bioihbjkbjnl/mcl2 huggingface dataset:
Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The overall goal of this study is to qualitatively explore how behavioral, cultural,
      psychosocial, and economic barriers and facilitators affect the decision to start and adhere
      to endocrine therapy (ET) among young breast cancer survivors of diverse racial, ethnic, and
      socio-economic backgrounds with hormone receptor positive (HR+) breast cancer
    

Detailed description: 
      A qualitative study that will use interviews to gain an in depth understanding of factors
      affecting the decision to start and adhere to endocrine therapy (ET) among young breast
      cancer survivors of diverse racial, ethnic, and socio-economic backgrounds with hormone
      receptor positive (HR+) breast cancer
    

Intervention name(s): Phone interview
Intervention type(s): Other
Intervention description(s): Collecting clinical and socio-demographic information.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Women of all races
      
Keywords: Breast Cancer
The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
Condition: Pain After the Surgical Extraction of Third Molars
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to assess the efficacy of local anesthetic and tramadol
      combinations in the prevention of pain after the surgical extraction of third molars.
    

Detailed description: 
      The surgical removal of impacted third molar teeth is a procedure that is frequently
      encountered in oral and maxillofacial surgery practices. Pain following these operations is
      one of the most important factors affecting patient satisfaction. Several pain-management
      strategies are available. An alternative approach to pain control is to maximize drug levels
      at the tissue injury site by administering drugs locally.

      Tramadol is a centrally acting opioid that provides good analgesia. It reduces the
      transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In
      addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the
      peripheral nerves have been presented in multiple clinical and laboratory studies.

      The aim of this study is to test the clinical efficacy of local anesthetic and tramadol
      combinations during and after the surgical extraction of the lower third molars.
    

Intervention name(s): Local anesthetic + tramadol hydrochloride; Only local anesthetic
Intervention type(s): Drug; Drug
Intervention description(s): Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block; Using articain HCL for inferior alveolar nerve block
Other intervention name(s): Articaine
Intervention MeSH terms: Tramadol; Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The patients were randomly divided into the following two groups using the sealed envelope method.
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tramadol; third molar extraction; analgesia
Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia
Condition: Acrophobia; Transcranial Direct Current Stimulation
Study type: Interventional

Summary: 
      The goal of this clinical trial is to examine whether transcranial direct current
      stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in
      acrophobia in college students with significant fear of heights. The main question it aims to
      answer are:

      • the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS
      active stimulated group and sham stimulated group and receive VRET.
    


Intervention name(s): tDCS; virtual reality exposure therapy
Intervention type(s): Device; Behavioral
Intervention description(s): High-definition tDCS (HD-tDCS, 4×1 montage, with 1 anode and 4 cathodes, (Soterix Medical, New York, NY, USA) was applied with battery-driven electrical stimulator (2001&4×1-C3A). The center electrode was anode and placed over FPz (according to the EEG 10-20 system in order to target the medial prefrontal cortex). The reference electrodes were cathodes and placed over AF7, AF8, F3, F4(see fig. 3). Participants were randomized to receive 20 minutes of active(1.5mA) or sham (0 mA) tDCS in a single-blind design. In order to ensure that participants can gradually adapted to the current change, there was a 15-second current rising process before the stimulation and, a 15-second current falling process after the stimulation. For sham tDCS, the device was automatically turned off after current reached 1.5 mA, thus providing 30s of ramping current stimulation, which made it difficult for participants to distinguish which kinds of stimulation they received.; The VRET was adapted on the basis of Öst's single exposure treatment paradigm and conducted by experienced psychotherapists following a standard exposure treatment manual.. An exposure therapy was divided into three parts: psychological education, exposure intervention and summary. Each scene started with a 10-min psychological education followed up with the tDCS stimulation. In exposure trail, participants ought to take an elevator to 100th, observe the environment and look down on the platform. The psychotherapist guided participants to be exposed to the VR environment and helped them experience the process of anxiety decline in the exposure trail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: virtual reality exposure therapy; acrophobia; Transcranial Direct Current Stimulation
Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to demonstrate the bioequivalence of capsules made from 2 different drug
      product batches. The reference batch was representative of the current commercial drug
      product and of the pivotal Phase III batches. The test batch was the drug product batch
      intended for future commercial use.
    


Intervention name(s): Dabigatran etexilate generation I; Dabigatran etexilate generation II
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Biomarkers and Preeclampsia Outcomes
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Prospective, observational, monocentric, non-interventional study.
    

Detailed description: 
      In practice, patients with preeclampsia are referred to the hospital for medical management
      only clinical signs & symptoms and standard biological tests are available for patient
      individualized care. Hence, a new diagnostic tool to distinguish and stratify the different
      patients referred is in need of proper triage.

      REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers
      (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.

      Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements
      (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA
      specifications (Health Insurance Portability and Accountability Act), and the ICH standards
      (International Conference on Harmonisation)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preeclampsia was defined according to the ACOG (The American College of Obstetricians and
        Gynecologists). The diagnosis of Preeclampsia was based on clinical judgment and routine
        laboratory findings at inclusion.

        Patients were suspected of Preeclampsia if they:

          -  presented with new onset hypertension and or proteinuria at or after 20 weeks of
             gestation

          -  developed an aggravation of their preexisting hypertension and or preexisting
             proteinuria

          -  or if they presented with symptoms such as right upper quadrant abdominal pain or
             headache with visual disturbances or PE-related findings (low platelets, elevated
             liver transaminases, Vascular Fetal Growth Restriction)
MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
Condition: Pre Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      The overarching objective of our work is to provide an inexpensive and scalable m-health tool
      to increase both volume and intensity of physical activity and reduce sedentary behavior in
      patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a
      text-messaging based intervention.
    

Detailed description: 
      This study will randomize participants to 2 groups, an intervention group that will receive a
      Fitbit and MapTrek, and a control group that will receive a Fitbit only. This study has 3
      specific aims.

      Aim 1- To determine if patients randomized to MapTrek walk more than the control patients.

      Aim 2- To determine if patients randomized to MapTrek generally walk at a faster pace during
      the day than control patients.

      Aim 3- To determine if patients randomized to MapTrek have less sedentary time during the day
      than the control patients.

      We expect to collect sufficient data to demonstrate the effectiveness of MapTrek, our
      prototype m-health tool, as an intervention to increase physical activity, heighten intensity
      of activity, and reduce sedentary behavior among a cohort of patients at risk for type 2
      diabetes.
    

Intervention name(s): MapTrek; Fitbit
Intervention type(s): Behavioral; Device
Intervention description(s): The objective of the study is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for or already diagnosed with pre-diabetes.; Fitbit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tactile Low Vision Labeling of Ophthalmic Drops
Condition: Low Vision Aids
MeSH terms: Vision, Low
Study type: Interventional

Summary: 
      The purpose of this study is an evaluation of a tactile labeling strategy developed in the
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify
      their topical ophthalmic drop treatments and the frequency with which they should be
      administered. The labeling strategy includes protrusions as frequency markers and shapes to
      differentiate between treatments of similar frequency prescription.
    

Detailed description: 
      The purpose of this study is an evaluation of a tactile labeling strategy developed in the
      Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in
      collaboration with the UTMB Maker Space to improve low vision patients capability to identify
      their topical ophthalmic drop treatments and the frequency with which they should be
      administered. The labeling strategy includes protrusions as frequency markers and shapes to
      differentiate between treatments of similar frequency prescription.

      The first aim is to evaluate the patient capability to identify the number of protrusions and
      therefore the frequency of administration prescribed. This should be completed in a timeframe
      that is not frustrating or problematic to the patient in practice.

      The second aim is to evaluate the patient ability to differentiate between drugs with similar
      frequencies based on a shape on the frequency protrusions in a tactile manner. This also
      should be completed in a timeframe that is not over burdensome or frustrating to the patient.
      The protocol is designed to evaluate this tactile labeling design in the population it is
      designed to support.
    

Intervention name(s): Tactile Labels for Drug identity and dose frequency
Intervention type(s): Device
Intervention description(s): The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single Group, Blinded, Sham controlled study
Masking: Single (Participant)
Primary purpose: Other
Keywords: Low Vision, Labeling, Tactile
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration
      of rosuvastatin and ezetimibe.
    

Detailed description: 
      rosuvastatin and ezetimibe(anti-dyslipidemia)
    

Intervention name(s): NVP-1205; rosuvastatin and ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2; coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
Other intervention name(s): NVP-1205(rosuvastatin+ezetimibe); Crestor and Ezetrol
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in ICU
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of
      white corpuscles is altered during pneumonia. In presence of bacterial growth on lung
      samples, the measure of autofluorescence of white corpuscles could help the clinicians to
      discriminate bacterial colonization from acute infection.
    


Intervention name(s): Autofluorescence of white corpuscle
Intervention type(s): Other
Intervention description(s): Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in intensive care units
      
Biospecimen description: 
      tracheal aspirate and bronchoalveolar lavages
    
Keywords: pneumonia; diagnosis; prognosis; tracheal aspirate; bronchoalveolar lavage
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore
      has the potential to improve the management of diabetic kidney disease when added to the
      standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin
      receptor blocker (ARB)).

      This non-confirmatory Phase 2 study was designed to determine the safety, tolerability,
      efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB
      at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes
      and nephropathy.
    

Detailed description: 
      This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and
      placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients
      receiving standard of care (optimal tolerated doses of ARB or ACEI) for diabetic nephropathy
      due to type 2 diabetes.

      The study consisted of three distinct study periods:

      Screening (Day -30 to Day-1): lasted up to a maximum of 30 days and comprised a screening /
      baseline assessment. This visit was used to confirm that the study inclusion and exclusion
      criteria were met and served as baseline assessment prior to randomization. Participant
      randomization occurred prior to day 1 as soon as participant eligibility was confirmed.

      Treatment period (Day 1-168): Participants were randomized in a 1:1 ratio to receive
      nidufexor 50 mg or placebo once daily for 24 weeks. Nidufexor and placebo were given in
      addition to SoC (optimal tolerated doses of ARB or ACEI).

      End of Study (EOS) and Safety follow-up (Day 169 to Day 197): Study assessments were
      performed until the EOS visit (Day 169). Post Study Safety Contact occurred approximately 28
      days after discontinuing study treatment until day 197.
    

Intervention name(s): Nidufexor; Placebo; Standard of Care (SoC)
Intervention type(s): Drug; Other; Drug
Intervention description(s): 50 mg (two 25 mg) LMB763 capsules for oral administration; Placebo capsules for oral administration; Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Other intervention name(s): LMB763
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes
Performance Study of New Media for Vitrification of Human Oocytes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte
      vitrification/warming media and the vitrification device Rapid-i™, when using vitrification
      as a cryopreservation method for human oocytes.
    

Detailed description: 
      A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half
      of the patients' oocytes will be vitrified and warmed (experimental group). The remaining
      oocytes will not be vitrified and will serve as the control group. In the second phase all of
      the patients' oocytes will be vitrified and the embryo transfer will be performed in a
      following cycle. This simulates the situation of a normal cryopreservation embryo transfer.
      The study population consists of 20 women who will undergo a fresh IVF cycle during the study
      period. The primary objective in the first phase is to assess survival, fertilization and
      embryo development after oocyte vitrification/warming with the new media. The results will be
      compared with results from sibling oocytes which have not been vitrified. Secondary
      objectives are to assess the clinical results such as implantation, miscarriage and pregnancy
      rate as well as delivery rate and neonatal outcome.

      The primary objective in the second phase is to assess the delivery rate after oocyte
      vitrification/warming with the new media. Secondary objectives are to assess survival,
      fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on
      the previously vitrified and warmed oocytes. The results will be compared with results from a
      control group of patients, treated at the same clinics within the same time period, using the
      same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a
      serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG
      testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be
      conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal
      heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful
      treatment, there will be a follow-up period of 6 months after study completion. From this
      follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be
      evaluated as well.
    

Intervention name(s): Vitrification medium oocyte, warming medium oocyte and Rapid-i
Intervention type(s): Device
Intervention description(s): Media and device for vitrification of human oocytes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Media for vitrification/warming of human oocytes
Effectiveness of Kinesio Tapping for the Treatment of Patients With Acute Low Back Pain: A Randomized Control Trial
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the
      treatment of patients with acute low back pain.

      In this study a total of 56 patients with acute low back pain were randomly allocated to the
      experimental group, KT along with conventional Physical therapy (PT), or the control group,
      conventional PT alone.
    

Detailed description: 
      The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the
      treatment of patients with acute low back pain.

      In this study a total of 56 patients with acute low back pain were randomly allocated to the
      experimental group, KT along with conventional Physical therapy (PT), or the control group,
      conventional PT alone. 28 Patients received KT in addition to conventional PT while 28
      patients received conventional PT alone for two weeks. Oswestry disability index (ODI) and
      numeric pain rating scale (NPRS) were used for the measurement of outcomes.
    

Intervention name(s): Conventional Physical Therapy; Kinesio Tapping
Intervention type(s): Other; Other
Intervention description(s): This is a combine protocol of different therapeutic exercises and heat therapy.; Kinesio Tapping is an adhesive and elastic fiber used for different outcomes like pain and swelling reduction among physical therapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low back pain, Kinesio tapping, conventional physical therapy, Oswestry disability index