bioihbjkbjnl/mcl2 huggingface dataset:
Photosensitization Study in Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata; Photosensitivity Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the potential for induction of photosensitization by P-3074 0.25%
      finasteride cutaneous solution compared to that of placebo vehicle cutaneous solution and a
      negative control (0.9% sodium chloride, NaCl)
    

Detailed description: 
      Healthy male volunteers, drawn from the general population, will be treated with P-3074
      solution, placebo vehicle control and 0.9% sodium chloride USP (negative control) by using 6
      induction applications on the back area and Ultraviolet A (UVA)/Ultraviolet B (UVB)
      irradiations during the 3 week induction period, a 10 day rest period, and a challenge phase
      of a 24-hour patch application, UVA and UVB irradiation followed by evaluation of
      photosensitization over the subsequent 72 hours.
    

Intervention name(s): Finasteride 0.25%; Placebo for Finasteride 0.25%; Negative Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cutaneous solution of finasteride 0.25%; vehicle cutaneous solution of P-3074; 0.9% aqueous NaCl
Other intervention name(s): P-3074; vehicle cutaneous solution; 0.9% aqueous NaCl
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
Condition: MDD; Treatment Resistant Depression; Smoking Cessation; Smoking
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label dosing pilot study of 15 patients aged 18-50 years of age with
      diagnoses of Major Depressive Disorder (MDD) randomized to 1 of 3 treatment arms.

      The study will consist of a screening evaluation performed within the course of 2 weeks,
      followed by an active treatment period of 28 days where treatment arm 1 will take a
      supervised dose of 300mg DXM every 14 days for 28 days, treatment arm 2 will take the FDA
      approved maximum daily ingestion for cough (60mg DXM) daily for 28 days, and treatment arm 3
      will take 1 supervised dose of 300mg DXM and 60mg for the remaining 28 days. After the active
      treatment period, subjects will be followed for 65 days with safety and psychiatric
      assessments at designated timepoints.
    


Intervention name(s): Dextromethorphan
Intervention type(s): Drug
Intervention description(s): Dextromethorphan will be administered and its tolerability evaluated.
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb
Condition: Pre-induction Dilation of Cervix
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Women undergoing mechanical cervical ripening for labor induction will be randomized to
      Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators
      (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
    

Detailed description: 
      Historically, mechanical methods were the first methods developed to ripen the cervix or to
      induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel
      (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade
      collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the
      effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as
      a mechanical dilator for cervical ripening. There are no data comparing this newly approved
      Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method.
      Therefore, The investigators propose a randomized controlled trial to determine the efficacy
      of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in
      pregnant women greater than 37 weeks.
    

Intervention name(s): Dilapan; Foley Catheter
Intervention type(s): Device; Device
Intervention description(s): Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.; Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.
Other intervention name(s): Osmotic cervical dilator; Foley Bulb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Labor; Foley; Dilapan; Cervical Dilators; Induction
Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association Atlas Correction
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the
      spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction
      procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct
      misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the
      treatment of headache, it has not been formally studied using clinical trials. There is some
      data indicating that NUCCA correction can increase intracranial compliance. This intracranial
      compliance can be measured by a magnetic resonance imaging (MRI) study before and then after
      a NUCCA procedure. In this study, the investigators hope to show that the correction of an
      atlas misalignment will increase intracranial compliance in subjects with migraine.
    


Intervention name(s): NUCCA atlas correction
Intervention type(s): Procedure
Intervention description(s): A chiropractic procedure involving correcting a misalignment of the atlas or "top" vertebra in the spine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; National Upper Cervical Chiropractic Association atlas correction
Maintenance of Efficacy of Extended-Release Guanfacine HCl in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long-term maintenance of efficacy of
      Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with
      attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short
      term treatment with SPD503.
    


Intervention name(s): Extended-release Guanfacine Hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight.; Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders
Condition: Minimally Conscious State; TBI
MeSH terms: Persistent Vegetative State; Consciousness Disorders
Study type: Interventional

Summary: 
      Chronic consciousness disorders have high level of impact on public health and its costs.
    

Detailed description: 
      Consciousness disorders have high impact on society and national health system. One of these
      disorders is vegetative condition in which, as in coma, there isn't any self or environmental
      consciousness but there is alertness, whereas in minimal state of consciousness at least part
      of awareness is conserved.

      In Emilia Romagna region about 80 people per million of inhabitants are hospitalized after
      cerebral damage, and after discharge about 1/5 of patients are stabilized in a consciousness
      disorder.

      The diagnosis of these disorders is based on neurobehavioural tests, for example JFK Coma
      Recovery Scale Revised (CRS-R).

      In these patients recovery of state of consciousness is one of the main challenges. There are
      very little evidences about treatment, it has been proposed the use of therapies that could
      modulate central nervous system activity, like specific drugs, neuroimaging and
      neuromodulation techniques such as transcranial magnetic stimulation and repetitive
      transcranial current stimulation.

      A non invasive neuromodulation technique is transcranial direct current stimulation (tDCS)
      which can modulate cortical excitability: cathodic current reduces excitability whereas
      anodic current increases it.

      In conclusion, tDCS is an easy technique to use, it's not invasive and it's an efficient tool
      for the modulation of cortical excitability that demonstrated reliable results in healthy
      subjects.

      As the tDCS can modulate cortical excitability it is likely that the combination of this
      stimulation tool with transcranial magnetic stimulation for the registration of cortical
      excitability could give important information about cerebral damage in patients with
      consciousness disorders and to test new treatments. It is also likely that the modification
      of cortical excitability could induce neurobehavioural changes.
    

Intervention name(s): real-tDCS
Intervention type(s): Device
Intervention description(s): Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Minimally Conscious State; tDCS
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Condition: Dermatitis Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      - Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed
      after skin tape stripping (STS) in predefined lesional skin in pediatric participants with
      moderate to severe atopic dermatitis (AD) treated with dupilumab.

      Secondary Objectives:

        -  Evaluate changes in skin barrier function with TEWL assessed after STS in predefined
           lesional and non-lesional skin in pediatric participants with moderate to severe AD
           treated with dupilumab in reference to normal skin of healthy volunteers.

        -  Evaluate time course of change in skin barrier function with TEWL assessed before and
           after STS in predefined lesional and non-lesional skin in pediatric participants with
           moderate to severe AD during dupilumab treatment phase and follow-up period in reference
           to normal skin of healthy volunteers.
    

Detailed description: 
      Total study duration including screening and follow-up was 32 weeks.
    

Intervention name(s): Dupilumab SAR231893
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
Other intervention name(s): REGN668
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
White Fish for Cardiovascular Risk Factors in Patients With Metabolic Syndrome: the WISH-CARE Study
Condition: Cardiovascular Risk Factors; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators performed this study to evaluate the efficacy of regular ingestion of white
      fish to reduce cardiovascular risk factors in patients with the metabolic syndrome, compared
      to a diet with no fish or seafood at all.
    

Detailed description: 
      This study was designed as a randomized cross-over multicenter clinical trial with
      participating centers from the CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn),
      coordinated by the Hospital Universitario Ramón y Cajal, Madrid. The investigators included
      adult patients with the metabolic syndrome as defined by the Third Report of the National
      Cholesterol Education Program, Adult Treatment Panel III. All the subjects were Caucasian
      from European ancestry. Patients were randomized after the screening visit to one of two
      sequences: 1) Sequence 1 to receive fish consumption first and then no fish. The individuals
      randomized to this arm continued with their previous alimentary habits, avoiding any
      significant nutritional imbalance, and with an ingestion of 7 serves of hake (each serve
      consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain) per week for a
      period of 8 weeks. Afterwards they continued for another 8 weeks with the same diet except
      for the avoidance of fish and any other seafood; 2) Sequence 2 for which they started with
      their previous alimentary habits, avoiding any significant nutritional imbalance, as well as
      any fish or seafood for the first 8 weeks. Afterwards they were changed to the same diet but
      with 7 serves of hake per week.
    

Intervention name(s): Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain); Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: white fish; Metabolic syndrome; Cardiovascular risk
Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study)
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with
      a method, called immune apheresis, that removes IgE from blood. In order to achieve this
      blood is taken continuously from the patient and then separated into plasma and blood cells
      by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound.
      The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total
      each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1
      cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3
      cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in
      plasma/serum by at least 50% measured before the first treatment in the first cycle and after
      the last treatment in the last treatment cycle. The new adsorber can be safely used in
      patients. A group of patients with conventional drug treatment and no apheresis treatment
      serves as control.
    


Intervention name(s): IgE adsorber
Intervention type(s): Device
Intervention description(s): Two plasma volumes of each patient in the apheresis group will be treated per session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma, bronchial; immunoadsorbents; apheresis; immunoglobulin E
Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of ADL5859 versus placebo and ADL5747
      versus placebo in relieving pain in participants with osteoarthritis of the knee.
    


Intervention name(s): ADL5859; ADL5747; Oxycodone CR; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): OxyContin
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: delta opioid receptor agonist; osteoarthritis; pain
Colorectal Cancer Screening in a Community Health Setting
Condition: Cancer of the Colon
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This randomized controlled pilot study at the Health Annex, Family Practice & Counseling
      Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the
      feasibility of a mailed FIT approach to CRC screening in a community health setting, and how
      patients respond to text messaging and behavioral economic engagement incentives.
    

Detailed description: 
      This is a single-center RCT at the Family Practice & Counseling Network (FPCN), a community
      clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74
      randomized to two study arms:

        1. text messaging outreach (text)

        2. text messaging outreach with lottery for 1/5 chance to win a financial incentive (text +
           lottery).

      Findings will provide data on the feasibility of this mailed FIT approach in a community
      health setting, and how patients respond to text messaging and behavioral economic engagement
      incentives.
    

Intervention name(s): Text-only; Text + Lottery
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.; Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Colorectal Neoplasms; Colonic Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Rectal Diseases
Evaluation of the Cosmetic Benefit of a Skin Cream in Healthy Females With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a Glycolic Acid Facial Peel Procedure
Condition: Skin Care
Study type: Interventional

Summary: 
      Evaluation of the local tolerance and cosmetic efficacy of a topical skin care formulation in
      healthy female participants with mild to advanced photo-damaged facial skin who have
      undergone a 70% Glycolic Acid facial peel procedure.
    

Detailed description: 
      A randomized, evaluator-blind, single-center and two-arm clinical study designed to evaluate
      the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy
      female participants with mild to advanced photo-damaged facial skin who have undergone a 70%
      Glycolic Acid facial peel procedure.
    

Intervention name(s): Cream (Test product); Cleanser (Reference Product); Sunscreen (Reference Product)
Intervention type(s): Other; Other; Other
Intervention description(s): Moisturizing cream with SPF (Sun protecting factor) 20; Moisturizing facial cleanser; SPF 50 sunscreen
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK3389404 is being developed for the treatment of CHB virus infection. The development goal
      for GSK3389404 is the establishment of a finite duration treatment that results in sustained
      suppression of hepatitis B virus (HBV) replication and viral antigen production after
      cessation of all treatments for CHB due to the restoration of a functional immune response in
      the absence of high antigen levels. This study is a multicenter, randomized double-Blind
      (sponsor un-blinded in Part 1), Placebo-controlled Study which will evaluate the safety,
      tolerability, PK, and PD profile of GSK3389404 in subjects with CHB and aim to establish
      proof-of-mechanism. The study will be conducted in two parts. Part 1 plans to enroll subjects
      primarily from the Asia-pacific region, including Japan and will be conducted as a single
      ascending dose (SAD) study with 5 planned cohorts ranging from 30 milligram (mg) to a maximum
      of 240 mg GSK3389404. Within each cohort, subjects will be randomized to receive either
      GSK3389404 or placebo in a 3:1 ratio. Cohorts A, B, C, C1, and D will be conducted in a
      sequential fashion; Cohort C1 is an optional cohort and may be dosed after Cohort C or in
      parallel with Cohort D. Part 2 will be conducted as a multiple-dose, dose-ranging study.
      Subjects will be randomized to different parallel dose levels and regimens or placebo. The
      dose levels of Part 2 will be selected after a review of Part 1 safety, Pharmacokinetic (PK)
      and Pharmacodynamic (PD) data. The treatments selected are 60 mg GSK3389404 weekly, 120 mg
      GSK3389404 bi-weekly, 120 mg GSK3389404 weekly or placebo. An optional Japanese part-2
      sub-study is planned. The total study duration for part 1 including screening, treatment, and
      post-treatment follow-up, will not be expected to exceed 13 weeks for each subject and for
      part 2, including screening, treatment and post-treatment follow-up, will not be expected to
      exceed 65 weeks for each subject.
    


Intervention name(s): GSK3389404; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3389404 is available as Clear colorless to slightly yellow solution for injection.; Placebo is available as a Clear colorless solution.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Pharmacodynamics; Efficacy; Chronic Hepatitis B; GSK3389404