bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.
Condition: Breast Cancer; Lung Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effectiveness of a natural nutraceutical in treating the known
      side effects of chemotherapeutic agents in cancer patients.
    

Detailed description: 
      This study will assess the effectiveness of a natural nutraceutical in treating the known
      side effects of chemotherapeutic agents in cancer patients. The study will be observing the
      standard treatment protocol for any degradation or enhancement due to the nutraceutical.
    

Intervention name(s): Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell); Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo; Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.; Placebo; Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).
Other intervention name(s): RaproCell
Intervention MeSH terms: Cisplatin; Docetaxel; Antineoplastic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized interventional parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cancer Breast Lung Prostate
TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
Condition: Placenta Accreta
MeSH terms: Placenta Accreta
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of
      morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative
      findings.
    

Detailed description: 
      -  This is a prospective study which will include 50 patients who will be selected from the
           outpatient and inpatient obstetric Ain Shams university maternity hospital.

        -  All patients will undergo the following :

             1. History taking

             2. Clinical examination.

             3. For each patient, the whole placenta will be scanned in a systematic fashion using
                both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to
                determine whether those patients suspected of having advanced invasive
                placentation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  This is a prospective study which will include 50 patients who will be selected from
             the outpatient and inpatient obstetric Ain Shams university maternity hospital.

          -  All patients will undergo the following :

               1. History taking

               2. Clinical examination.

               3. For each patient, the whole placenta will be scanned in a systematic fashion
                  using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI
                  to determine whether those patients suspected of having advanced invasive
                  placentation.
Anesthetic Management of Patients With Chronic Sleep Disorders
Condition: Narcolepsy; Idiopathic Hypersomnia; Restless Legs Syndrome
MeSH terms: Sleep Wake Disorders; Parasomnias; Restless Legs Syndrome; Narcolepsy; Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Study type: Observational

Summary: 
      The aim of this study is to describe and compare the anaesthesia history and possible
      problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy,
      idiopathic hypersomnia, and restless legs syndrome followed at the Montpellier Sleep Unit.

      For each participant, existing data from the medical record will be used, with their consent.
      All participants will complete a standardized questionnaire, concerning their history of
      anaesthesia, the course and possible complications, and questions about their treatment for
      their sleep disorder.
    

Detailed description: 
      This is both a retrospective and prospective single-center study. In the prospective part of
      the study, patients complete a self-questionnaire, with :

        -  a non-specific part, concerning the history of anaesthesia (locoregional or general),
           the patient's feelings about these anaesthesias (possible difficulties in waking up,
           pain) and details about the the course of the anaesthesia (including possible
           complications).

        -  a part specific to the sleep disease (possible rebound of symptoms, management of sleep
           treatments before and after anesthesia, sleep treatments before and after the different
           types of anesthesia).

      Evaluation Criteria:

      Main:

      Frequency of history of locoregional and general anesthesia, and their possible
      complications.

      Secondary:

      Frequency of patients with rebound symptoms, or with worsening symptomatology (in each of the
      3 groups, and in subgroups of patients with the same treatments), during locoregional and
      general anesthesia independently.

      Other parameters collected via self-questionnaire (and at the time of the initial evaluation,
      retrospectively on medical records):

        -  Sociodemographic data: age, gender, body mass index

        -  Data related to the disease: age of onset of symptoms, age of diagnosis

        -  Other associated medical conditions

        -  Type of surgery

        -  Type, date and the number of anesthesia: locoregional, general
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Patients will complete a questionnaire regarding their anesthesia history, course and possible complications, and Questions about their treatment for their sleep disorder.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients, older than 16 years at time of the study, diagnosed with a sleep disorder:
        narcolepsy (1 or 2), idiopathic hypersomnia and restless legs syndrome.
      
Keywords: Sleep; Anesthesia; Sedation; Surgery; drugs
Microbiome and Non-caloric Sweeteners in Humans
Condition: Glucose Intolerance; Glucose, Low Blood; Glucose, High Blood
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of
      combating weight gain and diabetes, by retaining sweet taste without increasing caloric
      intake. While they are considered safe, there is increasing debate regarding their potential
      role in contributing to metabolic derangements in some humans. The investigators recently
      demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice
      and, in preliminary experiments, in distinct human subsets, by functionally altering the gut
      microbiome, and that the gut microbiome plays an important role in mediating differential
      glucose responses to identical foods. The proportion of the human population that is
      susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that
      are shared between these individuals and whether and how the microbiome promotes the
      metabolic derangements remain to be addressed.
    


Intervention name(s): Glucose; Aspartame; Sucralose; Saccharin; Stevia; No Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Daily consumption of 5g of glucose, for 14 days.; Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.; Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.; Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.; Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.; Follow up without any dietary supplementation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study evaluates the retinal vascular features using optical coherence tomography
      angiography in patients that have been affected by COVID-19.
    

Detailed description: 
      To investigate the potential role of optical coherence tomography angiography in identifying
      the changes in retinal vessel density in patients that have been affected by COVID-19.

      The optical coherence tomography angiography represents a noninvasive diagnostic technique
      that allows a detailed analysis of retinal vascular features.
    

Intervention name(s): Optical coherence tomography angiography
Intervention type(s): Diagnostic Test
Intervention description(s): Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with previous diagnosis of COVID-19. They did not
        present other ophthalmological diseases.
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
Condition: Tetanus; Poliomyelitis; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the immunogenicity and reactogenicity of
      Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4
      and 5 months of age.
    


Intervention name(s): Infanrix-IPV/Hib™; Infanrix Hib™; Poliorix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular, three doses; Intramuscular, three doses; Intramuscular, three doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infanrix-IPV+Hib
Oral Cleft Prevention Trial in Brazil
Condition: Cleft Lip; Cleft Palate
MeSH terms: Cleft Palate; Cleft Lip
Study type: Interventional
Phase: Phase 3

Summary: 
      Cleft lip and palate are a significant component of morbid human birth defects in the
      developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus
      0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the
      state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.
    

Detailed description: 
      Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the
      impact of birth defects on fetal and neonatal health directly and maternal health indirectly.
      Craniofacial anomalies comprise a significant component of morbid human birth defects. The
      primary hypothesis is that folic acid supplementation of 4mg/day at preconception and during
      the first three months of pregnancy will decrease the recurrence of nonsyndromic cleft lip
      with or without clef palate (NSCL/P) in a high-risk group of women when compared to women
      taking 0.4 mg per day of folic acid. The total sample will include 2,000 women (that either
      have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg versus
      the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of
      NSCL/P in the total sample of subjects as well as the two study groups (4mg, 0.4 mg) to that
      of a historical control group.

      The primary outcome assessed is the rate of recurrences of NSCL/P in offspring of the trial
      mothers in each of the two study groups. Secondary outcomes include recurrence of NSCL/P
      compared to a historical control group; serum and red cell folate levels; severity of NSCL/P
      in offspring of trial mothers; twinning rate; miscarriage rate; preeclampsia; rates of other
      birth defects; birth weight; and gestational age. The sample size was based on historic
      tables of birth rates and the rates of cleft occurrences. The study hypothesizes that a total
      of 2000 subjects will be enrolled during a 2.5 year period; a dropout rate of 10%; birth rate
      for group A (women with NSCL/P) of 10% and a rate of 12% for group B (women with at least one
      child with NSCL/P); risk of cleft for group A is 7% and for group B is 4%; one-sided test
      with continuity correction.
    

Intervention name(s): Folic acid (0.4mg vs. 4.0mg)
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Cleft palate; Cleft lip; Folic acid; Global Network; Maternal and child health; International; Women's health; Brazil; Brasil; Latin America; ECLAMC; Congenital defects; Pregnancy
COVID-19 Progression in End-Stage Kidney Disease
Condition: SARS-CoV-2 Infection (Asymptomatic); SARS-CoV-2 Infection (Symptomatic)
MeSH terms: Infections; Communicable Diseases; COVID-19; Kidney Diseases; Kidney Failure, Chronic
Study type: Observational

Summary: 
      The purpose of this study is to collect genomic and clinical data among a cohort of
      hemodialysis patients and analyze the association between genetic markers and the development
      and severity of illness in response to SARS-CoV-2.
    

Detailed description: 
      COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global
      pandemic on March 11, 2020 and since that time there have been outbreaks on every continent
      except for Antarctica. Preliminary understanding of the virus suggests that some fraction of
      the population does not manifest clinical disease in response to infection, others manifest a
      relatively benign course of illness, and still others develop a fulminant course that
      eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic
      and epigenetic basis for differential susceptibility remains unknown.

      Patients receiving hemodialysis provide a good opportunity to understand genetic and
      epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care,
      such patients cannot shelter at home or maintain social distancing, but must instead report
      to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to
      and from dialysis using shared ride services, which furthers opportunity for exposure.
      Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher
      among hemodialysis patients than in the general public. Furthermore, frequent contact with
      the health care system among dialysis patients makes tracking clinical course comparatively
      easy.

      The purpose of this study is to collect genomic and clinical data among a cohort of
      hemodialysis patients and analyze the association between genetic markers and the development
      and severity of illness in response to SARS-CoV-2.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Type A & B participants must meet all of the following criteria:

          1. Is between 18 and 80 years of age, inclusive.

          2. Ability to provide informed consent.

          3. Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita
             dialysis center.

        3.2 Additional Inclusion Criteria: Type B (prior participant in genomics study)

        Type B participants must meet all of the above criteria and the following criteria:

        1. Enrollment in prior genomics study.
      
Biospecimen description: 
      -  SARS-CoV-2 IgG

        -  Genomic testing will be performed on participants with positive anti-SARS-CoV-2 IgG
           and/or with history of positive SARS-CoV-2 PCR results.
Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Condition: Chronic Idiopathic Thrombocytopenic Purpura; Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with
      Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori
      eradication on platelet count.
    

Detailed description: 
      Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori
      infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test.
      Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and
      treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors
      for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after
      treatment. Blood tests for platelet count will be performed every month for 6 months in both
      groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody
      will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter
      pylori at the end of the study.
    

Intervention name(s): lansoprazole, clarithromycin, amoxycillin
Intervention type(s): Drug
Intervention description(s): lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days
Other intervention name(s): lansoprazole or Prevacid; clarithromycin or Klacid; Amoxycillin or Ibiamox
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic idiopathic thrombocytopenic purpura; Helicobacter pylori infection; platelet
A Study of LY3502970 in Participants With Normal and Impaired Renal Function
Condition: Renal Insufficiency; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches
      the bloodstream and the time it takes for the body to get rid of it when given to
      participants with renal (kidney) impairment compared to participants with normal renal
      function. The safety and tolerability of LY3502970 will also be evaluated in these
      participants. The study will last up to 6 weeks including screening period.
    


Intervention name(s): LY3502970
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Investigation of Cardiac Function and Cardiovascular Risk Factors in Marathon Runners- The Munich Marathon Study
Condition: Modes of Exercise and Myocardial and Endothelial Function; Microcirculation; Subclinical Endorgan Damage; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to determine the cardiovascular risk involved in the exertional
      exercise of marathon running. The researchers aim to investigate the beneficial effects of
      regular well-dosed exercise on health and compare these findings with the effects of the
      extreme strains of marathon running. Subclinical injuries to heart and arteries are being
      investigated in different groups of runners, including obese participants.
    

Detailed description: 
      Regular exercise leads to an improvement of cardiovascular risc factors in patients with
      coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has
      anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an
      acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of
      preexisting plaques, may result in plaque rupture and acute myocardial infarction.

      The researchers aim to define the critical role of inflammatory markers and cardiovascular
      risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction
      in marathon runners.

      The study groups are divided into average trained runners (40 km/week), average trained obese
      runners and highly trained runners (> 70km/week). Training programmes are supervised by
      professional coaches. Individual scientific marathon contests are organized for the
      assessments.

      Diagnostic tools include measurements of pulse wave velocity and heart rate turbulence,
      echocardiography and, for the first time, MRI-scans pre- and post marathon running.
      Additionally, cardiovascular markers such as endothelial progenitor cells (EPCs)and
      adiponectin are measured. Inflammatory markers include c-reactive protein (CRP), interleukins
      and tumor necrosis factor.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male marathon runners with no more than one treated cardiovascular risk factor aged
        30-60 years. Participation of at least a 1/2 marathon in recent history.
      
Keywords: cardiovascular risc factors; inflammation; aerobic and exertional exercise
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and
      active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at
      Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to
      MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting
      conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered
      orally BID for 12 weeks in a blinded fashion.
    


Intervention name(s): PF-06650833; Placebo; Tofacitinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational; Placebo; Investigational
Other intervention name(s): Xeljanz
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment