bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug
      regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without
      Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
    


Intervention name(s): Tegobuvir (GS-9190); GS-9451; Pegasys®; Copegus®; GS-9451; Tegobuvir placebo; Pegasys®; Copegus®; Tegobuvir placebo; GS-9451 placebo; Pegasys®; Copegus®
Intervention type(s): Drug; Drug; Biological; Drug; Drug; Drug; Biological; Drug; Drug; Drug; Biological; Drug
Intervention description(s): Tegobuvir (GS-9190) capsule, 30 mg BID; GS-9451 tablet, 200 mg once daily (QD); peginterferon alfa-2a (solution for injection) 180 µg/week; ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); GS-9451 tablet, 200 mg QD; placebo matching Tegobuvir (GS-9190) capsule BID; peginterferon alfa-2a (solution for injection) 180 µg/week; ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); placebo matching Tegobuvir (GS-9190) capsule BID; placebo matching GS-9451 tablet QD; peginterferon alfa-2a (solution for injection) 180 µg/week; ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; HCV RNA; Polymerase inhibitor; Protease inhibitor; Treatment naïve; GS-9190; GS-9451
Relaxation Treatment in Total Knee Arthroplasty
Condition: Relaxation; Joint; Total Knee Arthroplasty; Exercise
Study type: Interventional

Summary: 
      Surgical techniques and treatment methods of the arthroplasty have been improved and the
      results after total knee arthroplasty (TKA) are generally good. However, some patients have
      suboptimal postoperative results with respect to pain and physical functioning and may not be
      satisfied with the results of their TKA. Psychological symptoms were found to be associated
      with these suboptimal results. The aim of the present study is to determine weather
      relaxation techniques had beneficial effects on pain, sleeping quality, functional status and
      physiological symptoms in TKA patients during their hospital stay.
    


Intervention name(s): Relaxation Treatment; Standard Exercises
Intervention type(s): Other; Other
Intervention description(s): Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min; The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1
Other intervention name(s): Standard Exercises; Relaxation Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effective Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal dosage of etanercept in patients
      treated for idiopathic juvenile arthritis
    

Detailed description: 
      Etanercept, a fully human soluble tumor necrosis factor (TNF) receptor fusion protein, has
      been demonstrated to be safe and efficacious for the treatment of patients with polyarticular
      JIA. However, many patients experience primary or secondary response failure, suggesting that
      individualization of treatment regimens may be beneficial. It has been shown that the
      clinical response to two anti-TNFalpha biological agents (infliximab, adalimumab) closely
      follows the trough drug levels and the presence of antibodies directed against the drugs.
      This study was undertaken to investigate whether serologic monitoring of etanercept
      bioavailability and immunogenicity in individual patients with JIA would be useful in
      optimizing treatment regimens to improve efficacy and tolerability
    

Intervention name(s): Blood test
Intervention type(s): Genetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: juvenile idiopathic arthritis; etanercept
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Condition: Cheyne-Stokes Respiration; Sleep Apnea, Central
MeSH terms: Apnea; Cheyne-Stokes Respiration; Sleep Apnea, Central
Study type: Interventional

Summary: 
      Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab
      polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter
      Cheyne Stokes Respiration, or Complex Sleep Apnea.
    

Detailed description: 
      Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one
      full night attended continuous positive airway pressure (CPAP) titration, and one full night
      attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV
      Advanced to use at home for 90 days.
    

Intervention name(s): BiPAP autoSV Advanced
Intervention type(s): Device
Intervention description(s): The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The main objective of the study is to estimate and compare the overall cost of care of
      patients over 60 months of follow-up between two groups: (1) patients undergoing
      robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing
      robot-assisted radical prostatectomy via laparotomy.

      The time horizon of the main objective changes to 60 months (due to the opportunity to access
      patient care consumption from the National Health Data System).
    

Detailed description: 
      The secondary objectives of this research are to compare the following between the two
      groups:

        -  The actual cost of the surgical prostatectomy.

        -  Erectile function at 0, 1, 6, 12 and 24

        -  Oncological results at 1, 6, 12 and 24 months.

        -  Functional results at 0, 1, 6, 12 and 24 months.

        -  Quality of life at 0, 1, 6, 12 and 24 months.

        -  Complication rates at 1 and 24 months.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men between the ages of 45 and 75 and who have been diagnosed with localised prostate
        cancer. The treatment option retained is radical prostatectomy.
      
Keywords: Radical prostatectomie; Robotic assistance; Laparotomy
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the safety and effectiveness of CNTF implants on
      vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This
      research is being done because there are no effective therapies for people with these retinal
      degenerations. They are genetic disorders that affect one's ability to see at night, and
      later cause tunnel vision and loss of central vision. Retinal degenerations affect the
      retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these
      cells die and cause permanent loss of vision.

      The implant is a small capsule that contains human retinal pigment epithelium cells. These
      cells have been given the ability to make CNTF and release it through the capsule membrane
      into the surrounding fluid. In this study, two different CNTF dose levels will be used: a
      high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.
    

Detailed description: 
      This study will involve about 18 visits over 2½ years for specific tests of the participant's
      vision and health. These visits may include visual exams, blood draw for laboratory testing,
      brief medical history and exam, and occasionally a questionnaire (survey), in addition to the
      visit for the surgical procedures. The primary effectiveness outcome for this study will be a
      visual field score one year after the implant surgery. There will be about 12 centers
      participating in this study, and up to 60 people enrolled, across the US. Each participant
      joining the study who has completed initial screening will then be scheduled to have a brief
      surgical procedure performed on each eye, one of which will include a very small cell-filled
      implant. Follow-up visits for repeat assessments will be required regularly to determine if
      the implant being tested is safe and effective for use to treat retinitis pigmentosa (RP).
    

Intervention name(s): NT-501; NT-501
Intervention type(s): Drug; Drug
Intervention description(s): High Dose; Low Dose
Other intervention name(s): CNTF implant; CNTF implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Retinitis Pigmentosa; eye disease; retinal disorder; CNTF
Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Condition: Maternal and Newborn Health
Study type: Interventional

Summary: 
      The study will evaluate the effects of a nutrition supplement for pregnant women on birth
      weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified
      food supplement will produce babies with a higher mean birth weight than those who do not.
    


Intervention name(s): Corn Soya Blend+
Intervention type(s): Dietary Supplement
Intervention description(s): A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia
Condition: Heparin-Induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate efficacy and safety of argatroban in the patients
      with heparin-induced thrombocytopenia (HIT)/ HIT and thrombosis syndrome (HITTS). This
      multi-center trial covers mainly the patients with cardiovascular diseases. Subjects are
      included in the trial when they are clinically diagnosed of HIT/HITTS. Initial dose of
      argatroban is 0.7μg/kg/min, which is about one-third of the approved dose in the US. The
      reason of the lower initial dose is that the approved dose of argatroban in Japan (for the
      treatment of ischemic stroke) is about 0.7μg/kg/min and safety of higher doses of the drug
      are not confirmed. A sub-study of pharmacokinetics is simultaneously conducted to reveal the
      relationship among the dose, aPTT, and blood drug concentration.
    


Intervention name(s): argatroban
Intervention type(s): Drug
Intervention description(s): beginning dose: 0.7microgram/kg/H
Intervention MeSH terms: Argatroban
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heparin-induced thrombocytopenia; argatroban; cardiac surgery; acute coronary syndrome; thrombosis; amputation; anticoagulation
VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open label, partially blinded clinical trial in which healthy volunteers will be
      administered experimental malaria vaccines. There will be seven experimental groups of
      volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21,
      in combination with the vaccine adjuvant, Matrix M.

      The study will assess the safety & immune responses to vaccination, and the efficacy of the
      vaccine.
    

Detailed description: 
      Arms 1a & 1b receive vaccines at 3 vaccinations at 4 week intervals and a booster vaccination
      approximately 12 months after the first vaccination.

      Arms 2a & 2b receive 3 vaccinations at 0, 4 and 24 weeks. The protected volunteers in 2a from
      the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the
      rechallenge, VAC072B.

      Arms 3a and 3b receive 3 vaccinations at 0, 4 and 8 weeks. The protected volunteers in 3a
      from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before
      the rechallenge, VAC072B.

      Arms 4a and 4b will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is
      fractional. Volunteers then have the option to be challenged 28 days after final vaccination.

      Group 5 will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional.
      Volunteers then have the option to be challenged 28 days after final vaccination.

      Groups 6 & 7 are control groups and will receive controlled human malaria infection (CHMI)

      Healthy volunteers will be recruited in England across four research sites in Oxford, London,
      and Southampton.
    

Intervention name(s): R21 Matrix-M vaccination; R21 Matrix-M vaccination and CHMI; R21 Matrix-M vaccination booster
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly; Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite; Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria challenge; Malaria vaccine
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
Condition: Recurrent Low Back Pain; Persistent Low Back Pain; Chronic Low Back Pain
MeSH terms: Recurrence; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      As low back pain is often a recurrent and sometime persistent problem, research into
      prevention is important. Chiropractors have traditionally treated patients with maintenance
      care, which means that patients are seen on a regular basis to prevent recurrences or to stop
      a persistent problem getting worse. However, it is not known if this has the expected effect.

      This study will test the effectiveness of the maintenance care approach. Patients with
      recurrent or persistent low back pain will be treated in accordance with two different
      models. The first model is the maintenance care model, meaning that chiropractors will see
      the patient on a regular basis, regardless symptoms. The other model means that patients
      should be treated patients only when they themselves experience symptoms bad enough to seek
      care. After one year, it will be possible to see if there has been any difference between the
      groups in terms of pain, disability, quality of life and total number of treatments over the
      study period and to investigate if there is any difference in the cost-effectiveness between
      the two treatment models.Thus, the study hypothesis is that there is no difference between
      the two models regarding the number of days with pain.

      This study will be a multi-centre trial, and as part of the study, it will be necessary to
      formalize a network of research clinics all over Sweden in which participating chiropractors
      accept to perform complex data collection. This network will then have the expertise and
      potential to perform future clinical studies together with networks in other countries,
      allowing large clinical trials across countries.
    


Intervention name(s): maintenance care; Treatment as needed
Intervention type(s): Other; Other
Intervention description(s): Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor; Participants may never receive treatment, there is no upper limit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of the Nella Women's Care Line
Condition: GYN Disorders
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Evaluation of the Nella Women's Care Line
    

Detailed description: 
      The Nella Women's Care Line is being studied in women undergoing a gynecological exam and
      other gynecological procedures that require visibility and access to the cervix.
    

Intervention name(s): Group 1: Nella VuSleeve; Group 2: Nella NuSpec; Group 3: NellaSpec; Group 4: Nella Insert
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Sleeve; Speculum; Speculum; Sleeve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with
      ADHD using a classroom study design.
    

Detailed description: 
      The study consists of two distinct treatment phases. The first is the 6-week open-label,
      treatment optimization phase during which subjects are titrated to an optimal daily dose of
      HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo
      treatment for an additional week prior to final testing during a laboratory school day.
    

Intervention name(s): HLD200; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): methylphenidate hydrochloride (MPH)
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thyroid Hormone Values and Anti-thyroid Peroxidase Antibody Positivity in Recurrent Pregnancy Loss
Condition: Autoimmune Thyroiditis; Recurrent Miscarriage
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Thyroid Diseases; Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease; Recurrence
Study type: Observational

Summary: 
      The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase
      (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy
      pregnancies. The primary objective is to find out the relationship between recurrent
      pregnancy loss with thyroid hormone levels and anti-TPO positivity.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study was carried out with a total of 103 patients by retrospectively examining the
        patients who applied to the Gynecology and Obstetrics Clinic of Bülent Ecevit University
        Faculty of Medicine between 2018-2022
      
Keywords: Thyroid Hormones; Anti Thyroid Peroxidase Antibody; Recurrent pregnancy loss
Tricaprilin in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and effectiveness of
      tricaprilin administered once a day for ninety days in subjects with mild to moderate,
      probable Alzheimer's disease.
    

Detailed description: 
      Substantial scientific evidence has shown that defects in glucose metabolism occur in
      Alzheimer's disease. Attempts to compensate for the reduced cerebral metabolic rates in AD
      have met with some success. Treatment of AD patients with high doses of glucose and insulin
      will raise cognitive scores. However, this effect is slight, and high doses of insulin can
      have adverse consequences. Administration of ketone bodies or their metabolic precursors such
      as medium chain triglycerides (MCTs) presents an attractive alternative to glucose and
      insulin. In a preliminary study, tricaprilin, an MCT, demonstrated pharmacological activity
      and statistically significant efficacy in improving short-term memory and attention
      performance after a single dose.

      Participants will be randomized to receive either tricaprilin or a matching placebo,
      administered once a day by mixing powder in a glass of liquid. The treatment period will last
      90 days, followed by a 2-week washout period. Each patient will be seen 5 times: at
      screening, baseline, and post-baseline days 45, 90, and 104. The visits will include physical
      and/or neuropsychological examinations, electrocardiograms (ECGs) and laboratory tests.
    

Intervention name(s): Tricaprilin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Powder formulation will be mixed in a liquid (approximately 8 oz).; Powder formulation will be mixed in a liquid (approximately 8 oz).
Other intervention name(s): AC-1202; Matching placebo to AC-1202
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ketones; Apolipoprotein E; ApoE genotype; cognitive function; glucose metabolism