bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
Condition: Uremia; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      Subclinical inflammation is a common phenomenon in patients receiving maintenance
      hemodialysis (MHD). This is because various pro-inflammatory cytokines are promoted due to
      metabolic acidosis, volume overload, and / or non-sterile dialysate.

      As important antioxidants, vitamin C was prominently consumed by oxidative stress and
      inflammation. So patients receiving dialysis therapy usually had a low plasma vitamin C
      level.

      It was documented that inflammation was associated with increased risk of cardiovascular
      morbidity and mortality in patients on dialysis. But the relationship between plasma Vitamin
      C and each of inflammatory markers and prealbumin was lacking. Because vitamin C had
      anti-inflammation effect on behalf of its electron receiving ability, the investigators made
      a hypothesis that vitamin C supplementation can reduce inflammation status in patients on
      maintenance dialysis
    

Detailed description: 
      Objective A cross-over study is designed to elucidate if oral vitamin C supplementation can
      reduce inflammation status in maintenance dialysis patients with low vitamin C level and high
      CRP level.

      Patients, Methods and Expected results Patients About 100 dialysis patients were recruited.
      Patients will be divided into two groups, and will be followed for at least 6 months.

      Methods Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then
      stop oral VitC for the next 3 months.

      Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral
      VitC 200mg per day in the next 3 months.

      The demographics were recorded. Plasma Vitamin C was measured by high-performance liquid
      chromatography. Serum albumin, prealbumin, high-sensitivity C-reactive protein (hsCRP),
      ferritin, hemoglobin will be measured.

      Expected results There may be positive effect of vitamin C supplementation on inflammation in
      maintenance dialysis patients with vitamin C deficiency and high CRP level.
    

Intervention name(s): oral vitamin C; oral vitamin C
Intervention type(s): Drug; Drug
Intervention description(s): cross-over study,2 arms Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.; Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.
Other intervention name(s): ascorbic acid; ascorbic acid
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dialysis,inflammation,vitamin C
A Study of LY3484356 in Healthy Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the amount of LY3484356 that is found in the
      blood stream and how long the body takes to get rid of it when given with and without food.
      Participants are healthy females of non-childbearing potential. The study will also evaluate
      the tolerability and safety of LY3484356 by collecting the information about any side effects
      that may occur. The participant's involvement with the study will last approximately 27 days,
      not including screening.
    


Intervention name(s): LY3484356; Omeprazole; Itraconazole; Carbamazepine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Itraconazole; Carbamazepine; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Analysis of Retinal Nerve Fiber Layer and Macular Thickness After Congenital Cataract Surgery
Condition: Congenital Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Congenital cataract is the main cause of form deprivation amblyopia in children. Current
      studies confirm that form deprivation amblyopia affects the retinal nerve fiber layer.
      However, there are different opinions about the effect of amblyopia on the optic nerve fiber
      thickness around the optic disc at home and abroad. Investigators have performed "cataract
      extraction with IOL implantation" on children with bilateral and unilateral congenital
      cataract. Investigators used OCT biometry to measure children's the retinal nerve fiber layer
      (RNFLT) and macular thickness (CMT) before and after surgery. Investigators dynamically
      observed changes in RNFL and CMT to explore the retinal mechanism of form deprivation
      amblyopia and help guide the clinical correct understanding of postoperative follow-up time.
    

Detailed description: 
      This prospective study reviewed children with CC who were undergoing cataract extraction with
      IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China.
      bilateral and unilateral CC children were placed in Study group, while age-matched normal
      children were included as controls. Children who were uncooperative to complete the
      preoperative and postoperative examinations were excluded.

      All eyes were divided into 4 groups. Group 1: form deprivation amblyopia of unilateral CC,
      Group 2: unaffected eyes of unilateral CC, Group 3: form deprivation amblyopia of bilateral
      CC, Group 4: normal eyes of normal children. The preoperative and postoperative data
      including sex, age at surgery, 7 position of RNFLT and CMT were collected.

      All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia.
      Investigators used OCT biometry to measure participants' the retinal nerve fiber layer
      (RNFLT) and macular thickness (CMT) before surgery and 1 week, 1 month, 3 months, and 6
      months and 1 year after surgery, and compared with age-matched normal children.
    

Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNFLT
A Study of LY2608204 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes.
      Study subjects will receive once daily doses of LY2608204 for a total treatment duration of
      up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until
      reaching the highest dose that they can tolerate.

      Continuous glucose monitoring devices will be employed for each patient to monitor for
      hypoglycemia during study treatment. Dose titration and dose reduction is determined for each
      individual patient based on their safety and glycemic data.
    


Intervention name(s): LY2608204
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): Glucokinase Activator
Intervention MeSH terms: Globalagliatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes glucokinase safety
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure, Diastolic; Weight Loss
MeSH terms: Heart Failure; Heart Failure, Diastolic; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle
      modification program on symptoms and signs of heart failure as well as laboratory and
      echocardiographic measures of cardiac structure and function. This will be a 6 month trial in
      50 patients with a clinical diagnosis of heart failure with preserved ejection fraction
      (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight
      management 15 week lifestyle change program which will involve weekly visits that rotate
      among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with
      the research Registered Nurse. Each patients baseline data will be used as the control and
      compared with the same measurements at the 6 month end point.
    


Intervention name(s): lifestyle modification
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
Condition: Gastrointestinal Hemorrhage
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the feasibility of a large study of stress ulcer prophylaxis in critically
      ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to
      require mechanical ventilation for more than 48 hours will be randomized to intravenous
      pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical
      ventilation.
    

Detailed description: 
      Despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent
      gastrointestinal (GI) bleeding, 60% of critically ill children receive these medications.
      This may have unintended consequences - increasing the risk of nosocomial infections - which
      may be more serious and common than bleeding these drugs are prescribed to prevent. A large
      randomized trial (RCT) is needed to assess the balance of these risks and benefits, to
      determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is
      not inferior to a strategy of routine stress ulcer prophylaxis. RCTs in pediatric critical
      care are exceptionally challenging to complete; thus, a rigorous pilot RCT is crucial. The
      pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and
      financially responsible. It is more likely that this carefully designed pilot trial will
      ensure that the larger trial we undertake is successful.
    

Intervention name(s): Pantoprazole; Placebo (for pantoprazole)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Creative Drama in Physiotherapy and Rehabilitation Education
Condition: Educational Problems
Study type: Interventional

Summary: 
      Candidates who will provide the health services of the future should be ready to provide the
      safe and best health care services. In order to achieve this, it is recommended to use new
      training programs and methods that will provide similar situations to the working environment
      in the training of health workers. There are very few studies on the empathy and
      communication perceptions that creative drama education will create with the patient on
      physiotherapy and rehabilitation department students. Therefore, this study, the
      investigators aimed to investigate the perceived effect of communication skills training
      integrated with creative drama on physiotherapy and rehabilitation students' empathy and
      communication skills that will develop with the patient.
    


Intervention name(s): Creative Drama Education
Intervention type(s): Other
Intervention description(s): Effective Communication with Creative Drama in Health Course will be given to students for 2 hours a week for 14 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Education
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of KUR-101 in Healthy Adults
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study
      drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of single
      doses of a new drug called KUR-101.

      Up to 58 healthy men or women aged between 18-55 will be enrolled in this study in two parts.

      Part 1 will involve a single ascending (increasing) dose (SAD) where 40 participants (5
      groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single
      oral dose of the study drug or placebo. The placebo will look the same as the study drug but
      will not contain any medicine.

      Part 2: will involve a crossover design where 18 participants will be randomised to receive a
      single oral dose of each of three interventions (study drug, placebo or a marketed form of
      oxycodone). Each dose is separated by 7 days and the participants are randomised so they do
      not know the order of the interventions.

      For Part 1 the total participation will last 9 days, of which 4 days (3 nights) will be spent
      in the clinic. One group of subjects in Part 1 will return to the clinic to receive a second
      dose of drug given with a high fat breakfast. In this group, the total participation will
      last 16 days, of which 8 days (7 nights) will be spent in the clinic.

      For Part 2 the total participation will last 23 days, of which 9 days (8 nights) will be
      spent in the clinic.
    

Detailed description: 
      This is a Phase 1, single-center, prospective, study of orally administered KUR-101 in normal
      healthy participants. The study will be conducted in two parts.

      Part 1 is a randomized, double-blind, placebo-controlled study to assess the safety,
      tolerability, PK, analgesic and respiratory effects of single ascending doses of orally
      administered KUR-101 in normal healthy participants. Once the MTD has been determined, this
      dose, or an alternate lower dose, will be taken into Part 2 of the study.

      Part 2 is a randomized, double-blind, placebo-controlled, three-period crossover study to
      assess the analgesic and respiratory effects of a single oral KUR-101 as compared to that of
      oxycodone in normal healthy participants.
    

Intervention name(s): KUR-101; OxyNorm; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of KUR-101; Single oral dose of OxyNorm; Single oral dose of placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for
      patients with AML with the FLT3-ITD mutation and information from these studies suggests that
      sorafenib may help to control leukemia. The purpose of this study is to find the highest dose
      of sorafenib for maintenance therapy that can be safely used in participants with AML who
      have undergone allogeneic stem cell transplant.
    

Detailed description: 
      Subjects will taken sorafenib orally either once or twice daily. Subjects will come to the
      Bone Marrow Transplant Clinic 3 times (on Day 8, 15, and 30) during the first month of
      treatment. After the first month, they will be seen every month for 3 months and then at 9 at
      6 and 9 months. Subjects will have a physical exam and be asked questions regarding general
      health and specific questions about any problems they might be having and any medications
      they are taking.

      Subjects will have standard blood tests every month for 12 months to check liver and kidney
      function and complete blood count.

      Subjects will have research blood tests on Days 8, 15 and 30 during the first month of
      treatment.

      Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment.

      Subjects will receive treatment for up to 12 months and be followed for 1 year after
      completing the study.
    

Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): Oral, 200 to 400 mg QD or BID
Other intervention name(s): BAY 43-9006
Intervention MeSH terms: Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; FLT3-ITD; Stem cell transplant
Bioavailability Study of COQUN ORAL FORMULATION
Condition: Male & Female Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to
      reach a level of plasma concentration which might assure its antioxidant effect if taken on a
      regular basis.
    

Detailed description: 
      The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24
      subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which
      will be followed by a one week wash-out period and then by a 4 week period of continuous
      administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided
      in the continuous treatment period into two groups, one group of 12 patients with intake of
      100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess
      multiple-dose profile of COQUN ORAL FORMULATION.

      Patients will have to fast the night before enrolment, for at least 10 hours. Patients will
      be requested to fill in a short diary in the multidose phase, on a daily basis, for
      confirming the product correct intake, and informing on any experienced adverse event and
      eventual medication taken for its solving.
    

Intervention name(s): COQUN ORAL FORMULATION
Intervention type(s): Dietary Supplement
Intervention description(s): COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To evaluate the best dosage between 100 mg OD or 100 mg BID for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
Masking: None (Open Label)
Primary purpose: Other
Keywords: COQUN; antioxidant; Bioavailability; CoQ10; Healthy
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to assess the wound healing efficacy (time to complete healing)
      of different adhesive bandages.
    


Intervention name(s): Marketed Adhesive Bandage #1; Marketed Bandage #2; Non-Marketed Bandage #1; Non-Marketed Bandage #2; Non-Marketed Adhesive Bandage #3; Non-Marketed Adhesive Bandage #4; Non-Marketed Adhesive Bandage #5
Intervention type(s): Device; Device; Device; Device; Device; Device; Device
Intervention description(s): On the randomized wound site, a marketed adhesive bandage will be applied.; On the randomized wound site, a marketed adhesive bandage will be applied.; On the randomized wound site, a non-marketed adhesive bandage will be applied.; On the randomized wound site, a non-marketed adhesive bandage will be applied.; On the randomized wound site, a non-marketed adhesive bandage will be applied.; On the randomized wound site, a non-marketed adhesive bandage will be applied.; On the randomized wound site, a non-marketed adhesive bandage will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of low-dose
      interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in
      patients with chronic hepatitis C.
    


Intervention name(s): interferon-alfa-2b and ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with chronic hepatitis C
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in
      moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of
      12-week open-label efficacy and safety study in responders.
    


Intervention name(s): tacrolimus; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): FK506; Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative colitis; tacrolimus; FK506; treatment outcome