bioihbjkbjnl/mcl2 huggingface dataset:
Blood Sample Analysis in Predicting Overall Survival in Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at blood sample analysis in predicting overall
      survival in patients with recurrent or metastatic head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To validate the mass spectrometry profile that is predictive of survival benefit in
           patients with recurrent or metastatic head and neck squamous cell carcinoma treated with
           EGFR inhibitors.

      OUTLINE: Plasma and serum samples are analyzed by matrix-assisted laser desorption/ionization
      time-of-flight mass spectrometry and classified according to prognosis ("good" vs "poor")
      using a previously developed predictive algorithm.
    

Intervention name(s): matrix-assisted laser desorption/ionization time of flight mass spectrometry
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E3301
      
Keywords: recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; salivary gland squamous cell carcinoma; stage IV salivary gland cancer
Prehabilitation for Prostate Cancer Surgery
Condition: Prostate Cancer Patients Undergoing Radical Prostatectomy
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Radical prostatectomy is the most common and effective treatment for localized prostate
      cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects,
      such as urinary incontinence, sexual dysfunction, and reduced physical function that
      collectively diminish health-related quality of life which may persist for up to two years
      postoperatively. The primary objective of this trial is to assess the feasibility of
      conducting of a multi-site randomized controlled trial to test the effect of a comprehensive
      prehabilitation program versus standard care for men with prostate cancer undergoing radical
      prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy
      in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle
      exercises) will report better health-related quality of life, urological symptoms, and
      physical fitness, physical activity, and pain, as well as a shorter postoperative length of
      stay than participants receiving standard preoperative care (pelvic floor muscle exercises
      alone). Our secondary objective is to report estimates of efficacy on several clinically
      important outcomes for this population that will be used for sample size calculations in an
      adequately powered trial.
    


Intervention name(s): Prehabilitation (PREHAB)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate cancer; Radical prostatectomy; Prehabilitation; Pelvic floor muscle exercises
Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
Condition: Covid-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia
      due to COVID-19, as measured by the proportion of patients alive and free of respiratory
      failure.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled, Phase 2, proof of concept study in
      hospitalized patients with mild to moderate pneumonia due to COVID 19. Written informed
      consent must be obtained from all patients during screening. Following completion of all
      screening assessments and meeting of eligibility criteria, patients will either receive
      antroquinonol or placebo for 14 days in combination with SoC therapy per local SoC policies.
    

Intervention name(s): Antroquinonol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): double-blind for antroquinonol and Placebo with same out-look and same frequency.; Capsule without active compound
Other intervention name(s): Hocena
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 2 Randomized, Double blind, Placebo Controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients with Mild to Moderate Pneumonia due to COVID 19
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antroquinonol; COVID 19; pneumonia
Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis
Condition: Endometriosis; Pelvic Pain
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat.
      In view of this, many patients seek assistance in complementary and alternative medicine,
      including homeopathic treatment. The absence of evidence in the literature raises controversy
      about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized
      trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the
      treatment of chronic pelvic pain of endometriosis.
    

Detailed description: 
      This is a randomized, double-blind and placebo controlled trial using individualised
      homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis.
      Patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to
      those of the estrogen adverse events will be recruited in the Sector of Endometriosis of the
      Clinical Division of Gynaecological of the Hospital das Clínicas of the Faculty of Medicine
      of the University of Sao Paulo. The selection process was carried out through the analysis of
      medical charts and self-completing of structured questionnaires. Satisfied the inclusion
      criteria, fifty patients were randomly and distributed to receive dynamized estrogen or
      placebo. The primary clinical outcome is the severity of the chronic pelvic pain. Statistical
      analysis will be by intention-to-treat and per protocol comparing homeopathic drug with
      placebo after 24 weeks of intervention.
    

Intervention name(s): dynamized estrogen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period).; The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.
Other intervention name(s): dynamized 17-beta estradiol; alcohol solution
Intervention MeSH terms: Estradiol; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Endometriosis; Pelvic pain; Homeopathy; RCT
Salt Intake and Lactobacillus Abundance
Condition: Healthy Volunteers; Probiotics; Sodium
Study type: Interventional

Summary: 
      To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative
      abundance of gut lactobillus species in healthy men
    


Intervention name(s): Probiotics; Salt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Day 1-21: 2 capsules per day; Day 8-21: 10 tablets à 600 mg per day
Other intervention name(s): Vivomixx; Slow Sodium Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT
Condition: Myeloid Leukemia; Precursor Myeloid Neoplasms; Lymphoid Neoplasms
MeSH terms: Leukemia; Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis, that the order of application of Busulfan
      (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem
      cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
    


Intervention name(s): Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation; Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
Intervention type(s): Drug; Drug
Intervention description(s): Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.; Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
Intervention MeSH terms: Cyclophosphamide; Busulfan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a
      Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients
      with an incomplete response to PPI treatment.
    


Intervention name(s): AZD3355
Intervention type(s): Drug
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Heartburn; Patient reported symptoms; Proton pump inhibitor
The Role of Endogenous Lactate in Brain Preservation and Counterregulatory Defenses Against Hypoglycemia
Condition: Type 1 Diabetes Mellitus; Hypoglycemia Unawareness
MeSH terms: Unconsciousness; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people
      with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation,
      characterized by suppression of hypoglycemic symptoms, eventually leading to hypoglycemia
      unawareness, which creates a particularly high risk of severe hypoglycemia. Recent evidence
      suggest a pivotal role for (brain) lactate in the pathogenesis of hypoglycemia unawareness.
      Indeed, exogenous lactate administration may preserve brain function and attenuate
      counterregulatory responses to and symptomatic awareness of hypoglycemia. It is unknown
      whether endogenous elevation of plasma lactate produces the same effects and whether such
      effects differ between patients with T1DM with and without hypoglycemia unawareness and
      healthy controls.

      Objective: To investigate the effect of elevated levels of endogenous lactate on brain
      lactate accumulation and on counterregulatory responses to, symptomatic awareness of and
      cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia
      unawareness and normal controls.

      Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through
      high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which
      in turn will attenuate counterregulatory hormone responses, appearance of symptoms and
      deterioration of cognitive function. Second, the investigators posit that these effects will
      be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM
      patients with normal awareness as a consequence of greater transport capacity of lactate into
      the brain.
    


Intervention name(s): High intensity exercise; Lay down comfortably
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3x30 seconds 'all out' sprints; rest
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 1 Diabetes Mellitus; Hypoglycemia unawareness; Lactate; high intensity interval exercise; MRS
Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This prospective, randomized, controlled study will evaluate the effects of oral nutritional
      supplementation plus dietary counseling versus dietary counseling alone in children at
      nutritional risk.
    


Intervention name(s): Oral Nutrition Supplement (ONS) Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling; Dietary counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Study of Inhaled Glucocorticosteroid Administration in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway
      inflammation in asthma patients.
    


Intervention name(s): Budesonide,hydrofluoroalkane-beclomethasone dipropionate; Budesonide,hydrofluoroalkane-beclomethasone
Intervention type(s): Drug; Drug
Intervention description(s): receive twice-daily administration; once-daily administration at bedtime
Intervention MeSH terms: Budesonide; Beclomethasone
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        University Hospital
      
Keywords: asthma patients; well-controlled
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by
      up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus
      surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy,
      and whether virologic response can be sustained once PegIFN treatment is discontinued.
      Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24
      weeks of PegIFN.
    


Intervention name(s): GSK3228836; PegIFN; NA therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be administered GSK3228836.; Participants will be administered PegIFN.; Participants will continue to receive their NA therapy for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised in a ratio of 1:1 to one of two treatment arms: 24 weeks GSK3228836 followed by up to 24 weeks PegIFN, or 12 weeks GSK3228836 followed by up to 24 weeks PegIFN.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; GSK3228836; Pegylated interferon; Nucleos(t)ide analogue; Sustained virologic response
Pathophysiological Mechanisms of Fibromuscular Dysplasia
Condition: Fibromuscular Dysplasia
MeSH terms: Fibromuscular Dysplasia; Hyperplasia
Study type: Interventional

Summary: 
      Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial
      disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown
      origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of
      narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery,
      arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several
      factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order
      to progress into identifying possible causative mechanisms of the disease, we design a
      pathophysiology study destined to assess endothelial function in patients with fibromuscular
      dysplasia and to identify possible plasmatic biomarkers of the disease.
    


Intervention name(s): blood samples; vascular echotracking
Intervention type(s): Other; Other
Intervention description(s): blood samples; endothelial function study and virtual histology study
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: fibromuscular; dysplasia; endothelium; microparticles; microRNA
Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors
Condition: Supratentorial Brain Tumors
MeSH terms: Brain Neoplasms; Supratentorial Neoplasms
Study type: Observational

Summary: 
      This study aims to determine the relationship between heart rate variability and
      intraoperative brain relaxation conditions in patients with brain tumors.
    

Detailed description: 
      Patients undergoing brain surgery for treatment of brain tumors will be studied to determine
      the relationship between heart rate variability and intraoperative brain relaxation
      conditions.
    

Intervention name(s): ANSiscope
Intervention type(s): Device
Intervention description(s): Heart rate variability will be assessed using ansiscope before surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients of either sex with supratentorial brain lesions who are posted for
        neurosurgery will be taken as study population. Patients who meet the inclusion criteria
        and give consent for the study will be included in the study
      
Keywords: Heart rate variability,; supratentorial brain tumors; optic nerve sheath diameter
Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Observational

Summary: 
      Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major
      complication that might be affected by pancreatic stump reconstruction technique. More than
      60 techniques were published in literature. Soft pancreas and small pancreatic duct size were
      major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa
      Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new
      and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk
      patients.
    

Detailed description: 
      Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major
      complication that might be affected by pancreatic stump reconstruction technique. More than
      60 techniques were published in literature. Soft pancreas and small pancreatic duct size were
      major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa
      Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new
      and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk
      patients.

      The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and
      analyzed to evaluate the new technique and its impact on the incidence of post-operative
      pancreatic fistula.
    

Intervention name(s): Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures
Intervention type(s): Procedure
Intervention description(s): Adding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures.
Other intervention name(s): Buttressing sutures
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with soft pancreas and pancreatic duct diameter ≤ 5 mm (15 Fr), who underwent the
        classic pancreaticoduodenectomy (Whipple) procedure for cancer pancreas. Supporting
        pancreatico-gastrostomy with buttressing sutures was used. It is an anastomotic
        modification by supporting it with trans-pancreatic and full-thickness gastric wall
        transverse mattress U- Shaped sutures to fix the posterior gastric wall envelope around the
        pancreatic stump, to alleviate any tension on the Pancreatico-Gastrostomy sutures.
      
Keywords: Cancer pancreas; Pancreaticoduodenectomy; Pancreaticogastrostomy
Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate which combination therapy is more effective for
      improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II
      receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics
    


Intervention name(s): Losartan 50mg/amlodipine 5mg; Losartan 100mg/amlodipine 5mg; Losartan 50mg/Hydrochlorothiazide 12.5mg; Losartan 100mg/Hydrochlorothiazide 25mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily, 1T, PO medication; once daily, 1T, PO medication; once daily, 1T, PO medication; once daily, 1T, PO medication
Other intervention name(s): amosartan 5/50mg; amosartan 5/100mg; Cozaar Plus; Cozaar Plus F
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment