bioihbjkbjnl/mcl2 huggingface dataset:
Rehabilitation Study in MS Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Intervention: Interferon beta-1b, FRP within 15 days after randomization; Interferon beta-1b, FRP about 6 weeks after randomization
Intervention description: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization; Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: KineSEP; Rehabilitation; Betaferon

Summary:

      Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing
      Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical
      ability of patients with and without FRP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and Male patients aged 18 and more;

          -  Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;

          -  First indication for Betaferon treatment (as described in Summary of Product
             Characteristics (SmPC));

          -  No relapse of multiple sclerosis (MS) in the last two months before the inclusion;

          -  Walking patients having an Expanded Disability Status Scale (EDSS) score between > 1
             and </= 4 at the inclusion visit;

          -  Female of child-bearing potential must agree to practice adequate contraception
             methods over all the duration of the study;

          -  Patient can follow all the study and comply with all procedures of the trial protocol

          -  Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count
             and differential white blood cell [WBC]) must be available and the results must be
             normal;

          -  Written informed consent.

        Exclusion Criteria:

          -  Any contraindication to Betaferon as described in the SmPC of the product;

          -  Patient with a previously orthopaedic surgical intervention within the past year of
             the inclusion;

          -  Patient previously included in this study;

          -  Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;

          -  Patient previously treated within the past 12 months with Betaferon;

          -  Participation in any clinical trial within the past 30 days involving the
             investigational drug intake.
Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Condition: Lymphoid Malignancies
MeSH terms: Neoplasms
Intervention: Idelalisib
Intervention description: Idelalisib 150 mg tablet administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to provide idelalisib to participants receiving
      GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit

          -  Evidence of a personally signed informed consent

        Key Exclusion Criteria:

          -  Known hypersensitivity or intolerance to any of the active substances or excipients in
             the formulation of idelalisib

          -  Toxicities that would preclude initiating therapy with idelalisib prior to enrollment

          -  Concurrent participation in another therapeutic clinical trial

          -  Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past
             28 days.

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]
Intervention description: 90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 551.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks,
      and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with
      chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90
      micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24
      weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly
      for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up
      in all treatment groups for the primary endpoint. The anticipated time on study treatment is
      3-12 months, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
             >500,000 copies/mL, and anti-HBs negative;

          -  liver disease consistent with Chronic Hepatitis B.

        Exclusion Criteria:

          -  antiviral therapy for CHB within previous 6 months;

          -  co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
             (HDV) or Human immuno deficiency virus (HIV);

          -  evidence of decompensated liver disease;

          -  medical condition associated with chronic liver disease.
Post Operative Sore Throat and Dexamethasone
Condition: Sore Throat; Pain
MeSH terms: Pharyngitis
Intervention: Placebo administration; Dexamethasone 0.05mg/kr administration; Dexamethasone 0.1mg/kg
Intervention description: Placebo administration; Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery.; Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Sore throat; Dexamethasone; Pain

Summary:

      Sore throat is a common postoperative complaint that can lead to morbidity and patient
      dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90%
      even under optimal intubating conditions. There are several factors that have been shown to
      contribute to postoperative sore throat such as patient related factors, type of anesthesia
      and type of surgery.

      Corticosteroids are also commonly used in the perioperative period to potentiate analgesics
      and as antiemetics. The preoperative administration of dexamethasone can decrease the
      incidence and severity of postoperative sore throat which is rated by patients as one of the
      most undesirable outcomes in the postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients undergoing outpatient laparoscopic gynecologic surgery

          -  ASA PS I and II

          -  Age between 18 and 64 years

          -  Fluent in English

        Exclusion Criteria:

          -  History of recent respiratory tract infection

          -  Pregnancy, breastfeeding

          -  Current treatment with analgesics

          -  Current use of corticosteroids

          -  Anticipated difficult intubation

          -  Risk factors for post-operative aspiration
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Hypoxia
Intervention: Lipo-PGE1
Intervention description: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Intervention MeSH terms: Alprostadil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on
      renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent
      magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were
      included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without
      diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1
      intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and
      after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and medullary
      R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including
      24 hours urinary protein and serum creatinine were collected. the investigators want to prove
      Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chronic kidney disease

        Exclusion Criteria:

          -  Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract
             infection, acute kidney injury, acute cardiovascular and cerebrovascular complications
             and diabetic emergencies, with the use of corticosteroid and diureses.
Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl
Condition: Healthy
Intervention: Fentanyl
Intervention description: Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Volunteer; Pharmacokenetics (PK) (plasma and Cerebrospinal Fluid [CSF])

Summary:

      A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and
      bioavailability study in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal healthy male or female between the ages of 18 to 65 years. Never smokers or
             Non-smokers (cessation of smoking ≥ 6 months ago). Body Mass Index (BMI =
             weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 32.0
             kg/m2.

        No clinically meaningful findings in the physical examination, oral and nasal examination
        and 12-lead electrocardiogram.

        Negative for drugs of abuse, alcohol, and nicotine. Negative for hepatitis A, B, and C and
        Human Immunodeficiency Virus (HIV). No clinical laboratory values outside of the acceptable
        range, unless, in the opinion of the Principal Investigator, they are deemed not clinically
        significant.

        Exclusion Criteria:

          -  Subject has a known history of allergic reaction, hypersensitivity, or clinically
             significant intolerance to opioids, fentanyl or components of the study drugs.

             2. Subjects with a high potential for opioid addiction (personal or family history).

             3. Subject is lactating or considered at risk of pregnancy. 4. Subject has impaired
             liver function (e.g., alanine aminotransferase [ALT] ≥ 3 times the upper limit of
             normal [ULN] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g.,
             hepatitis), or evidence of clinically significant liver disease or other condition
             affecting the liver that may suggest the potential for an increased susceptibility to
             hepatic toxicity with oral diclofenac exposure.

             5. Subject has any history of renal disease that, in the opinion of the investigator,
             would contraindicate study participation; or subject has significantly impaired renal
             function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2.

             6. Subject has a history or evidence of significant nasal pathology, including polyps
             or nasal obstructions.
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
Condition: HIV
Intervention: HIV therapy
Intervention description: Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
Intervention MeSH terms: Maraviroc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: maraviroc; naive; hiv; zidovudine; lamivudine; combivir; Clade A

Summary:

      One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and
      lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy
      and safety of this combination in a Russian population of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years of age.

          -  R5 HIV infection on screening tropism test.

          -  Viral load >1,000 copies/mL.

          -  Never previously treated with anti-HIV medicines.

        Exclusion Criteria:

          -  Previously treated with anti-HIV medicines.

          -  Hepatitis B co-infection.
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Brimonidine 0.33% gel (Br); CD07805/47 (Br) placebo gel; Ivermectin 1% cream (IVM); CD5024 (IVM) placebo cream
Intervention MeSH terms: Ivermectin; Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM)
      associated with Brimonidine 0.33% gel (Br) compared with the association of their respective
      vehicles in the treatment of moderate to severe rosacea.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Male or female subjects age 18 years or older;

          2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and
             pustules) of rosacea on the face;

          3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored
             3 or 4 according to Clinician's Erythema Assessment [CEA]);

          4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to
             the Investigator's Global Assessment [IGA]);

          5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

          6. Female subjects of childbearing potential must practice a highly effective method of
             contraception during the study;

          7. Females subjects of non-childbearing potential;

        Main Exclusion Criteria:

          1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that
             may be confounded with rosacea;

          2. Subjects with more than 2 nodules of rosacea on the face;

          3. Subjects with any uncontrolled chronic or serious disease or medical condition that
             may either interfere with the interpretation of the clinical trial results, or with
             optimal participation in the study or would present a significant risk to the subject;

          4. Subjects with known or suspected allergies or sensitivities to any component of the
             investigational and non-investigational products, including the active ingredients
             brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Condition: Cardiac Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: 68Ga-DOTATATE PET/CT; 18FDG PET/CT scan; 13NH3 PET/CT scan
Intervention description: 5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.; This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.; This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar
      accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so
      without the need for complex patient dietary preparation that is required with 18FDG PET/CT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

        Exclusion Criteria:

          -  Pregnant

          -  Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Mifepristone Induction for Fetal Demise
Condition: Intrauterine Fetal Demise; Fetal Death
MeSH terms: Fetal Death; Stillbirth
Intervention: Mifepristone; placebo
Intervention MeSH terms: Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mifepristone; randomized controlled trial; vaginal delivery; progesterone receptor modulator; induction of labor

Summary:

      Methods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or
      placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational
      age or greater.

      Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when
      compared to placebo, and in conjunction with other pharmacologic methods for induction of
      labor.

      Expected outcomes: The addition of a progesterone receptor modulator will expedite time to
      delivery of the fetus and ultimately improve the experience associated with induction of
      labor for fetal demise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Intrauterine fetal death as confirmed by absence of cardiac motion on ultrasound by
             Attending physician at the time of admission to the hospital.

          2. Estimated gestational age greater than 20 weeks

          3. Hemodynamically stable and appropriate for induction of labor as per primary clinical
             health team in house

          4. Women with one prior low transverse cesarean delivery

        Exclusion Criteria:

          1. History of 2 or more low transverse cesarean deliveries

          2. Prior classical cesarean delivery

          3. History of abdominal myomectomy

          4. Known or suspected allergic reaction to mifepristone

          5. Known or suspected adrenal gland disease

          6. Known or suspected bleeding diatheses or coagulopathies

          7. Known or suspected use of QTc-prolonging medication

          8. Known maternal medical or physical conditions that prohibits vaginal delivery
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone; Tretinoin; Tretinoin
Intervention description: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks; Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
Intervention MeSH terms: Dapsone; Tretinoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 163.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin
      gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe
      facial acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Facial acne vulgaris characterized by the following:

               -  30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;

               -  Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or
                  equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)

          -  Female subjects of childbearing potential must have a negative pregnancy test at
             baseline and practice reliable method of contraception throughout the study

        Exclusion Criteria:

          -  Non-compliance with washout period;

          -  History of clinically significant anemia or hemolysis;

          -  Skin disease/disorder that might interfere with diagnosis or evaluation of acne
             vulgaris;

          -  Allergy or sensitivity to any component of the test medications