bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Entocort for Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A Safety Study using Entocort EC for children with mild to moderate Crohn's Disease
    

Detailed description: 
      A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for
      the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
    

Intervention name(s): Entocort
Intervention type(s): Drug
Intervention description(s): Entocort capsules, oral
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp
Condition: Hypertension; Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this proof of concept study is to find out the efficacy of Marealis Refined
      Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting
      peptides on blood pressure in subjects with mild or moderate hypertension.
    


Intervention name(s): Marealis Refined Peptide Concentrate; Marealis Refined Peptide Concentrate; Marealis Refined Peptide Concentrate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1200 mg per os, once a day, 8 weeks; 600 mg per os, twice a day, 8 weeks; 0 mg per os, daily, 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized double-blind placebo-controlled study; peptide concentrate; Coldwater Shrimp; antihypertensive effect; mild hypertension; moderate hypertension; blood pressure
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402
      restricted epitope peptides URLC10, KOC1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
    

Detailed description: 
      URLC10 and KOC1 have been identified as cancer specific molecules especially in non small
      cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique.
      In a prior study, it has been shown that URLC10 and KOC1 are upregulated in human gastric
      tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified
      that peptides derived from these receptors significantly induce the effective tumor specific
      CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the
      safety, immunological and clinical response of those peptides. Patients will be vaccinated
      twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide
      (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be
      administered by subcutaneous injection. The patients will also receive oral chemotherapy
      (S-1) simultaneously. Repeated cycles of vaccine will be administered until patients develop
      progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study,
      we evaluate the safety and tolerability of these peptide vaccines. In the following phase II
      study, we evaluate the immunological and clinical response of this vaccine therapy.
    

Intervention name(s): URLC10, KOC1, VEGFR1 and VEGFR2
Intervention type(s): Biological
Intervention description(s): Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peptide Vaccine; URLC10; KOC1; VEGFR1; VEGFR2
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose
      [14C] selumetinib in volunteers
    


Intervention name(s): [C14] selumetinib (oral)
Intervention type(s): Drug
Intervention description(s): Single oral administration [C14] 75mg
Other intervention name(s): Selumetinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics, mass balance, AZD6244
Mechanisms of Increased Ambulatory Blood Pressure in Patients With Intradialytic Hypertension
Condition: Intradialytic Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is 1) to determine what physiologic factors (extracellular fluid
      overload or vasoconstriction) contribute more to increased blood pressure levels between
      dialysis treatments in hemodialysis patients whose blood pressure increases and decreases
      during hemodialysis and 2) to determine whether carvedilol provides better control of blood
      pressure between dialysis treatments than prazosin in patients whose blood pressure increases
      during dialysis.
    


Intervention name(s): Carvedilol vs. Prazosin
Intervention type(s): Drug
Intervention MeSH terms: Carvedilol; Prazosin
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study population includes hypertensive hemodialysis patients.
      
Biospecimen description: 
      Serum collection for measurement of endothelin-1, asymetic dimethylarginine
    
Keywords: Intradialytic Hypertension; Hemodialysis; Hypertension; Extracellular Volume; Endothelial Cell Dysfunction; Endothelin 1; Carvedilol
Sonographic Venous Doppler Imaging in End-Stage Renal Disease
Condition: Emergent Dialysis; Venous Doppler Ultrasound
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent
      hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally
      not as optimal as in dialysis units. It takes time to provide suitable conditions (personnel
      and equipment), the length of stay of patients in the emergency services is prolonged, and
      this may cause disruption of patient care in these areas where rapid patient care is
      provided. Therefore, the management of ESRD patients continues to be one of the serious
      problems faced by emergency physicians.

      Sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal
      vein) may be an alternative diagnostic method for need for urgent hemodialysis. Hereby,
      patients who don't need hemodialysis safely can be discharged from emergency services.
      Studies conducted so far have generally been based on predicting cardiorenal AKI and renal
      poor outcomes and have been designed in general ICU conditions.

      In this study, the researchers aimed to determine the diagnostic value of sonographic venous
      Doppler imaging the need for urgent hemodialysis in ESRD patients in the emergency services.
    


Intervention name(s): Sonography
Intervention type(s): Diagnostic Test
Intervention description(s): Sonographic Venous Doppler Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency department patients with end-stage renal disease
Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
Condition: Skin Aging; Wrinkles
Study type: Interventional

Summary: 
      The purpose of this study is to determine the clinical efficacy of a combination of
      Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin
      anti-aging properties. Specifically, the investigators aim to determine the increase in
      hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs
      of photoaging, particularly facial fine lines.
    


Intervention name(s): Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention is to be taken once daily, for 12 weeks.; The intervention is to be taken once daily, for 12 weeks.
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
Condition: Anesthesia; Analgesia; Acute Pain; Chronic Pain; Pectoralis Nerve Block; Erector Spine Plane Block; Patient Controlled Analgesia
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector
      spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node
      biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block
      (PECS II) 30 min before general anesthesia , while other one-third of patients will have only
      general anesthesia.
    

Detailed description: 
      It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours
      after mastectomy. But they do so by different mechanishms.

      This study is to survey that ESP and PECS II may supply acute and chronic analgesia by
      reducing pain scores in the first 24 hours and 3 months after the surgery, also the
      comparison of the analgesic activity among themselves for acute / chronic pain and opioid
      consumption will be searched.

      In this study patients are divided into three groups. Patients in PECS group will have PECS
      II block in a separate section from the operating rooms (PNB practice room). In addition,
      patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

      Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB
      practice room). In addition, PCA will be used in the first 24 hours postoperatively.

      Patients in control group will not be performed nerve block. Only general anesthesia (GA)
      will be performed in the operation room. In addition, PCA will be used in the first 24 hours
      postoperatively.
    

Intervention name(s): Pectoralis nerve block II; Erector spine plane block; Control
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): PECS II block will be performed 30 min. before general anesthesia.; ESP block will be performed 30 minutes before general anesthesia.; Only general anesthesia will be performed.
Other intervention name(s): PECS II; ESP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Regional Anesthesia; Acute and chronical pain; Pectoralis nerve block; Erector spine plane block
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel
      syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in
      changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64
      patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre
      controlled clinical trial. Patients will be randomized to receive either 2 capsules/day
      Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to
      Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL)
      scores will be also monitored.
    


Intervention name(s): Duolac7S; starch
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule two times everyday for 6 weeks; 1capsule two times everyday for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study in Relapse Prevention of Treatment-Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC)
      if used for a long time (47 weeks) makes patients suffering from Treatment Resistant
      Depression stable, determine if OFC is safe when used to treat patients with Treatment
      Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and
      fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression
      when treated for a long time (up to 47 weeks) and to assess the quality of life during
      treatment.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, active comparator-controlled, parallel study
      of participants with Treatment Resistant Depression (TRD), comparing the efficacy and safety
      of olanzapine and fluoxetine Combination (OFC) versus fluoxetine in relapse prevention of
      stabilized participants with TRD. The study will consist of 4 phases: a screening phase; a 6-
      to 8-week open-label acute treatment phase; a 10- to 12-week open-label stabilization phase;
      and a 27- to 29-week double-blind relapse prevention treatment phase. Participants who
      demonstrate response to open-label OFC during the acute treatment phase will continue into
      the stabilization phase. Participants who remain stable while receiving open-label OFC during
      this phase will be randomized to receive either OFC or fluoxetine during the double-blind
      relapse prevention phase. Investigators and participants will be blinded to the precise
      duration of the stabilization period, the definition of remission, and the criteria for entry
      into the relapse prevention phase; this information is described in a supplement given to
      Ethical Review Boards (ERBs) and regulatory authorities.
    

Intervention name(s): Olanzapine and Fluoxetine combination (OFC); Fluoxetine
Intervention type(s): Drug; Drug
Intervention description(s): Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks.
Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks.
Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks.; 25 or 50 mg/day fixed dosing for 27 weeks
Other intervention name(s): Symbyax; LY900000; Prozac; LY1101440
Intervention MeSH terms: Olanzapine; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Phenolic Acids on the Human Vasculature
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      This study evaluates effects of different doses of phenolic acids on healthy volunteers.
    

Detailed description: 
      It has been suggested that consumption of food rich in phenolic acids can help to improve
      vascular health, measured by flow mediated dilation (FMD).
    

Intervention name(s): 43.3 mg hydrolyzed green coffee extract; 86.6 mg hydrolyzed green coffee extract; 173 mg hydrolyzed green coffee extract; Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Reconstituted in water and given to subjects; Reconstituted in water and given to subjects; Reconstituted in water and given to subjects; Reconstituted in water and given to subjects
Other intervention name(s): Phenolic acid; Phenolic acid; Phenolic acid; maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Detection of Fabry Disease in Chronic Renal Failure Patients in Area Provence - Alpes - Côte d'Azur
Condition: Fabry Disease
MeSH terms: Fabry Disease; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called
      alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function
      properly. As a result, the lipid accumulates in the body, this leads to multisystem
      impairment, including progressive renal failure.

      Several studies have focused on the detection of this disease in end-stage renal failure
      patients, transplant or hemodialysis.

      This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a
      glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90
      and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine
      level greater than 0,5 g/l.

      This screening will be conducted by a blood test to measure the level of alpha-galactosidase
      A activity by micromethod from samples taken from blood spots on filter paper. If this assay
      was positive, confirmation of diagnosis of Fabry disease will done the standard method:
      macrodosage of leukocytic alpha-galactosidase A activity.

      This multicenter prospective study, openly contacted in medical practice, with patient
      follow-up corresponding to the management of renal insufficiency, will be offered to all
      departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.

      The objective of this study is to assess the prevalence of Fabry disease in the target
      population and to identify previously undiagnosed patients, enabling them to benefit from
      appropriate management of their disease, including whether need enzyme replacement therapy.
    


Intervention name(s): micromethod from samples taken from blood spots on filter paper
Intervention type(s): Other
Intervention description(s): a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine
Condition: Hepatitis A; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the immunogenicity and safety of three different
      immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A
      and B vaccine (HABV) in healthy Chinese infants.
    

Detailed description: 
      This study is a randomized double-blind, single-center, phase IV clinical trial. The purpose
      of this study is to compare the immunogenicity and safety of three different immunization
      schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine
      (HABV) in healthy Chinese infants between 18 and 24 months old. The subjects were randomly
      assigned into 3 groups. Subjects in group 1 each received 2 doses of HAV with a 6-month
      interval (at day 0 and month 6); subjects in group 2 each received 1 dose of HAV at day 0 and
      1 dose of HABV at month 6; subjects in group 3 each received 2 doses of HABV with a 6-month
      interval (at day 0 and month 6).
    

Intervention name(s): Inactivated Hepatitis A vaccine (HAV); Combined hepatitis A and hepatitis B vaccine (HABV)
Intervention type(s): Biological; Biological
Intervention description(s): Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.; Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose
Other intervention name(s): Healive (Sinovac Biotech Ltd.); lot No.: 201308046; Bilive (Sinovac Biotech Ltd.); lot No.: 201307017
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Short and Long Term Treatment With 4-AP in Ambulatory SMA Patients
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess whether 4-AP (Dalfampridine-ER, Ampyra) improves
      walking ability and endurance in adult patients with Spinal muscular atrophy (SMA) Type 3
      compared to placebo and whether the duration of treatment affects outcome.
    

Detailed description: 
      Spinal muscular atrophy (SMA) is a genetically determined neuromuscular disorder that results
      in muscle weakness and impaired functional mobility. Fatigue is a common symptom in SMA with
      a resultant impact on physical function and quality of life however the precise mechanisms
      are unknown. At present there is no treatment for SMA. There is evidence that 4-AP improves
      function in SMA animal models. In patients with multiple sclerosis, 4-AP was found to improve
      walking ability and diminish fatigue. The purpose of the study is to determine whether
      treatment with 4-AP is associated with an increase in walking speed and endurance compared to
      placebo and whether the duration of treatment affects outcome. The study comprises a short
      term treatment trial in which participants are treated for 2 weeks with 4-AP and placebo in
      random sequence followed by a long treatment trial of 6 weeks in which patients are also
      treated with placebo and 4 AP. The primary outcome measure of the clinical study will be the
      six minute walk test (6MWT), which has been documented to be a valid and sensitive instrument
      to identify fatigue among ambulatory SMA patients. We will also assess the effect of 4-AP on
      muscle and nerve electrical function via electromyography (EMG) during the short term trial.
      Results of this study may provide support for larger clinical trials.
    

Intervention name(s): 4-aminopyridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/twice daily; Crossover study involving one trial with sugar pill (placebo)
Other intervention name(s): dalfampridine-ER; Ampyra; Sugar pill
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; 4-aminopyridine; dalfampridine; Ampyra