bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cholinergic Augmentation on Measures of Balance and Gait
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Donepezil
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This study will compare the effects of placebo and donepezil, a drug that helps conserve
      concentrations of the neurotransmitter, acetylcholine, on measures of balance and gait in
      subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled,
      cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a
      physiological index of cholinergic function will be measured to determine if the deficits in
      balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil
      as a measure of drug efficacy. Cognitive tests like the Attention Network Test (ANT) will be
      administered to determine if changes in gait and balance are mediated by changes in
      attention.

      The results of this study will be the most direct test of the hypothesized role of
      cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The
      study is exploratory because it is not known whether donepezil will affect gait, balance or
      attention, nor which measures of gait, balance or attention will be sensitive to drug
      manipulation. The study's immediate goal is to determine the potential utility of cholinergic
      manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The
      findings of this trial are intended to lead to more sharply focused questions about the role
      of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine
      clinical utility of cholinergic manipulation to prevent falls and improve mobility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years old or older

          -  Diagnosis of idiopathic Parkinson's disease

          -  Stand unassisted (without use of an assistance device) and walk continuously for at
             least 2 minutes.

        Exclusion Criteria:

          -  musculoskeletal disorders that affect standing and walking

          -  Uncorrected vision disturbance

          -  Vestibular problems

          -  Major depression

          -  Hallucinations or other psychiatric disturbances

          -  Tachycardia

          -  Bradycardia

          -  Arrhythmias

          -  Peptic ulcer disease

          -  Use of anticholinergics

          -  Use of cholinesterase inhibitors

          -  Use of bladder antispasmodics

          -  Use of tricyclic antidepressants
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Condition: Epilepsy, Focal Seizures, Partial Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Natalizumab; Placebo
Intervention description: As specified in the treatment arm.; As specified in treatment arms.
Intervention MeSH terms: Natalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The placebo-controlled phase is followed by a 6-month open-label phase during which all subjects receive natalizumab.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug Resistant Focal Epilepsy, Natalizumab, Seizure

Summary:

      The primary efficacy objective of the study is to determine if adjunctive therapy of
      natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult
      participants with drug-resistant focal epilepsy. The secondary efficacy objective is to
      assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on
      additional measures of seizure frequency.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by
             electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with
             multifocal epilepsy may be included if all other entry criteria are met.

          -  Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or
             more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in
             combination) [Kwan 2010].

          -  Experiences 6 or more seizures during the 6-week prospective baseline period and is
             not seizure free for more than 21 consecutive days during the prospective baseline
             period

        Key Exclusion Criteria:

          -  Focal aware seizures without motor signs are the only seizure type.

          -  Diagnosis of generalized, combined generalized and focal, or unknown epilepsy

          -  Known progressive structural CNS lesion.

          -  History of seizures occurring in predominantly clustered patterns, as determined by
             the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during
             the 6-week prospective baseline period, where individual seizures cannot be counted.

          -  History of status epilepticus within the previous 6 months.

          -  Known history or presence of non-epileptic seizures.

        NOTE; Other protocol defined Inclusion/Exclusion criteria may apply
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Condition: Corneal Edema
MeSH terms: Corneal Dystrophies, Hereditary; Corneal Edema; Fuchs' Endothelial Dystrophy; Edema
Intervention: Netarsudil Ophthalmic; Netarsudil Ophthalmic
Intervention description: Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution; Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corneal Edema; Fuchs Corneal Dystrophy; Netarsudil Ophthalmic Solution

Summary:

      Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their
      efficacy in reducing or resolving corneal edema in subjects with FCD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults aged 18 years or older

          2. Documented diagnosis of FCD

          3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline
             Visit, in the eligible eye(s)

          4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the
             eligible eye(s)

        Exclusion Criteria:

          1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be
             required in the study eligible eye(s) within the study period

          2. Clinically significant ocular disease (other than FCD) or trauma in the eligible
             eye(s) which could interfere with study interpretation

          3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal
             refractive surgery in the eligible eye(s)
External Trigeminal Nerve Stimulation for Epilepsy
Condition: Epilepsy; Seizure Disorders
MeSH terms: Epilepsy; Seizures
Intervention: Trigeminal Nerve Stimulation
Intervention description: External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: partial seizures; poorly controlled epilepsy; intractable epilepsy; treatment resistant epilepsy; Trigeminal Nerve; Trigeminal Nerve Stimulation

Summary:

      This study investigates a new therapy for epilepsy called Trigeminal Nerve Stimulation (TNS).
      TNS involves external electrical stimulation of sensory nerve located above the eyes and over
      the forehead. The purpose of this study is to determine if TNS is safe and effective using a
      rigorous randomized active-control clinical trial design in 50 people with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18 - 70;

          -  No serious or progressive medical illness;

          -  A history of intractable partial seizures;

          -  At least two complex partial or tonic clonic generalized seizures per month in the
             last two consecutive months;

          -  MRI or EEG consistent with localization-related or partial epilepsy;

          -  Exposure to at least two antiepileptic drugs at adequate doses;

          -  Concurrent use of at least one antiepileptic drug at adequate doses;

          -  No change in antiepileptic dose for at least 30 days before study enrollment

        Exclusion Criteria:

          -  History of non-epileptic seizures;

          -  Inability to maintain accurate seizure calendars (self or caregiver);

          -  Frequent use of benzodiazepines for clusters defined as greater than four times a
             month;

          -  History of facial pain or trigeminal neuralgia;

          -  Concurrent vagus nerve stimulation;

          -  Pregnancy
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: Azithromycin; Povidone
Intervention description: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.; Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
Intervention MeSH terms: Azithromycin; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Azyter in patients affected by chronic blepharitis.

Summary:

      The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus
      placebo eye drops on the global ocular discomfort (VAS).
    

Eligibility criteria:

        Inclusion Criteria:

        -Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at
        least one eligible eye

        Exclusion Criteria:

          -  Monophtalmia

          -  Eyelid dysfunction

          -  Facial paralysis.

          -  Severe dry eye syndrome.

          -  Ocular metaplasia.

          -  Filamentous keratitis

          -  Schirmer test < 5 mm.

          -  Best far corrected visual acuity < 1/10.
A Study of 2 Doses of MAP0010 in Adult Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: MAP0010 low dose; MAP0010 high dose; Budesonide inhalation suspension 0.25mg; Budesonide inhalation suspension 0.5mg
Intervention description: a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol; a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol; a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol; a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Adult Asthmatics

Summary:

      The purpose of this study is to examine the blood levels of two doses of MAP0010 (a
      corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with
      twice daily dosing over 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult asthmatics with mild to moderate persistent asthma.

          -  18 to 45 (up to the 46th birthday) years of age.

          -  Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI,
             EPR-3 criteria.

          -  Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide)
             for at least 4 hours prior to clinic visits.

          -  Baseline FEV1 greater than or equal to 50% of predicted normal.

        Exclusion Criteria:

          -  Any other significant illness/abnormality

          -  A history of upper or lower respiratory tract infection within 2 weeks

          -  A history of acute or severe asthma attack requiring ICU admission or ventilatory
             support.
Chemotherapy for Participants With Lymphoma
Condition: Lymphoma, Large Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: enzastaurin; gemcitabine; rituximab; oxaliplatin
Intervention description: 1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years; 1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles; 375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles; 100 mg/m², IV, once every two weeks, four to eight 2 week cycles
Intervention MeSH terms: Rituximab; Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to help answer the following research questions:

        -  To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin
           (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free
           from disease and thus live longer.

        -  To assess for any side effects that might be associated with enzastaurin and R-GEMOX .

        -  To look at the characteristics and levels of certain genes and proteins to learn more
           about DLBCL and how enzastaurin works in the body.

        -  To look at the level of enzastaurin in the body and how long it remains.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent
             lymphoma

          -  Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or
             participants who have not progressed after stable disease (SD) obtained in 1st- or
             2nd-line.

          -  Measurable disease (lymph node greater than 1.5 cm)

          -  Adequate organ function

          -  Greater than or equal to 60 years or less than 60 (but greater than or equal to 18
             years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC)
             and autologous stem cell transplant (ASCT)

        Exclusion Criteria:

          -  Prior Allogeneic transplantation

          -  More than 2 prior anticancer treatment regimens

          -  Pregnant or breastfeeding

          -  Human-immunodeficiency-virus (HIV)associated lymphomas

          -  Brain metastases
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
Condition: Recurrent Chronic Hepatitis C Virus; Post Liver Transplant
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Recurrence
Intervention: Sofosbuvir; RBV
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
Intervention MeSH terms: Sofosbuvir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults
      who have had a liver transplant which has become re-infected with hepatitis C. The treatment
      period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last
      up to 72 weeks not including the screening visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation

          -  HCV RNA ≥ 10,000 IU/mL at screening

          -  Absence of organ rejection as documented by post transplant liver biopsy taken no more
             than 12 months prior to baseline/Day 1 visit

          -  Liver transplant ≥ 6 months and ≤ 12 years prior to screening

          -  Naive to all nucleotide/nucleoside treatments for chronic HCV infection

        Exclusion Criteria:

          -  Multiorgan transplant that includes heart or lung recipient

          -  Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant

          -  Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose
             of corticosteroid)

          -  Infection with hepatitis B virus (HBV) or HIV at screening

          -  Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy,
             hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated
             cirrhosis
Dysport in Vulvodynia Phase II Study
Condition: Vulvodynia
MeSH terms: Vulvodynia
Intervention: Botulinum toxin type A; Placebo
Intervention description: Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.; The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to define optimal doses of Dysport and evaluate its efficacy and
      safety compared with placebo for the treatment of vulvodynia.

      The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage
      2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1;
      Dysport or placebo) followed by an open label treatment period. One or two optimally safe and
      effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal

          -  Have vulvodynia for at least 6 months and for no more than 15 years

          -  Have provoked pain at the vestibule on a Q tip test

        Exclusion Criteria:

          -  Deep pain during intercourse

          -  Have genitourinary or gastrointestinal conditions which may interfere with the study

          -  Previous surgery that according to investigator's judgement may impact on study
             outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery,
             perianal surgery) or genital trauma or mutilation/cutting
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
Condition: Fragile X Tremor/Ataxia Syndrome
MeSH terms: Ataxia; Cerebellar Ataxia; Tremor; Syndrome
Intervention: citocoline
Intervention description: Ten subjects will receive 1,000mg once daily of citicoline. Each subject will stay on the study drug for 12 months. The outcome measures will be assessed at baseline and then again at the end of month 3, month 6, and month 12. The subjects will continue taking the same study drug at the same dose throughout the entire trial.
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine if citocoline is effective for balance
      abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor
      ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an
      open label pilot study, with study visits at baseline, 3, 6, and 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of FXTAS

               -  Serum creatine kinase, complete metabolic panel, complete blood count, liver
                  function tests, renal function tests, platelets and EKG are within normal limits

        Exclusion Criteria:

          -  Legal incapacity or limited legal capacity

          -  Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance
             <60 mL/min) or hepatic disease.

          -  Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by
             lab reports obtained from primary care physicians or conducted at baseline).

          -  Women of childbearing potential who are pregnant at the time of screening or who will
             not use adequate protection during participation of the study.

          -  Allergy/sensitivity to the drug of its formulations.

          -  Concurrent participation in another clinical study.

          -  Active substance use or dependence.

          -  Serious illness (requiring systematic treatment/or hospitalization) until the subject
             either completes therapy or is clinically stable on therapy, in the opinion of the
             site investigator, for at least 60 days prior to study entry.

          -  Inability or unwillingness of the subject or legal guardian/representative to give
             written informed consent.