bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Evaluation of a Mixed Compound of Antioxidants in Terms of Endothelium Damage/Function in Pediatric Subjects With Obesity.
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of our study was to test the effects on endothelium of a combination of curcumin,
      resveratrol, plus zinc, magnesium, selenium and Vitamin D in a cohort of pediatric subjects
      with obesity.
    

Detailed description: 
      The aim of our study was to test the effects on endothelium of a combination of curcumin,
      resveratrol, plus zinc, magnesium, selenium and Vitamin D in a cohort of pediatric subjects
      with obesity. Endothelial function was assessed using two methodologies: a "post occlusive
      release hyperemic test" (PORH) and a "heat provocation test" (HPT). Treatment tablet
      composition (Auxilie® Immuplus, Envicon Medical, Verona, Italy): Vitamin D3: 25,00 mcg, Folic
      acid: 90,00 mcg, Selenium: 55,00 mcg Magnesium: 300,00 mg, Zinc: 7,00 mg, Curcum (Meriva®):
      100,00 mg Polygonum dry extract: 20,41 mg (of which Resveratrol: 20,00 mg), Soy dry extract:
      37,50 mg. Placebo tablet composition: Saccharose, fructose, aroma, anti-agglomerate agents:
      fatty acids magnesium salts, silicium dioxide, colorant: riboflavin 5-sodium phosphate;
      sweetener: stevia glycoside, sucralose, neosperidin DC. Both tablets (treatment and placebo)
      were similar in form, color and flavor.
    

Intervention name(s): Auxilie® Immuplus, Envicon Medical, Verona, Italy
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. Height (cm) and weight (kg) were measured for each child at every visit. Endothelial function was assessed using two methodologies: a "post occlusive release hyperemic test" (PORH) and a "heat provocation test" (HPT).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using a computer-generated randomization schedule, study supplement and placebo were randomized (1:1) into 70 batches (each consisting of 6 packs containing 30 tablets a pack) and each was given a unique identification number. The coordinator of the study maintained the randomization list. Study physicians, other study personnel, and parents or legal guardians were blinded to of the batches of medication and to the identification. Subjects who satisfied the inclusion for the study were assigned an identification number (linked to a batch) in sequential order. Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. A number of tablets not taken equal to of greater of 2 tablets/month was considered not adherence to the study (drop out).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage
      in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain
      and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first.
      If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic
      options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells
      have showed the capacity of bone and cartilage regeneration.
    

Detailed description: 
      In this clinical study the investigators aim to investigate the safety of intra-articular
      injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the
      ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow
      aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed
      clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months
      postoperative to measure pain reduction and joint function improvement. Paraclinical studies
      (X-Ray and MRI) will be performed before and 6 months after treatment.
    

Intervention name(s): mesenchymal stem cell
Intervention type(s): Biological
Intervention description(s): intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
Other intervention name(s): stem cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: side effect; mesenchymal stem cell; ankle; osteoarthritis
Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      It seems plausible that increased aromatase activity in obese men, as a result of a larger
      fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition
      increases testosterone levels, which may affect hepatic and cardiac function.

      In this intervention study two groups of hypogonadal obese men are compared. Group A is
      treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a
      group with normal testosterone and low oestrogen concentrations. Group B is treated with
      placebo once every two days during four months; this group will retain low testosterone - and
      high oestrogenic concentrations.

      The primary objective of the study is to evaluate effects of changed sex steroids in obese
      men on hepatic and cardiac function.
    


Intervention name(s): Letrozole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One Letrozole 2.5 mg capsule every two days during four months; One placebo capsule every two days during four months
Other intervention name(s): Femara
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: with disturbed glucose metabolism; without disturbed glucose metabolism
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Condition: Anxiety, Dental; Dental Decay
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the post sedation events from three different multi-drug oral
      sedation regimens in order to help pediatric dentists determine the best course of action for
      their patients and prepare parents appropriately and caution them about the expected effects.
      Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post
      oral sedation procedure using surveys.
    


Intervention name(s): Regimen 1; Regimen #2; Regimen #3
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.; Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.; Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Dental
Serum Magnesium Levels in Desalination Tap Water and Outcomes in Acute Myocardial Infarction Patients
Condition: Myocardial Infarction; Death; Congestive Heart Failure; Acute-MI; Cardiovascular Disease
MeSH terms: Heart Failure; Cardiovascular Diseases; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with
      1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW)
      (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya
      MC).
    

Detailed description: 
      Extensive seawater desalination in Israel may decrease magnesium in drinking water (DW),
      causing hypomagnesemia and adverse health effects. We study the association between
      consumption of desalinated drinking water (DSW) and serum magnesium in acute MI (AMI)
      patients, Subjects 35-75 years of age with the first AMI will be prospectively recruited
      during 1 year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300
      patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients, served
      by non-DSW). Questionnaire will be developed to collect data on demographic variables (at
      home and work), water and beverages consumption habits (tap water, mineral water), dietary
      sources of Mg and Mg supplementations. Mg levels will be measured in DW from the patients'
      homes and in their serum on admission.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All Subjects 35-75 years of age with the first AMI will be prospectively recruited during 1
        year from 2 regions; the Departments of Cardiology at the Sheba Medical center (300
        patients, predominantly served by DSW) and the Nahariya Medical Center (150 patients,
        served by non-DSW).
      
Keywords: Desalinated Sea Water; Magnesium; Drinking Water
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, 2-period, fixed-sequence, multiple-dose, open-label study of the effect of
      PF-06651600 on Rosuvastatin pharmacokinetics in healthy participants. Approximately 12
      healthy male and/or female participants will be enrolled in the study.
    


Intervention name(s): PF-06651600; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): PF-06651600: 200 mg dose provided as four 50 mg oral tablets; 10 mg oral tablet
Other intervention name(s): Crestor ®
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics (PK)
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      PF-06266047 after first-time administration to healthy adult subjects.
    


Intervention name(s): Placebo; PF-06266047
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; PF-06266047
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PF-06266047; safety; tolerability; pharmacokinetics; first-in-human; healthy volunteers; PDE4; phosphodiesterase-4
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
Condition: Infectious Disease; Children, Only; Diet Modification
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      The study aims to explore whether prophylactic dietary supplementation with prebiotic
      inulin-type fructans is able to influence the intestinal microbiota and the frequency of
      infectious disease episodes in kindergarten children during a winter period.
    


Intervention name(s): prebiotic inulin-type fructan; Placebo maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school
      children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested
      versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a
      treatment period (24 weeks). The study will provide further data on safety and tolerability
      of ciclesonide.
    


Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Efficacy and Safety of Ciclesonide; Placebo
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Asthma; Ciclesonide; Child; Pediatric
Oral Bioavailability and Mass Balance Trial With Pimasertib
Condition: Locally Advanced or Metastatic Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single centered trial to evaluate the mass balance,
      bioavailability and metabolism of pimasertib in cancer subjects with locally advanced or
      metastatic solid tumors.
    


Intervention name(s): Pimasertib
Intervention type(s): Drug
Intervention description(s): Part A: Subjects will receive unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib will be administered as a bolus injection. On Days 3-21 (except Day 8), subjects will receive unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects will receive 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects will receive the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects will be administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
Other intervention name(s): MSC19363639B; AS703026
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass balance, bioavailability, cancer, 14C
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine
           HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets.

        2. Monitor the adverse events and ensure the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER
      Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA
      in healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Fexofenadine HCl + Pseudoephedrine HCl
Intervention type(s): Drug
Intervention description(s): Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited
Other intervention name(s): Allegra-D 24 hour ER Tablets
Intervention MeSH terms: Fexofenadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Fexofenadine Hydrochloride + Pseudoephedrine Hydrochloride
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
Condition: Malaria, Falciparum; Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers
      to determine their safety and ability to induce a measurable immune response against malaria.
    

Detailed description: 
      Malaria infection kills over 2 million people each year. It is a major problem for those who
      live in endemic areas and for travellers. There is clearly a great need for a safe effective
      malaria vaccine.

      The purpose of this study is to test two candidate malaria vaccines (FP9-PP and MVA-PP) in
      different concentrations and combinations. These live viral vectors encode a 'polyprotein' of
      six fused malaria antigens expressed at liver and blood stages of the malaria parasite
      lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox
      vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector
      instead. The two vaccines will be used in combination in a 'prime boost' strategy to enhance
      the response of the cellular immune system.

      This study will:

        1. Examine safety

        2. Examine immunogenicity

        3. Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following
           malaria challenge study (VAC027.2)
    

Intervention name(s): FP9-PP (FP9 polyprotein); MVA-PP (Modified Virus Ankara polyprotein)
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine; Prime-boost
Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and
      pharmacodynamic profiles of growth hormone using two different modes of growth hormone
      administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the
      thigh) in 8 adult male or female patients with growth hormone deficiency during interval
      exercise or in supine rest. The order of dosing regimen within the groups and between the
      groups will be randomised. All patients will go through four different treatment sessions:A/B
      Single subcutaneous bolus injection, supine rest without/with interval exercise, sessions
      C/D: Continuous subcutaneous infusion, supine rest without/with interval exercise.
      Hypotheses: 1) There is day-to-day variation of exogenous growth hormone, 2)Concentration of
      growth hormone decreases due to exercise compared to supine rest, 3)There is a circadian
      variation in pharmacokinetics of exogenous growth hormone infused subcutaneously
    

Detailed description: 
      The subjects will attend a screening visit and four treatment sessions. The dosing visits
      will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay
      for the infusion group.
    

Intervention name(s): Norditropin SimpleXx (growth hormone)
Intervention type(s): Drug
Intervention description(s): 3mg/subject/day over two consecutive days
Other intervention name(s): Norditropin® SimpleXx®
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone deficiency; circadian variation
Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
Condition: Pancreaticoduodenectomy; Drainage
Study type: Interventional

Summary: 
      The aim of this randomized prospective multicenter study is to demonstrate the hypothesis
      that early removal of drain could reduce the incidence of major complications (grade 2-4)
      after pancreaticoduodenectomy (PD) , when compared with later removal of drain.
    

Detailed description: 
      The objective of this randomized prospective multicenter study is to investigate the
      association between the time of removal of drain after pancreaticoduodenectomy (PD) and
      incidence of major complications (grade 2-4 complications). The investigators unite six
      pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or
      pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative
      pancreatic fistula (POPF) are recruited into the study. After obtaining informed consent,
      eligible patients are randomly allocated to early or late drain removal group on POD 3. In
      the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 5 or
      beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the
      secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric
      emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive
      complication index (CCI).
    

Intervention name(s): Early drain removal; Late drain removal
Intervention type(s): Other; Other
Intervention description(s): Removing drain(s) on postoperative day 3; Removing drain(s) on postoperative day 5 or later
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreaticoduodenectomy; Time of drain removal
Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate
Condition: Progressive Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this multicenter, single-arm, Simon two-stage, phase II trial is to determine
      the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with
      previously treated, histologically proven GIST whose disease has recurred or progressed while
      receiving 400 mg/day of Imatinib mesylate at any time during at least a 2 months' treatment
      period.
    


Intervention name(s): Imatinib mesylate
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progressive GIST; Resistance to Imatinib mesylate