bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
Condition: Photoaging; Wrinkle
Study type: Interventional

Summary: 
      This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted
      to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall
      photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a
      placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study
      participation.
    

Detailed description: 
      This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted
      to assess the efficacy and tolerance of an anti-aging daily serum (Cell 1) to improve
      moderate overall photodamage and skin fatigue of aging skin after 12-weeks days of
      twice-daily use when compared to the efficacy of a combination of a placebo-control (Cell 2).
      Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a dull
      appearance on the global face.

      Efficacy and tolerability were assessed through clinical grading at baseline, week 4, week 8,
      and week 12. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall
      eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance,
      and overall photodamage on the global face were performed at baseline and post-baseline by a
      clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at
      baseline and week 12 were performed by two board certified dermatologists.

      Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography
      were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects,
      a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies
      collected from the lateral, pre-auricular at baseline and week 12.

      A total of 62 subjects completed study participation (31 in Cell 1 and 31 in Cell 2).
    

Intervention name(s): Cleansing Lotion; Facial Moisturizer; Sunscreen SPF 40+
Intervention type(s): Other; Other; Other
Intervention description(s): Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).; Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.; Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.
Per FDA this intervention is an Over the counter
Other intervention name(s): Revision Skincare® Cleansing Lotion; Goodier Cosmetics Facial Moisturizer; Aveeno Positively Mineral Sensitive Skin SPF 40+)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled, single-center
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: anti-aging; daily serum
Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The
      purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at
      the dose exposures required for a clinical efficacy study in healthy adult participants.
      Participants will breathe a gas mixture that contains a low concentration of hydrogen gas in
      air through a high flow nasal cannula. Investigators will test for any changes in breathing
      and neurologic status, as well as lab tests during and following the exposure period.
    

Detailed description: 
      Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic
      organs. Clinical trials abroad have shown promise that treatment of patients suffering from
      stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the
      early recovery period.

      The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas
      at the dose exposures required for a clinical efficacy study in healthy adult volunteers.

      Study design. Eight (8) healthy adult participants will be recruited from the greater Boston
      area for this study. Consenting participants will be admitted to the hospital and will
      undergo a series of screens (questionnaires, examination, tests) to ensure suitability to
      participate. Eligible and consenting participants will then undergo exposure to 2.4% H2 in
      medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours.
      Participants will be screened for adverse effects as follows: vital signs every 8 hours,
      nursing assessment of symptoms (codified based on the National Cancer Institute's Common
      Terminology Criteria for Adverse Events, CTCAE) every 8 hours, bedside spirometry daily,
      mini-mental state exam daily, physician physical exam daily, and serum testing (blood count,
      chemistry, liver and coagulation profile, venous blood gas) following exposure period.
    

Intervention name(s): Hydrogen
Intervention type(s): Drug
Intervention description(s): Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Metabolic Evaluation of Nutrition in Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Observational

Summary: 
      Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good
      appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The
      pathological mechanism is barely understood. Although feeding difficulties may play a part in
      this, other constitutional factors as altered metabolic processes are suspected. Irregular
      breathing is a common clinical feature, reflecting the immaturity of the brainstem in RTT.
      The primary pathophysiology is a defective control mechanism of carbon dioxide exhalation
      that leads to chronic respiratory alkalosis or acidosis. We assume that chronic respiratory
      acidosis or alkalosis causes derangement of the metabolic equilibrium in RTT females with
      important nutritional consequences.

      The aims of this pilot study are to describe the nutritional status of the RTT girls and to
      examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic
      processes as a possible cause of impaired nutritional status.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of a well-defined group of thirteen Dutch RTT girls with
        complete clinical, molecular and neurophysiological work-up.
      
Biospecimen description: 
      Whole blood, serum, dried blood spot, leukocytes, erythrocytes, urine.
    
Keywords: Rett syndrome.; Nutritional status.; Metabolic alterations.
Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address
      specific underlying sensorimotor issues that may affect children's performance during daily
      routines and occupations. The intervention takes place in the context of play, emphasizes the
      active participation of the child, involves a collaborative relationship between the
      occupational therapist and the child, and focuses on participation-oriented outcomes that are
      collected at regular intervals throughout the intervention program. In general, its content
      is to improve the child's occupational performance.

      The program, which will be carried out in accordance with the Ayres Sensory Integration
      Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with
      autism and the dependence of the child on the caregiver in self-care activities. It is
      predicted that this whole process will increase the participation and his performance of the
      child with autism in his occupations related to his daily life.

      H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the
      child with autism spectrum disorder.
    


Intervention name(s): Ayres Sensory Integration Therapy; Home Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.; These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ayres Sensory Integration; Occupational Performance
RDEA3170 AME Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the characteristics of absorption, metabolism, and excretion (AME)
      of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries
      (µCi) of [14 C]RDEA3170 in healthy adult male subjects.
    


Intervention name(s): RDEA3170 10 mg
Intervention type(s): Drug
Other intervention name(s): RDEA3170 10 mg dose oral solution with 500 μCi of [14C]RDEA3170
Intervention MeSH terms: Verinurad
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Retorna Facial Cream in the Treatment of Facial Wrinkles
Condition: Facial Wrinkles
MeSH terms: Facies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of Retorna facial cream usage in the
      reduction or total correction of facial wrinkles. The duration of this double-blind placebo
      controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be
      recruited and randomized for the study is 148. Occurrence of adverse effects will also be
      evaluated.
    


Intervention name(s): Retorna; Placebo
Intervention type(s): Other; Other
Intervention description(s): Dosage commensurate with surface to be treated, Retorna facial cream (Topical use), twice a day, for 4 weeks.; Dosage commensurate with surface to be treated, Placebo facial cream (Topical use), twice a day, for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Facial cream; natural product; facial wrinkles
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of
      the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary
      objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when
      injected twice with time intervals of 6 or 12 weeks to healthy adults.
    


Intervention name(s): rdESAT-6 + rCFP-10
Intervention type(s): Biological
Intervention description(s): rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: tuberculosis; diagnosis; ESAT-6; CFP-10; skin test; Skin test for the diagnosis of tuberculosis infection
Xolair Enhances Oral Desensitization in Peanut Allergic Patients
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.
    

Detailed description: 
      We hypothesize that pretreatment with anti-IgE mAb will greatly reduce the side effects and
      allergic reactions that occur during oral desensitization to peanut and will enhance the
      development of oral tolerance in patients with severe peanut allergy.

      We will follow the patients for 5 years following study completion.
    

Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): Omalizumab is an antibody that helps decrease allergic responses in the body
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peanut allergy; Xolair
Exploratory Study of ZG-801 for the Treatment of Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of
      ZG-801 for the treatment of hyperkalemia in Japanese patients.

      To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to
      confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.
    


Intervention name(s): patiromer; patiromer; placebo; placebo; patiromer; patiromer; patiromer; patiromer
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1); Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1); Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1); Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1); Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2); Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2); Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3); Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy
      subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to
      consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a
      single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three
      cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK.
      Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single
      cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety,
      tolerability, PK and efficacy.
    


Intervention name(s): GSK1265744
Intervention type(s): Drug
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy volunteer,; HIV infected subjects
Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of
      participants in China.

      Primary objective:

        -  To describe the safety in terms of occurrence of serious adverse reactions and grade 3
           adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given
           as a single dose in 20 adults and 20 children.

      Secondary objective:

        -  To describe the full reactogenicity profile after administration of sanofi pasteur's
           Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
    

Detailed description: 
      Participants will be enrolled sequentially into the study groups to receive one dose of
      ADACEL at Day 0 (Visit 1) and will be followed-up for 28-35 days.
    

Intervention name(s): Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap; Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (IM); 0.5 mL, Intramuscular (IM)
Other intervention name(s): ADACEL™; ADACEL™
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; ADACEL®; Tdap vaccine
Effects of Bright Light Therapy in Mild Traumatic Brain Injury
Condition: Concussion, Mild; Post-Concussion Symptoms; Sleep Problems
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Dyssomnias; Parasomnias; Post-Concussion Syndrome
Study type: Interventional

Summary: 
      Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in
      our society. Patients with post-concussion syndrome have been shown to have deficits on tests
      of short term memory, divided attention, multi-tasking, information processing speed, and
      reaction time, as well as alteration in mood and emotional functioning. Many patients have
      other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and
      chronic headaches. Furthermore, sleep disruption of one of the most common complaints in
      patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with
      mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer
      outcome, while resolution of the sleep disturbance is associated with improvement in
      cognitive functioning.

      Despite recent evidence of the correlation between sleep quality and recovery from traumatic
      brain injury, and the well-established role of sleep in neural plasticity and neurogenesis,
      there have been virtually no direct studies of the causal effects of sleep on recovery
      following mTBI. However, it is quite likely that sleep plays a critical role in recovery
      following brain injury.

      A particularly promising non-pharmacologic approach that shows potential in
      improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright
      light therapy. For the proposed investigation, we hypothesize that bright light therapy may
      be helpful in improving the sleep of patients with a recent history of mTBI and may also have
      other mood elevating effects, both of which should promote positive treatment outcome in
      these individuals. Bright light therapy may increase the likelihood that they will recover
      more quickly, benefit more extensively from other forms of therapy, and build emotional and
      cognitive resilience.
    


Intervention name(s): wavelength-1 bright light; wavelength-2 bright light
Intervention type(s): Device; Device
Intervention description(s): 6 weeks of daily light exposure, 30 minutes per morning; 6 weeks of daily light exposure, 30 minutes per morning
Other intervention name(s): Philips goLITE energy light; Philips goLITE energy light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild traumatic brain injury; Concussion; Sleep problems; brain imaging; functional magnetic resonance imaging (FMRI)
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)
Condition: Behcet's Disease; Panuveitis; Posterior Uveitis; Retinal Vasculitis
MeSH terms: Behcet Syndrome; Uveitis; Panuveitis; Uveitis, Posterior; Retinal Vasculitis; Vasculitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate if interferon-alpha2a is superior to the standard
      treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's
      disease.
    

Detailed description: 
      Behcet's disease is a multisystem vasculitis often involving ocular (retinal) blood vessels
      (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in
      25 to 50% of the patients irrespective of immunosuppressive treatment.

      The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard
      treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal
      vasculitis) Behçet's Disease (BD) and significantly improves visual prognosis and quality of
      health and life of the patients with ocular BD and is acting more rapidly than standard
      treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular
      BD which can be maintained without further medical treatment.

      The patients are randomised into two treatment groups (IFN/CSA) and treated for one year
      according to an algorithm which adapts dosages to clinical course. A crossover from one
      treatment arm to the other is planned in case of inefficacy.
    

Intervention name(s): Cyclosporin A; Interferon-alpha2a
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels; 3-6 million iU per day sc., augmented to up to 9 if necessary, later reduced (according to clinical response) to 3 x 3 million iU /week.
Other intervention name(s): Sandimmun neoral; Roferon
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ocular Behcet's disease; Panuveitis; Posterior Uveitis; Retinal vasculitis; Treatment; Interferon-alpha; Cyclosporin A