of tenapanor in subjects with constipation-predominant
      irritable bowel syndrome (IBS-C) as defined by the ROME III criteria and who have active
      disease as determined after a two-week screening period. Subjects who qualify and are
      randomized into the study will either receive 50mg BID of tenapanor or placebo BID for 12
      week treatment period and then undergo a 4 week placebo controlled randomized withdrawal.
    

Detailed description: 
      During the 12-week treatment period, subjects will record daily assessments including:
      frequency and timing of bowel movements; sensation and complete bowel emptying; consistency
      of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort,
      abdominal bloating, abdominal fullness and abdominal cramping. Subjects will also record
      weekly assessments including: adequate relief of IBS severity, and constipation severity.

      At the end of the 12-week treatment period, there will be a 4-week randomized withdrawal
      period in which subjects who complete the study in Tenapanor group will be randomized to
      either Tenapanor 50mg BID or placebo BID (1:1) and subjects who complete the study in the
      placebo group will be assigned to receive Tenapanor 50mg BID.
    

Intervention name(s): Tenapanor; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791; AZD1722
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor
Condition: Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma
MeSH terms: Glioblastoma; Astrocytoma; Oligodendroglioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter study evaluating the safety and tolerability of Toca 511 administered
      intravenously to patients with recurrent or progressive Grade III or Grade IV Gliomas who
      have elected to undergo surgical removal of their tumor. Patients meeting all of the
      inclusion and none of the exclusion criteria will receive an initial dose of Toca 511
      administered as an intravenous, bolus injection, followed approximately 11 days later by an
      additional dose injected into the walls of the resection cavity at the time of planned tumor
      resection. Approximately 6 weeks later, patients will begin treatment with oral Toca FC, an
      antifungal agent, and repeated every 4 weeks. All patients enrolled in this study will be
      encouraged to participate in a continuation protocol that enables additional Toca FC
      administration and the collection of long-term safety and response data.
    


Intervention name(s): Toca 511; Toca FC
Intervention type(s): Biological; Drug
Intervention description(s): All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene, intravenously and then intracranially. CD converts the antifungal 5-fluorocytosine (5-FC) to the anti-cancer drug 5-fluorouracil (5-FU) in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after the second administration of Toca 511,patients will begin 7-day course of oral 5-FC, repeated every 4 weeks for the duration of the study.
Other intervention name(s): vocimagene amiretrorepvec; retroviral replicating vector (RRV); flucytosine, 5-FC, 5-FC XR, Toca FC
Intervention MeSH terms: Flucytosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioma; glioblastoma; glioblastoma multiforme; Grade IV astrocytoma; brain cancer; recurrent glioblastoma; GBM; AA; AOD; anaplastic astrocytoma; anaplastic oligodendroglioma; anaplastic oligoastrocytoma; malignant glioma; high grade glioma
Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential
      cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each.
      Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or
      matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on
      each dosing day. The dose levels to be administered will be based on the safety, tolerability
      and PK results of the single dose and food effect study (W 4873 01 study; PRA-code
      WOE384EC-123841).
    


Intervention name(s): WCK 4873; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nafithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
To Access the Effects of Mucositis in Adults With Dental Implants
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical research for the treatment of mucositis subjects who have dental implants for a
      minimum of one-year.
    


Intervention name(s): Triclosan and Fluoride; Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Brush twice daily; Brush twice daily
Other intervention name(s): Total Toothpaste; Ultrabrite toothpaste
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Rolandic Epilepsy Genomewide Association International Study
Condition: Rolandic Epilepsy
MeSH terms: Epilepsy; Epilepsy, Rolandic
Study type: Observational

Summary: 
      We have discovered a small change in the genetic code which increases the risk of the
      brainwave abnormality that is found in rolandic epilepsy. We now wish to confirm this using a
      second much larger sample of patients. We will investigate the other genetic changes that
      cause people with the brainwave abnormality to develop seizures, as well as problems with
      speech, coordination, attention and learning.
    

Detailed description: 
      Epilepsy is a common neurological disorder affecting 1% of the population. There are over 30
      types of epilepsy, some common, some rare. Most epilepsies arise in childhood and have a
      genetic cause. Approximately 25% of child patients have "Rolandic Epilepsy" or RE, also known
      as Benign Epilepsy with Centrotemporal Spikes (BECTS). RE has a complex genetic basis,
      probably made up of combinations of susceptibility variants in different genes. Children with
      RE quite often have other symptoms that affect their speech, attention, reading ability or
      coordination. The goal of this study is to find the genetic basis for susceptibility to
      seizures and associated comorbidities for RE using genomewide association approaches.

      We know that RE has a genetic basis and we recently discovered the genetic cause of the EEG
      pattern seen in RE. The goal of REGAIN is to now find the genetic basis for susceptibility to
      seizures and the associated symptoms above. Our hope is to be able to improve diagnosis and
      understand why each child with RE is different, and perhaps point us towards new treatments
      that are more effective and have fewer side effects.

      We will compare the genetic code of 3,000 children with RE against a similar number of people
      not affected by epilepsy. With the proposed large sample of participants, we will be able to
      pinpoint the exact changes that might lead to seizures or attention problems for example.
      Learning the genetic basis for these problems will deepen our understanding of the mechanisms
      and lead to new treatments or cures.
    

Intervention name(s): Blood draw; Existing samples
Intervention type(s): Other; Other
Intervention description(s): Participation includes one visit for one blood draw per recruited patient. 10-20ml peripheral venous blood will be taken from the antecubital fossa. The DNA from the blood sample will then be extracted and resequenced for analysis.; Control DNA samples will be used that have been previously acquired in other studies.
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Target population is 3,000 participants with a diagnosis of Rolandic Epilepsy (1,000 UK).
      
Biospecimen description: 
      Whole blood
    
Keywords: Epilepsy; Rolandic; Genetics; Genomewide Association Study; RE; Neurology; Pediatrics
Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioavailability of aliskiren and valsartan as a single tablet
      compared to the same doses of the two drugs given as two separate tablets in healthy
      subjects.
    


Intervention name(s): Aliskiren; Valsartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aliskiren , Valsartan, bioavailability, hypertension; Healthy male and female subjects
Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the highest tolerated dose, safety and activity of
      HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
    


Intervention name(s): HCD122
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dose-finding; monoclonal antibody; Multiple Myeloma
Motivational Interviewing for PrEP Uptake
Condition: the Intervention Condition is a Brief Motivational Interviewing Session
Study type: Interventional

Summary: 
      The aim of the proposed supplemental study is to test a single session motivational
      interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk
      young Black men who have sex with men (YBMSM) and to determine whether previous assignment to
      study condition moderates these outcomes.
    

Detailed description: 
      The aim of the proposed supplemental study is to test a single session motivational
      interviewing (MI) program designed to promote the acceptance and use of PrEP for high-risk
      young Black men who have sex with men (YBMSM) and to determine whether previous assignment to
      study condition moderates these outcomes. In the parent study we had the foresight to include
      a cross-sectional survey of men's attitudes toward PrEP use as part of their first follow-up
      assessment. Using that data, we will identify the predictors of readiness to accept PrEP and
      we will use these findings to inform the design of a brief Motivational Interviewing session
      (MI-PrEP) that will promote uptake of PrEP. We will enroll 65 YBMSM who have completed the
      12-month follow-up assessment from the parent study and 35 YBMSM (same inclusion criteria)
      from either of two clinics used in the parent study (the Crossroads Clinic or the Open Arms
      Clinic) who did not participate in the parent study. Using small block randomization, these
      100 men will be assigned to the MI-PrEP condition or to the standard of care only control
      condition. At the conclusion of the enrollment session men will be asked if they would like
      to schedule an appointment to begin taking PrEP. This same offer will be made again
      approximately 14 days after the enrollment session. The dependent variables will thus include
      measures of whether men made/kept an appointment to begin PrEP and, if so, how much time
      elapsed before doing so and whether they filled the prescription for PrEP. For those who do
      fill the prescription we will test their blood for levels of tenofovir and emtricitabine
      after 3 months of time has elapsed. Group differences (Intervention vs. Control) in uptake,
      time to uptake, and actual use/adherence of PrEP are hypothesized to favor those receiving
      the MI-PrEP intervention program. If this is the case then an initial body of evidence will
      exist supporting the potential efficacy of a Motivational Interviewing-based, single session
      intervention that can be delivered to YBMSM in clinical settings.
    

Intervention name(s): motivational interviewing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention