bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, phase 1, open-label, fixed-sequence study under fasting
      conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the
      single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.
    


Intervention name(s): Dextromethorphan HBr; GC4419
Intervention type(s): Drug; Drug
Intervention description(s): A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3; Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4
Intervention MeSH terms: Dextromethorphan; Avasopasem manganese
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
Condition: Healthy; Elderly
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized controlled trial to evaluate the safety of Lactobacillus
      rhamnosus GG (LGG) versus placebo in elderly subjects receiving the trivalent inactivated
      influenza vaccine. Lactobacilli are part of the normal flora of the intestine. LGG is one of
      several strains of Lactobacilli that is used as a probiotic or microorganism administered to
      confer "health benefits". Our research is focused on studying the possible therapeutic
      effects of LGG. The study hypotheses are:

        1. LGG or placebo administered twice daily will be safe and well tolerated in elderly
           subjects who have just received the trivalent inactivated influenza vaccine

        2. The immune response to the influenza vaccine at day 21, 28, 56, and at the end of the
           influenza season will be higher in the LGG group than the placebo group

        3. The occurrence rate of influenza like illness during the influenza season will be lower
           in the LGG group than in the placebo group

        4. The diversity of the microbiota in nasopharyngeal and stool specimens at day 21, 28, 56
           and at the end of the influenza season will be greater in the LGG group than the placebo
           group.
    


Intervention name(s): Lactobacillus rhamnosus GG ATCC 53103 (LGG); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days; Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.
Other intervention name(s): Culturelle; LGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: LGG; Immune response; Influenza vaccine; Elderly; Healthy; Microbiome
A Study of Quilizumab Versus Placebo in Patients With Refractory Chronic Spontaneous Urticaria
Condition: Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will
      assess the efficacy and safety of additional quilizumab therapy in adult patients with
      Chronic Spontaneous Urticaria resistant to antihistamine treatment.
    


Intervention name(s): Placebo; Quilizumab
Intervention type(s): Drug; Drug
Intervention description(s): Two administrations by subcutaneous injection; Two administrations by subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MEMP1972A
Fibroblast Specific Inhibition of LOXL2 and TGFbeta1 Signaling in Patients With Pulmonary Fibrosis.
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a two part study. In the first part, the pharmacokinetic profile of
      Epigallocatechin-3-gallate (EGCG) in normal human volunteers given a single oral dose will be
      determined to set the dose for the second part of the study. In the second part of this
      study, lung biopsy fragments and urine samples from patients with interstitial lung disease
      treated with EGCG will be evaluated in biochemical assays and compared to samples from
      untreated control patients.
    

Detailed description: 
      This is an interventional study intended to test inhibition of a signaling pathway in vivo in
      patients with interstitial lung disease, but not intended to affect lung function or disease
      modifications. Doses of oral Epigallocatechin-3-gallate (EGCG) that achieve plasma levels
      known to be safe in human volunteers and likely to target fibroblast TGFbeta RI kinase will
      be established. Disposable fragments of biopsies will be evaluated in biochemical assays
      including pSmad3 and Snail 1 or assayed to determine lysyl oxidase-like 2 (LOXL2) protein and
      LOXL2 enzyme activity. Urine collected before and after EGCG exposure will be used to
      determine whether terminal collagen cross-link breakdown products, termed
      pyridinoline/deoxypyridinoline (PYD/DPD) are changed from baseline. Blood collected before
      and after EGCG exposure will be assayed for serum biomarkers.
    

Intervention name(s): Epigallocatechin-3-gallate (EGCG)
Intervention type(s): Drug
Intervention description(s): Epigallocatechin-3-gallate (EGCG) capsules
Other intervention name(s): Teavigo
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness
Condition: Sleep
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional

Summary: 
      This randomized controlled trial evaluates the effect of acupressure application on nurses'
      sleep quality and daytime sleepiness providing care in surgical clinics. This study
      hypothesizes that acupressure improves sleep quality and reduces daytime sleepiness.
    

Detailed description: 
      Methods: In the study, 60 nurses were randomly assigned to acupressure and placebo
      acupressure groups. To the acupressure group (n = 30), an average of 10 minutes will be
      applied to the Shen Men, the 7th acupoint (HT7) of the heart meridian located between the
      ulna and pisiform bones, on the radial side of the flexor carpi ulnaris tendon, and the
      Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg,
      four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 30),
      the points 1.5 cm away from the HT7 and SP6 points (four points in total) will be applied for
      an average of 10 minutes. The primary outcome of the research is the effect of acupressure on
      the sleep quality of nurses. The secondary outcome of the study is to determine the effect of
      acupressure on daytime sleepiness. The outcomes will be collected before and four weeks after
      the acupressure and placebo acupressure administration.
    

Intervention name(s): Acupressure; Plasebo acupressure
Intervention type(s): Other; Other
Intervention description(s): The experimental group will start with HT7 points and continue with SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.; In the control group, the application will start with the points 1.5 cm around the HT7 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.
Other intervention name(s): Acupress; Acupress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: Acupressure; placebo acupressure; nurses; sleep quality; daytime sleepiness
Refraction Determination Analysis
Condition: Myopia,; Hyperopia,; Astigmatism,; Presbyopia,; Eye Strain,
MeSH terms: Astigmatism; Presbyopia; Hyperopia; Asthenopia
Study type: Interventional

Summary: 
      Correlating the accuracy of a refraction done over telemedicine to that of a standard
      refraction, with a study hypothesis that the results will be equivalent.
    


Intervention name(s): Telemedicine refraction; Traditional refraction
Intervention type(s): Device; Device
Other intervention name(s): Glasses,; Contact lenses,; Refractive surgery,
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Conventional, Overdenture and Palateless Overdenture Oral Health Impact Comparison Study
Condition: Jaw, Edentulous
MeSH terms: Jaw, Edentulous
Study type: Observational

Summary: 
      This study will identify and enroll patients already scheduled to receive guided maxillary
      implant placement with palateless overdenture. Standard clinical practice will be followed
      for this multi-stage process. The study purpose is to evaluate the degree of satisfaction
      during the standard progression in order to determine at which post edentulous stage patients
      achieve maximum satisfaction using the Oral Health Impact Profile 49 (OHIP 49).
    

Detailed description: 
      The OHIP 49 will be administered at pre-treatment (edentulous condition) and after each visit
      (i.e., newly fabricated conventional denture, conversion to a 4 implant retained overdenture
      and finally a 4 implant retained palateless overdenture). Additionally they will be recalled
      yearly for 5 years.

      Participants will have an interim denture fabricated to be worn for 10-12 weeks. During this
      time, participants will have 4 implants placed and continue wearing the interim denture. At 8
      weeks after implant placement, participants will have locator attachments placed on implants
      and the interim denture snapped into place, termed the 'overdenture.' After 10-12 weeks of
      wearing this overdenture, patients will receive a new denture, termed 'final palateless
      overdenture,' which consists of a denture snapped into the 4 implants without a palate.
      Participants will be evaluated at a 10-12 week followup from insertion of this prosthesis.
      Participants will complete questionnaires at each stage of treatment.

      One year after delivery of the final palateless overdenture and for five consecutive years
      patients will be asked to return for a follow up appointment.

      Estimated duration of patient participation is approximately 5 years and 8 months (271
      weeks). Estimated time for active clinical treatment is 8 months (32 weeks) with
      understanding of flexibility based on laboratory fabricated denture frameworks and
      adjustments needed for approval of esthetics.
    

Intervention name(s): Overdenture treatment
Intervention type(s): Device
Intervention description(s): Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UNC Graduate Prosthodontics Clinic
      
Keywords: overdenture; overlay; implant supported; denture; dental prosthesis; maxillary
The Effects of Mood on Cerebral Perfusion
Condition: Cerebral Perfusion
Study type: Interventional

Summary: 
      Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by
      physiological and lifestyle factors. In this study, the investigators want to investigate the
      effects of a different mood state (neutral, positive and negative mood), induced using
      subjects own memories, on both global and regional cerebral perfusion, measured with arterial
      spin labeling.
    


Intervention name(s): Mood induction (using own memories); Arterial spin labeling MRI; Physiological monitoring
Intervention type(s): Behavioral; Device; Device
Intervention description(s): Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI; Single PLD PCASL; During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD
      patients to obtain clinical experience regarding efficacy and safety. In this study, subjects
      received paroxetine 20mg-40mg once daily after an evening meal.
    


Intervention name(s): Paroxetine
Intervention type(s): Drug
Intervention description(s): Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted.
Dosage adjustment will be made at the discretion of the PI or Sub-PI
Intervention MeSH terms: Paroxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics
      and other nutrients. This study will focus on the effects of fiber and probiotics on
      digestive health and health well being in selected Filipino mothers
    


Intervention name(s): ANMUM In-Shape Nutritional Milk Powder for Active Mothers
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation; Bowel movement; Intestinal health
Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software
Condition: Partially Edentulous Maxilla; Partially Edentulous Mandible
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The primary aim of the present study is to compare the accuracy of a full digital workflow
      for dental implants insertion to a partially digital workflow, for a limited edentulous space
      (1 to 3 dental units), in the maxilla or mandible.
    

Detailed description: 
      Improvements of dental digital technologies are nowadays enabling clinicians to take the
      digital impressions of the dental arches, therefore avoiding the use of conventional
      impression materials. Digital impression procedures are claimed to be an approach to improve
      the accuracy of dental restorations by minimizing the error prone to conventional impression
      and gypsum model casting, enabling a high degree of standardization. Patients often prefer
      intraoral scan when compared to the traditional impression. Digital impression is also
      recommended when patients have remaining teeth that are extremely mobile or misaligned, due
      to the risk of exfoliation during the conventional impression procedure.

      Despite its poor scientific and clinical evidence, the use of digital technologies into the
      daily practice registers a rapidly growing.

      The precision of digital impressions depends on two different parameters: the resolution of
      the optical scanning system, and the precision of the matching algorithm which may
      significantly influence the precision of full arch scans. In order to minimize the effect of
      matching artifacts, only small parts of the dental arch in close vicinity of the teeth are
      recommended to be scanned.

      For prosthetic restoration purpose, several studies regarding the accuracy of digital vs
      analogue impression have been performed, but none comparing the accuracy of digital vs
      partially digital workflow for prosthetically driven guided dental implant insertion.
    

Intervention name(s): Full digital workflow; Partially digital workflow
Intervention type(s): Procedure; Procedure
Intervention description(s): Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.; Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT.
Each patient will be randomly assigned to one of the following protocol for dental implant insertion:
Full digital workflow (n=27 patients/sites),
Partially digital workflow (n=27 patients/sites).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental implants; digital workflow; guided surgery
Rivaroxaban Laboratory Monitoring in Switzerland 2: Therapeutic Dose (RivaMoS 2)
Condition: Healthy
Study type: Observational

Summary: 
      Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
      for prophylaxis of venous thromboembolism after major orthopedic surgery. Additionally, RXA
      is approved by Swissmedic to be used at a therapeutic dose for primary therapy of VTE and for
      prophylaxis of cerebrovascular events in non-valvular atrial fibrillation.

      This is an explorative laboratory study to evaluate the intra-individual variability of RXA
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
    

Detailed description: 
      Rivaroxaban (RXA; brand name Xarelto®) is an oral direct factor Xa inhibitor that is applied
      for prophylaxis of venous thromboembolism (VTE) after major orthopedic surgery of the lower
      limbs such as hip and knee replacement surgery. Additionally, RXA is approved by Swissmedic
      to be used at a therapeutic dose for primary therapy of VTE and for prophylaxis of
      cerebrovascular events in non-valvular atrial fibrillation.

      Monitoring of RXA concentration (conc.) is generally not required because of its stable
      pharmacokinetic and pharmacodynamic profile, even in patients with renal insufficiency.
      However, there are several clinical situations, in which it may be desirable to measure the
      RXA plasma conc. The range of RXA conc. is wide among individuals with typical peak levels of
      median 244 µg/L (IQR 175-360) and trough levels of median 32 µg/L (IQR 19-60) with once daily
      doses of 20 mg RXA.

      This is an explorative laboratory study to evaluate the intra-individual variability of RXA
      conc. in time and to standardize assays among 9 Swiss laboratories to determine RXA conc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male volunteers aged 18-65 years
      
Biospecimen description: 
      Plasma samples for coagulation assays
The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the association of adverse environmental factors,
      parental psychopathology, family functioning and genetic factors and the response to
      methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity
      Disorder.
    

Detailed description: 
      Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide
      estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in
      many aspects of the patient´s life, such as academic achievements, peers relationships and
      physical injuries. There are few studies assessing predictive factors of clinical response to
      treatment. Different patterns of family functioning, such as high family conflict and low
      family cohesion might be associated with a poor treatment response, possibly mediating the
      effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental
      psychopathology has been associated with a poorer prognosis and is related with family
      functioning. Adverse social factors have long been studied and are associated with an
      increased risk for general mental disease, including ADHD, as well as a poorer prognosis.
      Different genetic factors have been studied and associated with different aspects of the
      disorder and different clinical responses to treatments. There are no studies evaluating how
      those factors interact with each other in a Brazilian population.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention description(s): Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Attention Deficit Disorder; Attention Deficit Disorders with Hyperactivity; Hyperkinetic Syndrome; Family Function; Adverse Factors; Parental Psychopathology