bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis
Intervention: Risedronate; Placebo/Risedronate
Intervention description: 5 mg/day; placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Postmenopausal Women; Osteoporosis

Summary:

      The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on
      BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women who sequentially completed studies RVE009093, RVE1996077,
             RVE1998080

        Exclusion Criteria:

          -  Less than 60% compliant between drug start and month 21

          -  Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements,
             calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection >10,000 IU
             vitamin D, investigational drug
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Ciclesonide; Placebo
Intervention description: 160mcg Inhaler; Matching Placebo Inhaler
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 400.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide)
      Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a
      multicenter, randomized, double-blind, placebo controlled study
    

Eligibility criteria:

        Inclusion Criteria

        Patients eligible for enrollment in the study must meet all the following criteria:

          1. Male and female adults and adolescents (12 years of age and above).

          2. Positive SARS-CoV-2 rapid molecular diagnostic test within 72 hours prior to
             enrollment.

          3. Patient is not currently hospitalized or under immediate consideration for
             hospitalization at the time of enrollment.

          4. Patient is currently experiencing symptoms of fever, cough, and/or dyspnea.

          5. Patient has an oxygen saturation level greater than 93%.

          6. Ability to show adequate use of MDI, including inhalation technique.

          7. Patient, parent/legal guardian, or legally-authorized representative must have signed
             a written informed consent before administration of any study-specific procedures.

        Exclusion Criteria

        Patients meeting any of the following criteria are not eligible for participation in the
        study:

          1. Existence of any life-threatening co-morbidity or any other medical condition which,
             in the opinion of the investigator, makes the patient unsuitable for inclusion.

          2. History of hypersensitivity to ciclesonide.

          3. Treatment with inhaled or intranasal corticosteroids within 14 days of the screening/
             enrollment/randomization visit.

          4. Treatment with oral corticosteroids within 90 days of the
             screening/enrollment/randomization visit.

          5. Participation in any other clinical trial or use of any investigational agent within
             30 days of the screening/enrollment/randomization visit.

          6. Currently receiving treatment with hydroxychloroquine/chloroquine.

          7. Patients with cystic fibrosis.

          8. Patients with idiopathic pulmonary fibrosis.
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: pregabalin; placebo; pramipexole
Intervention description: capsules; 300 mg once-per-day; 4 weeks of treatment; capsules; 0 mg once-per-day; 4 weeks of treatment; capsules; 0.5 mg once-per-day; 4 weeks of treatment
Intervention MeSH terms: Pregabalin; Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome

Summary:

      The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole
      versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of restless legs syndrome with a total score of 15 or more points on the
             International RLS rating scale (IRLS).

          -  RLS symptoms interfering with sleep on 3 or more nights per week for at least 6
             months.

          -  PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time
             of at least 3 hrs and less than 6.5 hrs.

        Exclusion Criteria:

          -  Secondary RLS.

          -  Daytime RLS symptoms requiring treatment.

          -  Primary sleep disorder.

          -  Sleep apnea.

          -  Night or shift work.

          -  Concurrent medical disorder that could interfere with efficacy assessment or present a
             safety concern.

          -  Pregnant or lactating women.

          -  Women of child-bearing potential not using acceptable method of birth control.

          -  Use of prohibited medication.
Atomoxetine for Freezing of Gait in Parkinson's Disease
Condition: Parkinson's Disease; Freezing of Gait
MeSH terms: Parkinson Disease
Intervention: ATM FOG in PD
Intervention description: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Phase: Phase 3
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: 80 Years
Healthy volunteers: No

Summary:

      Subjects are being asked to participate in this study to determine the safety and
      effectiveness of a drug called atomoxetine in the treatment of freezing of gait for
      Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market
      for the treatment of attention deficit. It works to increase the amount of norepinephrine (a
      chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been
      approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has
      been found to be well tolerated in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn
             and Yahr stage 2-4

          2. A positive response to item 14 of the UPDRS, part 2.

          3. Age range 18-80

          4. Ability to walk a minimum of 20 feet without assistive device and with one observed
             freezing episode which may be triggered by visual cue

          5. Letter of medical clearance by primary care physician dated within preceding 2 months
             of subject's initial active study visit.

          6. Stable on PD medications for ≥ 3 months

             -

        Exclusion Criteria:

          1. Intolerance to drug class

          2. Mini-Mental Status Examination <26/30

          3. No observable episodes of freezing of gait despite common visual cues

          4. Not on stable PD medications for 3 months

          5. Subjects who whose gait disturbance is due to other conditions not related to PD or
             FOG.

          6. Current use of monoamine oxidase inhibitor (MAO-I)

          7. Hypersensitivity to drug class

          8. Narrow angle glaucoma

          9. Pheochromocytoma

         10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would
             be expected to deteriorate if their heart rate or blood pressure were to increase in a
             clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats
             per minute in heart rate).

         11. Patients with uncontrolled hypertension.

         12. Patients with a history of symptomatic tachyarrhythmias.

         13. Presence of uncontrolled depression and suicidal ideation.

             -
Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone HCl
Intervention description: Once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 489.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Schizophrenia; SM-13496; Latuda; Lurasidone

Summary:

      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is more efficacious than
      placebo. The study will also evaluate the safety and tolerability of lurasidone as compared
      to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to enter the study, each patient must comply with the following inclusion
        criteria:

          -  Provide written informed consent and aged between 18 and 75 years of age.

          -  Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.

          -  Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate
             and reliable contraception for duration of study.

          -  Able and agrees to remain off prior antipsychotic medication for the duration of
             study.

          -  Good physical health on the basis of medical history, physical examination, and
             laboratory screening.

          -  Willing and able to comply with the protocol, including the inpatient requirements and
             outpatient visits.

        Exclusion Criteria:

          -  Considered by the investigator to be at imminent risk of suicide or injury to self,
             others, or property.

          -  Any chronic organic disease of the CNS (other than schizophrenia)

          -  Used investigational compound within 30 days.

          -  Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence
             within the last 6 months.
NINDS CRC Chronic Migraine Treatment Trial
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: propranolol LA; topiramate; placebo
Intervention description: Propranolol LA up to 240 mg/day; Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists.; an inactive substance
Intervention MeSH terms: Topiramate; Propranolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: chronic migraine, migraine prevention, chronic headache

Summary:

      The purpose of this study is to compare the reduction in the number of severe headache days
      at six months in people with chronic migraine treated with topiramate and propranolol versus
      those treated with topiramate and a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chronic migraine for at least 6 months

          -  Age ≥ 18 years and age of migraine onset 60 or younger

          -  EKG performed in the last 12 months

        Exclusion Criteria:

          -  Prior neuro-imaging suggesting secondary structural causes of headache

          -  Beck Depression Inventory FastScreen score of 13 or greater or other severe
             psychiatric disorder

          -  Contraindication to or prior intolerance of topiramate or propranolol (no history of
             sinus bradycardia, heart block, heart failure, diabetes prone to hypoglycemia, asthma,
             kidney stones)

          -  History of kidney failure or nephrolithiasis

          -  A female who is currently pregnant or lactating or planning to become pregnant in the
             next year, or is of child-bearing potential and not practicing an acceptable form of
             birth control

          -  Currently requires butalbital or opioid drugs for acute headache treatment 10 or more
             days a month

          -  Failure of prior trials with at least 50 mg of topiramate combined with at least 80 mg
             of propranolol

          -  Use of other migraine preventive drugs (Medications graded as groups 1, 2, 3, and 4 in
             the AAN Evidence-based Guideline: valproate, divalproex sodium, gabapentin,
             amitriptyline, nortriptyline, protriptyline, beta-blocker, calcium channel blocker,
             cyproheptadine; and tizanidine) within the last two months or has received botulinum
             toxin injection in the past 3 months
Effects of Omegas 3 and 6 on Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Naltrexone; PUFAs; Placebo; Naltrexone + Placebo
Intervention description: A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.; Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.; A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).; A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: Male
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: PUFAs; Alcoholism; Treatment; Effectiveness

Summary:

      Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some
      studies have shown that alcohol alters the environment of the membranes, mainly by modifying
      their permeability through the lipid fraction. These lipids are known as essential fatty
      acids (EFA) because they are obtained only through the diet, as the human body is unable to
      synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3,
      are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and
      metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

      Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol
      dependent patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  severe alcohol dependence

          -  no history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine
             or neurological pathologies, as well as no history of psychiatric disorders,
             dependences other than alcohol and/or tobacco, and blood test results outside the
             reference range

        Exclusion Criteria:

          -  history of allergic processes, hepatic, cardiovascular, renal, pulmonary, endocrine or
             neurological pathologies

          -  dependences other than alcohol and/or tobacco

          -  psychiatric disorders

          -  test laboratories results outside the reference range
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 374.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51
      (JE-PIV) in healthy subjects aged > or = 18 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Written informed consent obtained prior to study entry

        Exclusion Criteria:

          -  History of clinical manifestation of any flavivirus infection

          -  History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue
             fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for
             inclusion, these subjects will be part of the safety population, but will not be
             analyzed for immunogenicity in the per-protocol analysis)

          -  Use of any other investigational or non-registered drug or vaccine in addition to the
             study vaccine during the study period or within 30 days preceding the first dose of
             study vaccine

          -  Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

          -  A family history of congenital or hereditary immunodeficiency

          -  History of autoimmune disease

          -  Any acute infections within 4 weeks prior to enrollment

          -  Infection with HIV, Hepatitis B or Hepatitis C

          -  Pregnancy, lactation or unreliable contraception in female subjects
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Belimumab 200 mg SC; Standard therapy
Intervention description: Placebo; Belimumab 200 mg SC; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 839.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subcutaneous; Lupus; Systemic Lupus Erythematosus; SLE; Belimumab; Autoimmune Disease; Antibodies

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab
      administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age.

          2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.

          3. Active SLE disease.

          4. Autoantibody-positive.

          5. On stable SLE treatment regimen which may include corticosteroids (for example,
             prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
             (for example, azathioprine, methotrexate, mycophenolate, etc.)

        Exclusion Criteria:

          1. Pregnant or nursing.

          2. Have received treatment with any B cell targeted therapy (for example, rituximab or
             belimumab).

          3. Have received treatment an investigational biological agent in the past year.

          4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.

          5. Have severe active lupus kidney disease.

          6. Have severe active central nervous system (CNS) lupus.

          7. Have required management of acute or chronic infections within the past 60 days.

          8. Have current drug or alcohol abuse or dependence.

          9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis
             C.

         10. Have a history of hypersensitivity reactions to contrast agents or biological
             medicines.