bioihbjkbjnl/mcl2 huggingface dataset:
Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy
Condition: Hepatic Cirrhosis; Minimal Hepatic Encephalopathy
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional

Summary: 
      Hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden
      of diseases with therapeutical difficulties for its given morbidity and mortality and the
      high recurrence it poses. Its treatment remains a challenge for most of the cases. Even more,
      minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a
      subclinical entity. As so, the investigators propose an auxiliary treatment for the
      management of such patients with minimal hepatic encephalopathy, using a specific diet
      consisting on hyperproteic and fibre-rich foods along with two independent interventions,
      whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate
      of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic
      encephalopathy itself to none hepatic encephalopathy.
    


Intervention name(s): Auxiliary Treatment; Hyperproteic and fiber-rich diet; Nitazoxanide
Intervention type(s): Other; Dietary Supplement; Drug
Intervention description(s): Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months; Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet; Nitazoxanide tablets 400 mg, bid, orally for 6 months
Other intervention name(s): Biogaia; Probiotics
Intervention MeSH terms: Nitazoxanide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic cirrhosis; Minimal hepatic encephalopathy; Hyperproteic and fiber-rich diet; Lactobacillus reuteri; Psychometric Hepatic Encephalopathy Score (PHES); Critical Flicker Frequency (CFF)
Phase 1 Study of NGM313 in Healthy Adult Participants
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of NGM313, both single
      dose and multiple doses, in normal healthy overweight and obese adult participants.
    


Intervention name(s): NGM313; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Development and Experimental Application of a New Thoracostomy Trocar
Condition: Pneumothorax
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy
      process that is difficult for unskilled physicians, whereas the use of a traditional trocar
      is relatively likely to damage internal organs. In this study, investigators developed a new
      trocar and examined its usefulness.
    

Detailed description: 
      The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure
      that the chest tube proceeds in only one direction. The mold also has a mark to indicate
      insertion depth. Sixteen participants without experience with thoracostomies observed one
      closed thoracostomy procedure using the new trocar and then performed three thoracostomies on
      a cadaver. For each of these thoracostomies, investigators measured the time required for
      chest tube insertion, the position of the tip of the chest tube within the thoracic cavity,
      the difficulty associated with the procedure, and the volunteer's confidence after the
      procedure.
    

Intervention name(s): Trocar
Intervention type(s): Device
Intervention description(s): Closed thoracostomy using the new trocar
Intervention model: Single Group Assignment
Masking: Single (Participant)
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients
Condition: Sleep; Sleep Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      This study aims to evaluate the accuracy of apnea detection and automated sleep analysis by
      the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5
      sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in
      adults during a physician-referred overnight sleep study due to suspicion of sleep-disordered
      breathing.
    

Detailed description: 
      The study will enroll up to 70 adults who are referred to the Stanford Sleep Medicine Center
      by their physician for an overnight polysomnographic sleep study due to suspicion of
      sleep-disordered breathing, with the aim of collecting 60 usable data sets (i.e., eligible
      subjects with high-quality PSG and Dreem recordings). Upon arrival to the clinic, patients
      provide informed consent, are interviewed to determine eligibility, and complete a detailed
      demographic, medical, health, sleep, and lifestyle questionnaire (Alliance Sleep
      Questionnaire; ASQ). After the ASQ, participants are fitted with the PSG and the Dreem
      headband by the sleep technologist. During the PSG sleep study, the Dreem headband records
      EEG, pulse, oxygen saturation (SO2), movement, and respiratory rate. Many participants may
      undergo a split-night study with a continuous positive airway pressure (CPAP) device during
      their participation, as deemed necessary by the clinical staff pursuant to the sleep study.

      The PSG data from the first 30 eligible participants will be manually scored by 5 sleep
      technologists. These manually-scored PSG data files (referred to as the training dataset)
      will be synchronized with Dreem data files from the same night and the synchronized files
      will be used to train Dreem's deep learning algorithms. Following training, the algorithms
      will be deployed to automatically score the final 30 participants' Dreem datasets (testing
      dataset). Finally, PSG records for the second 30 participants will be provided to the sponsor
      and manually scored by 5 sleep technologists. The manual scoring results will be compared to
      the Dreem automatic analysis to determine the accuracy of Dreem's apnea-hypopnea index (AHI)
      severity detection and sleep staging algorithms.
    

Intervention name(s): Dreem
Intervention type(s): Diagnostic Test
Intervention description(s): Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG. Pursuant to the physician-ordered diagnostic study, clinical staff may determine a split-night study with CPAP to be appropriate for any participant, simultaneous with the PSG and Dreem.
Intervention model: Single Group Assignment
Intervention model description: Dreem
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Automated Sleep Staging; Automated Apnea Detection
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
Condition: Hepatitis B, Chronic (CHB)
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open label, randomized, comparative, multi-center study. Subjects will be screened
      within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the
      selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated
      interferon alfa-2b (PegIntron) (1.5 mcg/kg body weight) or (2) oral adefovir 10 mg daily. The
      treatment phase will be 24 weeks for PegIntron and 48 weeks for adefovir. All subjects
      completing the assigned treatment phase will be followed up for an additional 48 weeks for
      PegIntron and 24 weeks for adefovir as observation phase. The primary objective is to
      establish the efficacy profile of PegIntron. Secondary objectives are to compare the efficacy
      profile of PegIntron with that of adefovir, compare efficacy of PegIntron in lamivudine-naïve
      and lamivudine-experienced subjects, and to establish the safety profile of PegIntron in
      treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.
    


Intervention name(s): Pegylated interferon alfa-2b (PegIntron); Adefovir dipivoxil (adefovir)
Intervention type(s): Biological; Drug
Intervention description(s): Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks; 10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks
Other intervention name(s): SCH 54031, Peg-Intron; Hepsera
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Adefovir; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B virus; Pegylated interferon alfa-2b (PegIntron)
Study of UK Adults With Congenital Adrenal Hyperplasia.
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Observational

Summary: 
      Congenital Adrenal Hyperplasia (CAH) is one of the commonest inherited diseases, affecting
      1:14,200 live births. It is the result of a genetic defect in one of the enzymes (in most
      cases 21-hydroxylase) required for cortisol biosynthesis, leading to reduced levels of
      cortisol and aldosterone, increased ACTH concentrations and consequently increased adrenal
      androgen production. Patients suffer from problems with growth and development and as adults
      patients may have problems with fertility, virilisation in women, testicular masses in men
      and both men and women have an impaired quality of life. Patients have to take life-long
      therapy. Despite its frequency knowledge surrounding the management of adults with CAH
      remains fairly limited. There has been a lot of work describing the management of children
      with CAH but to date there is no consensus on how to manage adults. To address this issue a
      number of adult endocrinologists in the UK under the auspices of the Society for
      Endocrinology have established a country wide study (CaHASE) to undertake research in order
      to set standards of care for adult patients with CAH.

      In CAH the severity of the symptoms experienced by affected individuals varies depending on
      the mutation and the genetic background of the individual. The ability to tailor CAH therapy
      on an individual basis, as determined by the severity of the underlying defect and an
      understanding of the likely natural history of the disease, is a key goal in clinical
      management. Correlation of phenotype (clinical status) and genotype (the underlying 21
      hydroxylase gene mutation) will facilitate stratification of severity and provide an
      important contribution to the debate on potential mechanisms of individualised therapy. For
      instance it may become clear that certain CAH genotypes are associated with specific long
      term outcomes. In time, this could lead to suggesting different treatment strategies in
      certain groups. Moreover, genotype data are important if we are to address the relative
      contribution of environment (e.g. treatment) vs. genetics on long term outcomes.

      This multi-centre study aims to:

        1. - Investigate the medical health of adults with congenital adrenal hyperplasia.

        2. - Investigate the relationship between the genotype of the patient and the phenotype.

        3. - Investigate the quality of life of adults with congenital adrenal hyperplasia.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        UK Adults with Congenital Adrenal Hyperplasia
      
Keywords: Congenital Adrenal Hyperplasia; Quality of Life; Genotype; Metabolic outcomes
Pap Smear Collection With the Papette Brush
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This research study is comparing Pap smear collection techniques using the Papette brush to
      traditional spatula and cytology brush for cervical cancer screening
    

Detailed description: 
      At the investigators institution the investigators have been using both the traditional
      spatula and cytology and the Papette brush for Pap smear collection. The investigators will
      be comparing adequacy of sample rates, provider perceived pain and bleeding and overall
      satisfaction with each collection technique.
    

Intervention name(s): Papette brush collection; Spatula/cytology brush collection
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Cervical cell brush that gathers collects cervical cells during Pap smear collection; Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pap Smear Collection
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of 6 weeks of treatment with
      beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as
      assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability
      of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.
    


Intervention name(s): BDP; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.; Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Other intervention name(s): QNASL®; Beclomethasone dipropionate
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric Subjects
Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of bicalutamide
      50 mg tablet (test) versus Casodex® (reference), administered as 1 x 50 mg tablet under fed
      conditions.
    


Intervention name(s): Bicalutamide
Intervention type(s): Drug
Intervention description(s): 50 mg Oral Tablet
Other intervention name(s): Casodex®
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bioequivalency
Improving Prostate Lesion Classification and Development of a PI-RADS 3 Classifier
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The investigators propose an AI methodology combining machine learning, histological results
      and expert image interpretation for the development of a PI-RADS 3 classifier.
    

Detailed description: 
      Prostate cancer is the most common carcinoma in male patients in Western industrialized
      countries. Multiparametric prostate MRI (mpMRI) can select patients who may be potential
      candidates for biopsy. In this study, the investigators present a comprehensive methodology
      that evaluates a multitude of AI algorithms and assesses their performance on a large and
      high-quality dataset, aiming to generate an efficient model and develop a PI-RADS 3
      classifier. By combining the power of machine learning with the information provided by
      mpMRI, histopathological results as well as expert image interpretation, the investigators
      attempt to improve the diagnostic accuracy, which in the future my lead to more informed
      clinical decisions and reduce unnecessary biopsies.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the study population will be patients of a primary care clinic
      
Keywords: prostate cancer; artificial intelligence
The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy
Condition: Nephrotic Syndrome; Glomerulonephritis; Membranous Nephropathy
MeSH terms: Kidney Diseases; Proteinuria; Nephrotic Syndrome; Nephrosis; Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional

Summary: 
      Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections,
      drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori
      (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the
      prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria
      level in patients with MN will be investigated.
    

Detailed description: 
      Membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. It is thought
      to be mainly a primary or idiopathic form; however, it may also be secondary to many other
      diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the
      presence of Helicobacter Pylori antigen was investigated in renal tissue from needle biopsy
      samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication
      on proteinuria level in patients with MN will be investigated.
    

Intervention name(s): lansoprazole, amoxicillin, clarithromycin
Intervention type(s): Drug
Intervention description(s): lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: nephrotic syndrome; Helicobacter pylori infection; proteinuria; membranous nephropathy
Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, dose escalation study aimed at evaluating the safety, early
      efficacy and potential biomarkers of (+)-epicatechin in patients with Becker or Becker-like
      Muscular Dystrophy (BMD).
    

Detailed description: 
      The safety and tolerability of three escalating doses of (+)-epicatechin will be assessed and
      early effectiveness measured by changes in plasma biomarkers, tissue biomarkers from muscle
      biopsies, cardiac imaging, and on clinical function assessments of participants' muscle
      strength. All patients will receive oral (+)-epicatechin for a total duration of
      approximately 52 weeks. Three doses of (+)-epicatechin will be tested in sequential 2 month
      periods with total daily doses of 75, 150, and 225 mg/day (+)-epicatechin. Doses will be
      escalated every 2 months, if tolerated, for the first 6 months of the study. Participants
      will then continue to receive the highest does they tolerated for an additional 6 months.
    

Intervention name(s): (+)-Epicatechin
Intervention type(s): Drug
Intervention description(s): (+)-Epicatechin is a synthetic flavanol
Other intervention name(s): EB 002; EPM-01
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stage I/II NSCLC Perioperative Chemotherapy
Condition: Non-small Cell Lung Cancer Stage I and II; Peri-operative Chemotherapy
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The addition of chemotherapy to lung cancer surgery is now considered as the standard of
      care. Solid data support postoperative chemotherapy but only few results are available in the
      preoperative setting. To define which timing of perioperative chemotherapy offers the best
      survival improvement, the IFCT 0002 study is conducted in France.
    

Detailed description: 
      In this multicenter study, patients are randomized to receive either two preoperative
      chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy,
      or two preoperative plus two postoperative cycles in case of response.
    

Intervention name(s): gemcitabine + cisplatine; Paclitaxel + Carboplatine
Intervention type(s): Drug; Drug
Intervention description(s): gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22); paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)
Intervention MeSH terms: Paclitaxel; Gemcitabine; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment