bioihbjkbjnl/mcl2 huggingface dataset:
Hydroxytyrosol and Vitamin E in Pediatric NASH
Condition: NAFLD
Study type: Interventional
Phase: Phase 3

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly
      becoming the one of most common causes of chronic liver disease in children. The pathogenesis
      of NAFLD is generally considered the result of a series of liver injuries, commonly referred
      as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative
      stress could be responsible of disease progression to non-alcoholic steatohepatitis (NASH).

      Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with
      antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several
      anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation
      and platelet aggregation.

      Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with
      conflicting results. It inhibits proinflammatory cytokine production and attenuates the
      release of profibrogenic agents and liver collagen.

      The purpose of this interventional study is to evaluate the efficacy and tolerability of
      Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.
    

Detailed description: 
      80 children and adolescents (4-16 years) with biopsy-proven NASH will be enrolled. They will
      be randomized to treatment with hydroxytyrosol and vitamin E (n: 40 pts) or an identical
      placebo (n: 40 pts) given orally for a period of 16 weeks. Patients will undergo a medical
      evaluation at baseline (enrollment) and after 4 months (end of treatment). Anthropometric
      measures and laboratory assay, includin liver enzymes, gluco-insulinemic and lipid profiles
      will be performed at baseline and at the end of the study. Hepatic ultrasound examination
      will be performed at enrollment and at the end of the study.

      Serum sample for determination of markers of inflammation and oxidative stress will be
      collected at enrollment and at the end of the study.

      A stool sample for analysis of gut microbioma will be collected at enrollment and at the end
      of the study.
    

Intervention name(s): Hydroxytyrosol plus Vitamin E; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This group will treated with 2 pills daily, each containing 3.75 mg of hydroxytyrosol plus 5 mg of Vitamin E, given orally for 16 weeks; This group will treated with 2 identical placebo pills daily given orally for 16 weeks.
Other intervention name(s): Hydroxytyrosol, alpha-tocopherol
Intervention MeSH terms: Vitamin E; Tocopherols; alpha-Tocopherol; 3,4-dihydroxyphenylethanol; Phenylethyl Alcohol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)
Condition: Healthy; Dermal Pharmacokinetic Measurements
Study type: Interventional

Summary: 
      The overall aim of this clinical study is to develop a general bioequivalence (BE) testing
      method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this
      study BE of different lidocaine/prilocaine products will be assessed and factors that
      influence dOFM data variability will be evaluated.
    

Detailed description: 
      The study will involve 20 healthy adult participants. Dermal pharmacokinetic (PK) profile of
      three different lidocaine/prilocaine products will be assessed in parallel at different skin
      sites on the same participant.

      For BE evaluations a reference product will be compared against itself and an approved
      generic test product as positive control and against a non-equivalent test product as
      negative control. Additionally different non-invasive measurements (e.g. TEWL) will be
      conducted and results will be correlated with lidocaine/prilocaine PK data to identify
      factors that might influence skin penetration.

      dOFM probes will be inserted into the dermis to monitor the dermal drug concentrations up to
      12 h post-dose in topically treated skin sites. Blood samples will be drawn to rule out
      systemic appearance of lidocaine and/or prilocaine.
    

Intervention name(s): Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA); Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA); Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany); Dermal open flow microperfusion; Blood sampling
Intervention type(s): Drug; Drug; Drug; Device; Procedure
Intervention description(s): Topical application; Topical application; Topical application; Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis.
16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site).
From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose).; 1 sample will be taken pre-dose and 12 samples post-dose.
Other intervention name(s): Reference product; Generic test product; Non-equivalent test product
Intervention MeSH terms: Lidocaine; Prilocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermal open flow microperfusion
A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
Condition: Lupus Erythematosus, Systemic; Lupus Erythematosus; Fatigue
MeSH terms: Lupus Erythematosus, Systemic; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as
      measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
    


Intervention name(s): RAYOS; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): FDA approved RAYOS for indication of fatigue in Lupus.; FDA approved corticosteroid frequently used for SLE.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial investigates the effects of FE 200440 compared to placebo on implantation rate in
      women undergoing IVF/ICSI treatment
    


Intervention name(s): Barusiban (FE 200440); Placebo Comparator
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mindfulness-Based Intervention in Breast Cancer Patients Undergoing Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      There is evidence that mindfulness-based interventions (MBIs) such as meditation,
      mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and
      reduce stress in breast cancer survivors. These interventions are becoming increasingly
      popular in cancer survivors. However, little is known about the feasibility and effect of
      MBIs administered during the interval of time of chemotherapy, on QOL and stress. The
      investigators are planning a MBI intervention study developed specifically for breast cancer
      survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for
      at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women receiving
      chemotherapy for breast cancer.
    


Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Meditation, body scan, yoga.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and
      Vomiting (PONV)
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients
      describe PONV as more irritant in the postoperative course than the endured pain.
      Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect
      wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is
      not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and
      parathyroid surgery in a randomized controlled clinical trial.
    

Intervention name(s): Placement of a wound drain post surgery (Redon; Medicoplast); No-drain after surgery
Intervention type(s): Device; Other
Intervention description(s): The wound drain, type Redon Drainage 3.0 mm in diameter; After surgery, no drain was put
Other intervention name(s): Redon Drainage (Ref. 750), 3.0 mm in diameter; Medicoplast, 66557 Illingen, Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PONV; thyroid; surgery; nausea and vomiting; postoperative
Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Condition: Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional

Summary: 
      Objective of this study is to investigate the intracameral level of ganciclovir following
      topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior
      uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment
      infection, either uveitis or endothelitis, who have a positive aqueous real time PCR (RT-PCR)
      and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir treatment in
      the past 1 month, will be recruited in the study after taking an informed consent. with
      active CMV anterior segment infection confirmed by a positive aqueous real time PCR (RT-PCR)
      and have not had any form of ganciclovir treatment in the past 1 month were recruited in the
      study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. Following 6
      weeks of treatment, tears and aqueous samples will be collected. Aqueous will be sent for
      RT-PCR for CMV status. Ganciclovir drug level in both tears and aqueous will be measured by
      HPLC method. Clinically, degree of the intraocular inflammation, Intraocular pressure (IOP)
      and central corneal thickness (CCT) will be recorded at baseline and post-treatment.
    


Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention description(s): Treatment with topical ganciclovir ointment
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytomegalovirus; uveitis; endotheliitis; ganciclovir
To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2
Condition: COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional

Summary: 
      An open experimental design was used in this study, and 240 subjects were planned to be
      enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine
      (CHO cells) after sequential intensification in populations vaccinated with two doses of
      marketed Novel Coronavirus inactivated vaccine.
    

Detailed description: 
      One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the
      upper arm deltoid muscle muscle of the subject
    

Intervention name(s): Recombinant Novel Coronavirus vaccine (CHO Cells)
Intervention type(s): Biological
Intervention description(s): The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19 vaccine
Taste Test of a New Formulation of Sildenafil (Revatio)
Condition: None Volunteer
Study type: Observational

Summary: 
      taste of formulation
    

Detailed description: 
      taste test None
    

Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention description(s): Oral suspension of sildenafil.
Intervention MeSH terms: Sildenafil Citrate
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: taste test
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women
Condition: Postpartum Weight Retention
MeSH terms: Overweight; Gestational Weight Gain
Study type: Interventional

Summary: 
      the aim of the study was to investigate the effect of aerobic and resisted exercise program
      on lipid profile and quality of life in overweight breastfeeding women.
    

Detailed description: 
      Although previous studies reported that exercise training during the postpartum period could
      improve the lipid profile and quality of life in overweight women and reduce the postpartum
      fatigue . None of them had investigated the effect of aerobic and resisted exercises on lipid
      profile and quality of life in overweight breastfeeding women.this trial will include 2
      groups:

      Group (A): was consist of 27 overweight breastfeeding women, who received nutritional
      recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per
      week for 12 weeks.

      Group (B): was consist of 27 overweight breastfeeding women, who received the same
      nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2
      times per week plus exercise training (aerobic + resisted) for 12 weeks.
    

Intervention name(s): Nutritional recommendation and Faradic stimulation program; aerobic and resisted exercise for 12 weeks
Intervention type(s): Other; Other
Intervention description(s): proper maternal nutrition and fluid intake during breast-feeding per day for 12 weeks and2 sessions per week, each session 20 minutes, for 12 weeks. Frequency of 65 Hz, and width pulse 300 ms, with contraction time 10 sec and relaxation time 10 sec; Each woman in group (B) participated in a moderate exercise program (aerobic+resistive), 3 days/week, for 12 weeks. The session began with 15 minutes of aerobic exercise on a bicycle ergometer, at 60% of heart rate reserve (HRR), with HRR estimated (220-age-resting heart rate). Then, the participant was performed 15 minutes of resistive exercise (two sets of 8-12 repetitions at 75% of one repetition maximum (1-RM) for basic core exercises in the form of hip lifts, knee extension and flexion, crunches, shoulder flexion and extension, elbow flexion and extension with resistance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; breastfeeding; Overweight; lipid; life quality
the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
Condition: Rehabilitation; Stroke; Brain-computer Interface
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke has become the first cause of death and disability among Chinese adults. 70%-80% of
      patients cannot live independently due to disability, which has brought a heavy burden to
      families, medical institutions and society. How to better evaluate and improve post-stroke
      motor and cognitive dysfunction has always been a hot research topic. With the rapid
      development of brain-computer interface technology, rehabilitation assessment based on
      quantitative EEG analysis is gradually being applied in the medical field. So we designed a
      brain-computer interface based on hierarchical task induction-pedaling rehabilitation
      training system to investigate the effectiveness on the rehabilitation of stroke patients.
    


Intervention name(s): Brain-computer Interface-Pedaling Training System; Traditional Pedaling Training System
Intervention type(s): Device; Device
Intervention description(s): The Brain-computer Interface-Pedaling Training System includes four parts: computer, monitor, EEG testing equipment and pedaling training equipment. The patient wears an EEG detection device, which calculates brain movement participation every 0.5 seconds. The system will provide real-time visual/auditory/somatosensory feedback to patients based on the results of participation, so that patients can participate in motor function training more attentively.; The patient will wear the same EEG equipment that will only collect data, but not guide training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and immunogenicity of
      Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in
      prime-boost regimens in HIV-uninfected, healthy adult volunteers.
    

Detailed description: 
      The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing
      the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and
      Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.

      Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for
      12 months after the last vaccine administration (16 months after the first vaccination). It
      is anticipated that it will take approximately 6 months to enroll the study. Approximately 64
      volunteers (48 vaccine and 16 placebo recipients) will be included in the study.
    

Intervention name(s): SeV-G(NP) (0.2mL, 2x10^7 CIU); SeV-G(NP) (0.2mL, 2x10^8 CIU); Ad35-GRIN (0.5mL)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Delivered intranasally by drops; Delivered intranasally by drops; (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; AIDS; HIV vaccine; HIV prevention
Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.
Condition: Hepatitis, Viral, Human
MeSH terms: Hepatitis A; Hepatitis, Viral, Human; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Little is known about the nature and extent of the disturbance in hepatic function and
      biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the
      functional implications and response to treatment are difficult to predict. This study aims
      to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C
      (CHC) who are eligible for treatment in accordance with the established consensus guidelines
      in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline
      (within one month of starting treatment), at 3-monthly intervals during treatment, for up to
      12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment.
      This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972
      in detecting changes in biliary clearance during and after treatment for CHB and CHC.
    


Intervention name(s): NRL972
Intervention type(s): Drug
Intervention description(s): Single dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and
      safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the
      treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects
      who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment
      groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the
      treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
    

Intervention name(s): Rabeprazole sodium; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Other intervention name(s): Aciphex
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD; erosive GERD; erosive esophagitis
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug
      interaction study.
    


Intervention name(s): Warfarin; Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Warfarin 5 mg once daily; Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Warfarin 5 mg + Pitavastatin 4mg
Intervention MeSH terms: Warfarin; Rosuvastatin Calcium; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers