bioihbjkbjnl/mcl2 huggingface dataset:
Diabetic Retinopathy Candesartan Trials
Condition: Type 1 Diabetes
MeSH terms: Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine whether candesartan, compared to placebo reduces the
      incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients
      without retinopathy.

      The secondary objective is to determine whether candesartan, compared to placebo,
      beneficially influences the rate of change in urinary albumin excretion rate (UAER).

      This study is part of the DIRECT Programme also including secondary prevention studies of
      diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three
      pooled studies is to determine whether candesartan, compared to placebo, reduces the
      incidence of microalbuminuria in type 1 and type 2 diabetic patients.
    


Intervention name(s): candesartan cilexetil
Intervention type(s): Drug
Intervention description(s): 32 mg once daily oral tablet given over 60 months
Other intervention name(s): ATACAND
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Insulin-Dependent
Effects of Heating Transfusion on Brain Function
Condition: Blood Transfusion
Study type: Observational

Summary: 
      To inversitage whether routine warming of blood is harmful to brain fuction of sugical
      patients receiving massive transfusion.
    

Detailed description: 
      Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury
      in animal experiments and in clinics.In a recent study, it has been shown that perioperative
      warming was associated with a higher incidence of cognitive dysfunction in elderly
      patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect
      on brain function of surgical patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult paitents scheduled for major surgery.
      
Biospecimen description: 
      Serum
    
Keywords: Heating transfusion
Comparing Warm Versus Cool Temperature Water During Colonoscopy
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The purpose of this study will be to determine if the temperature of water used during
      insertion of colonoscopy makes a difference in patient discomfort and sedation requirements.
      The hypothesis of this study is patients receiving screening colonoscopy utilizing the water
      insertion method with room temperature (cool) water will have similar pain scores and
      medication requirements compared to water insertion method using body temperature (warm)
      water.
    


Intervention name(s): Warm vs Cool water
Intervention type(s): Procedure
Intervention description(s): Body vs Room temperature water used during insertion of colonoscopy
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: colonoscopy; colon cancer screening; patient discomfort scores; sedation medication requirements; water insertion method
A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety and tolerability of 2 dose levels of
      MK-0653H in Japanese participants. The primary hypotheses are that the administration of
      MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe
      and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol
      (LDL-C) after 12 weeks of treatment.
    


Intervention name(s): Ezetimibe 10 mg; Rosuvastatin 2.5 mg; Placebo for Ezetimibe; Placebo for Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Electrophysiological Evaluation of Motor Dysfunction in Liver Cirrhotic Patients
Condition: Liver Cirrhoses; Peripheral Neuropathy
MeSH terms: Liver Cirrhosis; Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      cross sectional observational study, aimed to assess the electrophysiological function of the
      motor units in liver cirrhotic patients.
    

Detailed description: 
      Liver cirrhosis is a global health problem which could be associated with several
      neurological manifestations. The associated peripheral neuropathy could be assessed by
      conventional nerve conduction studies.

      Objective: The study aims at early detection of peripheral neuropathy among patients of liver
      cirrhosis by conventional nerve conduction studies and quantitative EMG methods. In addition,
      the study aims at finding out correlation between peripheral neuropathy and severity of the
      liver cirrhosis.

      Methods: This a cross-sectional study conducted on fifty-six liver cirrhotic patients, that
      had been recruited from the Endemic medicine department/outpatient clinics and their
      age-gender matched sixty-one healthy controls. The recruited patients were clinically
      assessed .Both conventional nerve conduction studies and quantitative EMG techniques in the
      form of MUNE calculation, using modified spike -triggered technique and IPA ratio evaluation
      were performed for the allocated cirrhotic patients.
    

Intervention name(s): Nerve conduction studies and Quantitative EMG ( MUNE and IPA)
Intervention type(s): Diagnostic Test
Intervention description(s): Nerve Conduction Studies: Electrophysiological method that tests the presence/absence of peripheral neuropathy.
MUNE: Electrophysiological technique that assess number of motor units. IPA: Electrophysiological method that assess interference pattern and hence, borderline cases of neuropathy/ myopathy
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty-Six liver cirrhotic patients that were recruited from the Endemic medicine department
        and its outpatient clinics, at Kasr Alainy hospitals, Cairo University.
      
Keywords: Liver cirrhotic patients- Motor Dysfunction-Fatigue.
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Condition: Growth Hormone Deficiency, Pediatric; hGH (Human Growth Hormone); Endocrine System Diseases; Hormones; Pituitary Diseases
MeSH terms: Dwarfism, Pituitary; Pituitary Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth
      hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be
      given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females)
      with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH :
      Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus,
      Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and
      the United States.
    


Intervention name(s): Once weekly subcutaneous injection of TransCon hGH; Once daily subcutaneous injection of Genotropin
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly subcutaneous injection; Once daily subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Growth Hormone; hGH; GHD; rHGH; Pediatric Growth Hormone Deficiency; Long Acting Growth Hormone; Somatropin; Prodrug; Growth Failure; Growth Hormone Replacement Therapy; Sustained Release; Sustained Release Growth Hormone; Growth Hormone Deficiency
A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Condition: Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Interventional

Summary: 
      The primary goal with this study is to document whether patients can maintain their normal
      bowel microbiota by staying at home compared to those who live at home but are treated in
      clinic, and those who are treated in the hospital. In addition, the investigators would
      predict that the quality of life will be higher for those patients treated at the medical
      home compared to those that stay at the hospital. The investigators also predict that the
      costs associated with this approach will be significantly lower compared to hospitalized
      patients. Finally, the investigators propose that the treatment related morbidities and
      mortality will not be different between the two groups.
    

Detailed description: 
      Subjects enrolled in the medical home arm and those serving as concurrent controls will have
      the following studies:

        1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly
           for the first four weeks, at day 60 and 100.

        2. The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected
           weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a
           daily food diary.

        3. Other assessments for toxicities or GVHD will proceed as per current standard of care,
           for a total blood draw amount of 100 mls from home care subjects and concurrent
           controls.
    

Intervention name(s): Home Care
Intervention type(s): Other
Intervention description(s): This is the interventional arm where patients receive the transplant care in their homes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: stem cell transplant; bowel microbiota; home care
Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to test bioequivalence of a assumed key active compound vs. natural
      fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood
      glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for
      assumed key active compound vs. natural extract falls between 0.8 - 1.25.
    

Detailed description: 
      The basic study design for this Williams design consists of six distinct treatment sequences;
      within each of the treatment sequences the treatments are duplicated.
    

Intervention name(s): Natural fruit extract; Assumed active; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Natural fruit extract consumed with rice; Assumed key active consumed with rice; Rice only
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Blood glucose
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective is to confirm the hypothesis that azithromycin used in combination with
      chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic,
      uncomplicated malaria due to P. falciparum in children in African countries.
    


Intervention name(s): Azithromycin plus Chloroquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2); Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
Intervention MeSH terms: Azithromycin; Chloroquine; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: P. Falciparum Malaria; drug treatment; clinical trial
Renal Cysts and Primary Aldosteronism
Condition: Primary Aldosteronism
MeSH terms: Hyperaldosteronism
Study type: Observational

Summary: 
      During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra
      plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin
      concentration and renin activity are analysed from these samples. Adrenal computed
      tomographies are analysed for cysts and other possible pathology by a blinded radiologist.
      Aim is to evaluate correlation between renal pathology and renin measurements.
    

Detailed description: 
      Aim of the study is to evaluate the prevalence of renal cysts and their association with
      renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in
      patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.

      In a prospective study up to 200 patients who have been referred to Tampere University
      Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical,
      medication, radiological and laboratory information according to Endcrine Society guidelines
      is collected. Interventional radiologist will draw venous blood from both renal veins and
      from IVC for later renin analyses. One, blinded radiologist will record renal pathology of
      cysts but also other abnormal radiologic features.

      An interim analysis will be done when 60-100 patients have been recruited or at 6-12 months
      from the start of the study. Study will be stopped if significant difference can be found in
      renin measurement in patients with renal cysts compared with patients without renal cysts.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein
        sampling
      
Biospecimen description: 
      Plasma
    
Keywords: Adrenal vein sampling; Renal cysts; Renin concentration; Renin activity
Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
Condition: Pancreaticobiilary Diseases; Endoscopic Retrograde Cholangiopancreatography
Study type: Observational

Summary: 
      Selective cannulation is an essential step for the success of ERCP. The successful
      cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and
      duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is
      suggested that the size, morphology, orientation and location of major duodenal papilla
      (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the
      related evidences are limited. The investigators hypothesized that special anatomy of
      papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper
      location, could increase the difficulty of cannulation. Here the investigators investigated
      the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the
      procedure of cannulation in patients undergoing ERCP.
    


Intervention name(s): MDP
Intervention type(s): Other
Intervention description(s): evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with native papilla who underwent ERCP
      
Keywords: ERCP; anatomy of major duodenal papilla
Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis
Condition: Leishmaniasis, Cutaneous; Helminthiasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous; Helminthiasis
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic
      therapy combined with standard pentavalent antimony in the treatment of subjects co-infected
      with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is
      that early intervention with antihelminthic therapy will improve response rates to antimony
      in subjects with cutaneous leishmaniasis.
    

Detailed description: 
      Leishmaniases are a group of diseases caused by a parasite and transmitted by the sand fly.
      There are a number of diseases associated with infection ranging from simple skin lesions to
      a severe, fatal form. The standard treatment of cutaneous leishmaniasis (CL) is a 20 day
      course of antimony which, although fairly effective, has multiple side effects and is
      difficult to administer. The populations that are affected by leishmaniasis are usually also
      affected by intestinal helminths (worms). It is unknown what effect these two diseases have
      on each other and the immune system. As pathology in CL is mediated by an inflammatory
      reaction and helminths down regulate inflammation, helminthic infection may be beneficial for
      leishmaniasis. However, a recent study by our research group suggested that subjects infected
      with both leishmania and helminths have longer healing times and are less likely to respond
      to antimony. Since failure of initial therapy often results in repeat courses of the drug or
      development of more severe disease, we propose a study to investigate the role of early
      treatment for co-existing helminth infections in improving response rates to antimony in
      subjects with CL.
    

Intervention name(s): Anti-helminthic; meglumine antimony
Intervention type(s): Drug; Drug
Intervention MeSH terms: Anthelmintics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The primary objective is to determine the change in frequency of complete spontaneous bowel
      movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123
      in healthy adult women with functional constipation.
    

Detailed description: 
      Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the
      Bristol Stool Form scale), pain during defecation (according to the visual analogue scale
      [VAS] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of
      ingested capsules of investigational product will be recorded daily by the subjects
    

Intervention name(s): Lactobacillus gasseri DSM 27123; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 109 CFU (divided in two doses) per day for 28 days; Two doses per day for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Female; Constipation; Lactobacillus gasseri DSM 27123; Probiotics
Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.
Condition: Non-Small Cell Lung Cancer; Epigenetic Therapy
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Response Rate
    

Detailed description: 
      Objective response rate to Nivolumab preceded by epigenetic priming. Response will be
      assessed by RECIST 1.1 criteria, baseline scans for this assessment will be the baseline
      scans done within 4 weeks of enrollment.
    

Intervention name(s): Azacitidine; Entinostat; Nivolumab
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): 5-AZA, Vidaza; Opdivo
Intervention MeSH terms: Nivolumab; Azacitidine; Entinostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis
      and improve liver function in patients who receive long term total parenteral nutrition.
    

Detailed description: 
      PROTOCOL OUTLINE:

      This is a randomized, double blind, placebo controlled study.

      Patients receive either daily choline chloride in their total parenteral nutrition (TPN)
      solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning
      at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose
      of choline provided may be required based on plasma free choline levels and patient
      tolerance. Additionally, all patients record the type and amount of their food intake on a
      daily basis.

      Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning
      with week 12 for the remainder of the 24 weeks, and then again at week 34.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): choline chloride
Intervention type(s): Drug
Intervention MeSH terms: Choline
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: gastrointestinal disorders; hepatic steatosis; rare disease