bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%
Condition: Nasolabial Folds Correction
Study type: Interventional

Summary: 
      Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without
      lidocaine 0.3%: comparison within subjects (half face method)
    

Detailed description: 
      Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that
      foresaw the comparison within subjects of the investigational product versus investigational
      product with Lidocaine 0.3% (half face method); assignation of right or left face side to the
      two injective treatments was choose by the Investigator according to a previously defined
      randomisation list.

      Primary end point of the study was to evaluate the filling and bio-revitalizing activity on
      nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.

      It was also aim of this study to show if the addition of Lidocaine 0.3% to the
      investigational product (extemporaneous mixture) could have reduced the discomfort/pain
      sensation perceived by the subject during the injection procedure, without altering the
      aesthetic performance.
    

Intervention name(s): Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%; Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)
Intervention type(s): Device; Device
Intervention description(s): The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list).
A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.; The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations .
A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal
      reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session.
      This is a randomized three period cross-over study including treatment with Terbutaline, a
      20% basal reduction for six hours, or no treatment (control).
    

Detailed description: 
      In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects
      must have been diagnosed with type 1 diabetes for at least one year and on an insulin pump
      for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an
      HbA1c less than 10.0% and normal thyroid function. Subjects can not have had a severe
      hypoglycemic episode in the last three months, any other illness or treatment that may affect
      the wearing of a continuous glucose monitor or the completion of the study as determined by
      the investigator. Subjects may not use drugs containing pseudoephedrine within 48 hours of
      the study visits.

      This study consists of three overnight visits at the Clinical Translational Research Center.
      Meals eaten during the study will be consistent for each of the three visits.

      Subjects will participate in a standardized afternoon exercise session on a treadmill as has
      been done in previous Diabetes Research in Children Network studies. Exercise will begin at
      4pm and must be completed by 6pm. Dinner will be eaten at the end of the exercise.

      At 9pm, treatment will be given as determined by the randomization group the subject is
      assigned to. The treatment includes either an oral dose of 2.5mg Terbutaline, a 20% basal
      reduction for six hours or no treatment as the control. Blood glucose levels will be measured
      every 30 minutes until 6am.
    

Intervention name(s): Terbutaline; 20% basal insulin reduction; Control
Intervention type(s): Drug; Other; Other
Intervention description(s): Oral (2.5mg) one time administration at 9:00pm; Basal insulin rate is reduced by 20% the normal (home dose) for six hours.; No treatment is given for the study. This arm is for comparison with the two intervention arms.
Other intervention name(s): β2-adrenergic agonist; 80% basal insulin; No intervention
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Terbutaline; Adrenergic Agonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Exercise; Hypoglycemia
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate
      the safety and tolerability of BI 730357 in healthy subjects following oral administration of
      single rising doses after fasting and/or non-fasting conditions. The secondary objective is
      the exploration of the pharmacokinetics (PK) including dose proportionality, and
      pharmacodynamics of BI 730357 after single dosing.

      The objective of the Bioavailability (BA) part (trial part 2) will be to explore the relative
      bioavailability of tablet fasted versus oral solution fasted and the influence of food on the
      bioavailability of tablet fasted versus tablet fed.
    


Intervention name(s): Placebo; BI 730357; BI 730357
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; powder for reconstitution of an oral solution (PfoS); BI 730357 film-coated tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors
Condition: Metastatic Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus
      gemcitabine in Subjects with solid tumors.
    

Detailed description: 
      An open-label Phase 1b study to investigate the preliminary safety and activity of
      aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors administered at doses
      of 170, 250 or 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2
      gemcitabine on Days 1 and 8 every 21 days.
    

Intervention name(s): aldoxorubicin; aldoxorubicin; aldoxorubicin; gemcitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.; administered at 250 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.; administered at 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
Other intervention name(s): INNO-206; INNO-206; INNO-206
Intervention MeSH terms: Gemcitabine; Doxorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aldoxorubicin; INNO-206; solid tumors; gemcitabine; phase 1
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Condition: Tobacco Use Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Little is known about the best ways to help young people stop smoking. Bupropion (a
      medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The
      purpose of this study is to determine if bupropion is also effective in treating smokers
      between the ages of 12 and 25 years old. This study also compares the effectiveness of
      bupropion used as a supplement to behavioral treatment versus behavioral treatment used
      alone. In addition, the study evaluates whether hormonal response to stress measured prior to
      the start of treatment predicts whether individuals respond well to treatment with
      medication.
    

Detailed description: 
      Cigarette smoking and other forms of tobacco exposure are one of the leading preventable
      causes of morbidity and mortality in the United States. Most smokers begin smoking during
      adolescence, and though they seem motivated to quit smoking, they frequently fail. Although
      behavioral treatments are available, they have not been very successful in past studies.

      Depressed adults may have more difficulty quitting smoking than non depressed adults; this
      finding may also apply to depressed youth. The purpose of this study is to determine the
      effectiveness of bupropion in combination with standard behavioral treatment in helping young
      smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether
      hormonal response to stress measured prior to treatment initiation predicts whether
      individuals respond well to treatment with bupropion.

      Participants in this double-blind study will be randomly assigned to receive either bupropion
      or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks,
      with weekly study visits. Study visits will last 30 minutes to 1 hour and will include
      medication monitoring, self-reported and biological measures of smoking, and behavioral
      treatment. Participants will have follow-up visits six months after completion of treatment.
    

Intervention name(s): Bupropion-SR; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 150mg tablets taken orally twice daily for 9 weeks.; Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Other intervention name(s): Wellbutrin-SR; Placebo match for Bupropion (Wellbutrin) SR
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescents, cigarettes, smoking, tobacco
Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
Condition: Immunotherapy
Study type: Interventional
Phase: Phase 3

Summary: 
      We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in
      contrast to the standard specific immunotherapy.

      Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22
      patients for 6 weeks with the shortened scheme.
    

Detailed description: 
      see above
    

Intervention name(s): specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
Intervention type(s): Biological
Intervention description(s): We treat each patient with mite-allergen following the two different protocols.
Other intervention name(s): Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunotherapy; Mite; Asthma; bronchial provocation; SIT; specific immunotherapy
Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl
Condition: Topical Heat Application for Intraoperative Abortion Pain Management
Study type: Interventional

Summary: 
      Paracervical blocks are routinely used in first trimester surgical abortions and are a proven
      method for decreasing procedural pain. Even when paracervical anesthesia is used, an
      overwhelming majority of women still report at least moderate pain during a first trimester
      abortion procedure. Other than some non-pharmacologic modalities (music and visualization),
      only the addition of intravenous medication has been shown to reduce procedural pain. Applied
      topical heat is effective in alleviating pain in other medical subspecialties, and in
      gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for
      intraoperative pain control during first trimester abortion.

      The investigators plan to conduct a double-blinded, randomized, controlled trial
      investigating the utility of topical heat application as an adjunct to paracervical block in
      first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score,
      measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators
      will look at the effect of heat application on pain at time of speculum placement,
      paracervical block, tenaculum placement, cervical dilation and overall pain. Patient
      satisfaction will also be assessed. If found to reduce pain during abortion under local
      anesthesia, the use of heat could offer an inexpensive, safe and universally available
      adjunct to the paracervical block during this procedure.
    


Intervention name(s): heat
Intervention type(s): Other
Intervention description(s): activated heating pad to lower abdomen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Condition: Analgesia in Patients With Open Inguinal Hernia Surgeries
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
    

Detailed description: 
      Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia
      In Patients Undergoing Open Inguinal Hernia Surgical Repair
    

Intervention name(s): Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries
Intervention type(s): Drug
Intervention description(s): Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Intervention MeSH terms: Acetaminophen; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Closure of Skin Incision Using CO2 Laser
Condition: Wound
MeSH terms: Surgical Wound
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of using Temperature
      Controlled Laser Soldering System for soft tissue bonding.
    

Detailed description: 
      Skin incisions can be closed by a variety of method which create temporary approximation of
      the wound edges until natural healing process ensue and reach a phase, where it is closed and
      can sustain the daily tensile forces.

      The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied
      Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser
      Soldering system for soft tissue bonding.

      This system includes features that make laser soldering suitable for clinical use. The
      Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device,
      Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip
      device (Clamps) and concentrated Human Albumin as a soldering agent.
    

Intervention name(s): Temperature Controlled Laser Soldering
Intervention type(s): Device
Intervention description(s): This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incision; Wound Closure; Laser Tissue Soldering
Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers, Study 1
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the comparative tolerability, metabolism and pharmacokinetics of individual
      enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation
      of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and
      SPQ and the racemic mixture RSPQ) in normal healthy human volunteers.
    

Detailed description: 
      The primary objective of this project is to investigate the comparative tolerability,
      metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers.

      The overall approach is as follows: in 36 healthy volunteers with documented normal G6PD
      activity, we will administer a single oral dose of RPQ, SPQ, or RSPQ. At various times after
      dosing, we will draw blood samples, in which we will record the plasma levels of the parent
      drugs, along with plasma and urinary metabolites. The comparative pharmacokinetics,
      tolerability and hematological effects of these two enantiomers and the racemate will be
      assessed.
    

Intervention name(s): Primaquine, R-Primaquine, S-Primaquine, SR Primaquine
Intervention type(s): Drug
Intervention description(s): Cohort 1: Eighteen individuals (6 per group) Cohort 2: Eighteen individuals (6 per group)
Group 1-15 mg of S-Primaquine followed by one-week washout, 15 mg of R-Primaquine followed by one week washout, and 30 mg of RS-Primaquine.
Group 2- 15 mg of R-Primaquine followed by one-week washout, 30 mg of RSPQ followed by one week washout, and 15 mg of SPQ.
Group 3- 30 mg of RS-Primaquine followed by one week washout,15 mg of SPQ followed by a one week washout, and 15 mg of RPQ.
Other intervention name(s): Primaquine
Intervention MeSH terms: Primaquine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Effect of Galvanic Stimulation on vHIT and VEMP Tests
Condition: Vestibular System Disorder
MeSH terms: Vestibular Diseases
Study type: Interventional

Summary: 
      Introduction: Galvanic vestibular stimulation (GVS) is a well-established technique with a
      history spanning over a century, primarily used to manipulate the vestibular system. Recent
      interest has surged in its potential for understanding human vestibular function and aiding
      in functional recovery. GVS applies electrical currents to the mastoid region, modulating
      vestibular afferents, and induces specific effects based on the participant's posture and
      current polarity. While GVS's impact on the central nervous system and its potential to aid
      in functional recovery have been studied, its immediate effects on vestibular reflexes remain
      less explored.

      Methods: In this study, thirty healthy adult participants underwent ocular and cervical
      vestibular evoked myogenic potential (VEMP) tests, as well as the velocity Head Impulse Test
      (vHIT) before and immediately after one hour of GVS application. Statistical analyses were
      performed to assess changes in VEMP and vHIT results.
    


Intervention name(s): Galvanic Vestibular Stimulation
Intervention type(s): Device
Intervention description(s): Galvanic Vestibular Stimulation (GVS) is a non-invasive technique that uses low-level electrical currents to stimulate the vestibular system, affecting balance, posture, and eye movements. It has applications in research, clinical assessment, and rehabilitation of vestibular and balance-related issues, as well as potential applications in cognitive and motor function enhancement.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: galvanic vestibular stimulation; VEMP; vHIT
Biomarkers in Blood Samples From Patients With Stage IV Melanoma Previously Treated With Sargramostim
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood from patients treated with sargramostim in the
      laboratory may help doctors learn more about the effects of sargramostim on cells. It may
      also help doctors understand how patients respond to treatment.

      PURPOSE: This research trial studies biomarkers in blood samples from patients with stage IV
      melanoma previously treated with sargramostim.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To correlate circulating myeloid-derived suppressor cells (MDSC) and Treg frequencies
           with clinical outcome.

      Secondary

        -  To correlate circulating anti-sargramostim (GM-CSF) antibody levels with clinical
           outcome.

      OUTLINE: Archived peripheral blood mononuclear cells and serum samples are analyzed for
      circulating myeloid-derived suppressor cells, Treg (CD3+/CD4+/CD25hi/FOXP3+) frequency, and
      anti-sargramostim (anti-GM-CSF) antibody levels by flow cytometry and anti-GM-CSF
      neutralizing antibody assay.
    

Intervention name(s): flow cytometry; immunologic technique; laboratory biomarker analysis
Intervention type(s): Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patient enrolled on E4697 from whom samples were submitted for research
      
Keywords: stage IV melanoma