bioihbjkbjnl/mcl2 huggingface dataset:
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
Condition: Autism
MeSH terms: Heavy Metal Poisoning; Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Many children with autism have a reduced level of glutathione and a reduced ability to
      excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair,
      provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an
      FDA-approved medication for treating lead poisoning in children, is effective in increasing
      excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize
      that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic
      symptoms in some children with autism.
    

Detailed description: 
      This study will assess the safety and efficacy of the use of DMSA (an FDA-approved medication
      for treating lead poisoning in children) for the off-label treatment of symptoms of autism in
      children with autism and significant body burden of toxic metals.
    

Intervention name(s): DMSA - dimercaptosuccinic acid
Intervention type(s): Drug
Intervention description(s): dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Other intervention name(s): Succimer
Intervention MeSH terms: Succimer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: autism; toxic metals; DMSA; dimercaptosuccinic acid; chelation
Radiation Dose in Humans From Orally Administered Tc99m-Heparin
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a research study of a new agent used for evaluation of inflammation in the GI tract.
      This agent is investigational and thus is being studied to determine appropriate dosing and
      administration in both normal controls (i.e. people without gastrointestinal complaints) and
      patients with eosinophilic disease (i.e. those with an immune reaction and inflammation in
      their bodies with a certain cell called an eosinophil).

      The study will test whether the radiolabeled agent will bind to the inflammation of
      eosinophilic esophagitis patients because an animal model of eosinophilic esophagitis which
      shows the striking deposition of eosinophil granule proteins is not available.
    


Intervention name(s): Computerized Tomography scan; Single Photon Emission Computed Tomography scans; Technetium Tc 99M; Planar Images; Esophagogastroduodenoscopy
Intervention type(s): Radiation; Radiation; Drug; Radiation; Procedure
Intervention description(s): imaging scan from a person's eyes to their thighs; imaging scan taken during, and after, the administration of the radioactive agent; subjects are administered radioactive heparin as part of study participation.; 2 dimensional imaging - whole body planar scans; esophagogastroduodenoscopy with tissue biopsies
Other intervention name(s): CT scan; SPECT scans; Radioactive Heparin
Intervention MeSH terms: Heparin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: dose assessment of orally administration of Tc99m-Heparin in healthy control and Eosinophilic Esophagitis patients
Masking: None (Open Label)
Primary purpose: Basic Science
Psychological Profile of Dental Patients
Condition: Indication for Modification of Patient Psychological Status
Study type: Observational

Summary: 
      The objective of this descriptive investigation was to evaluate the psychological profile of
      dental patients in three levels: global level, the dimensional level, and the discrete
      symptom level and to compare it with a control group.
    

Detailed description: 
      Many people is afraid of dental treatment specially local anesthesia and do not refer to
      dental clinics until they are obliged due to dental pain. There are so many articles in the
      literature about dental phobia and fear of anesthetic injection. Due to these evidences,
      dental people are supposed to show elevated psychological dimensions such as anxiety, and
      somatization.

      We are going to know which psychological dimensions of dental patients may be elevated when
      they refer to dental clinics.
    

Intervention name(s): Psychological Measurement
Intervention type(s): Other
Intervention description(s): Measurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale
Other intervention name(s): psychological assessment of the subjects
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients who referred to a dental office in Isfahan city, Iran. The chief complaints of
        them were not the same.
      
Keywords: Dental patients; Psychological Profile
Triple-arm pH Comparison
Condition: In Vitro Fertilisation Outcome
Study type: Interventional

Summary: 
      The culturing human embryo in vitro is a process of myriad contributing elements. From these
      factors is the pH of embryo culture media, which is crucial for embryo development. The
      investigators plan to examine three different pH values of the culture media on the live
      birth rate of in vitro cultured human embryos.
    

Detailed description: 
      In vitro fertilisation laboratory is the black box in which early human embryo development of
      infertile couple occurs. This laboratory holds many variables such as incubator type, air
      quality, brands of culture media, culture temperature and the pH of culture medium. Despite
      the importance of the culture medium pH, there is no single RCT has examined its effect on
      live birth rate post in vitro fertilisation. The investigators of this study believe that
      leaving this crucial element to the wishes of large companies and media designers is unwise.
      This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro
      cultured human embryos.
    

Intervention name(s): Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6; Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6; Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
Intervention type(s): Other; Other; Other
Intervention description(s): Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.; Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.; Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: pH; IVF; live birth rate
Pediatric Distal Radius US Study
Condition: Distal Radius Fractures
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic
      musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting.
      Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound
      will be compared to x-ray diagnosis under routine conditions in the investigator's injury and
      fracture treatment evening clinic. Data will be collected and recorded during the duration of
      the 12 week study. Through the literature review and experience with ultrasound, the
      investigators anticipate that diagnostic ultrasound will provide very high sensitivity and
      specificity in diagnosing distal radius fractures in children.
    


Intervention name(s): Diagnostic Ultrasound; X-ray imaging
Intervention type(s): Device; Radiation
Other intervention name(s): Sonosite Ultrasound
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with wrist injury
      
Keywords: Diagnostic ultrasound
Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The overarching question addressed in the current project is: Does dietary nitrate
      supplementation (8 weeks) improve physiological function in patients with peripheral arterial
      disease (PAD)? The investigators will specifically address whether dietary nitrate
      supplementation enhances blood vessel function, blood pressure regulation, and exercise
      capacity. The proposed project uses an array of clearly defined measurements which will allow
      investigators to quantify blood vessel function (vasodilator responsiveness and arterial
      stiffness), blood pressure (variability and responsiveness to stress), and functional
      capacity before and after 8 weeks of dietary supplementation.
    


Intervention name(s): Sodium Nitrate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Sodium Nitrate (1g/day) for 8 weeks; Microcrystalline cellulose (daily) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nitrates; blood flow; vascular function; exercise
Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of consuming various lentil varieties in
      mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and
      insulin as compared to white rice or white potato alone.
    

Detailed description: 
      Eligible participants will undergo a total of 6 study visits. During each visit, a fasted
      blood sample will be taken by fingerprick, and approximately 500µL of blood will be dripped
      into a collection tube. The participant will then consume a meal of either: white bread,
      white rice (or white potato), or white rice with lentils (or white potato with lentils).
      White bread will be consumed on the first study visit and the rest of the meals will take
      place in random order in the visits following. Each meal will provide a total of 50g
      available carbohydrate. Six more blood samples will be taken by fingerprick at 15, 30, 45,
      60, 90 and 120 minutes after the beginning of the meal.
    

Intervention name(s): Various lentil varieties (varying in slow digested starch content)
Intervention type(s): Other
Intervention description(s): Randomized, cross-over block design.
Comparison of glycemic and insulinemic responses following meals composed of:
white rice or white rice combined with 1 of 3 different lentil varieties or
white potato or white potato combined with 1 of 3 different lentil varieties
Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.
Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Lentils; Post-prandial; Glycemic response; Insulin response; Diabetes; Mixed meal; Glycemia; Slowly digestible starch; Post-prandial glycemia
Assessment of the Biodistribution and Safety of [18F]MNI-968 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1
      receptor targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-968 as a D1
      receptor targeted radiopharmaceutical. The specific objectives are:

        -  To determine the radiation dosimetry of [18F]MNI-968

        -  To assess the safety and tolerability of a single dose of [18F]MNI-968
    

Intervention name(s): [18F]MNI-968
Intervention type(s): Drug
Intervention description(s): Healthy volunteers recruited for the study will undergo a single [18F]MNI-968 injections and PET scans.
Other intervention name(s): PF-06730110
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
Condition: Pain; Anxiety
Study type: Observational

Summary: 
      The study is looking at whether wearing a virtual reality device will help reduce pain and
      anxiety during minor procedures
    

Detailed description: 
      Patients who are undergoing minor plastic surgery procedures will be assigned to either wear
      a virtual reality device or to listen to music of their choice. Patients will still get the
      standard lidocaine/novocaine numbing agent. Patients will be asked questions about their
      anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of
      anxiety and pain.
    

Intervention name(s): Virtual reality; Music
Intervention type(s): Other; Other
Intervention description(s): A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.; Music of the patient's choice will be played
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for minor elective plastic surgery procedure
DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
Condition: Nasolabial Fold Wrinkles
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being undertaken to:

        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic
           acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment
           of dermal nasolabial fold wrinkles at 13 months following the last application of study
           treatment.

        -  Document the types and incidence of adverse events reported with DL6049 (injectable
           poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events
           will be assessed for an additional 12 months following discharge from the main study in
           subjects treated with DL6049.
    


Intervention name(s): DL6049 (injectable poly-L-lactic acid)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and
      treatment compared to conventional standard care in patients with OA of the knee.
    


Intervention name(s): Complex Ayurvedic Treatment; Conventional Care
Intervention type(s): Other; Other
Intervention description(s): In the Āyurveda group treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.; Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis, Osteoarthrosis, Arthritis, Arthrosis
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Condition: Graft Rejection
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection
      that can happen after heart transplantation.

      It is usually used in combination with other immunosuppressive drugs such as cyclosporine.
      The purpose of this study is to evaluate the change in kidney function after beginning
      everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with
      everolimus, in adult cardiac transplant patients who have had their transplanted heart for at
      least 1 year and who have cardiac allograft vasculopathy.
    


Intervention name(s): everolimus
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: transplant, heart, adult, everolimus; allograft rejection
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, multi-center, parallel-group study designed to compare
      the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle
      systems to placebo.
    

Detailed description: 
      This is a randomized, double-blind, multi-center, parallel group study designed to compare
      the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle
      systems to placebo. Subjects who have consented and meet the entry criteria will be
      randomized to one of four blinded treatment groups. There will be a screening period of up to
      1 week, followed by a run-in period to record migraine activity. The run-in period is to
      determine eligibility for randomization, and is planned to be 4 weeks in duration but may be
      extended up to an additional 4 weeks to accommodate scheduling. Qualified subjects will
      randomize to the double-blind treatment period at Day 0 and will have up to 8 weeks to
      confirm and treat a qualifying migraine. Using the eDiary to confirm they are experiencing a
      qualified migraine, subjects will self-administer the patch or patches and continue to
      respond to questions in the eDiary for 48 hours post treatment administration.
    

Intervention name(s): ZP-Zolmitriptan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system; Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: migraine; migraine headache; acute migraine; acute migraine headache
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral
      dose of [14C]TVB-2640 healthy male subjects.
    


Intervention name(s): [14C]-TVB-2640
Intervention type(s): Drug
Intervention description(s): 50 mg of TVB-2640 oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Absorption; Metabolism; Excretion; Radiolabeled Dose; Mass Balance [14C]
Comparison of Cathelicidin Expression in Skin and Saliva in Patients With Atopic Dermatitis and Psoriasis
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Observational

Summary: 
      Cathelicidins are small proteins in the human body that protect against infection. The
      purpose of this study is to determine if the amount of cathelicidins and other small proteins
      found in saliva can predict the amount of these in the skin of people who have acute atopic
      dermatitis (AD) or psoriasis.
    

Detailed description: 
      People with AD or psoriasis are very sensitive to skin infections and inflammations. A group
      of small proteins known as cathelicidins are known to be responsible for immune defense
      against such infections. People with AD or psoriasis seem to be missing these proteins from
      their skin. The purpose of this study is to determine if the amount of cathelicidins and
      other small proteins in saliva is a predictor for the amount found in the skin.

      This is a single visit observational study. People with AD or psoriasis, as well as healthy
      participants, are being recruited for this study. Participants will provide a detailed
      medical history and undergo a physical examination. In addition, saliva and blood collection,
      and skin punch biopsies will be performed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Generally healthy individuals
      
Biospecimen description: 
      Blood, skin, and saliva samples will be retained
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Condition: Norovirus Infection
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      There is a need for safe, highly infectious Norovirus inocula for use in Norovirus
      vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune
      response among vaccinated and unvaccinated subjects. The purpose of this study is to generate
      the infection and illness rate and immune response data necessary for the conduct of future
      investigation of Norovirus vaccine studies.
    


Intervention name(s): Norwalk GI.1 Virus
Intervention type(s): Biological
Intervention description(s): Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Masking: None (Open Label)
Primary purpose: Other