bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
Condition: Healthy; Stress
Intervention: Passiflora incarnata; Placebo
Intervention description: 3 x 1 tablet per day for 3 days; 3 x 1 ablet per day for 3 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 25 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pascoflair; tsst; passiflora incarnata; non smoking male; and female volunteers

Summary:

      A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora
      incarnata L. in an acute stressful situation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Healthy male and female subjects

          -  Non-smoker;

          -  Age 25 to 45 years;

          -  BMI ≥ 19 to ≤ 30 kg/m2

        Exclusion Criteria:

          -  Any known allergies to the test substance;

          -  Any known addiction to drugs, alcohol or positive results in the drug screening test;

          -  Any serious general illness, ongoing or within the last 12 months;

          -  Any febrile illness (> 24 hrs.) within 7 days prior to treatment;

          -  Any antibiotics for the last four weeks before study inclusion;

          -  Diabetes mellitus;

          -  Known heart disease, hypertension, kidney disease, significant respiratory disease,
             epilepsy, or rheumatoid arthritis;

          -  Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS)
             which could place the subject at risk or interfere with the accuracy of the study
             results;

          -  Pregnancy or lactating;

          -  Current participation or participation in any type of clinical study in the past week;

          -  Current or past participation in a TSST study;

          -  Employees of the Sponsor or the CRO;

          -  Any other medication that, in the opinion of the Investigator is likely to affect
             their response to treatment;

          -  Clinically relevant abnormalities in physical examinations, vital signs, clinical
             chemistry, or haematology as judged by the Investigator;

          -  Any other condition the Investigator or their duly assigned representatives believes
             may affect the ability of the individual to complete the study or the interpretation
             of the study results.
A Randomized Controlled Trial of Mandatory Naps for Physicians in Training
Condition: Fatigue
MeSH terms: Fatigue
Intervention: Mandatory Naps
Intervention description: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 352.0
Sex: All
Healthy volunteers: No
Keywords: sleep deprivation; fatigue

Summary:

      This study will consist of a randomized controlled trial in which the investigators test the
      feasibility and effectiveness of mandatory nap programs for physicians in training. One site
      will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The
      other will be the oncology service of the Hospital of the University of Pennsylvania. The
      primary outcome will be the amount slept while on call. The first year will test the efficacy
      of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour
      mandatory nap schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Residents in the University of Pennsylvania Internal Medicine Training Program who are
             rotating through either Philadelphia VA Medical Center Medical Service or Hospital of
             University of Pennsylvania Oncology Service

        Exclusion Criteria:

          -  Refusal to consent to participate
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; Belimumab 1 mg/kg; Belimumab 10 mg/kg
Intervention description: Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.; Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.; Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 865.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autoimmune Diseases; Lupus; SLE; Systemic Lupus Erythematosus; Belimumab; Antibodies

Summary:

      The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on
      quality of life of two different doses of belimumab administered in addition to standard
      therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE)
      disease.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by ACR criteria.

          -  Active SLE disease.

          -  Autoantibody-positive.

          -  On stable SLE treatment regimen.

        Key Exclusion Criteria:

          -  Pregnant or nursing

          -  Have received treatment with any B cell targeted therapy.

          -  Have received treatment with a biological investigational agent in the past year.

          -  Have received IV cyclophosphamide within 180 days of Day 0.

          -  Have severe lupus kidney disease.

          -  Have active central nervous system (CNS) lupus.

          -  Have required management of acute or chronic infections within the past 60 days.

          -  Have current drug or alcohol abuse or dependence.

          -  Have a historically positive test or test positive at screening for HIV, hepatitis B,
             or hepatitis C.
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Matching Placebo for Upadacitinib; Upadacitinib
Intervention description: Matching placebo tablets; Upadacitinib tablets
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 624.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; Crohn's Disease; Efficacy; Safety

Summary:

      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo as induction therapy in participants with moderately and severely active Crohn's
      disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CD for at least 3 months prior to Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score.

          -  Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
             disease (SES-CD) on an endoscopy confirmed by a central reader.

          -  Demonstrated an inadequate response or intolerance to any biologic therapy for
             infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
             corticosteroids or methotrexate (MTX).

          -  Participant with the following ongoing known complications of CD: abscess (abdominal
             or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or
             any other manifestation that might require surgery while enrolled in the study.

          -  Participant with ostomy or ileoanal pouch.

          -  Participant diagnosed with conditions that could interfere with drug absorption
             including but not limited to short gut or short bowel syndrome.

          -  Screening laboratory and other protocol pre-specified analyses show abnormal results.
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Condition: Candidiasis, Invasive; Candidemia; Mycoses
MeSH terms: Infections; Mycoses; Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Isavuconazole; Caspofungin; Voriconazole
Intervention description: Administered by intravenous infusion.; Administered by intravenous infusion.; Administered by intravenous infusion.
Intervention MeSH terms: Voriconazole; Caspofungin; Isavuconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 450.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Invasive Candida infections; BAL8557; ASP9766; Isavuconazole; Candidemia; Candidemia and other invasive candida infections; Phase III study

Summary:

      The purpose of the study is to compare the safety and efficacy of isavuconazole versus
      caspofungin followed by voriconazole in the treatment of candidemia and other invasive
      Candida infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with candidemia or with an invasive Candida infection

          -  Presence of fever, hypothermia or other appropriate local sign of infection

          -  Female patients must be non-lactating and at no risk of pregnancy

        Exclusion Criteria:

          -  Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
             esophageal or genital candidiasis; or candidal lower urinary tract infection or
             Candida isolated solely from respiratory tract specimens

          -  Patients with candidemia who failed a previous antifungal therapy for the same
             infection

          -  Patients previously enrolled in a phase III study with isavuconazole

          -  Patients with a body weight <40kg
Phase IIIB Subcutaneous Abatacept Monotherapy Study
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: abatacept; Methotrexate (MTX)
Intervention description: solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open; Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in
      the absence of an IV loading dose of abatacept
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Rheumatoid Arthritis

          -  Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog
             scale

          -  Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except
             for methotrexate

        Exclusion Criteria:

          -  Received treatment with rituximab

          -  Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba
             columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin
             inhibitors, or D-Penicillamine
Low-level Light Therapy for Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: low-level light therapy; Placebo
Intervention description: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.; we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 88.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Primary Dysmenorrhea; Pain

Summary:

      The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach of
      skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinical diagnosis of primary dysmenorrhea.

          -  a self-reported visual analog scale (VAS) for menstrual pain intensity over 7 on a
             scale of 0-10.

        Exclusion Criteria:

          -  diagnosis of a serious medical or psychiatric illness, endometriosis or uterine
             fibroids, uterine adenomyosis, those taking oral contraceptives within the last 1
             month, those who were pregnant or in whom the pregnancy test was positive were
             excluded.
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: exemestane (Aromasin); tamoxifen + exemestane
Intervention description: exemestane, orally, 25 mg, for 5 years; tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
Intervention MeSH terms: Tamoxifen; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9779.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given
      sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast
      cancer.

      This Pfizer sponsored trial is part of an international collaboration of investigators
      conducting 7 similar yet independent studies in 9 countries. This study is designed to be
      part of the larger TEAM trial where the data from these 7 studies will be combined. A
      pre-specified analysis of the pooled data will be conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically/cytologically confirmed adenocarcinoma of the breast, followed by
             adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if
             indicated.

          -  Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being
             considered.

        Exclusion Criteria:

          -  Those patients not deemed to have had potentially curative primary surgical treatment
             or one of the following criteria:

          -  Inflammatory breast cancer

          -  Histologically positive supraclavicular nodes

          -  Ulceration/infiltration of local skin metastasis

          -  Neoadjuvant chemotherapy

          -  Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion

          -  ER and PR negative primary tumor or ER/PR unknown status.
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live); Comparator: M-M-R II; Comparator: Varivax; Comparator: Placebo
Intervention description: A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous injection at Day 1; A Single 0.5 mL subcutaneous placebo injection at Day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 801.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study was conducted to determine if ProQuad may be used in place of the second dose of
      M-M-R II routinely given to children 4 to 6 years old who were previously immunized with
      M-M-R II and Varivax.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  Received primary dose of M-M-R II at less than or equal to 12 months of age

          -  Received primary dose of Varivax at less than or equal to 12 months of age

          -  Negative history of varicella, zoster, measles, mumps, and rubella

        Exclusion Criteria:

          -  history of receiving more than once dose of M-M-R II or Varivax

          -  Any immune impairment or deficiency

          -  Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
             vaccination

          -  Vaccination with an inactive vaccine with in the past 14 days

          -  Vaccination with a live vaccine within the past 30 days

          -  Receipt of immune globulin, or blood product in the past 5 months
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Condition: Erythema; Rosacea
MeSH terms: Rosacea; Erythema
Intervention: AGN-199201; Vehicle to AGN-199201
Intervention description: AGN-199201 applied to the face once daily for 29 days.; Vehicle to AGN-199201 applied to the face once daily for 29 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle
      for the treatment of persistent moderate to severe facial erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe persistent facial erythema associated with rosacea.

        Exclusion Criteria:

          -  Greater than 3 inflammatory lesions on the face

          -  Current treatment with monoamine oxidase (MAO) inhibitors

          -  Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or
             Sjogren's syndrome.
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
Condition: Refractory Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Intervention: Esomeprazole (D961H) twice daily; Esomeprazole (D961H) once daily
Intervention description: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening; One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1398.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Refractory Reflux Esophagitis,; Japanese,; Nexium,; twice daily,; oral administration

Summary:

      This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to
      evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20
      mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux
      esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of
      presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA)
      classification
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures.

          2. Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy
             despite of at least 8-week treatment using standard doses of PPIs.

          3. Patients must fulfill at least one of the following criteria such as (i) RE with LA
             grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was
             diagnosed more than 1 year before visit 1.

          4. Patients who are able to complete the Patient Diary

        Exclusion Criteria:

          1. Male or female aged less than 20 years at the time of informed consent.

          2. Patients with current evidence of the gastrointestinal diseases/conditions such as
             esophageal stricture to interfere with the evaluation of the study etc

          3. Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.

          4. Previous esophageal, gastric or duodenal surgery except simple closure of perforated
             ulcer, simple endoscopic treatment with simple operation etc

          5. Current or historical evidence (within 12 weeks prior to randomisation) of the
             diseases/conditions as judged to interfere with the evaluation of the study.