bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Condition: HC-BPPV
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Intervention: Gufoni maneuver; Head-shaking maneuver; sham maneuver
Intervention description: For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).; For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.; For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: BPPV(benign paroxysmal positional vertigo); HC-BPPV(BPPV involving the horizontal semicircular canal); Nystagmus; Treatment outcome; Horizontal Canal Benign Paroxysmal Positional Vertigo

Summary:

      The purpose of this study was to compare the immediate efficacies of each treatment maneuvers
      in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  a history of brief episodes of positional vertigo,

          -  direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic
             nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning
             positions,

          -  no spontaneous nystagmus during upright sitting position, and

          -  absence of identifiable central nervous system disorders that could explain the
             positional vertigo and nystagmus.

        Exclusion Criteria:

          -  central positional nystagmus with identifiable CNS lesions that could explain the
             positional nystagmus
Natalizumab (Tysabri) Re-Initiation of Dosing
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Natalizumab
Intervention MeSH terms: Natalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1094.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; MS

Summary:

      The primary objectives for the initial treatment period of this study are to further evaluate
      the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions
      and immunogenicity following re-exposure to natalizumab and confirming the safety of
      switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS)
      therapies to natalizumab. The primary objective for the long-term treatment period of this
      study is to evaluate the long-term impact of natalizumab monotherapy on the progression of
      disability measured by Expanded Disability Status Scale (EDSS) changes over time.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803
             (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a
             magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study

          -  Subjects who are considered by the Investigator to be free of signs and symptoms
             suggestive of progressive multifocal leukoencephalopathy and willing to discontinue
             and remain free from concomitant immunosuppressive or immunomodulatory treatment
             (including IFN-beta and glatiramer acetate) while being treated with natalizumab
             during the study.

          -  In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322
             (NCT00306592) in Canada will be allowed to enter this study at the start of the
             long-term treatment period (Week 52 - 480).

        Key Exclusion Criteria

          -  Considered by the Investigator to be immunocompromised

          -  History of persistent anti-natalizumab antibodies, based upon testing from prior
             natalizumab studies

          -  History of any major disease or malignancy

          -  Discontinued natalizumab in a previous study due to allergic reaction

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Bevacizumab; liposomal doxorubicin; paclitaxel; topotecan
Intervention description: 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks; 40mg/m2 iv every 4 weeks; 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle; 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
Intervention MeSH terms: Paclitaxel; Bevacizumab; Doxorubicin; Liposomal doxorubicin; Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 361.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin
      added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian,
      fallopian tube or primary peritoneal cancer with disease progression within 6 months of
      platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or
      topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive
      Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on
      study treatment is until disease progression. Patients will then receive standard of care,
      those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >/=18 years of age

          -  epithelial ovarian, fallopian tube or primary peritoneal cancer

          -  platinum-resistant disease (disease progression within <6 months of platinum therapy)

          -  EOCG performance status of 0-2

        Exclusion Criteria:

          -  non-epithelial tumours

          -  ovarian tumours with low malignant potential

          -  previous treatment with >2 chemotherapy regimens

          -  prior radiotherapy to the pelvis or abdomen
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
Condition: Parkinson's Disease; Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Sarizotan; Placebo
Intervention description: Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks.; Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 506.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Dyskinesia; Dyskinesia associated with dopaminergic treatment

Summary:

      The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is
      effective in the treatment of dyskinesia associated with dopaminergic treatment of
      Parkinson's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is an out-patient.

          -  The subject presents with a diagnosis of idiopathic Parkinson's disease.

          -  Prior therapy with all registered Parkinsonian medication is allowed.

        Exclusion Criteria:

          -  (For female subjects) The subject is pregnant or lactating.

          -  The subject is participating in another clinical study or has done so within the past
             30 days.

          -  The subject has received neurosurgical intervention related to PD.

          -  The subject has relevant renal impairment.

          -  The subject has relevant hepatic impairment.

          -  The subject is suffering from any dementia or psychiatric illness.

          -  The subject has a history of allergic asthma.
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Condition: Vaginitis Trichomonal or Due to Trichomonas
MeSH terms: Trichomonas Infections; Trichomonas Vaginitis; Vaginitis
Intervention: MTZ 500 mg twice daily x 7 days; MTZ 2 g
Intervention description: MTZ 500 mg twice daily x 7 days; MTZ 2 g
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: This was an open label study
Enrollment: 623.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Trichomonas vaginalis; metronidazole

Summary:

      The overall goal of this project is to determine the influence of patient treatment and host
      factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
    

Eligibility criteria:

        Inclusion Criteria:

          -  female

          -  English speaking

          -  >= 18 years old

        Exclusion Criteria:

          -  HIV-infected

          -  unable to provide informed consent

          -  pregnant

          -  breast feeding

          -  treated by their provider for Bacterial vaginosis (BV) at visit
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Metvix and natural daylight PDT; Metvix and conventional PDT
Intervention description: Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.; Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Intervention MeSH terms: Methyl 5-aminolevulinate; Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to compare efficacy and safety of Metvix® natural
      daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with
      Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female above 18 years;

          2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without
             clinical diagnosis of moderate AK on the target areas (TAs);

        Exclusion Criteria:

          1. Subject with clinical diagnosis of at least one severe AK on TAs

          2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin
             cancer) on the TAs;

          3. Subject with pigmented AK on the TAs
This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696 200 mg BID; Enalapril 10 mg BID
Intervention description: LCZ696 200 mg BID; Enalapril 10 mg BID
Intervention MeSH terms: Enalapril; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic heart failure; cardiovascular death; hospitalization; outcome study; BNP; KCCQ; eGFR

Summary:

      The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity
      and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give written informed consent before any assessment is performed.

          -  Outpatients ≥ 18 years of age, male or female.

          -  Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction (EF =<
             35%) and elevated BNP.

          -  Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d
             or equivalent for at least 4 weeks.

          -  Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at
             a stable dose for at least 4 weeks.

        Exclusion Criteria:

          -  Use of other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer.

          -  History of hypersensitivity or allergy to any of the study drugs, drugs of similar
             chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected
             contraindications to the study drugs.

          -  Previous history of intolerance to recommended target doses of ACEIs or ARBs

          -  Known history of angioedema.

          -  Requirement of treatment with both ACEIs and ARBs.

          -  Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
             symptoms that may require intravenous therapy).

          -  Symptomatic hypotension and/or a SBP < 100 mmHg.

          -  Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula

          -  Serum potassium > 5.2 mmol/L.

        Other protocol-defined inclusion/exclusion criteria may apply.
A Long-Term Safety Study of ALKS 5461
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: Sublingual tablet, taken daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1485.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Agree to use an approved method of contraception for the duration of the study

          -  Have the potential to safely benefit from the administration of ALKS 5461

          -  Have a diagnosis of major depressive disorder (MDD)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a positive test for drugs of abuse

          -  Currently pregnant or breastfeeding

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years, or received
             more than 1 course of electroconvulsive treatment during their lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within the past 60 days

          -  Additional criteria may apply
ACT-293987 in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: ACT-293987
Intervention description: Tablets, twice daily
Intervention MeSH terms: Selexipag
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-label; PAH; Pulmonary Arterial Hypertension

Summary:

      Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the
      safety and tolerability of ACT-293987 in patients with PAH who participated in the
      double-blind study AC-065A302 (GRIPHON)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated to the double-blind study AC-065A302 and either had a
             morbidity event or had completed the study as scheduled per protocol.

          -  Signed informed consent.

        Exclusion Criteria:

          -  Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin
             analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in
             AC-065A302/GRIPHON.

          -  Severe hepatic impairment (Child-Pugh C).

          -  Females who are pregnant or who plan to become pregnant during the study, or are
             breastfeeding.

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results, such as drug or alcohol dependence, or
             psychiatric disease.
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Brolucizumab; Aflibercept
Intervention description: 6 mg/0.05mL solution for intravitreal injection; 2 mg/0.05mL solution for intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, randomized, double-masked
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 535.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: neovascular age-related macular degeneration; nAMD; intravitreal injection; IVT; anti-VEGF; brolucizumab; aflibercept; EYLEA; double-masked; MERLIN; BEOVU

Summary:

      This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg
      dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related
      macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular
      Endothelial Growth Factor (VEGF) injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Diagnosis of wet age-related macular degeneration (AMD)

          -  Currently receiving anti-VEGF injections

        Exclusion Criteria:

          -  Active infection or inflammation in either eye

          -  Significant fibrosis in the study eye

          -  Recent ocular surgery

          -  Uncontrolled glaucoma

          -  Use of medications as specified in the protocol

          -  Pregnant, nursing

          -  Of child-bearing potential unless using highly effective method of contraception
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
Condition: Transthyretin Familial Amyloid Polyneuropathy
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Intervention: tafamidis
Intervention description: tafamidis meglumine 20 mg QD
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: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Transthyretin amyloid polyneuropathy with V30M or non-V30M transthyretin mutation.

          -  Subject had amyloid documented by biopsy in accordance with institutional site
             standard of care.

        Exclusion Criteria:

          -  Primary amyloidosis and secondary amyloidosis.

          -  History of liver transplant.
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: U0267; Vehicle
Intervention description: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).; All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Plaque-type Psoriasis; Psoriasis

Summary:

      The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects at least 12 years old and in good general health.

          -  Mild to moderate plaque-type psoriasis

        Exclusion Criteria:

          -  Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs;
             or to any component of the investigational formulations

          -  History of hypercalcemia or of vitamin D toxicity.

          -  Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.

          -  Other serious skin disorder or any chronic medical condition that is not well
             controlled.

          -  Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four
             weeks of enrollment.

          -  Use of topical therapies that have a known beneficial effect on psoriasis, within 2
             weeks of enrollment.

          -  Systemic medications for other medical conditions that are known to affect psoriasis
             within the past four weeks of enrollment.

          -  Use of any investigational therapy within 4 weeks of enrollment.

          -  Pregnant women, women who are breast feeding, or sexually active women of child
             bearing potential who are not practicing an acceptable method of birth control.