bioihbjkbjnl/mcl2 huggingface dataset:
Retinol on Human Skin Aging in East Asian Descent
Condition: Intrinsic Aging of Skin
Study type: Interventional
Phase: Phase 4

Summary: 
      There has been increasing evidence for different rates of natural aging in humans and one of
      the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of
      topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or
      vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,
      studies of retinol in humans have largely occurred in white populations and so this study
      aims to focus on skin aging in individuals of East Asian descent as they represent a majority
      of the world population. This study aims to better characterize the molecular basis of
      rejuvenation effects and to potentially discover new topical agents with similar and/or more
      effective preservation of skin youthfulness.
    


Intervention name(s): Retinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Retinol in the form of vitamin A lotion; Placebo of Retinol
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo
      (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and
      such data is important for clinicians to have.
    

Detailed description: 
      The primary objective of this study is to determine the equivalence of generic clozapine
      tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are already
      taking generic clozapine and are switched to FazaClo.

      In this study, patients receiving a stable twice-daily dose of generic clozapine formulation
      for the past one month will be switched to FazaClo. A trough steady-state clozapine and
      desmethylclozapine concentrations will be taken thrice while patient is on generic Clozapine.
      After the third clozapine level patients will be switched from their generic clozapine
      formulation to FazaClo, at the same dosage and treatment regimen as the generic clozapine
      formulation they had been receiving. Trough steady-state clozapine and desmethylclozapine
      concentration levels will be taken twice, 7 days and 14 days after starting Fazaclo.
    

Intervention name(s): Fazaclo
Intervention type(s): Drug
Intervention description(s): single-arm
Other intervention name(s): Fazaclo clozapine
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Schizophrenia; Schizoaffective Disorder; Orally dissolving clozapine; orally disintegrating clozapine; bio-equivalence; desmethylclozapine; clozapine plasma level; equivalence; fazaclo; generic clozapine
Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      To investigate the effect of CoDuSe balance training and step square exercises on the risk of
      falls in multiple sclerosis. BACKGROUND: risk of fall & balance disabilities are considered
      serious problems in multiple sclerosis which results in loss of balance & physical
      inactivity.

      ………HYPOTHESES:

      This study hypothesized that:

      CoDuSe balance training and step square exercises will have a significant effect on the risk
      of falling in multiple sclerosis

      RESEARCH QUESTION:

      Is there an effect of CoDuSe balance training and step square exercises on risk of fall in
      multiple sclerosis?
    

Detailed description: 
      Fifty-two patients with multiple sclerosis will participate in this study.

      The patients will randomly be divided into two equal groups; the control group which received
      the conventional selected exercise program and the study group received the same exercise
      training program in addition to CoDuSe balance training and step square exercises, three
      times per week for four weeks.

      The Evaluation will done pre and post interventions included:

      Biodex balance system (Risk falling), Short Physical Performance Battery (SPPB) & Morse Fall
      Scale.
    

Intervention name(s): CoDuSe balance training and step square exercises; conventional balance training
Intervention type(s): Other; Other
Intervention description(s): The standardized intervention targeted visual, somatosensory, and vestibular aspects of balance and will be included with balance exercises
Examples of core stability exercises as follows: in supine position with knees bent, slowly slide one heel forward to straighten leg; and, in four-point kneeling position, slide one foot in a straight line away from the body and lift the leg off the floor.
Examples of dual-task exercises as walking while turning one's head and juggling a balloon.
Examples of sensory strategies as standing and walking on uneven surfaces and standing with eyes closed.; static and dynamic balance training exercises from sitting, standing and ambulation activities
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group which received conventional selected exercise program in form of static and dynamic balance training exercises and study group received the same exercise training program in addition to CoDuSe balance training and step square exercises, three times per week for four weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CoDuSe; balance; step square exercises; risk of fall; Multiple Sclerosis
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
Condition: Metastatic Tumors
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the clinical safety and efficacies of
      cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed
      solid tumors including GI/lung/cervical cancers
    

Detailed description: 
      KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression
      profile analysis by the use of cDNA microarray in the previous studies. The investigators
      have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1,
      TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated
      with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore,
      when vaccinated these peptides, specific CTLs were determined after the vaccination.
      Therefore the investigators focused on the prevention of further expansion of the solid
      tumors highly expressing these 5 proteins using these 5 peptides.
    

Intervention name(s): 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
Intervention type(s): Biological
Intervention description(s): 1mg each of 5 peptides with IFA. 4 weekly s.c. administration.
Other intervention name(s): 5 peptide cocktail
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epitope peptide; cyclophosphamide; interleukin-2
Blood and Muscle Response to Cheddar Cheese in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this project is to use a cross over design in young healthy male and female
      adults:

        1. To determine the amino acid blood response to the acute ingestion of cheddar cheese in
           comparison to that of milk.

        2. To determine the muscle mTORC1 response to the acute ingestion of cheddar cheese in
           comparison to that of milk.
    

Detailed description: 
      Each subject will take part in two metabolic studies. Each metabolic study was designed to
      test the acute blood and muscle response to an ingested amount of either cheddar cheese or
      milk. Approximately, one month after the first experiment (Metabolic Study #1), the
      participant will complete the second experiment (Metabolic Study #2) which was exact in
      design and at the same time of day as the first study but the participant ingested the
      alternate food product. The morning of the metabolic studies, the participant will arrive at
      the clinical research center after a 10h fast. A catheter will be placed in the participants'
      arm for blood sampling. Next, the participant will undergo a fasted thigh skeletal muscle
      biopsy. Following the muscle biopsy, the participant will consume either cheddar cheese (65g)
      or milk (370 mL) each amounting to 20g of protein. Subsequent muscle biopsies will occur at
      60 and 180min after product ingestion. Blood sampling will occur in the fasted state and
      periodically after ingestion of the products (up to 300min).
    

Intervention name(s): Cheddar Cheese; Milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20g of protein from cheddar cheese; 20g of protein from milk
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants take part in an experiment in which they consume cheese then at another time consume milk
Masking: None (Open Label)
Primary purpose: Basic Science
ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      Mood disorders, including depression and anxiety, are one of the main causes of the overall
      disease burden worldwide.

      In recent years, the efficacy of certain botanicals as an alternative solution for depression
      has been evaluated in a number of clinical trials.

      However, only few studies looked at the effects of these botanicals on mood in healthy
      subjects.

      The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups
      methodology is to assess the acute and chronic effects of daily supplementation with a
      proprietary and standardized botanical extract in comparison to placebo in healthy adults
      aged 18-60 years with self-reported low mood.
    

Detailed description: 
      The chronic effect of the active product on mood, anxiety, perceived stress, quality of life
      and cortisol secretion & metabolism will be assessed through validated questionnaires and
      urine collection after 2, 4 and 8 weeks of daily supplementation.

      The acute effect of the product will be assessed after a single dose and exposure to an acute
      psychological stressor. Before, during and after the stressor, saliva samples will be
      collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic
      Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.
    

Intervention name(s): Proprietary, standardized botanical extract; Placebo (maltodextrin)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules/ day providing the proprietary botanical extract as unique active ingredient; 2 capsules/ day providing no active component
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Mood; Anxiety; Stress; Dietary supplement; Botanical
Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda
Condition: Child Development
Study type: Interventional

Summary: 
      Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community
      based lay workers.
    

Detailed description: 
      The Family Strengthening Intervention for early childhood development was created and piloted
      for feasibility and acceptability in an ongoing protocol #15440 with Harvard Internal Review
      Board titled, "Developing and Piloting a Quantitative Behavioral Assessment Battery,
      Estimating Prevalence of Mental Disability among HIV/AIDS-affected Youth, and Piloting an
      Adapted Mental Health Intervention for HIV/AIDS-Affected Children in Rwanda." Research
      personnel have been adapting the existing recruitment materials/sessions and 15 Module Manual
      (FSI-ECD) with a focus on making the manual and corresponding materials more user friendly
      for community based lay worker "coaches."

      This preliminary testing will provide an opportunity to administer a planned full scale
      1,000+ household cluster randomized control trial on a smaller scale in order to learn from
      our materials that have been adapted for community based lay workers. This will also allow us
      to test our supervision and training structures to make necessary adaptation ahead of the
      planned full scale trial.

      After all beneficiary households have completed the FSI-ECD intervention, each community
      based lay worker will complete a qualitative and quantitative exit assessment of his/her
      experience delivering the intervention, as well as ongoing feedback during the administration
      of FSI-ECD; allowing for the intervention and support structure to be strengthened for future
      iterations.
    

Intervention name(s): FSI ECD
Intervention type(s): Other
Intervention description(s): Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.
Other intervention name(s): Family Strengthening Intervention for ECD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Development; Home Visiting; Parenting Program; Social Protection; Public Works
Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether 48 weeks treatment with once-daily
      injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and
      related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough
      to warrant further investigation.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is responsible for an increasing prevalence of
      liver disease and is becoming the commonest cause of liver disease in the western world.
      NAFLD is recognised to be the hepatic manifestation of the metabolic syndrome, which is a
      cluster of metabolic abnormalities characterised by abdominal obesity, insulin resistance,
      impaired glucose metabolism, hypertension and dyslipidaemia. In its mildest form there is an
      accumulation of fat in the liver (steatosis) without any liver damage, however in many cases
      it progresses to non-alcoholic steatohepatitis (NASH), and cirrhosis.

      Current treatment options for NASH are limited in efficacy, necessitating the development of
      more effective options. New agents such as Glucagon-like Peptide-1 (GLP-1) agonists that
      improve diabetic control and facilitate weight loss have been suggested as therapies in NASH.

      No published studies to date have assessed the impact of the GLP-1 agonist, Liraglutide, on
      liver histology and metabolism in obese patients with NASH. This study hypothesises that
      treatment with liraglutide will result in a significant improvement in histological disease
      activity in overweight patients with NASH, in the presence or absence of Type 2 Diabetes
      (T2DM)
    

Intervention name(s): Liraglutide; Liraglutide-placebo
Intervention type(s): Drug; Other
Intervention description(s): 1.8 mg once daily, subcutaneous injection; 1.8 mg once-daily, subcutaneous injection
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15
      milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.
    


Intervention name(s): Tavapadon
Intervention type(s): Drug
Intervention description(s): Oral tablets
Other intervention name(s): CVL-751; PF-06649751
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinsonian Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Dopamine Agonist; Dopamine Therapy
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world
      and it´s expected to become the 3rd cause of death in 2020 and the majority cause of
      morbidity. Besides that, in Portugal COPD patients become more dependents each day.

      Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM)
      diagnose that will allowed to identify the acupoints.

      The investigators are interested in to assess acupuncture efficacy on physical exercise
      tolerance in COPD patients.An experimental, controlled, randomized, double blind study was
      done. Patients were recruited according TCM diagnose to optimize potential therapeutic
      effects.
    


Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture.
The method used to randomized was flipping a coin, when got heads they went to verum group and when got tails they went to sham group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial
Condition: Endodontic Treatment of Primary Teeth
Study type: Interventional
Phase: Phase 3

Summary: 
      The maintenance of primary teeth until their exfoliation has been one of the main purposes of
      Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the
      permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous
      teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to
      conduct a randomized clinical trial with longitudinal follow-up of two years, double blind,
      to compare the degree of success of endodontic treatment in primary among the most used
      folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.
    

Detailed description: 
      After approval by the ethics committee of the patients Faculty of Dentistry, University of
      São Paulo that having root canal filling of primary teeth will be invited to participate in
      the study. A clinical examination and prior radiographic diagnosis and also a quality of life
      questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will
      be-held. The patient will be randomized to one of two groups and will be held endodontics by
      a blind handler. The patient will be accompanied with periods of one week, six months, 12
      months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS
      questionnaire will be reapplied to those responsible. The outcome will be the success or
      failure of endodontic treatments evaluated through permanent tooth in the arch on clinical
      and radiographic conditions of normality. The longevity of the treatments will be evaluated
      by estimating survival rates by Kaplan-Meier. The differences between the survival rates
      according to the type of proposed endodontic treatment will be analyzed using the log-rank
      test with a minimum significance level of 5%.
    

Intervention name(s): Endodontic treatment using Vitapex; Endodontic treatment using Guedes Pinto
Intervention type(s): Drug; Drug
Intervention description(s): Endodontic treatment using Vitapex; Endodontic treatment using Guedes Pinto paste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Endodontics; Deciduous teeth; Iodoform pastes; Treatment Refusal
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with
      generalized pustular psoriasis (GPP).
    

Detailed description: 
      This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore
      the immunogenicity of imsidolimab in subjects with GPP.
    

Intervention name(s): Imsidolimab high dose; Imsidolimab low dose; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): intravenous; intravenous; intravenous
Other intervention name(s): ANB019; ANB019
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IL-36 Receptor; Interleukin 36; Imsidolimab