bioihbjkbjnl/mcl2 huggingface dataset:
The 3DKnee™ System: A Post-Market Study
Condition: Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis; Varus Deformity; Avascular Necrosis
MeSH terms: Arthritis; Necrosis
Intervention: 3DKnee
Intervention description: Subjects with knee osteoarthritis and willing to participate in the study
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™
      system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic
      implant in the knee. Each knee will be designated as a separate subject and followed for a
      period of 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  This must be a primary knee replacement on this knee.

          -  Have knee joint disease related to one or more of the following

               -  degenerative joint disease, including osteoarthritis or traumatic arthritis

               -  Avascular necrosis of the femoral condyles

               -  Post-traumatic loss of joint configuration, particularly when there is
                  patellofemoral erosion, dysfunction or prior patellectomy

               -  Moderate valgus, varus, or flexion deformities

               -  Rheumatoid arthritis

          -  Patient is likely to be available for evaluation for the duration of the study

          -  Able and willing to sign the informed consent and follow study procedures

          -  Patient is not pregnant

          -  Patient must be over 18 years of age

        Exclusion Criteria:

          -  If there has been a total knee replacement on this knee in the past (no revisions
             allowed in study)

          -  Infection, or history of infection, acute or chronic, local or systemic

          -  Alcoholism or other addictions

          -  Muscular, neurological or vascular deficiencies which compromise the affected
             extremity

          -  Obesity

          -  Insufficient bone quality

          -  Loss of ligamentous structures

          -  High levels of physical activity

          -  Materials sensitivity

          -  Prisoner

          -  Mental conditions that may interfere with the patient's ability to give an informed
             consent or willingness to fulfill the study requirements

          -  Patient is pregnant

          -  Is younger than 18 years of age
Anti-D for Treating Thrombocytopenia in Adults Infected With Hepatitis C Virus With or Without HIV Co-Infection
Condition: Thrombocytopenia; Hepatitis C; HIV Infections
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis; Thrombocytopenia
Intervention: Anti-D
Intervention description: 30-minute infusion administered in an outpatient setting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; HCV; Hepatitis C; Thrombocytopenia

Summary:

      Thrombocytopenia occurs when a person's blood has a decreased number of platelets, which are
      cells involved in blood clotting. This condition may lead to uncontrolled bleeding and can be
      fatal. Thrombocytopenia commonly occurs with hepatitis C virus (HCV) infection or as a result
      of standard HCV treatment. Anti-D is an antibody approved by the Food and Drug Administration
      (FDA) for the treatment of HIV-related thrombocytopenia. The purpose of this study is to
      determine the safety and effectiveness of intravenous anti-D for the treatment of
      thrombocytopenia in patients with HCV infection who are starting or already undergoing
      treatment with peginterferon alfa-2 and ribavirin. This study will recruit HCV patients both
      with and without HIV co-infection.
    

Eligibility criteria:

        Inclusion Criteria for All Participants:

          -  HCV-infected

          -  Currently on treatment for HCV OR plan to begin treatment for HCV at the start of this
             study

          -  Platelet count less than 50,000 cells/microl

          -  Hemoglobin greater than 10 g/dl OR greater than 11 g/dl if peginterferon
             treatment-naive

          -  Red blood cells are Rh (D) antigen-positive

          -  Negative Coombs direct antibody test

        Inclusion Criteria for HIV Infected Group:

          -  HIV-infected

        Inclusion Criteria for HIV Uninfected Group:

          -  HIV-uninfected

        Exclusion Criteria:

          -  Prior treatment with intravenous immunoglobulin (IVIG), anti-D, or other medication
             for the treatment of thrombocytopenia within 30 days of study entry

          -  Prior serious reaction to plasma products

          -  Absence of spleen

          -  Evidence of thrombotic thrombocytopenic purpura (TTP) OR cause of thrombocytopenia
             other than HCV infection, HCV treatment, or HIV infection
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase
Condition: Hip Dysplasia; Postoperative Complications
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Postoperative Complications
Intervention: Dexamethasone
Intervention description: intravenous
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the effect of a single preoperative high-dose steroid
      injection on complications in the immediate postoperative phase after periacetabular
      osteotomy. Primary outcome is the proportion of patients who have moderate to severe
      postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific
      complications in the post anaesthesia phase, pain and nausea the first 5 days, wound
      infection and readmissions the first 30 days after surgery.

      The investigators hypothesize that the frequency of moderate to severe pain and organspecific
      complications in the post anaesthesia care unit will be lower among patients receiving high
      dose dexamethasone. The investigators hypothesize, that there will be no difference in wound
      infections or readmissions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned unilateral periacetabular osteotomy

          -  informed signed consent

        Exclusion Criteria:

          -  Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)

          -  ongoing (<30 days) use of immunosuppressive therapy

          -  insulin dependent diabetes

          -  pregnancy/breastfeeding

          -  allergies toward study medication, or medication in the standard treatment

          -  surgery cannot be performed
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Condition: Acne Prone Skin
MeSH terms: Acne Vulgaris
Intervention: Facial Cleanser and Moisturizer SPF 30
Intervention description: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: acne, pediatric

Summary:

      The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam
      Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 7-11 years of age

          -  Subjects with acne-prone skin [Global severity of acne (GSA) Score of 1 (almost clear)
             or 2 (mild) and any oiliness evaluation score or GSA Score of 0 (none) with an
             oiliness evaluation score greater than or equal to 1 (mild)]

        Exclusion Criteria:

          -  Subjects with any visible skin condition or facial hair that could interfere with the
             evaluations

          -  Subjects taking other medications, supplements, or non-prescription treatments that,
             in the opinion of the principal investigator/board certified dermatologist, could
             interfere with the test results including any regimen of steroidal/non steroidal
             anti-inflammatory drugs or antihistamines

          -  Subjects currently under the treatment for asthma or diabetes (insulin-dependent only)

          -  Subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or
             body art (tattoos, permanent or temporary) on the face, which could interfere with
             subsequent evaluations of dermal responsiveness
Sedative-Anxiolytic Effects on Simulated Driving Performance
Condition: Psychomotor Impairment
MeSH terms: Psychomotor Disorders
Intervention: Alprazolam 2mg (2ALP/PLC); Alprazolam 1mg (1ALP/PLC); Alprazolam 0.5mg (0.5ALP/PLC); Zolpidem 10mg (ZOL/PLC); Placebo (PLC/PLC); Alprazolam 1mg (PLC/ALC)
Intervention description: 2mg alprazolam administered at night, placebo administered in the morning.; 1mg alprazolam administered at night, placebo administered in the morning.; 0.5mg alprazolam administered at night, placebo administered in the morning.; 10mg alprazolam administered at night, placebo administered in the morning.; Placebo administered at night, placebo administered in the morning.; Placebo administered at night, 1mg alprazolam administered in the morning.
Intervention MeSH terms: Zolpidem; Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Participants and outcomes assessors were masked with respect to each individual intervention.
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car
      the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed
      or in the morning before using a driving simulator to assess impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  valid driver's license

          -  english-speaking and literate

        Exclusion Criteria:

          -  using daily medication for chronic condition

          -  acute narrow angle glaucoma

          -  previous adverse experience with study drugs

          -  experiences motion sickness in response to driving simulator

          -  BMI > 30

          -  women who are pregnant, lactating, or planning on becoming pregnant

          -  regular use of tobacco products

          -  current substance use disorder

          -  clinically significant ECG

          -  current ongoing psychiatric disorder
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Placebo; Adalimumab
Intervention description: Subcutaneous injections administered as described in arm description; Subcutaneous injections administered as described in arm description
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Axilla; Inguinal region; Hurley Stage I, II, or III; Adalimumab; Secondary intention; Abcess and inflammatory nodule (AN) count

Summary:

      The objective of this study was to assess the safety and efficacy of adalimumab prior to
      surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were
      surgical candidates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa
             (HS) for at least 1 year (365 days) prior to the Baseline visit

          -  Participant must have at least 3 distinct anatomical regions involved with
             inflammatory (also termed 'active') HS lesions; plus

               -  either one axilla or one inguinal region (limited to the inguino-crural fold and
                  adjacent areas) that requires excisional surgery, and

               -  with at least one of the other affected HS regions (e.g., contralateral inguinal
                  region, buttocks, inframammary region) rated as Hurley Stage II or III

          -  Participant must have a total abscess and inflammatory nodule (AN) count of greater
             than or equal to 3 at the Baseline visit within the HS non-surgical sites

          -  The HS surgical site must contain at least one active HS lesion

          -  The HS surgical site must require excisional surgery and is large enough to require
             healing by secondary intention as assessed by the designated surgeon

        Exclusion Criteria:

          -  Participant has a draining fistula count of greater than 20 at the Baseline visit

          -  Participant requires surgery at any anatomical site other than an unilateral axilla or
             inguinal region site

          -  Participant requires surgical management prior to Week 13

          -  Participant requires, based on the designated surgeon's assessment, excisional surgery
             with primary closure as the method of closure being most beneficial for the
             participant
Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor
Condition: Pregnancy
Intervention: Buccal Misoprostol; Vaginal misoprostol
Intervention description: Buccal rather than Vaginal misoprostol for induction of labor; Vaginal rather than buccal misoprostol for induction of labor
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue,
      is a widely accepted induction agent, that has been proven safe and effective for induction
      of labor. It stimulates both cervical ripening and uterine contractions, thus making it an
      ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of
      different administration routes and effects on uterine contractility, side effects, and
      safety. Vaginal misoprostol has been shown to be superior over oral administration however
      patients often prefer a more tolerable route. Buccal administration has already been shown to
      be as effective as vaginal misoprostol for cervical ripening and induction in both first
      trimester and second trimester abortions. There is minimal research comparing buccal versus
      vaginal for third trimester induction of labor. The investigators study is a prospective,
      double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol
      in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal
      misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willingness to participate / consent in a placebo-controlled trial

          -  Age 18 and older

          -  Pregnancy between 34 and 42 years of gestation

          -  Admitted for labor induction because of either medical, obstetric, or psychosocial
             indications

          -  Live singleton fetus

          -  Bishop score less than or equal to six

          -  Cephalic presentation

          -  Reactive non-stress test or Negative contraction test

        Exclusion Criteria:

          -  Premature rupture of membranes

          -  Multiparity > 5

          -  Contraindication to vaginal or labor delivery

          -  Suspected placental abruption

          -  Significant hepatic, renal or cardiac disease

          -  Known hypersensitivity to misoprostol or prostaglandin analogue

          -  Recent prostaglandin administration for induction of labor

          -  Multifetal pregnancy

          -  Macrosomia > 4500g estimated fetal weight by ultrasound or leopold
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: entecavir; entecavir; peginterferon alfa-2a [Pegasys]
Intervention description: 0.5mg po daily for 8 weeks; 0.5mg po daily for 48 weeks; 180 micrograms sc/week for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential
      treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who
      have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to
      one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po
      daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study
      treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >=18 and </= 65 years of age

          -  HBeAg positive chronic hepatitis B

          -  Pre-treatment with entecavir for 9-36 months

        Exclusion Criteria:

          -  Antiviral, antineoplastic or immunomodulatory treatment

          -  Co-infection with active hepatitis A, C or D, or HIV

          -  Evidence of decompensated liver disease

          -  History or other evidence of a medical condition associated with chronic liver disease
             other than viral hepatitis
Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI)
Condition: Chronic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis; Fibrosis
Intervention: Perfusion MRI
Intervention description: 1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: liver fibrosis; liver cirrhosis; chronic hepatitis; magnetic resonance imaging

Summary:

      Patients with chronic liver disease are at high risk of developing liver scarring (fibrosis),
      with ultimate risks of cirrhosis and liver cancer that may require liver transplant. The
      investigators would like to develop non invasive advanced Magnetic Resonance Imaging (MRI)
      techniques (MR diffusion, perfusion and elastography) to assess the degree of liver damage in
      patients with chronic liver disease. These techniques combined could reach high diagnostic
      performance for detection of liver fibrosis; and could decrease the number of liver biopsies,
      which have risks and sample only a small portion of the liver.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic liver disease (including viral hepatitis, alcoholic hepatitis, non alcoholic
             steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, etc..)

          -  18 years of age and older

          -  Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as
             part of routine clinical care.

          -  Liver transplant or liver resection performed within 6 months, as part of routine
             clinical care.

          -  Patient is able to give informed consent for this study and agrees to provide a blood
             sample

        Control group

          -  Patients without history of liver disease and healthy volunteers

          -  18 years of age and older

          -  Subject is able to give informed consent for this study and agrees to provide a blood
             sample

        Exclusion Criteria:

          -  Age less than 18 years

          -  Unable or unwilling to give informed consent

          -  Contra-indications to MRI

          -  Electrical implants such as cardiac pacemakers or perfusion pumps

          -  Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial
             hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or
             steel implants

          -  Ferromagnetic objects such as jewelry or metal clips in clothing

          -  Pregnant subjects

          -  Pre-existing medical conditions including a likelihood of developing seizures or
             claustrophobic reactions.