bioihbjkbjnl/mcl2 huggingface dataset:
Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the discontinuation rate of schizophrenia patients
      receiving multiple sequential 2 mL injections of long acting injectable risperidone (an
      atypical antipsychotic medication) when administered into the deltoid muscle once every 2
      weeks.
    

Detailed description: 
      This is an open-label, multiple-dose, multicenter study in chronic schizophrenia patients,
      who are receiving long-acting injectable risperidone 25 or 37.5-mg injections into the
      gluteal muscle, and clinically require a higher dose. The study consists of a pretreatment
      screening phase, an 8-week, open label treatment phase during which patients will receive 4
      sequential 2 mL injections with long-acting injectable risperidone (37.5 or 50 mg)
      administered every 2 weeks into the deltoid muscle in alternate arms (right versus left) for
      each visit; and a post treatment phase consisting of end of study evaluations upon completion
      of all the study procedures on Day 57 or at early withdrawal. The study hypothesis is that
      repeated injections of long-acting injectable risperidone into the deltoid muscle will be
      safe and well tolerated as assessed by the percent of patients who discontinue after at least
      2 injections. Safety was assessed using adverse events (including occurrence of
      extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical
      laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital
      signs, physical examinations, electrocardiograms, and injection site evaluation. The patients
      will receive 4 injections with long-acting injectable risperidone (37.5 or 50 mg)
      administered as 1 injection every 2 weeks into the deltoid muscle.
    

Intervention name(s): Risperidone long-acting injectable
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; Risperidone; Long acting injectable; Intradeltoidal injection
Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre, open label, phase 2, randomised controlled trial of patients with
      advanced triple negative breast cancer (TNBC) who have received no more than one line of
      chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be
      treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by
      atezolizumab.
    


Intervention name(s): SABR; Atezolizumab
Intervention type(s): Radiation; Drug
Intervention description(s): Single Dose Group: this group will receive 20 Gy of radiation in a single dose within 10 days of randomisation Fractionated Dose: Participants in this dose will receive a total of 24Gy of radiation given as 3 separate fractions of 8 Gy each.; All participants will commence atezolizumab (within 5 days of last SABR dose) 1200 mg every 3 weeks for 24 months
Intervention MeSH terms: Atezolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with triple negative breast cancer will be randomised to receive either SABR 20Gy in one fraction or 24 Gy in 3 fractions , they will then go onto receive atezolizumab for up to 24 months
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
Condition: Organ Transplant Rejection; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile
      of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of
      0.1 mg/kg by subcutaneous (SC) injection in healthy subjects.
    

Detailed description: 
      This is a first-in-human study to assess the safety and pharmacokinetic (PK) profile of
      sustained-release (SR) tacrolimus, which will be administered as a single dose of 0.1 mg/kg
      by subcutaneous (SC) injection in healthy subjects.

      The short-term general investigational plan is to evaluate sustained release tacrolimus in
      healthy volunteers for up to 30 days in an exploratory trial to determine safety and drug
      concentrations in blood. The results from this study will inform the long-term goal of this
      program, which is to provide an improved treatment modality for prophylaxis of organ (kidney,
      liver and heart) transplant rejection with the additional benefit of enhancing medication
      compliance. These improvements have the potential to mitigate both the personal and economic
      burden of this disease.
    

Intervention name(s): Sustained Release Injectable Tacrolimus
Intervention type(s): Drug
Intervention description(s): Long-acting formulation of tacrolimus developed using Auritec's proprietary Plexis drug delivery technology.
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Immunosuppressant; Sustained-release; Plexis
Psychedelics and Wellness Study (PAWS)
Condition: Depression, Anxiety, PTSD
MeSH terms: Depression
Study type: Observational

Summary: 
      The Psychedelics and Wellness Study (PAWS), is an anonymous online survey investigating the
      interrelationship between psychedelics and wellness. The study population is adults ages 18
      and older that have taken a psychedelic at least once. The maximum sample size is 5,000
      survey respondents. It is expected that this anonymous online survey will support the
      hypothesis that there is a robust interrelationship between past psychedelic use and its
      impact on wellness.
    

Detailed description: 
      Following a four-decade moratorium, the therapeutic use of psychedelics has once more
      captured the collective attention of the medical community and the public at large. Now, at
      the forefront of a renaissance in psychedelic research, this study is investigating the
      interrelationship of psychedelics and mental wellness - a state of well-being in which the
      individual realizes his or her own abilities, can cope with the normal stresses of life, can
      work productively and fruitfully, and is able to make a contribution to his or her community.
      This work will be unique in that it will collect both objective and subjective data to assess
      the interrelationship between psychedelic and wellness. It will lend support to the growing
      body of research in the use of psychedelics for both mental health conditions and the pursuit
      of overall mental wellness.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults ages 18 and older that have taken a psychedelic at least once.
      
Keywords: Psychedelics, Wellness
The Effect of Avocado Consumption on Vascular Health
Condition: Focus: Avocado Consumption & Vascular Health
Study type: Interventional

Summary: 
      The study will investigate the effect of avocado consumption on markers of vascular health.
      Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be
      utilized. Participants will either receive a typical American diet, or a modified typical
      American diet in which avocado is substituted for foods that contain moderate and high
      amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
    


Intervention name(s): Diet Treatment
Intervention type(s): Other
Intervention description(s): Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility. Participants will be instructed to eat all foods and only foods provided to them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
GutMe!: IBS and Collagen Protein Powder an Interventional Study
Condition: Irritable Bowel Syndrome; Irritable Bowel; Irrit
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      In this study we would like to understand how or if a food-based supplement affects gut
      symptoms such as bloating, stomach cramps and irregular bowel habits. Through using a digital
      symptom tracking app for a few weeks, you may just learn more about exactly what is
      triggering your symptoms!
    


Intervention name(s): Collagen Protien Powder
Intervention type(s): Dietary Supplement
Intervention description(s): Collegen Protein Powser
Intervention model: Single Group Assignment
Intervention model description: Single arm interventional study.
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Condition: Pneumococcal Disease; 13-valent Pneumococcal Vaccine
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal
      conjugate vaccine in Alaskan Native Children.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose); 3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose); 2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose); 2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart ); 1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: 13 valent Pneumococcal Conjugate Vaccine; Antibody Response; safety; Alaskan Native Children
Progression of Active Microcavitated Carious Lesions on Primary Molar Occlusal Surfaces
Condition: Dental Caries in Children; Pit and Fissure Sealant; Toothbrushing
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Objective: To verify the progression of active microcavitated carious lesions on occlusal
      surfaces of primary molars after the orientation of the brushing technique associated with
      fluoride dentifrice compared to resin sealant, through a 12-month randomized clinical trial.
      Methodology: We selected 22 children from 4 to 9 years old from the public school system of
      the city of Juazeiro do Norte-Ceará, with at least one primary molar presenting an active
      caries lesion score 3 of the International Caries Detection and Assessment System (ICDAS).
      Randomization was performed en bloc and stratified by two conditions (age and caries
      experience). The selected teeth were divided into two groups: the first (G1) was submitted to
      brushing with fluoridated toothpaste; and the other group (G2) to the resin sealing
      technique, whose application of the material was performed under absolute or relative
      isolation, selected through a second randomization. The molars undergoing treatment were
      evaluated at 6- and 12-month returns. Caries progression was evaluated according to the type
      of treatment, dental group and sealant retention by the Chi-square test. For cost analysis,
      the variance test (ANOVA) was used.
    


Intervention name(s): 1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).
Intervention type(s): Procedure
Intervention description(s): After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil).
The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pit and fissure sealants; Pediatric dentistry; Toothbrushing
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo as induction therapy in participants with moderately and severely active Crohn's
      disease (CD).
    


Intervention name(s): Matching Placebo for Upadacitinib; Upadacitinib
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo tablets; Upadacitinib tablets
Other intervention name(s): ABT-494; RINVOQ®
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upadacitinib; Crohn's Disease; Efficacy; Safety
Computerised Intervention/Treatment for Adolescent Depression and Low Mood:
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study forms the second phase of previous work to examine the effectiveness of
      computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low
      mood/depression.

      Depression affects around 2% of adolescents. Antidepressants are not recommended for this age
      range as a first line treatment because of concerns about their usefulness and side effects.
      Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is
      effective and one of the main treatments recommended for depression. It has been suggested
      that computerised versions of CBT (cCBT) may be effective for treating depression in young
      people who may prefer this to seeing a therapist face-to-face, but little research exists to
      date to support this. This study examines the feasibility of running a large scale randomised
      controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help
      websites for adolescents with low mood and depression (LMD).

      Eligible and consenting participants will complete several questionnaires to assess their
      mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to
      selected websites providing self help for LMD. Participants will complete further mood
      questionnaires 4 and 12 months after treatment completion/withdrawal. We have already
      recruited 97 individuals to this trial but aim to recruit a further 48 participants to
      collect further information.

      We are also keen to find out whether sending participants text messages before sessions and
      around follow up periods will increase attendance/completion. Therefore all trial
      participants will receive text messages from the research team during their participation.
    


Intervention name(s): Stressbusters; Websites
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cCBT; Self help websites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Computerised Cognitive Behaviour Therapy; Adolescents; Depression; Low Mood
Ranibizumab in Patients With Branch Retinal Vein Occlusion
Condition: Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional
Phase: Phase 4

Summary: 
      In a recent study we could show that the early retinal venous vasoconstriction after grid
      photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual
      outcome after three months. This could be of clinical importance, because the degree of
      vasoconstriction might be an early marker of treatment success, compatible with the idea that
      hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of
      retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is
      done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF
      treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a
      vasoconstrictor response in retinal vessel in patients with BRVO is tested.
    

Detailed description: 
      To investigate the response of retinal vessel diameters to lucentis treatment in patients
      with BRVO and to correlate these changes with changes in functional outcome after 3 months.

      Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO

      30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous
      administration of Ranibizumab (Lucentis ™)

      Main outcome measure: Retinal vessel diameters

      Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity,
      macular sensitivity assessed with Microperimetry, objective functional response assessed with
      mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a
      Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of
      Vienna), angiographical outcomes.
    

Intervention name(s): Lucentis
Intervention type(s): Drug
Intervention description(s): intravitreally administration of 0.05 ml Lucentis
Other intervention name(s): RANIBIZUMAB (Lucentis 0.05 ml, Novartis)
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lucentis, macular edema, branch retinal vein occlusion
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Condition: Growth Disorder
MeSH terms: Dwarfism; Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      After approval of amendment (g), patients who were still receiving study drug at the time
      were scheduled for a study visit. In addition, patients who had discontinued early from the
      core, blinded phase of the study were contacted.

      All of these patients were offered the opportunity to enter the unblinded extension phase (if
      they met eligibility criteria) and continue somatropin treatment (regardless of initial
      treatment randomization) until they reached final height.
    


Intervention name(s): somatropin, rDNA origin, for injection
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
Condition: Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective was to study whether normal growth velocity can be maintained with adapted GH
      dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled
      catch up growth (=difference to target height reached, less than - 0.6 SDS).
    

Detailed description: 
      The aim of the trial is to study the effect of adapted GH treatment in order to find an
      individualized GH dose maintaining normal growth velocity close to target height SDS and
      normal metabolism after fulfilled catch up growth in prepubertal children treated with
      individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the
      individual the lowest effective GH dose during maintenance period, maintaining normal growth
      velocity and metabolism, i.e. a satisfactory biological active dose.
    

Intervention name(s): Genotropin
Intervention type(s): Drug
Intervention description(s): Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment; growth hormone; childhood; short stature