bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Freezing of gait is a late stage complication of Parkinson's disease in which patients note
      that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and
      the secondary complications that can result from falls such as fractures and
      hospitalizations. While levodopa can help freezing of gait in some patients, it does not help
      in all, and the dose needed to treat freezing may be limited by side effects of the
      medications. Currently there are no treatments targeted towards freezing of gait and the goal
      of this research is to see if Modafinil could be one such drug to help freezing of gait in
      Parkinson's disease.
    

Detailed description: 
      Freezing of gait is a late stage complication of Parkinson's disease in which patients note
      that their feet feel stuck or glued to the ground. This can lead to imbalance and falls and
      the secondary complications that can result from falls such as fractures and
      hospitalizations. While levodopa can help freezing of gait in some patients, it does not help
      in all, and the dose needed to treat freezing may be limited by side effects of the
      medications. Currently there are no treatments targeted towards freezing of gait and the goal
      of this research is to see if Modafinil could be one such drug to help freezing of gait in
      Parkinson's disease.

      Approximately 20 subjects aged 18 or older with idiopathic Parkinson's disease with freezing
      of gait will be asked to enroll in the study from the patient population in the movement
      disorders clinic at the University of Arkansas for Medical Sciences (UAMS). Subjects will be
      assigned randomly 1:1 to an early start and delayed start arm of the study. In the early
      start arm subjects will receive 24 weeks of 50 mg oral daily Modafinil while subjects in the
      delayed start arm will receive 12 weeks of placebo followed by 12 weeks of 50 mg oral daily
      Modafinil. Assessments will be performed prior to initiation of medication at the screening
      visit, as well as at 12 weeks of the treatment phase. The assessments will include
      questionnaires to determine the frequency and severity of freezing of gait, level of mood,
      anxiety and apathy and quality of life, physical examination and tests of cognitive function.
      Objective assessment of patients walking will be conducted using a pressure sensor
      impregnated mat at each visit.
    

Intervention name(s): modafinil 50mg; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule oral daily; 1 capsule oral daily
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled delayed start
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: freezing of gait
Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, double-blind phase I clinical study of
      anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and
      antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of
      disease progression.
    


Intervention name(s): Placebo; Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)
Intervention type(s): Drug; Drug
Intervention description(s): Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.; INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
Other intervention name(s): Control; INOSARS
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; SARS-CoV-2; Immunoglobulin fragments; Hyperimmune equine serum; Passive immunotherapy
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional

Summary: 
      Previous study showed that afternoon cosyntropin testing was associated with a sevenfold
      increased likelihood of failing the 1μg test. However, in that study, investigators used a
      20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther
      current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a
      short 2.5 cm tube.
    

Detailed description: 
      In earlier studies investigators claimed that subnormal cortisol response using plastic tubes
      might result from cosyntropin adherence to the tube and loss of the delivered dosage. It was
      shown that 21.6-58.6% of ACTH dosage had not been recovered when pushed through 20.3 cm
      plastic tube, and loss of ACTH may be up to 70% when cosyntropin was delivered through a
      plastic 30 cm scalp vein set.

      Moreover, it was previously shown that afternoon cosyntropin testing was associated with a
      sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators
      used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In
      ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation
      using a short 2.5 cm tube.
    

Intervention name(s): low-dose cosyntropin stimulation test
Intervention type(s): Diagnostic Test
Intervention description(s): Each subject recruited in the study will undergo low dose cosyntropin stimulation test via intravenous short 2.5 cm plastic tube. 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). For each subject, serum and salivary cortisol will be measured just before cosyntropin administration and 30 minutes later.
Intervention MeSH terms: Cosyntropin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cosyntropin stimulation test; low-dose
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Condition: Hepatitis C Viral Infection; Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir
      and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in
      treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.
    

Detailed description: 
      A study to evaluate the safety and effect of treatment with experimental antiviral drugs
      alone or in combination with ribavirin in treatment-naïve participants with genotype 1b
      hepatitis C infection. The study will test the safety and anti-viral activity of two regimens
      administered for a duration of 12 weeks. Secondary objectives of this study are to determine
      the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA
      kinetics during treatment.
    

Intervention name(s): Faldaprevir; TD-6450; Ribavirin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): BI 201335; Ribasphere®
Intervention MeSH terms: Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fundus Image-guided Focal Electroretinography, Usability Study
Condition: Healthy; Macular Edema; Macular Degeneration
MeSH terms: Macular Degeneration; Macular Edema
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the usability of fundus image-guided focal
      electroretinography device with healthy subjects and with macular edema and macular
      degeneration patients.
    

Detailed description: 
      In this study, we will study the usability of focal electroretinography device combined with
      slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG
      recording from the desired retinal area.

      In phase I, the usability of the investigational device is tested with 10 healthy volunteers.
      The examinations include focal ERG and noise tests with commercial ERG electrodes. The
      stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One
      electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.

      In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients
      having either macular edema or macular degeneration. The aim of the phase II is to test
      whether the investigational device can be used to record focal ERG signal from the desired
      symptomatic retinal area.
    

Intervention name(s): ERG electrode tests for fundus image-guided focal ERG; Fundus image-guided focal ERG
Intervention type(s): Device; Device
Intervention description(s): Investigate the patient comfort, usability and signal-to-noise ratio of different commercial CE marked ERG electrodes.; Record focal ERG from a healthy retinal area and from an area with visible symptoms.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The usability of the investigational device is examined first with 10 healthy subjects and afterwards with total of 10 patients suffering either from macular edema or macular degeneration.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electroretinography; ERG
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects on the single-dose drug levels of
      mavacamten in healthy participants.
    


Intervention name(s): Mavacamten Capsule 1; Mavacamten Capsule 2; Mavacamten Capsule 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Other intervention name(s): BMS-986427, MYK-461; BMS-986427, MYK-461; BMS-986427, MYK-461
Intervention MeSH terms: Sulconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Participants; Mavacamten; Bioequivalence
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and
      cervicovaginal samples will be taken most mornings around the AM dose. Two visits, ~14 hrs in
      length will be required on Day 1 and 7. The purpose of this study is to measure how much
      raltegravir is found in the genital tract after taking it orally.
    

Detailed description: 
      This study is looking at blood and cervicovaginal fluid (CVF) samples of healthy volunteers
      taking raltegravir. The purpose of this study is to measure the extent that raltegravir
      penetrates into other body compartments, such as the genital tract. Subjects will take the
      study drug for 7 days, a total of 10 visits to the research center will be required. A
      screening visit will occur on no more than 28 days On Days 1 and 7 the subject will stay in
      the research center for approximately 12 hours for scheduled blood and CVF sampling. Days 3-6
      and 8-9 will involve a short visit to the research center for one pre-dose blood and CVF
      sample before the morning dose. A follow up visit will occur about 7-10 days after last dose.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): 400mg raltegravir BID x 7 days
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Condition: Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Mirror Study is a randomized, double-blinded mono-centre trial the access the
      periinterventinal and postinterventional administration of clopidogrel in patients with
      peripheral vascular disease.
    

Detailed description: 
      Clopidogrel is approved for secondary prevention of atherosclerosis in patients with
      peripheral vascular disease. Currently there are no data about the amount of platelet
      activation during peripheral arterial intervention, the effect of clopidogrel on platelet
      adhesion and its clinical impact.

      Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the
      intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and
      microcirculation will be assessed as well as clinical endpoints.
    

Intervention name(s): clopidogrel
Intervention type(s): Drug
Intervention description(s): Best endovascular treatment either with one or the other drug arm should be investigated
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peripheral arterial intervention; atherosclerosis; platelets; Age above 18
Safety and Efficacy Study of Centanafadine Sustained-Release (CTN SR) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase 2b, randomized, double-blind, multicenter, 2-period, 2-treatment, crossover
      study to evaluate safety and efficacy of CTN SR compared with placebo in adults with ADHD.
      Efficacy was also evaluated in the subgroup of adults with ADHD treated with a target CTN SR
      dose of 400 mg/day.
    


Intervention name(s): CTN SR; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): CTN SR tablets, daily, Orally.; Matching-placebo tablets daily, orally.
Other intervention name(s): Centanafadine Sustained-Release
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: centanafadine sustained-release; Attention-Deficit Hyperactivity Disorder
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized
      Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in
      Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.
    

Detailed description: 
      The hypothesis of the study is that the efficacy of BCD-131 is equivalent to that of Mircera®
      based on the analysis of the primary endpoint (changes in the Hb level over the period of
      evaluation as compared to the baseline Hb level ) during the 21-week period of treatment.

      This study is a study of the maintenance treatment of anemia. The study will include up to
      100 dialysis patients with stage 5D chronic kidney disease, established efficacy of dialysis
      and renal anemia without other causes of anemia, receiving erythropoiesis-stimulating agents
      (ESA) and reaching target hemoglobin levels.
    

Intervention name(s): BCD-131; Mircera
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneously monthly; subcutaneously monthly
Other intervention name(s): pegylated darbepoetin beta; Methoxy polyethylene glycol-epoetin beta
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect and CYP1A2 Induction Study in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food and smoking on healthy older subjects taking
      pomalidomide.
    

Detailed description: 
      This study will be conducted in two parts. Parts 1 and 2 may be conducted in parallel and
      subjects are only allowed to participate in one part.

      In Part 1, subjects will be randomly assigned to receive a single oral dose of 4 mg
      pomalidomide on Day 1 under fed (standard high fat breakfast) or fasted conditions. After a
      washout period of at least 3 and no more than 7 days, subjects will receive a single oral
      dose of 4 mg pomalidomide under the opposite condition to what they received in the first
      period.

      In Part 2, healthy male smoker subjects must smoke approximately 20 cigarettes per day for a
      total of 10 days. Non-smokers will neither smoke nor be in the presence of smokers. All
      subjects will receive orally a 200-mg caffeine capsule on Day 6, and on Day 8, subjects will
      receive a single oral dose of 4 mg pomalidomide.

      For both Parts 1 and 2, serial blood samples will be collected for determination of plasma
      pomalidomide concentrations.
    

Intervention name(s): Pomalidomide; Caffeine; Tobacco
Intervention type(s): Drug; Other; Other
Intervention description(s): Capsules; Capsules; Cigarettes
Intervention MeSH terms: Pomalidomide; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteer; Pharmacokinetics; Pomalyst; Pomalidomide; Food effect; smoker
Dermatological Assessment of Photoallergy and Phototoxicity
Condition: Sensitivity, Contact
MeSH terms: Dermatitis, Phototoxic; Dermatitis, Photoallergic; Dermatitis, Contact
Study type: Interventional

Summary: 
      This is a clinical study for health care product safety assessment. The research will be
      conducted with 40 subjects*, aged 18 to 70 years. The product will be applied on the right
      and/or left participant back for 3 consecutive weeks. After 10 days, will have another
      application of the same product, which will be removed in 24 hours. Medical evaluation will
      be available throughout the study to assess possible adverse events.

      The objective of the study is to observe the effects of the application of the product on the
      skin and prove the absence of photoallergy and phototoxicity.

      * 29 completed the trial
    

Detailed description: 
      40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick
      classification). The patch test will be used to verify the absence of photoallergy and
      phototoxicity by the investigational products. The products will be applied twice a week for
      3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in
      contact with the skin for 24 hours, after product removal the area will be irradiated with
      ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of
      wash out.
    

Intervention name(s): Health care product (gel)
Intervention type(s): Other
Intervention description(s): hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)
Intervention model: Single Group Assignment
Intervention model description: Clinical trial, single-arm
Masking: None (Open Label)
Primary purpose: Other
Happy Smooth Study
Condition: Infant Term Birth
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the stool composition and GI tolerance of an
      experimental formula with a new fat blend plus L. reuteri vs control formula.
    

Detailed description: 
      Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate
      the stool composition and GI tolerance of 140 healthy, term infants fed with an infant
      formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled
      infants will participate in the trial for approximately 71 days.
    

Intervention name(s): Experimental Infant Formula; Standard Infant Formula
Intervention type(s): Other; Other
Intervention description(s): Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum; Standard bovine milk-based infant formula, fed ad libitum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other