bioihbjkbjnl/mcl2 huggingface dataset:
A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized open-label, single-dose, parallel group study will investigate
      the relative bioavailability of a high concentration liquid formulation (HCLF) versus the
      reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be
      randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.
    


Intervention name(s): gantenerumab; gantenerumab
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous injection of a high concentration liquid formulation; Single subcutaneous injection of a lyophilized formulation
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease
Condition: Dry Eye Syndrome; Ocular Surface Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Observational

Summary: 
      Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is
      known that various inducers are involved. However, it is still necessary to study how
      influencing factors are related to dry eye syndrome and ocular surface disease and how
      treatment for dry eye syndrome and ocular surface disease is helpful.
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Observation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ocular discomfort related to DED who visit the Hallym University Kangnam
        Sacred Heart Hospital between June 2016 and June 2017.
Surgical Therapy and Survival in HCC/ C.F. Zhang et al.
Condition: Hepatocellular Carcinoma; Surgery
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This study utilizes a new method to explore compare the overall survival (OS) and
      cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent
      different types of surgery. The SEER database, which is one of the most comprehensive and
      authoritative databases concerning cancer, was used to estimate the survival benefit of
      patients who underwent local tumor destruction (LTD), wedge or segmental resection (WSR),
      lobectomy resection (LR), liver transplantation (LT), or non-surgery. This study discovered
      surgery offered a survival benefit compared with non-surgery for young patients with stage
      I-II HCC. Furtherly, LT is associated with superior survival than WSR, LR and LTD in those
      patients. Our results facilitate the selection of surgical strategies.
    

Detailed description: 
      The SEER data contain no identifiers and are publicly available for studies of cancer-based
      epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from
      Institutional Review Board approval and the need for informed consent was waived. The
      submitted magazine requires registration on the website, so this operation is needed.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18-45, regardless of race。
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 1 of 7)
Condition: Exposure to Man-made Visible Light
Study type: Interventional

Summary: 
      NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the
      Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5
      arms, in total 350 participants will be assessed in all 7 sub-studies.

      General study information: This is a randomized, cross-over, quantitative study, which
      investigates physiological variables, mood, and affect of healthy participants in response to
      colored light exposure. The Participants take part in 5-8 arms and are exposed to colored
      light only, or are additionally asked to solve cognitive tasks during the colored light
      exposure. Primary aim is to measure the change in several physiological variables, mood, and
      affect during colored light exposure of 15 or 45 minutes. The risk for the participants is
      negligible and comparable to the risk during daily life.
    


Intervention name(s): Visible light exposure
Intervention type(s): Other
Intervention description(s): Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebral oxygen metabolism; functional near-infrared spectroscopy; partial pressure of carbon dioxide; heart rate variability; blood pressure; affect; mood; respiration; systematic randomized cross-over study; systemic physiology; electro-dermal activity; pulse-respiratory quotient
Importance of Liver Innervation for the Osmopressor Response in Humans
Condition: PHYSIOLOGICAL PHENOMENA
Study type: Interventional

Summary: 
      In patients with autonomic dysfunction water drinking elicits a pressor response mediated by
      sympathetic activation. If any, in healthy subjects there is only a slight increase in blood
      pressure. However, the sympathetic activation is observable by resting energy expenditure
      increases greater than 20%.

      The investigators believe that the response to water may be mediated through sympathetic
      activation elicited by osmosensitve spinal afferents in the liver. Therefore, the
      investigators want to test water in liver transplant patients who have a denervated liver.
      Kidney transplant patients serve as control subjects. The investigators hypothesize that the
      increase in norepinephrine after water drinking is blunted in liver transplant recipients.
    


Intervention name(s): 500ml water intake
Intervention type(s): Dietary Supplement
Intervention description(s): subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Water drinking; osmoreceptors; autonomic failure; syncope; blood pressure; liver transplant
Characterization of New Human Models of Non-histaminergic Itch
Condition: Papain; Itch; Skin Prick Test (SPT)
Study type: Interventional

Summary: 
      In this experiment the investigators would like to test a new new human itch model based on
      papain, and to characterize the sensory quality and temporary aspects of papain skin prick
      test (SPT) in comparison to the inactivated-cowhage delivery system.
    

Detailed description: 
      The most used model of non-histaminergic itch is cowhage but this models presents several
      problems, such us the impossibility of standardizing the amount of the spicules inserted in
      the skin and the difficulty of obtaining the substance. These aspects bring us the necessity
      to find a new and more standardized model of non-histaminergic itch.

      Papain is a cysteine protease extracted from papaya plant that is known to cause itch if
      applied to the skin. For these reasons the investigators would like to test a new new human
      itch model based on papain, and to characterize the sensory quality and temporary aspects of
      papain skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
    

Intervention name(s): Papain 10 µg; Papain 50 µg; Papain 100 µg; Vehicle; Papain 1 SPT; Papain 5 SPT; Papain 25 SPT; Cowhage
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug; Drug; Other
Intervention description(s): The area will be exposed to 10 µg of papain.; The area will be exposed to 50 µg of papain.; The area will be exposed to 100 µg of papain.; The area will be exposed to vehicle; Papain will be applied by 1 SPT prick thought the skin; Papain will be applied by 5 SPT pricks thought the skin; Papain will be applied by 25 SPT pricks thought the skin; The last area will be exposed to cowage spicules (made chemically inert by autoclaving) soaked in 5 mg/ml papain solution.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Augmented Human Intelligence in Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Researchers are testing whether a computer program (called a clinical decision support tool)
      can help clinicians predict how a patient with depression will respond to antidepressant
      medication.
    


Intervention name(s): Clinical decision support tool
Intervention type(s): Other
Intervention description(s): Adults (aged 18-64 years) who meet DSM-5 diagnostic criteria for non-psychotic unipolar major depressive disorder (MDD) and meet study eligibility criteria will receive 8 weeks of open-label treatment with an SSRI or SNRI antidepressant. Depressive symptoms will be assessed using the subject- and clinician-rated versions of the 16-items QIDS scale (QIDS-SR and QIDS-CR) and the 17-item HAMD at baseline, week 2 (via telephone), week 4, and week 8; with an additional phone contact at week 24. The QIDS scale scores at 2- and 4-weeks will be entered into the AHI-based clinical decision support tool, and the outcome predicted by the tool (e.g., the predicted eventual treatment outcome at 8 weeks) will be recorded. Clinicians and patients will be blinded to the clinical decision support tool prediction of outcome provided at the 2- and 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.
Condition: Immediate Dental Implants Connective Tissue Graft Esthetic Zone
Study type: Interventional

Summary: 
      Aim of current study to evaluate connective tissue graft combined with immediate implant
      placement as an innovative option for less facial gingival tissue recession, less pocket
      depth and less clinical attachment loss versus immediate implant alone.
    

Detailed description: 
      P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate
      implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial
      gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment
      loss, tissue biotype, keratinized mucosal width and bleeding on probing.

      P.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology
      Department - Cairo University. Screening of patients will continue until the target
      population is achieved. Identifying and recruiting potential subjects is achieved through
      patient database.
    

Intervention name(s): Intervention group:(Group B) connective tissue graft combined with immediate implant.
Intervention type(s): Procedure
Intervention description(s): Patients will be treated with connective tissue graft combined with immediate implant.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients was randomly classified into two groups:
Group A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immediate dental implant, Connective tissue graft, Esthetic zone.
Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir
Condition: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Herpes Simplex; Herpes Zoster; Varicella Zoster Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      A new paediatric formulation (oral liquid) has been developed for flexible and accurate
      dosing of valacyclovir in children. To establish the bioavailability of this new formulation,
      healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The
      concentration of valacyclovir in their blood after exposure to the oral liquid will be
      measured and compared to the tablet.
    

Detailed description: 
      Bioequivalence of the new valcyclovir formulation will be tested according to the EMA
      guideline for bioequivalence.
    

Intervention name(s): valacyclovir tablet; valacyclovir oral solution
Intervention type(s): Drug; Drug
Intervention description(s): 16 healthy adult volunteers (18-55 yr) will be exposed to one tablet; 16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once
Other intervention name(s): Zelitrex
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; valacyclovir; paediatric formulation
A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
Condition: Acute Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is being conducted to assess the efficacy and safety of recombinant Human
      Prourokinase in the acute pulmonary embolism.
    


Intervention name(s): Recombinant Human Prourokinase; Alteplase
Intervention type(s): Drug; Drug
Intervention description(s): The drug is used for intravenous thrombolysis therapy; The drug is used for intravenous thrombolysis therapy
Other intervention name(s): rhPro-UK; Actilyse; rtPA
Intervention MeSH terms: Tissue Plasminogen Activator; Saruplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
T and B Cells in Graves' Orbitopathy
Condition: Graves Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Study type: Observational

Summary: 
      Graves orbitopathy (GO) is an inflammatory eye disease associated in 95% of patients with
      Graves' hyperthyroidism (GH), in ~3-4% with hypothyroid autoimmune thyroiditis, and in ~1-2%
      with thyroid autoimmunity in the absence of thyroid dysfunction, the former known as
      euthyroid GO. The pathogenesis of GO is autoimmune, with the TSH-receptor being considered
      the major autoantigen, thereby establishing a pathogenetic link between the thyroid and
      orbital tissue. Thus, TSH-receptor is expressed by orbital fibroblasts, where it forms a
      complex with the IGF-1 receptor. Unlike GH, which is notoriously caused by TSH-receptor
      stimulating autoantibodies, GO is believed to reflect cell-mediated autoimmunity, as
      suggested by studies showing a Th1-like pattern of cytokine release by primary cultures of
      orbital infiltrating lymphocytes from GO patients. On the other hand, a role of B lymphocytes
      has emerged in recent years based on the observation that the anti-CD20 monoclonal antibody
      rituximab has a beneficial effect on GO activity, as demonstrated by a recent randomized
      clinical trial in which rituximab was compared with intravenous glucocorticoids (GC), being
      the former the standard treatment of moderately-severe GO. The explanation for the findings
      was that B lymphocytes are involved in the pathogenesis of GO as antigen-presenting cells.
      However, in spite of the above mentioned promising observations, another randomized clinical
      trial in which rituximab was compared with placebo provided opposite results. Thus, rituximab
      had no effect at all on GO. Data from the two studies were confronted and major differences
      between the two cohorts emerged, especially concerning GO activity, leading to the conclusion
      that rituximab may be effective for active, but not for inactive GO. Rituximab has been
      employed also for autoimmune diseases other than GO, including type 1 diabetes. In the
      former, it was shown that the effectiveness of rituximab paralleled the presence of
      CD20-positive infiltrating lymphocytes in pancreas islets. We therefore postulated that
      something similar may occur in GO, because of which we planned the present, perspective,
      observational study, aimed at determining the presence and immunohistochemical features of
      lymphocytes infiltrating orbital tissues in patients with GO and to relate them with the
      clinical features of GO.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention related to the study is foreseen
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with Graves' orbitopathy to undergo orbital decompression
      
Biospecimen description: 
      Fibroadipose orbital tissue samples
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Condition: Post Partum
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot randomized controlled trial to assess the effects of advanced supply of
      emergency contraception versus routine care in a teen postpartum population. The goals are to
      assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the
      prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse
      exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to
      assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and
      unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.
    


Intervention name(s): Plan B (Levonorgestrel)
Intervention type(s): Drug
Intervention description(s): PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Teen; Plan B; Post Partum; Emergency Contraception
Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first
      one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away
      from the pylorus.
    


Intervention name(s): laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants
Condition: Skin Care
Study type: Interventional

Summary: 
      The objective of this clinical study is to assess the irritation and sensitisation potential
      of a cosmetic test product after repeated semi-occlusive patch applications to healthy human
      participants by following a conventional HRIPT methodology under supervision of a
      dermatologist.
    

Detailed description: 
      The first phase of the study is an Induction Phase; a known amount of each product (test and
      control) is applied, under a semi-occlusive patch. Patches will remain on the skin for 48
      (±2) (weekdays) or 72 (±2) (including inclusive weekends) hours during this phase. Induction
      phase lasts for 3 weeks. After the Induction Phase participants will enter a Rest Phase of 2
      weeks duration, during which no patches are applied. After the Rest Phase, participants will
      return to the clinical site for the Challenge Phase. In this phase a challenge patch
      containing the test and control products is applied to virgin skin for 48 (±2) hours then
      assessed 30 minutes (maximum 1 hour) following removal, 24 (± 2) and 48 (±2) hours later.
    

Intervention name(s): Facial micellar cleanser; Saline Solution: Sodium Chloride (NaCl; 0.9%)
Intervention type(s): Other; Other
Intervention description(s): Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.; Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and
      is frequently used in the empirical treatment of hospital-acquired infections because of its
      antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam
      exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor.
      Because a majority of infections are treated empirically, it is necessary to achieve a T >
      MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens,
      including those with only moderate susceptibility The aim of this study is to compare the
      same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous
      infusion. A pharmacokinetic study will be performed in patients treated by extended (loading
      dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min
      followed by 16G /24h).

      A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine
      95% probability of target attainment (PTA95) versus MIC
    


Intervention name(s): piperacillin continuous infusion; piperacillin extended infusion
Intervention type(s): Drug; Drug
Intervention description(s): piperacillin continuous infusion; piperacillin extended infusion
Intervention MeSH terms: Piperacillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infectious disease; piperacillin; continuous infusion; extended infusion