bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the recommended phase 2 dose and overall safety and
      tolerability of TRC105 when given in combination with capecitabine for the treatment of
      patients with progressive or recurrent metastatic breast cancer.
    

Detailed description: 
      All patients were required to sign a consent form prior to undertaking any study-related
      procedures. Prospective patients were screened to determine if they qualified for the study
      within 28 days of enrollment. Patients who qualified received TRC105 i.v. over 1 to 4 hours
      on Day 1, Day 4, Day 8 and Day 15 of the initial 21-day cycle and Day 1, Day 8 and Day 15 of
      every subsequent 21-day cycle in combination with 1000 mg/m2 capecitabine BID for 14 days of
      each 21-day cycle. Those who tolerated TRC105 without any infusion reactions were eligible
      for reduced infusion durations. After 3 cycles of treatment, patients who demonstrated a
      response of complete response (CR), partial response (PR) or stable disease (SD) were
      eligible for additional treatment for up to six months (9 total cycles). Upon discussion with
      TRACON, patients judged by the Principal Investigator to be benefiting from treatment were
      able to continue treatment on this protocol beyond six months.

      Toxicities were graded according to the NCI CTCAE Version 4.0. Patients who exited the study
      for reasons other than drug-related toxicity prior to completion of the first 21-day cycle
      were replaced. Intra-patient dose escalation was not allowed.
    

Intervention name(s): TRC105; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): IV; oral
Other intervention name(s): carotuximab; xeloda
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TRC105; Breast Cancer; CD105; Endoglin; TRACON Pharma; Roswell Park Cancer Institute; Department of Defense
Social Media Obesity Treatment for College Students
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a randomized trial designed to translate and deliver programs via social media for a
      healthy body weight to university students. Specifically, in this trial, we will randomly
      assign 450 overweight/obese (BMI between 25-45kg/m2) university students (ages 18-35)
      enrolled at two colleges (George Washington University and University of
      Massachusetts-Boston) to one of two social media weight loss treatments (personalized or
      generic) or a contact control. The social media treatments consist of Facebook groups to
      provide social support, connectedness and intervention content, as well as daily text
      messages. Assessments will be conducted at baseline, 6, 12, and 18 months post baseline, with
      the primary outcome being weight loss at 18 months. We hypothesize that: a) Tailored Social
      Media will lose significantly more weight at the above time points compared with Targeted
      Social Media. b) Both the Tailored Social Media and Targeted Social Media groups will have
      greater weight loss at the 6, 12, 18 month follow-ups than Contact Control. The secondary aim
      is to evaluate changes in metabolic risk factors among those participants who have maintained
      at least 5% weight loss at 18 months. We hypothesize that participants who achieve a 5%
      weight loss at 6 and 18 months will have significantly lower triglycerides, higher HDL
      cholesterol, and lower blood pressure than those who do not achieve and maintain that weight
      target. Finally, we will conduct additional formative work to evaluate the implementation
      feasibility of this intervention on college campuses, including an assessment of costs as
      well as the sustainability infrastructure using the PRISM (Practical, Robust Implementation
      and Sustainability Model) model as a guide. The results of this study have the potential to
      significantly impact the delivery of obesity treatment services on college campuses.
    


Intervention name(s): Social Media Treatments
Intervention type(s): Behavioral
Intervention description(s): Each of the three intervention groups offers information that has been shown to be important for college students to have a healthy body weight. All three groups provide information on topics that we know are related to having a healthy body weight, like managing stress, keeping track of how you spend your time, and increasing self-awareness of certain health behaviors. Two of the three programs are focused on weight loss for a healthy body. The third group focuses on having a healthy mind, body and having energy during college.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Condition: Gastroduodenal Ulceration
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury
      after the oral administration of an investigational product, PL2200, and a marketed 325 mg
      immediate-release aspirin product.
    

Detailed description: 
      Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule
      at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury
      that may have been caused by study medication.
    

Intervention name(s): PL2200; Aspirin tablets
Intervention type(s): Drug; Drug
Intervention description(s): PL2200, containing 325 mg aspirin active ingredient; 325 mg aspirin tablets (USP)
Other intervention name(s): PL-ASA
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteer; comparison of incidence of; treatment groups.
Fasted Exercise Training in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study compares aerobic exercise training performed before breakfast (i.e., in the fasted
      state) to similar training performed after breakfast in people with type 2 diabetes. Training
      will take place over 16 weeks.
    

Detailed description: 
      People with type 2 diabetes (T2D) are encouraged to increase their physical activity (PA).
      Sometimes, increasing the amount of PA can be difficult. Therefore, simply recommending that
      individuals preform more exercise may not be effective in the long term. Recent short-term
      studies have started to explore how to maximize the effect of a single bout of exercise. For
      example, short term studies suggest that exercise performed after a meal may decrease blood
      sugars more than exercise performed after a meal. However, research in people without
      diabetes shows this may not be the best approach in the long-term. To date, no long-term
      study has compared the effects of exercise performed at different times of the day in people
      with T2D.

      This study will compare the effects of 16 weeks of regular exercise before breakfast compared
      to 16 weeks of regular exercise after breakfast. It is expected that exercise before
      breakfast (i.e., in the fasted state) will lead to greater improvements in blood sugar
      control, without the addition of more exercise. It could be very motivating for people with
      diabetes to know that they can get more benefits from exercise by changing when exercise is
      performed, rather than trying to increase the amount of exercise.
    

Intervention name(s): Fasted Exercise; Postprandial Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.; Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Glycated hemoglobin; Liver fat; Continuous glucose monitoring
Use of a Multimedia Presentation for Informed Consent
Condition: Improving Informed Consent Process
Study type: Interventional

Summary: 
      This is a prospective cohort study in which the standard verbal informed consent process for
      ketamine sedation is compared to a multimedia informed consent process. The goals include
      determining if parents prefer a multimedia consent process and evaluating the effectiveness
      of multimedia consent process.
    

Detailed description: 
      BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy.
      Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it
      follows that MMP would improve IC in clinical settings.

      OBJECTIVE: To determine if MMP for the IC process for ketamine sedation improves parental
      satisfaction and comprehension as compared to standard practice.

      DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of
      pediatric patients. Phase one was a randomized, prospective study that compared the standard
      verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents
      completed a survey evaluating their satisfaction of the IC process and assessing their
      knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction
      with the IC process and knowledge of ketamine sedation.
    

Intervention name(s): Multimedia Presentation for Ketamine sedation
Intervention type(s): Other
Intervention description(s): PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Informed consent; Ethics
PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation
      System to Treat Paroxysmal Atrial Fibrillation
    

Detailed description: 
      This is a prospective, multi-center, safety and feasibility study. Subjects will undergo
      percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the
      investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be
      followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of
      arrhythmia after a 90-day Blanking Period and other relevant outcome measures.
    

Intervention name(s): FARAPULSE Endocardial Multi Ablation System
Intervention type(s): Device
Intervention description(s): Ablation using the FARAPULSE Endocardial Multi Ablation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the suitable infusion dose of norepinephrine for
      prophylaxis against post-spinal anesthesia hypotension.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended
      for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential
      substitute drug for phenylephrine, norepinephrine has gradually been used in parturients
      undergoing cesarean section. There's some evidence that prophylactic infusion of
      norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension
      in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is
      still unknown. The purpose of this study is to investigate the suitable infusion dose of
      norepinephrine for prophylaxis against post-spinal anesthesia hypotension.
    

Intervention name(s): Norepinephrine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.; Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Other intervention name(s): Vasopressors; NS
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Norepinephrine; Hypotension; Cesarean section; Dose-finding
Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS
Condition: Healthy Older Adults
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a combination of intensive training of
      visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation
      (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine
      the underlying neuronal mechanism.
    


Intervention name(s): tDCS; training
Intervention type(s): Device; Behavioral
Intervention description(s): transcranial direct current stimulation (tDCS); intensive training of visual-spatial abilities (in LOCATO task)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: healthy older adults; tDCS; LOCATO task; visual-spatial learning
Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?
Condition: Hypotension Drug-Induced
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Mucosal bleeding is the most frequent complication with endoscopic nasal
      surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading
      to increased complications, operation duration, and blood loss. There are several
      pharmacological techniques for the appropriate control of intraoperative bleeding.

      Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a
      premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries.

      Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical
      trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under
      general anesthesia at our hospital. Patients were randomly allocated into two equal groups;
      group L, received oral labetalol, and group M, received oral metoprolol.
    


Intervention name(s): Labetalol Hydrochloride Oral Tablet; Metoprolol Tartrate Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Labetalol 200 mg; Metoprolol 100 mg
Other intervention name(s): Labipress tablets; Betaloc tablets
Intervention MeSH terms: Metoprolol; Labetalol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: controlled hypotension; endoscopic nasal surgery; labetalol; metoprolol
The Effect Nature Sounds and Music on Hemodialysis Patients
Condition: Hemodialysis Complication; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The study was conducted as a randomized controlled experimental research to examine the
      effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.

      The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who
      received treatment in the hemodialysis units of three hospitals, one university, one
      education research and one state hospital in Antalya province, met the inclusion criteria and
      consented to participate in the study. Patients were homogenously divided into intervention
      (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age,
      gender and hemodialysis duration. Patients in the intervention group were subjected to nature
      sounds/music during the hemodialysis procedure, while patients in the control group were not
      subjected to any intervention during the procedure. The data were collected by face-to-face
      interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring
      Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval,
      institutional permissions and written consent of the patients were obtained for the
      implementation of the study. Number, percentage, mean, standard deviation, minimum and
      maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests,
      the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and
      Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.
    


Intervention name(s): Nature sounds
Intervention type(s): Behavioral
Intervention description(s): Nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over.
Other intervention name(s): music
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
ROLE OF URINARY BIOMARKER NEUTROPHIL GELATINASE ASSOCIATED LIPOCALCIN (NGAL) IN EARLY PREDICTION OF AKI IN CIRRHOSIS OF LIVER
Condition: Renal Failure
MeSH terms: Liver Cirrhosis
Study type: Observational

Summary: 
      Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although
      novel treatments have shown some promising results , acute kidney injury remains a major
      complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI
      occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most
      frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis
      , with prevalence rates estimated around 68%, 25%, and 33%, respectively.

      The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis
      has contributed to an increased awareness and earlier detection of AKI. However, some
      important problems remain. One of the main issues is the differential diagnosis of AKI,
      particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is
      important because treatment is different; renal replacement therapy (RRT) is used for the
      former, and vasoconstrictors and albumin are used for the latter.
    

Detailed description: 
      Aim of the study:

      To determine utility of NGAL in chronic liver disease patients with acute kidney injury.

      Objective:

        1. To compare urine NGAL values in HRS and Non-HRS group.

        2. To determine optimal cutoff of urine NGAL for early determination of HRS.

      Plan of investigation:

      All the following investigations will be done at admission for the patients who satisfy the
      inclusion criteria

      Routine blood investigations :

      CBP, LFT, PT- INR, RFT urine sodium on day 1 urine spot urine protein creatinine ratio CUE
      Urine c/s Urine NGAL Serum creatinine will be repeated on Day 3.
    

Intervention name(s): Biomarkers
Intervention type(s): Other
Intervention description(s): Kidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        120
IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study
Condition: Muscle Injury
Study type: Observational

Summary: 
      Our objective is to evaluate the inter and intra observer reproducibility of the measure of
      elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of mucles of
      patients with and without hamstring injury.

      76 patients will be evaluated cross sectionally twice by two ultrasonographists.
    

Detailed description: 
      Muscle trauma mainly results from sporting activities and accounts for 10 to 55% of sports
      injuries.

      Information on ARFI muscle trauma management is scarce. The present study sought to assess
      the initial ARFI characteristics of muscle in sports people with and without injury.

      Our objective here is to evaluate the inter and intra observer reproducibility of the measure
      of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of muscles of
      patients with and without hamstring injury.

      76 patients will be evaluated cross sectionally twice by two ultrasonographists(and then we
      will evaluate the evolution after 3 months for patient with injury according to the ARFI
      results).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients justifying an ultrasound evaluation for suspicion of muscle injury
      
Keywords: muscle