bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and
      pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with
      moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males)
      receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts
      (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study
      for all patients will be Day 14; adverse events and concomitant medications will be
      documented throughout the study.

      Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of
      metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of
      VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure
      heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG,
      laboratory examinations (clinical chemistry, liver function, haematology/coagulation,
      urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined
      in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure
      (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline,
      pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy
      Intensity Level (TIL).
    

Detailed description: 
      Intravenous administration of study medication for each patient will start as soon as
      possible but not later than 12 hours after trauma. Patients in Group 1 will receive open
      label study drug (VAS203). Patients in Group 2 and 3 will be randomised to treatment with
      VAS203 or placebo.

      In addition to study treatment, each patient will receive the best "standard of care" for the
      study centre; no treatment will be withheld.
    

Intervention name(s): VAS203; Saline
Intervention type(s): Drug; Drug
Intervention description(s): i.v. infusion; i.v. infusion
Other intervention name(s): Ronopterin; 0.9 % NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Development, Feasibility and Acceptability of an iCBT Intervention for Adolescents With Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of the feasibility study is twofold: 1) to test the feasibility of the study design,
      and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when
      delivered with different levels of therapist support. The feasibility trial will provide
      important information on the initial participant responses, and on how to properly collect
      data in the subsequent RCT.

      The feasibility trial is conducted as a randomized study with 16 participants consisting of
      two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week
      period. Participants in the guided iCBT condition will receive the new iCBT intervention with
      planned feedback after each completed module. Participants in the on-demand iCBT condition
      will receive the intervention with on-demand feedback that is participant-initiated. In both
      conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there
      is no evidence on what amount of therapist support is sufficient for adolescents, the allowed
      time spent giving feedback will not differ between the two conditions in the feasibility
      trial. Thus, data on engagement will be collected to inform how the two treatment conditions
      differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where
      the same measures will be administered as are planned in the RCT.

      Acceptability of the intervention will be investigated by conducting semi-structured
      interviews with the participants. The interview will include an evaluation of the
      intervention, client satisfaction and potential reasons for drop out.

      The results from the feasibility trial will be used to inform the subsequent RCT and to
      revise the intervention, procedures, and conditions if needed.
    


Intervention name(s): CoolMinds
Intervention type(s): Behavioral
Intervention description(s): CoolMinds consists of 11 adolescent sessions and 9 parent sessions to be completed simultaneously during a 14-week treatment period. The main components comprise psychoeducation, cognitive restructuring, exposure therapy, and relapse prevention. The parent program also comprises information on how to handle school absenteeism for parents and teachers or pedagogues. The intervention is mainly transdiagnostic within the anxiety disorders but also includes diagnosis specific modules and content allowing for more personalized treatment. The treatment is delivered via a telephone app but can also be accessed via computer.
Other intervention name(s): Internet-based cognitive behavioral therapy; Technology-delivered cognitive behavioral therapy; iCBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
Condition: Hemorrhagic Fever With Renal Syndrome
MeSH terms: Hemorrhagic Fevers, Viral; Hemorrhagic Fever with Renal Syndrome; Syndrome; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the immune responses of two different doses (1.0 mg
      and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan
      virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a
      blind, participants in the two-dose group will receive one dose of normal saline placebo. All
      of the groups will also receive a booster dose 6 months after first vaccination. The results
      will help to determine which dose and vaccination schedule will be best to move forward in
      the vaccine development process.
    

Detailed description: 
      The study will enroll 4 randomized groups of 30 subjects each for a total of 120 subjects.
      These groups will be split so that 60 individuals receive the 1.0 mg dose and the other 60
      receive the 2.0 mg dose. Every subject will receive a total of 3 injections on Days 0, 28,
      and 56. Half of each of these groups (n = 30) will receive 2 vaccine injections at Days 0 and
      56 (normal saline placebo on Day 28) while the other half will receive 3 vaccine injections
      at Days 0, 28, and 56. All subjects will receive a booster dose at Day 168 to help assess
      immunogenicity with this booster dose. All doses will be administered with the TDS-IM device.
      All subjects will be followed until at least Day 252 (a 12 month follow-up visit may be
      requested). Subjects will complete post-injection memory aids for 7 days after each
      injection. There will also be up to 12 alternates enrolled and used to replace any original
      subject who fails to complete all 3 scheduled primary injections and Day 70 follow-up visit.
    

Intervention name(s): HTNV/PUUV DNA vaccine; Placebo; TriGrid Delivery System (TDS)
Intervention type(s): Biological; Biological; Device
Intervention description(s): HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2); 0.9% sodium chloride; The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other intervention name(s): Hantaan Virus/Puumala Virus DNA Vaccine; Normal saline placebo; TriGrid Delivery System for intramuscular delivery (TDS-IM)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hantaan virus; Puumala virus; HFRS
Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery
Condition: Anorectal Disorder
MeSH terms: Rectal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate whether being randomized to an aggressive
      postoperative non-narcotic pain regimen that treats pain from multiple different pathways may
      decrease postoperative pain levels, decrease constipation, and decrease the dependency on
      opioid medications after anorectal surgery versus the standard of care for managing pain.
      This use of a more aggressive pain regimen is considered an enhanced recovery after surgery
      (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by
      both decreasing the use of narcotics and their detrimental effects as well as increasing the
      benefit of using additional non-narcotic pain medication.
    

Detailed description: 
      Although pain is a predictable part of the postoperative experience, inadequate management of
      pain is common and can have profound implications Most patients who undergo surgical
      procedures experience acute postoperative pain, but evidence suggests that less than half
      report adequate postoperative pain relief. Many preoperative, intraoperative, and
      postoperative interventions and management strategies are available for reducing and managing
      postoperative pain. Mostly, pain is treated with opioids which are narcotics. medically they
      are primarily used for pain relief and these are historically considered "safe" drugs as they
      do not impose an increased risk of bleeding, kidney, or stomach problems. However, many
      patients taking high dose opioids have a higher risk of constipation. Unrelieved
      postoperative pain may result in economic and medical implications such as extended lengths
      of stay, readmissions, and patient dissatisfaction with medical care. With the rising concern
      over narcotic use, physicians are increasingly seeking alternative ways to help patients
      manage pain throughout their hospital stay and beyond However, few studies in anorectal
      surgery have shown that using an aggressive postoperative non-narcotic pain regimen (ERAS)
      can help reduce postoperative pain and decreased returns to emergency care.
    

Intervention name(s): ERAS; Standard of care
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol; Oxcodone PO Ketorolac IV only (intraop)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on
      the the pulmonary function of adult asthmatic Egyptian patients
    

Detailed description: 
      Asthmatic patients are recruited and divided into two groups. One receives Alfacalcidol
      beside their normal medications while the other acts as a control group receiving the normal
      asthma medication.

      Both groups are followed up for four months.
    

Intervention name(s): Alfacalcidol
Intervention type(s): Dietary Supplement
Intervention description(s): 1-alpha hydroxy cholecalciferol 1 mcg
Other intervention name(s): One alpha
Intervention MeSH terms: Alfacalcidol; Hydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioavailability Study of FL-101 in Healthy Male and Female Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-center, randomized, open-label, single dose, parallel study to assess
      the absolute bioavailability of FL-101 when administered via the subcutaneous (SC) and
      intravenous (IV) routes.
    

Detailed description: 
      This single-center, randomized, open-label, single dose, parallel study will assess the
      absolute bioavailability of 150 mg FL-101 when administered via the SC and IV routes. The
      study will consist of a Screening Period (up to 28 days), followed by Baseline assessments
      and an inpatient Study Treatment Period of 24 hours (Day 1 and Day 2). Subjects will return
      to the clinic as outpatients for study procedures including, but not limited to, blood
      samples to be obtained for both PK and antibody assessments at pre-specified time points.
    

Intervention name(s): FL-101-Intravenous; FL-101-Subcutaneous
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg administered via the IV route; 150 mg administered via the SC route
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Absolute Bioavailability
Presurgical Evaluation of Skin Cancers Using HIFU
Condition: Skin Cancer, Non-Melanoma
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      1. To ensure complete elimination of lesions with maximum preservation of function and
           aesthetics.

        2. To elaborate the Ultrasonographic features of skin cancers.

        3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety
           margins by histopathiological examination..

        4. To follow up the patient postoperatively for incomplete excision or recurrence by
           clinical and HIFU examination.
    

Detailed description: 
      The skin is the most superficial and largest body organ, due to its function as a surface
      covering for the body, enables the performance of noninvasive diagnostic and investigative
      procedures.

      Of all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g.
      basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).

      Techniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous
      lesions, making them excellent pre-operative tools varying considerably in their penetration,
      resolution, and applicability.

      High frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a
      painless non-radioactive imaging diagnostic method based on the reflection of sound waves
      through body tissues.

      High frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to
      the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic
      perilesional area.

      High frequency ultrasound examination of each lesion should consist of:

        1. A morphologic study analyzing the structural sonographic pattern and margins;

        2. the measurement of the largest transverse diameter and thickness;

        3. Color Doppler USG for perilesional vessels ; and

        4. in cases suspicious for malignancy, the surrounding areas are scanned for locoregional
           metastasis.
    

Intervention name(s): HIFU
Intervention type(s): Device
Intervention description(s): Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
Other intervention name(s): Esaota MyLabSeven
Intervention model: Single Group Assignment
Intervention model description: Using high frequency ultrasound in identification of safety margins of skin cancers
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Pulsed Electromagnetic Stimulation on DOMS
Condition: Electromagnetic Fields
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effect of Pulsed Electro Magnetic Field
      application on delayed muscle soreness in healthy Quadriceps femoris muscle.
    

Detailed description: 
      Participants will complete 100 consecutive fall jumps from a 0.60 m high platform to generate
      Delayed muscle soreness. After landing, participants will be encouraged to jump vertically
      immediately with maximum force. Five sets of 20 jumps will be performed with 10-second
      intervals between each jump, with a 2-minute rest between sets.Immediately after the
      implementation of the exercise protocol that will cause delayed muscle soreness, the
      participants will be randomly divided into 2 groups. Pulsed Electromagnetic Field or sham
      Pulsed Electromagnetic Field application will be applied to the non-dominant extremities of
      the participants.

      The participants will be evaluated before (0), 24, 48 and 72 hours after the delayed muscle
      pain protocol.

      Pain intensity of the participants will be evaluated with Visual Pain Scale (VAS), muscle
      fatigue will be evaluated with Modified Borg Scale, muscle performance will be evaluated with
      one-leg jump test, and muscle tenderness will be evaluated with an algometer.

      In addition, serum creatine kinase and myoglabin values will be tested by laboratory
      analysis.
    

Intervention name(s): Pulsed electromagnetic fields; Sham Pulsed electromagnetic fields
Intervention type(s): Other; Other
Intervention description(s): receiving Pulsed electromagnetic fields 3 times, immediately after the onset of delayed muscle soreness, 24 and 48 hours later.; Sham application will be applied with the same device without applying magnetic current.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Real or sham pulsed electromagnetic fields
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electromagnetic Fields; Delayed Onset muscle soreness
Promoting The Self-Regulation Of Energy Intake
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The goal of this study is to develop and test the efficacy of a scientifically-based,
      culturally competent seven-session parent directed, obesity prevention program focused on
      parental feeding strategies that support young children's self-regulation of intake.
    

Detailed description: 
      The intervention program was developed and piloted. Expected outcomes: At the end of the
      intervention program, it is expected that parents in the intervention group will: 1) use more
      child-centered (e.g., repeated presentation of new foods, involvement in food preparation)
      and less parent-centered feeding directives; 2) be less likely to show an indulgent and more
      likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores
      on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher
      levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions).
      Children in the intervention group are expected to: 1) show more willingness to try new
      foods, and 2) show increased self-regulation of energy intake. At the end of the
      interventions, children are expected to show greater consumption of fruits and vegetables
      (including consuming a wider variety of fruits and vegetables). All effects are expected to
      continue through the 6- and 12-month follow-ups, although the effects sizes will diminish.
      Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in
      children's BMI percentiles by the 6- and 12-month follow-ups for the intervention
      group-especially for the top 25% of the BMI percentile range. No parental BMI effects are
      expected.
    

Intervention name(s): Parent and child groups focused on self-regulation of eating
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Evaluate ACT-246475 Fate in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate how quickly and to what extent ACT-246475 is
      absorbed, distributed, metabolized (broken down) and eliminated from the body. ACT-246475
      will be labeled with 14-Carbon (14C) and, in this way can be traced in blood, urine, and
      feces. This study will also investigate how safe is ACT-246475 and how well it is tolerated
      when administered to healthy male volunteers.
    


Intervention name(s): ACT-246475
Intervention type(s): Drug
Intervention description(s): Single s.c. dose of 16 mg ACT-246475 including 3.7 MBq (100 μCi) 14C-radiolabeled ACT 246475
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Glycaemic Response Testing
Condition: Glycaemic Index; Glycaemic Response
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether added food ingredient(s) affect glycemic
      responses to a liquid meal tolerance test (LMTT).
    


Intervention name(s): Dietary Intervention; Dietary Intervention; Dietary Intervention
Intervention type(s): Other; Other; Other
Intervention description(s): 300 ml of liquid food product; 300 mL of liquid food product; 300 ml of liquid food product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Safety and Efficacy of Adjunct Carvedilol in Children With Moderate Heart Failure
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase
      ejection fraction of the heart under echo. All interpretation of data will be sent to Boston
      Children's Hospital to be reviewed, which is the primary research center in this study. There
      are 5 hospitals participating in this study. The population targeted are children with
      moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome
      after placing them on Carvedilol is to change their ejection fraction on echo. The patients
      will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose.
      Secondary outcome is to increase quality of life, exercise tolerance and decrease their
      symptom scores as noted on their questionnaires.
    


Intervention name(s): Carvedilol
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol
Primary purpose: Diagnostic
Keywords: moderate heart failure