bioihbjkbjnl/mcl2 huggingface dataset:
Low Dose Metronomic Poly-chemotherapy for Metastatic CRC
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the activity of a new regimen of treatment for patients with
      metastatic colorectal carcinoma. This includes a combination of well-known chemotherapy
      agents and anti-inflammatory agents, when administered orally at low daily doses and without
      planed brakes (Low Dose Metronomic regimen), in contrast with the conventional and already
      exhausted regimens of treatment at Maximal Tolerated Doses (MTD) which required pre-planned
      brakes between treatment days.
    

Detailed description: 
      Patients suffering from metastases of colorectal cancer whose tumor cells develop resistance
      to conventionally administered treatments are in need for new methods of treatment.

      While their chemotherapy had been administered up till then at the classical regimen of
      Maximal Tolerated Doses (MTD), which is aimed to directly killing maximal fractions of tumor
      cells, the present study evaluates the clinical benefit of a treatment which is based on old
      chemotherapeutic and old anti-inflammatory drugs, when these are administered at low doses,on
      daily basis and orally taken, without planed brakes (Low Dose Metronomic regimen).

      Treatments based on this type of regimen have already been studied on other models of cancer
      and showed the capacity of suppressing tumor growth by a new category of anti-tumor effects.
      Namely, by affecting factors and mechanisms which prevail in the microenvironment that
      surrounds tumor deposits, thus circumventing the resistance of their cancer cells to
      chemotherapy.
    

Intervention name(s): Capecitabine; Cyclophosphamide; Methotrexate; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Xeloda; Endoxan; Abitrexate, Methotrexat "Ebewe", Metoject medac; Celebra, Celcox
Intervention MeSH terms: Celecoxib; Cyclophosphamide; Capecitabine; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Condition: Metabolic Syndrome; Albuminuria
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80%
      of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the
      aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual
      diet of type 2 DM with MS and compare this intervention with an usual diet without this
      supplement.
    

Detailed description: 
      The aim of this study was to evaluate the effect of soluble fiber (guar gum) on the MS
      components (International Diabetes Federation-2005 and WHO): blood pressure, plasma glucose,
      triglycerides, HDL, central obesity (waist, BMI),and albuminuria. Secondary objectives are:
      effect of guar gum on serum fatty acids, , PCR, endothelin 1, and fibrinogen. Primary
      outcomes were alterations on MS components.

      Forty-four type 2 diabetic outpatients were included in a randomized clinical trial:
      treatment 1- guar gum (10g/day) + usual diet; treatment 2- usual diet. The duration of each
      treatment was six weeks. Three days weight diet records with concurrent 24h urinary
      collections (protein intake estimative), clinical and laboratory evaluation were performed at
      baseline and after 4 and 6 weeks. Serum fatty acids were measured in total triglycerides
      fractions by gas chromatography.
    

Intervention name(s): guar gum
Intervention type(s): Dietary Supplement
Intervention description(s): guar gum 10g/day for six weeks
Other intervention name(s): benefiber; guar gum group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; diet; fiber; Serum lipids; Albuminuria
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed
      sequences, multiple dose study in healthy male and/or female recreational opioid users.

      This study is being primarily conducted to assess the effect on respiratory drive of morphine
      administered after multiple doses of AZD4041 compared to morphine administered alone in
      healthy recreational opioid users.

      The study will include up to 44 participants who will be randomised to either AZD4041 and
      morphine (28 participants) or placebo and morphine (16 participants). This is to ensure
      completion of at least 36 subjects (24 AZD4041 + morphine, and 12 Placebo + morphine on Day
      15).

      The total study duration will be up to 54 days (including screening) per participant.
    


Intervention name(s): AZD4041 and morphine; Placebo and morphine
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive 2 doses of morphine (IV administration) and multiple doses of AZD4041 (Oral solution); Participants will receive 2 doses of morphine (IV administration) and multiple doses of Placebo (Oral solution)
Intervention MeSH terms: Morphine
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders
Condition: Achalasia; Hypertensive LES
MeSH terms: Esophageal Achalasia; Esophageal Motility Disorders; Esophageal Spasm, Diffuse
Study type: Interventional

Summary: 
      Spastic esophageal motility disorders induced significant symptoms including dysphagia,
      retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel
      approach to perform myotomy through the esophagus with long submucosal tunnel. This study
      aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from
      animal study to clinical practice in human.
    


Intervention name(s): Per Oral Endoscopic Myotomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Achalasia, Hypertensive LES
VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography
Condition: Coronary Artery Disease; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study is to prospectively evaluate the effectiveness of low-volume
      contrast media (CM) injection protocols adapted to tube voltage in patients undergoing
      Coronary Computed Tomography Angiography (CCTA).
    


Intervention name(s): Ultravist 370Mg I/Ml Solution for Injection
Intervention type(s): Drug
Intervention description(s): Reduced contrast-volume injection protocols based on patient specific tube voltage.
Other intervention name(s): Iopromide
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The study population includes 120 patients who present to radiology department for
        clinically indicated CCTA scan. In order to be included patients must meet all inclusion
        criteria and none of the exclusion criteria.
      
Keywords: Computed Tomography
Effectiveness of a Vitamin Mineral Supplement
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete
      vitamin supplement with or without a combined omega-3 fatty acid supplement on selected
      clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus
      omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and
      C-reactive protein than those taking the other supplements.
    

Detailed description: 
      Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3,
      or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for
      all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week
      washout period before beginning the study. Participants taking the Cooper Complete one-a-day
      vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL
      cholesterol, and C-reactive protein than those taking the other supplements.
    

Intervention name(s): Cooper Complete One-A-Day Vitamin Supplement
Intervention type(s): Drug
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: supplement; omega-3 fatty acid; Homocysteine; LDL cholesterol
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral
      dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
    

Detailed description: 
      There were 3 to 4 cohorts of 2 patients per receptor group. Lu AF35700 was administered as
      multiple oral doses for up to 21 days before the PET scans were performed. The doses in all
      groups were selected with the aim of characterising the exposure response (occupancy) curve.
      The doses for all groups, with the exception of A1, B1, and C1, were subject to change within
      the dose range already investigated and found tolerable. The next dose for the groups was
      established at a dosing conference based on an evaluation of the occupancy obtained, and
      safety, tolerability, and pharmacokinetic data from all previous cohorts.
    

Intervention name(s): Lu AF35700
Intervention type(s): Drug
Intervention description(s): 5 mg tablets for oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.
Condition: PREGNANCY
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Perioperative nausea and vomiting may occur in 50-80% of patients undergoing cesarean
      section.

      Metoclopramide is a well known Dopamine receptor antagonist that acts at the Chemoreceptor
      trigger zone and is used effectively for the prevention and treatment of nausea and vomiting.
      Propofol can antagonize Serotonin receptors in the area postremal and is associated to a
      reduced incidence of postoperative nausea and vomiting. Some studies have shown that propofol
      can prevent intraoperative nausea and vomiting during cesarean section.

      The control of risk factors and the pharmacological prophylaxis of nausea and vomiting
      reduces effectively their incidence.

      In this randomized, double blind, case-control study the efficacy of propofol alone,
      metoclopramide alone and in combination in controlling nausea and vomiting were compared. A
      risk factor control strategy was associated to each study group.
    


Intervention name(s): PROPOFOL; METOCLOPRAMIDE; PLACEBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS; METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS; SALINE INFUSION
Intervention MeSH terms: Metoclopramide; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NAUSEA; VOMITING; CESAREAN SECTION; PREVENTION; PROPOFOL
Pharmacokinetic Study of Testosterone Enanthate
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
    

Detailed description: 
      Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area
      Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the
      treatments and reference arm.

      Safety comparisons were based upon the occurrence, severity and rate of treatment emergent
      adverse events.
    

Intervention name(s): QuickShot™ - 50 mg Treatment B; QuickShot™ - 100 mg Treatment A; Delatestryl 200 mg IM Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QuickShot™ for the delivery of testosterone; QuickShot™ for the delivery of testosterone; Standard of care
Other intervention name(s): Testosterone; Testosterone enanthate; Testosterone; Testosterone enanthate; Testosterone; Testosterone enanthate
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism; Testosterone enanthate
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
Condition: Chikungunya
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study
      investigating three dose levels of VLA1553 after a single immunization.

      120 study participants will be enrolled into the study to receive three different doses (30
      subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be
      given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of
      20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a
      blinded, randomized manner in the three study arms.

      A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination
      will be sufficient to induce high titer neutralizing antibodies and protect subjects from
      CHIKV viremia.

      Study participants will be followed up until 13 months after initial vaccination.
    


Intervention name(s): VLA1553
Intervention type(s): Biological
Intervention description(s): I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: VLA1553; Chikungunya; CHIKV; Live-attenuated Chikungunya virus vaccine
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD)
      concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A
      direct assay for free 25OHD was introduced recently.

      The aim of the study was to evaluate differences in vitamin D metabolism between young adults
      with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects
      and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for
      12 weeks.
    


Intervention name(s): vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D
The Effects of Aripiprazole on Patients With Metabolic Syndrome
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goal of this study is to assess the effect of aripiprazole on patients who
      developed metabolic syndrome while taking other second generation antipsychotic medications.
    

Detailed description: 
      Schizophrenia, schizoaffective disorder and bipolar disorder are severe and disabling
      disorders, associated with marked social or occupational dysfunction, tenfold suicidal risk,
      intensive healthcare resource utilization and poor prognosis. Atypical antipsychotics
      developed in the last decade are proving beneficial to a subset of patients. These agents
      share a reduced risk for EPS and tardive dyskinesia in comparison with first generation
      antipsychotics. They also appear to improve negative, cognitive, and depressive symptoms
      while being at least as efficacious as first generation "typical" drugs in controlling
      positive symptoms of schizophrenia and schizoaffective disorder. Unfortunately, during the
      late 1990's, case reports and studies began to document a number of adverse events associated
      with the use of most second generation antipsychotics such as weight gain, hyperlipidemia and
      hyperglycemia subsumed under the name "metabolic syndrome". Aripiprazole has a unique
      pharmacological mechanism, making this drug the ideal medication for treatment to patients
      who experience metabolic syndrome from other second generation antipsychotics. In numerous
      pervious trials, it has been demonstrated that aripiprazole is a safe and effective treatment
      for schizophrenia, schizoaffective disorder and bipolar disorder and that it may actually
      reduce plasma glucose levels and improve lipid profiles, lowering the risk for cardiovascular
      disease and /or diabetes. Thirty patients with Diagnostic and Statistical Manual of Mental
      Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or
      bipolar disorder who have experienced a 10 pound increase in weight while on a second
      generation antipsychotic or hyperlipidemia, or hyperglycemia, will switch to aripiprazole and
      be monitored for any improvement in BMI, lipids and glucose.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychiatry; Antipsychotic; Psychopharmacology; Clinical Trial; Open Label; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Metabolic Syndrome
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002
Condition: Malnutrition; Gastric Cancer
MeSH terms: Stomach Neoplasms; Malnutrition
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients
      at nutritional risk. The primary endpoint was the complication rate and the second endpoint
      was the length of stay.
    


Intervention name(s): carbohydrates; vitamins
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Malnutrition; Gastric cancer; preoperative nutrition
A Pilot Clinical Study of PET Scanning in Evaluation of Vaccine Reactogenicity
Condition: Positron-Emission Tomography; Immunization Reaction
Study type: Interventional

Summary: 
      This study forms part of an integrated, multi-study effort to identify potential biomarkers
      of reactogenicity to vaccines. We have selected PET-CT as it is in routine clinical use and
      has been serendipitously shown to image lymph nodes and injection site inflammation after
      immunisation.The study's objectives are exploratory:

        1. To methodically characterise relative anatomical distribution and intensity of
           post-immunisation innate immune activation visualised by PET-CT after immunisation with
           adjuvanted and non-adjuvanted vaccines.

        2. To correlate PET/CT changes with diary card recorded symptoms of reactogenicity.
    


Intervention name(s): Immunization
Intervention type(s): Biological
Intervention description(s): Immunisation with one of four licensed vaccines
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Influence of Sedentary Time on Skeletal Muscle Protein Metabolism
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      This study will investigate the influence of increased sedentary time on long-term measures
      of muscle protein synthesis and metabolic health. The investigators will test the hypothesis
      that increased time spent in sedentary behaviours will lead to a reduction in long-term
      measures of muscle protein synthesis and compromised metabolic health.
    

Detailed description: 
      Sarcopenia, the loss of muscle mass with age, is thought to be accelerated by an inactive,
      sedentary lifestyle. Increased sedentary time has consistently been associated with lower
      muscle mass and compromised metabolic health. However, there is currently a lack of direct
      evidence to support these associations.

      Therefore, this study will investigate whether increased sedentary time (reduced step count
      and exercise cessation) directly influences long-term measures of muscle protein synthesis
      and metabolic health in young, active adults. Following a 7 day period of normal habitual
      physical activity, participants will undertake a 7 day period of step reduction and exercise
      cessation. It is hypothesised that 7 days of increased sedentary time will result in a
      reduction in long-term rates of muscle protein synthesis and a worsening of metabolic health.
    

Intervention name(s): 7 days of habitual physical activity followed by 7 days of reduced physical activity
Intervention type(s): Behavioral
Intervention description(s): Young, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science