bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels
Condition: Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the safety profile of AZD4721 after single doses at different dose
      levels
    

Detailed description: 
      A study to investigate safety and tolerability of single ascending doses of AZD4721 given to
      healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a
      suspension.
    

Intervention name(s): AZD4721 Solution; AZD4721 Placebo; AZD4721 Suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1-9 mg/mL liquid solution; Liquid solution; 9 mg/g liquid suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy volunteers, Phase 1
Oxytocin and Emotion Recognition
Condition: Health
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study was designed to investigate the effects of a single dose of synthetic
      oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are
      presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary
      the level of awareness. In a randomized placebo-controlled between-subject design,
      recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition.
      We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed
      with limited awareness.
    


Intervention name(s): Syntocinon 24 IU; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Prostate Cancer Patients With Biochemical Recurrence
Condition: Patients With Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging
      techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up
    

Detailed description: 
      When BCR is present, detection of recurrence as well as the location, distribution and number
      of metastatic sites would determine the choice of subsequent management. In the search of
      malignancy in patients with BCR, standard of care tests include Pelvic CT or MRI (to look for
      recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal
      metastases. However, standard of care testing has a low diagnostic yield of only 11% of
      patients for visualizing sites of disease (5). Thus, there is a clear need for better imaging
      approaches. 18F-Fluciclovine is a synthetic amino acid PET tracer approved by the Food and
      Drug Administration in June of 2016 for the detection of sites of recurrence in men with
      rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6),
      based on its diagnostic performance (7,8). However, there is a gap in the literature
      regarding prospective studies evaluation of detection rate of 18F-Fluciclovine compared to
      current standard of care imaging techniques. Therefore, 18F-Fluciclovine has already been
      approved by the FDA and covered CMS and insurance companies but is yet to be included in the
      NCCN guidelines in the work up of PCa patients with BCR.
    

Intervention name(s): Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)
Intervention type(s): Diagnostic Test
Intervention description(s): Standard of care-Pelvic CT or MRI and MDP bone scan + or - 18F-NaF PET/CT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male subjects age 18-89
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to measure and contrast implicit and explicit learning
      performance in patients with schizophrenia relative to young and elderly healthy volunteers.
    

Detailed description: 
      This is an exploratory study involving schizophrenic patients (Group 1) and young and elderly
      healthy volunteers (Group 2 and 3 respectively). No investigational medicinal product will be
      administered. For all participants enrolled (Group 1 to 3) the study will consist of an
      eligibility screening examination (from Day -21 up to and including Day 1) and 3 cognitive
      assessment days. Cognitive assessments will be made on 2 subsequent days (Days 1 and 2) which
      are separated by overnight sleep. In addition, a session will be performed on Day 7.
      Completion of the cognitive test batteries can occur at any time during the day provided that
      the completion time is comparable on all test days. For each participant, the maximal study
      duration will not exceed 4 weeks.
    

Intervention name(s): Cognitive Test Battery 1; Cognitive Test Battery 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT_Expl); Delayed Recall and Recognition Test; and Pursuit rotor.; The Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Schizophrenia; Young healthy volunteers; Elderly healthy volunteers; Learning performance
Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label, multi-center clinical study is to assess the safety, tolerability,
      pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants
      with Type 1 spinal muscular atrophy (SMA). The study consists of two parts, an exploratory
      dose finding part (Part 1) and a confirmatory part (Part 2) which will investigate Risdiplam
      (RO7034067) for 24-months at the dose selected in Part 1.
    


Intervention name(s): Risdiplam
Intervention type(s): Drug
Intervention description(s): Risdiplam will be administered orally.
Other intervention name(s): RO7034067, Evrysdi
Intervention MeSH terms: Risdiplam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home Based Resistance Training For Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the biological and psychosocial benefits of a home-based
      resistance-training program for sedentary, obese adults living with type 2 diabetes.
    

Detailed description: 
      Obese individuals with type 2 diabetes will be randomly assigned to either an experimental
      group where they will perform moderate to high intensity resistance training (50-60% 1RM
      weeks 1-3 and 70-85% 1RM in weeks 4-16) three times per week for 16 weeks or to a
      non-training control group. All resistance training will be performed at home using a
      multigym apparatus. A personal trainer (PT) will come to the homes of each participant in the
      experimental group to make sure that exercises are being performed safely with the correct
      technique, and at the prescribed intensity. In the first two weeks, the PT will come to all 3
      sessions per week. In weeks 3-4 this will be reduced to 2 times per week, in weeks 5-8 the PT
      will come once per week and in the last 8 weeks once bi-weekly.
    

Intervention name(s): Resistance Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Resistance Training
Hepatic Fibrosis Non-invasive Methods Questionnaire
Condition: Cirrhosis; Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Due to the limitations and the invasive nature of liver biopsy, there has been extensive
      interest in developing non-invasive tests to measure liver fibrosis (1). These are
      alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of
      cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include
      radiological studies, transient elastography (TE), and serum markers. We aim at studying
      acceptability, reliability, applicability and practical aspects of invasive and noninvasive
      methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
    

Detailed description: 
      Due to the limitations and the invasive nature of liver biopsy, there has been extensive
      interest in developing non-invasive tests to measure liver fibrosis (1). These are
      alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of
      cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include
      radiological studies, transient elastography (TE), and serum markers. We aim at studying
      acceptability, reliability, applicability and practical aspects of invasive and noninvasive
      methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

      Methods:

      The study is a survey study among hepatologists. Four thousand hepatologists will be invited
      to participate in the questionnaire through e-mail invitations to answer 50 questions of the
      questionnaire. The questionnaire will be hosted on Survey monkey website and results will be
      analyzed to get the consensus opinion of participants for the use of invasive and
      non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting
      their preferences.

      Statistical analysis plan Analysis of data will be performed using Statistical Package for
      Scientific Studies 17 for Windows. Description of qualitative variables will be in the form
      of numbers (No.) and percent (%). Description of quantitative variables will be in the form
      of mean, standard deviation (SD). Questionnaire results will be compared against different
      baseline characteristics of the studied group. According to the type and distribution of
      data, suitable tests for inferential statistics will be used. Significance of the results
      will be presented in the form of P-value.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hepatologists
Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a prospective randomized control clinical trial which is sponsored by the
      researchers. The purpose of this study is to determine the effectiveness of
      Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer
      patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1)
      enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group)
      or standard chemotherapy without goserelin (chemotherapy alone group). All patients are
      stratified according to age (<35years vs.36-44years), hormone receptor status (HR+ or ER+
      vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based
      vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure,
      follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and
      disease-free and overall survival will be compared between two groups to evaluate the
      effectiveness of protect against ovarian failure.
    


Intervention name(s): goserelin; standard chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Gonadotropin-Releasing Hormone Agonist; (Anthracyclines/cyclophosphamide) followed by paclitaxel or doxetaxel; doxetaxel/cyclophosphamide; doxetaxel or paclitaxel/Anthracyclines; fluorouraci/Anthracyclines/cyclophosphamide followed by doxetaxel or paclitaxel; doxetaxel/Anthracyclines/cyclophosphamide; Anthracyclines/cyclophosphamide;
Other intervention name(s): Gonadotropin-Releasing Hormone Agonist; AC-P; TC; TA; TAC; FAC followed by T; AC
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Premenopausal Breast Cancer; Preservation of Ovarian Function; Gonadotropin-Releasing Hormone Agonist
Corneal Epithelial Stem Cells and Dry Eye Disease
Condition: Dry Eye Syndromes; Dry Eye; Ocular Inflammation; Ocular Surface Disease; Ocular Discomfort; Blepharitis
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Blepharitis; Inflammation
Study type: Interventional

Summary: 
      To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product
      (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments.
      This pilot study will carefully observe and monitor each qualifying and willing individual
      for response to treatment, signs of toxicity and adverse effects from the treatment, and for
      ability of the treatment to improve comfort and restore vision.
    

Detailed description: 
      Eligible patients presenting with severe dry eye disease that have failed treatment with
      conventional measures will be screened for inclusion into the study. The treatment will
      consist of administration of formulated topical eye drops containing cadaveric epithelial
      stem cell-derived product. These eye drops will be transplanted by topical
      self-administration by the patient four times daily in both eyes for a three month interval.
    

Intervention name(s): Corneal Epithelial Stem Cell Transplant
Intervention type(s): Other
Intervention description(s): Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cell therapy; dry eye disease
Food Effect Study of CTP-543 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted
      conditions.
    

Detailed description: 
      This open-label, single-dose study will assess in healthy subjects a solid oral dose
      formulation of CTP-543 under fasted and fed conditions.
    

Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): Once daily dosing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Safety; Bioavailability; Pharmacokinetics
Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension
Condition: Pulmonary Hypertension; Breathing-Related Sleep Disorder
MeSH terms: Respiratory Aspiration; Hypertension, Pulmonary; Sleep Wake Disorders; Parasomnias; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the differential short-term effect of nocturnal oxygen,
      acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms,
      exercise capacity and nocturnal breathing disturbances in subjects with pulmonary
      hypertension and sleep related breathing disorders

        -  Trial with medicinal product
    


Intervention name(s): acetazolamide; Supplemental oxygen; Non-invasive ventilation; Room air; Placebo tablet
Intervention type(s): Drug; Other; Procedure; Other; Drug
Intervention description(s): 250 mg bid; Oxygen deliverded by nasal cannula; Bi-level non-invasive ventilation via nasal mask; Room air applied via sham oxygen concentrator; Placebo tablet (Mannitol) similar to acetazolamide
Other intervention name(s): Diamox; Oxygen concentrator
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breathing-Related Sleep Disorder; Pulmonary Hypertension
CD36 in Nutrient Delivery and Its Dysfunction
Condition: Insulin Resistance; Endothelial Dysfunction
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This proposal will test the hypothesis that chronic treatment with sildenafil with and
      without the use of nitric oxide substrate, L-arginine, protects against fatty acid induced
      impairment of endothelial function, improves insulin-stimulated microvascular recruitment,
      insulin sensitivity and glucose uptake in CD36 rs3211938 G-allele carriers.
    

Detailed description: 
      Subjects carrying the G-allele of CD36 coding SNP rs3211938 that results in 50% reduction of
      CD36 levels in ~25% of African Americans have endothelial dysfunction. Endothelial
      dysfunction results in impairment of insulin's vascular actions and eventually reduced
      insulin sensitivity. Insulin induces microvascular recruitment via stimulation of nitric
      oxide(NO)-cGMP pathway, which facilitates nutrient flux, e.g., glucose to skeletal muscle.
      Elevated fatty acids impair insulin-stimulated microvascular recruitment and reduce insulin
      sensitivity. Chronic treatment with sildenafil increases vascularity and muscle glucose
      uptake in high fat fed mice. In humans, Drs. Shibao (PI) recently reported that a 3-month
      treatment with sildenafil improves insulin sensitivity in patients with impaired glucose
      tolerance. More relevant to this project, endothelial dysfunction improved after 4-week
      treatment with sildenafil in G-allele carriers. This proposal will test the hypothesis that
      chronic treatment with sildenafil with and without the use of NO substrate, L-arginine,
      protects against fatty acids induced impairment of endothelial function, improves
      insulin-stimulated microvascular.

      The protocol design was changed to single arm design.
    

Intervention name(s): Sildenafil Citrate in G allele carrier; Sildenafil Citrate in non G allele carrier
Intervention type(s): Drug; Drug
Intervention description(s): chronic use of phosphodiesterase 5 inhibitor in G allele carrier; chronic use of phosphodiesterase 5 inhibitor in Non G allele carrier
Other intervention name(s): viagra, revatio,; viagra, revatio
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CD36; Endothelial dysfunction; African Americans
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are:

      To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
    


Intervention name(s): Phentolamine Ophthalmic Solution 0.75%; Pilocarpine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Pilocarpine ophthalmic solution; Topical sterile ophthalmic solution
Other intervention name(s): Nyxol; Nyxol®; Phentolamine Ophthalmic Solution Vehicle
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions; Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nyxol; Presbyopia; Pilocarpine
Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF)
      compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic
      Restorative Treatment approach (ART).
    

Detailed description: 
      This study is a three arm randomized controlled clinical trial, where children with an age
      range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the
      outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry,
      Alexandria University after securing necessary consents. Sixty teeth are randomly allocated
      into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver
      diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an
      antibacterial agent, and Group III serves as a negative control.
    

Intervention name(s): Silver Diamine Fluoride; Chlorhexidine; Atraumatic Restorative Treatment without Disinfection
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect); Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect); Atraumatic Restorative Technique will be performed without cavity disinfection
Other intervention name(s): SDF; CHG
Intervention MeSH terms: Chlorhexidine; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atraumatic Restorative Treatment; Chlorhexidine; Silver Diamine Fluoride; Primary Teeth