bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab Pegol; Placebo
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/mL
Route of Administration: Subcutaneous use; Active Substance: isotonic sodium chloride solution
Pharmaceutical Form: Solution for injection
Concentration: 1 mL
Route of Administration: Subcutaneous use
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Crohn's Disease; CDP870; Certolizumab pegol

Summary:

      This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in
      patients with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Patients who are diagnosed with Crohn's disease (according to the Crohn's disease
             diagnostic criteria developed by the research group on intractable inflammatory bowel
             disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting
             date of the observation period

          -  Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450
             inclusive during the observation period

          -  C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the
             start of the observation period

        Exclusion Criteria:

          -  Stoma patient

          -  Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF
             alpha antibody

          -  Patients who participated in a clinical study with CDP870

          -  Pregnant or lactating patients, patients of childbearing potential, or patients who
             will attempt pregnancy during the study period

          -  Patients who are judged inappropriate for enrollment by the principal investigator or
             subinvestigators

        Exclusion Criteria:
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: RhACE2 APN01; Physiological saline solution
Intervention description: Patients will be treated with APN01 intravenously twice daily (BID).; Patients will be treated with placebo intravenously twice daily (BID).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with
      COVID-19 to block viral entry and decrease viral replication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hospitalized male or female

          2. Diagnosed to be COVID-19 POSITIV

          3. Signed Inform Consent Form

        Exclusion Criteria:

          1. Any patient whose clinical condition is deteriorating rapidly

          2. Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV
             antibody

          3. History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy that, in the opinion of the investigator or Medical
             Monitor, contraindicates their participation

          4. Pregnant females as determined by positive serum or urine hCG test prior to dosing

          5. Lung transplantation

          6. Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis
             or peritoneal dialysis

          7. There are other uncontrolled co-morbidities that increase the risks associated with
             the study drug administration, that are assessed by the medical expert team as
             unsuitable

          8. Patient in clinical trials for COVID-19 within 30 days before ICF

          9. Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell
             transplants)
ET-01 in Subjects With Lateral Canthal Lines, LCL-208
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
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
Intervention model description: sequential cohort, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  females 25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet on contraction

          -  adequate vision to assess facial wrinkles in a mirror

          -  willingness to refrain from products affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

          -  subjects should be in good general health

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: SB218352_15; SB218352_8; SB218352_4; SB218352_2; SB218352_8AL; SB218352_4AL; SB218352_2AL
Intervention description: Non-adjuvanted pandemic influenza A formulation 1 vaccine; Non-adjuvanted pandemic influenza A formulation 2 vaccine; Non-adjuvanted pandemic influenza A formulation 3 vaccine; Non-adjuvanted pandemic influenza A formulation 4 vaccine; Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine; Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine; Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: prophylaxis of pandemic influenza

Summary:

      Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which
      most of the population lacks immunity. If such virus is pathogenic to human and demonstrates
      the ability to transmit from person to person, the result is a global outbreak of disease
      that affects a high percentage of individuals in a short period of time and is likely to
      cause substantially increased mortality and morbidity in all countries of the world.
      Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have
      been directly transmitted to humans, raising concern over the possibility of a new influenza
      pandemic among the world's immunologically naive populations. In order to face this kind of
      situation, a pandemic influenza vaccine has to be developed.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol

          -  A male or female aged over 60 years at the time of vaccination.

          -  Written informed consent obtained from the subject.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the administration of the study vaccine, or
             planned use during the study period.

          -  Participation in an earlier study with a candidate pandemic H9N2 vaccine.

          -  Acute disease at the time of enrolment.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Drug and/or alcohol dependency.
Neem Lotion With Combing for Lice
Condition: Pediculoses; Head Lice
MeSH terms: Lice Infestations
Intervention: Neem-based lotion plus louse comb; Neem-based lotion plus grooming comb
Intervention description: Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb; Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a Phase IIa randomised, assessor blinded, parallel group study in which half the
      participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with
      a head louse detection and removal comb and the remainder were treated with Nice 'n Clear
      plus combing with a normal grooming comb
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females who are found to have an active head louse infection, i.e. the
             presence of live lice. Detection combing will be done with a fine-toothed plastic
             detection comb, until at least one louse is found.

          -  People who give written informed consent and/or, if the participant is below 16 years
             of age, whose guardian gives written informed consent to participate in the study.
             Assent/verbal assent forms will be required for those between the ages of 4 and 16
             years of age. There is no maximum age limit.

          -  Participants must be available for the duration of the study i.e. 15 days.

        Exclusion Criteria:

          -  People who have been treated with other head louse products within the previous 2
             weeks (14 days).

          -  People who have undergone a course of antibiotic treatment using Cotrimoxazole,
             Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such
             a course.

          -  People whose hair has been bleached, colour treated, or semi-permanently waved within
             the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home
             use wash in/wash out colouring agents are acceptable.

          -  People who have taken part in another clinical study within 4 weeks prior to entry to
             this one.

          -  Females who are pregnant or breast-feeding.

          -  Participants who have already taken part in this study.

          -  People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion
             (including allergy to Paraben preservatives)

          -  Children under 6 months of age.
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
Condition: Cardiorenal Syndrome
MeSH terms: Cardio-Renal Syndrome; Syndrome
Intervention: Furosemide intravenous solution; Chlortalidone; Spironolactone
Intervention description: Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.; One 50 mg pill administrated every 24 hours in group B; One 50 mg pill administrated every 24 hours in group B
Intervention MeSH terms: Chlorthalidone; Furosemide; Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Its a randomized, controlled, phase II, 2-arm, double-blind clinical trial
Masking: Double (Participant, Investigator)
Masking description: Double-blind clinical trial
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In double-blind clinical trial, determine renal recovery with two different furosemide
      strategies in patients with type 1 cardiorenal syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Comply with both clinical diagnosis of acute kidney injury by serum creatinine
             according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and
             acute decompensate heart failure as clinical assessed by the clinical team in charge.

          -  Have agreed and signed informed consent

        Exclusion Criteria:

          -  Patient in chronic dialysis either peritoneal dialysis or hemodialysis.

          -  History of being a renal transplant recipient

          -  History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal
             replacement therapy in the last 3 months

          -  Pregnancy

          -  Impossibility to administer medication by the oral route
Brain Function and Structure in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Citalopram; Placebo
Intervention description: 20 mg or 40 mg daily for 8 weeks; Placebo daily for 8 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: substance abuse; cocaine; impulsivity; serotonin; MRI

Summary:

      The purpose of this study is to examine the role of brain MRI findings in predicting
      treatment outcomes among individuals with cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine
             dependence who are seeking treatment.

        Exclusion Criteria:

          1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             marijuana, nicotine, or alcohol

          2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
             requiring ongoing treatment and/or making study participation unsafe

          3. Significant current suicidal or homicidal ideation

          4. Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure
             disorder, bleeding disorder, or prolonged QT interval on EKG)

          5. Taking CNS active concomitant medications

          6. Taking medications known to have significant drug interactions with the study
             medication

          7. Having conditions of probation or parole requiring reports of drug use to officers of
             the court

          8. Impending incarceration

          9. Pregnant or breast feeding for female patients

         10. Inability to read, write, or speak English

         11. Having plans to leave the immediate geographical area within 3 months

         12. Unwillingness or not competent to sign a written informed consent form

         13. Individuals who have pacemakers, metal or electromechanical implants or metallic
             foreign bodies

         14. Patients who are known to be HIV positive will not be included due to possible CNS
             effects of HIV.

         15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal
             symptoms.
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
Condition: Pain
Intervention: CA-008; Ketorolac; Acetaminophen IV; Fentanyl; Bupivacaine Hydrochloride; Lidocaine HCl; Celecoxib; Acetaminophen Oral; Lidocaine Hydrochloride; Exparel
Intervention description: Drug: CA-008 4.2 mg reconstituted in saline; 30 mg IV at the onset of anesthesia; 1 g at the onset of anesthesia; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; 0.25% 30 mL (75 mg) prior to surgery; 1.5% 12 mL at the end of surgery; 200 mg PO bid each day postoperative; 1 g postoperative; 2% 15 mL at the end of surgery; Bupivacaine liposome injection suspension
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Lidocaine; Fentanyl; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult aged 18 - 65 years old

          2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3

          3. Planning elective Bunionectomy repair

          4. For both males and females: using an acceptable method of birth control

          5. If a female: not pregnant or breastfeeding

          6. Have a body mass index ≤ 36 kg/m2

        Exclusion Criteria:

          1. Have another painful condition, other than bunion-related pain, that may require pain
             treatment during the study period

          2. Have active skin disease or another abnormality at the anticipated site of surgery
             that could interfere with the planned surgery.

          3. Have a known allergy to study medications.

          4. Have a history of significant medical, neuropsychiatric or other condition, including
             a clinically significant abnormal clinical laboratory test values

          5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.
Phase 2 DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Intervention: Botulinum Toxins, Type A; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: heel pain

Summary:

      The specific aim of the study is to compare the safety and efficacy of a single
      administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar
      fasciitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent, including authorization to release health information

          -  Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis

          -  Persistent heel pain for more than three months

          -  Women of child bearing potential must have negative pregnancy test at Screening and
             Injection Visits and must use an effective method of birth control during the course
             of the study

        Exclusion Criteria:

          -  Previous surgery on the midfoot or hindfoot

          -  Neuromuscular disease

          -  Systemic muscle weakness

          -  Planning a pregnancy during the study

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days prior to first visit
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: Filgotinib; Placebo; Standard of Care
Intervention description: 200-mg tablet administered orally once daily; Placebo to match filgotinib tablet administered orally once daily; Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Male
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effect of filgotinib on semen
      parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing
      spondylitis, or non-radiographic axial spondyloarthritis.

      Results of this study may be pooled with the results of a separate study being conducted in
      participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the
      same objective.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
             or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening,
             meeting the corresponding specific disease classification criteria as specified in the
             protocol

        Key Exclusion Criteria:

          -  Previously documented problems with male reproductive health

          -  Prior diagnosis of male infertility

          -  Use of any prohibited concomitant medication as outlined by protocol

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.