bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of RCT on the Efficacy of the Osteopathic Consultation in Computer Users
Condition: Trapezius Muscle Strain
Study type: Interventional

Summary: 
      This study investigates the feasibility of conducting a large scale Randomized Controlled
      Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity
      of pain and changing electromyographic activity in the musculature of the neck-shoulder
      region for the computer user's population.
    


Intervention name(s): Osteopathic Consultation; Sham Osteopathic Consultation
Intervention type(s): Other; Other
Intervention description(s): A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.; A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
Condition: Anaphylactic Reaction
MeSH terms: Anaphylaxis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the relative bioavailability of inhaled epinephrine compared
      with 0.3mg epinephrine administered IM in healthy male and female participants.
    

Detailed description: 
      DMC-IH1 (Investigational Product) is a capsule containing epinephrine bitartrate dry powder
      blend contained within a single-use, proprietary inhalation device.

      The planned dosages for inhalation are 0.3 mg on Visit 2, 1.3 mg (dose will not exceed 6 mg)
      on Visit 3, and 4 mg (dose will not exceed 6 mg) on Visit 4.

      The study will comprise 3 periods: Screening, Treatment, and Follow-up. Total duration of the
      study is approximately 66 days including -28 days from screening to visit to follow up
    

Intervention name(s): EpiPen ®.; Epinephrine (0.3mg) inhaled; Epinephrine (1.3mg); Epinephrine (4mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.; Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2; A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.; A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions
Condition: Periodontitis, Chronic; Periodontal Diseases; Periodontal Bone Loss
MeSH terms: Alveolar Bone Loss; Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the additional effect of antimicrobial photodynamic
      therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone
      and porcine collagen membrane.
    


Intervention name(s): Scaling and root planing; Toluidine Blue O
Intervention type(s): Procedure; Drug
Intervention description(s): Furcation treatment by scaling and root planing; Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
Other intervention name(s): Antimicrobial photodynamic therapy
Intervention MeSH terms: Tolonium Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth design. One side of mouth is test and the other is control side.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontal Guided Tissue Regeneration; Photochemotherapy
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the ability of new anti-HIV agents to penetrate
      different body compartments in HIV negative men who have sex with men and transgender women.
      These new agents might be considered for pre-exposure prophylaxis regimens in the future.
      This study will include 90 healthy, HIV-negative men who have sex with men and transgender
      women who are not taking hormones aged 18-49 years. Participant must be willing to
      participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and
      willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
    

Detailed description: 
      Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to
      be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among
      MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal
      mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV
      prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP
      entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to
      prevent HIV infection. However, current tenofovir- based regimens have shown to have side
      effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study
      is designed to examine the ability of these new agents to penetrate mucosal tissues and
      potentially prevent HIV infection during RAI exposure for MSM and TGW.
    

Intervention name(s): Truvada; Genvoya
Intervention type(s): Drug; Drug
Intervention description(s): Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.; Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preventative Medicine; Infectious Diseases; Sexually Transmitted Diseases
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in
      healthy subjects.
    


Intervention name(s): AGN-223575 Formulation A; AGN-223575 Formulation B; AGN-223575 Formulation C; AGN-223575 Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.; One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.; One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.; One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Laser Treatment Of Vascular Lesions On Vocal Cords
Condition: Ectasia
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      Small vascular malformations (SVM) on the vocal fold is a common problem that can disturb the
      voice. The pulsed dye laser (PDL) has been successfully used for treatment of blood vessel
      abnormalities in surface tissue, through its high selectivity for destroying targeted blood
      vessels while sparing normal tissue. However, there is no study to determine its clinical
      benefit for treatment of SVMs on vocal fords. In this proposed study, we plan to make such a
      determination.We will determine whether PDL will produce better and quicker voice improvement
      than the conventional surgeries, in 20 patients (10 cases of each group) with vocal fold SVM.
      We expect that this less invasive laser treatment will provide an ideal and excellent option
      for this disease.
    

Detailed description: 
      Clinically, small vascular malformations (SVM) on the vocal fold is a common problem that can
      disturb the voice. Currently, this problem is treated with endoscopic microsurgery with the
      use of a Carbon dioxide (CO2) laser or other microsurgeries. However, those treatments are
      unsatisfactory because of their invasive nature. The pulsed dye laser (PDL) has been
      successfully used for treatment of blood vessel abnormalities in surface tissue, through its
      high selectivity for destroying targeted blood vessels while sparing normal tissue. Even
      thought this process has been in use clinically for the past 5 years, there is no study to
      determine its clinical benefit for treatment of SVMs on vocal fords, by comparing it with
      routine surgeries. In this proposed study, we plan to make such a determination, by comparing
      the voice recovery and voice improvement between this laser and those routine surgeries (with
      CO2 laser or "cold" instrument).

      Our specific aim is to determine whether PDL will produce better and quicker voice
      improvement than the conventional surgeries, in 20 patients (10 cases of each group) with
      vocal fold SVM. This is the first study to determine clinical benefit of the microvascular
      targeting (MVT) technique of laser to treat vocal fold SVMs, by a comparison of the voice
      results between these two groups. We expect that this less invasive laser treatment will
      provide an ideal and excellent alternative to current surgical approaches for treatment of
      this disease.
    

Intervention name(s): Pulse Dye laser (PDL); CO2 laser or other traditional surgeries
Intervention type(s): Procedure; Procedure
Intervention description(s): one-time PDL, in 10 subjects; once-time CO2 laser or other conventional surgeries, in other 10 subjects
Other intervention name(s): the laser made by Cynosure Inc, Mass; the laser made by Cynosure Inc. Mass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ectasia; vascular lesions; vocal cords; voice; pulsed dye laser
Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion > 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies
Condition: Endoscopic Submucosal Dissection
Study type: Observational [Patient Registry]

Summary: 
      Colorectal cancer has become a public health priority considering its increased prevalence
      and high mortality rate when diagnosed late. As a consequence, many countries have promoted
      and uptaken of colorectal cancer screening programs leading to an increasing detection of
      advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy)
      guidelines states that the majority of those colonic and rectal superficial lesions can be
      removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal
      Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of
      colonic and rectal lesions with high suspicion of limited submucosal invasion.
      Histologically, a resection is curative for the patient when the adenocarcinoma is
      well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion),
      with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer
    


Intervention name(s): Endoscopic Submucosal Dissection
Intervention type(s): Procedure
Intervention description(s): Endoscopic Submucosal Dissection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hgh Risk Colorectal Cancer
Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics
Condition: Anesthesiology Devices Associated With Adverse Incidents; Intraocular Pressure
Study type: Interventional

Summary: 
      In this study, participants aimed to compare the effects of direct laryngoscopic endotracheal
      intubation and videolaryngoscopic intubation with C-MAC videolaryngoscope and McGrath
      videolaryngoscope on intraocular pressure and hemodynamics.
    

Detailed description: 
      The maintenance of airway opened is one of the main responsibility of the anesthetist.
      Intubation procedure during anesthesia application benefits such as airway opening, airway
      and breathing control, aspiration hazard, respiratory effort and dead space reduction,
      surgical comfort and airway control during resuscitation. Laryngoscopy and tracheal
      intubation increases in heart rate, blood pressure and the intraocular pressure. The
      sympathetic-adrenal activity caused by the stimulation of the laryngeal and tracheal tissues
      is responsible for these negative effects. Endotracheal intubation with videolaryngoscopy is
      an alternative method used in airway management. Laryngoscopy and tracheal intubation under
      general anesthesia and laryngeal mask and airway control techniques cause different
      hemodynamic and catecholamine levels.
    

Intervention name(s): Direct laryngoscope; C-MAC videolaryngoscope; McGrath videolaryngoscope
Intervention type(s): Device; Device; Device
Intervention description(s): Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, double blind Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tracheal intubation; videolaryngoscopy; hemodynamics; intraocular pressure
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to determine the safety and tolerability of single and multiple
      oral ascending doses of AJM347 in healthy male participants, and to assess the
      pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the
      same population. This study will also aim to determine the single and multiple oral ascending
      dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to
      determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347
      and its metabolite in the same population.
    


Intervention name(s): AJM347; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: AJM347; pharmacokinetics; food effect study; pharmacodynamics
Efficacy of a Brown Seaweed Powder for Glycemic Control
Condition: Blood Glucose
Study type: Interventional

Summary: 
      The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and
      explore dose-response relationship by comparing two different doses.

      The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood
      glucose.
    


Intervention name(s): 500 mg InSea2®; 250 mg InSea2®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a
      single iv dose of E-WE Thrombin in healthy adult subjects.
    


Intervention name(s): E-WE Thrombin- Dose 1; E-WE Thrombin- Dose 2; E-WE Thrombin- Dose 3; E-WE Thrombin- Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.; Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.; Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.; Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.; Participants received a single intravenous dose of placebo.
Other intervention name(s): AB002- Dose 1; AB002- Dose 2; AB002- Dose 3; AB002- Dose 4
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
Condition: Placenta Accreta Spectrum
MeSH terms: Placenta Accreta
Study type: Observational

Summary: 
      The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents
      a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this
      risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for
      multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding.
      This approach has reduced maternal morbidity rates, including less blood loss, fewer
      transfusion requirements and, intraoperative urologic injuries as well as improve fetal
      outcome.

      Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended
      first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta
      accreta include an inability to visualize the normal retroplacental clear zone, irregularity,
      and attenuation of the uterine-bladder interface, retroplacental myometrial thickness,
      presence of intraplacental lacunar spaces, and bridging vessels between the placenta and
      bladder wall when using color Doppler.

      The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict
      PAS based on US parameters in a high-risk population by retrospective data analysis. The
      probability of histological invasion was found to increase with increasing the PAI score.
      This study aimed to prospectively evaluate the diagnostic performance of the PAI in the
      prediction of PAS in relation to histopathological findings.
    


Intervention name(s): Ultrasound evaluation, with grayscale and color Doppler imaging
Intervention type(s): Device
Intervention description(s): In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant females during the third trimester of pregnancy, with a single fetus in the
        current pregnancy, a previous delivery by at least 1 cesarean section and having an
        anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation),
      manufactured by Bolder Arzneimittel GmbH & Co. KG to Boehringer Ingelheim compared to
      ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim
      do Brasil Química e Farmacêutica Ltda.
    


Intervention name(s): Ambroxol hydrochloride soft pastille; Mucosolvan ® adult syrup
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ambroxol
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy
      of lebrikizumab administered subcutaneously (SC) in adult participants with persistent
      moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical
      corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a
      12-week blinded treatment period, and an 8-week safety follow-up period. Following screening
      visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a
      protocol-specified topical therapy regimen will be initiated. At the end of the run-in
      period, participants who have: 1) demonstrated compliance with the protocol-specified TCS
      regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.
    


Intervention name(s): Lebrikizumab; Placebo; TCS Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lebrikizumab will be administered SC as per the schedule specified in the respective arms.; Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.; TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment