bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well the vaccine is tolerated at sites where
      administrations are given and any effects it may have on subjects' wellbeing. The study will
      also test the ability of vaccine to reduce hepatitis B disease.
    

Detailed description: 
      Hepatitis B virus (HBV) is responsible for the most common form of parenterally transmitted
      viral hepatitis. It is estimated that approximately 350 million people worldwide are
      persistent carriers of the virus and it is a major cause of acute and chronic infections of
      the liver, with significant associated morbidity and mortality. Chronic infection occurs in
      98% of new-born children infected by vertical transmission from the mother and in 5% of
      individuals infected after 2 years of age. About 25% of these subjects will progress to
      cirrhosis and 20% of this subgroup will develop hepatocellular carcinoma - one of the most
      common cancers world wide. HBV is a non-cytopathic virus and liver injury is mainly mediated
      by the host immune response against virus-infected liver cells and by the production of
      inflammatory cytokines. A vigorous, polyclonal and multispecific cytotoxic and helper T cell
      response to HBV is readily detectable in the peripheral blood of subjects with acute
      self-limited hepatitis B, but is weak, antigenically restricted (mono- or oligospecific) or
      undetectable in subjects with chronic infection. A vigorous T cell response is thus believed
      to be responsible for the elimination of the hepatitis B virus. The aim of a therapeutic
      vaccine would be to enhance natural responses by boosting the appropriate cellular immune
      response to HBV. The purpose of this study is to evaluate the safety and tolerability profile
      of the pPDPSC18 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )
    

Intervention name(s): ppdpSC18 administered by PMED
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: DNA vaccine; immunotherapy; Hepatitis B Virus; Particle Mediated Epidermal Delivery
Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective of the study is to determine which baseline and yearly response factors
      (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24,
      and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives
      are: To identify prognostic factors at Baseline that predict overall disease-free status at
      Month 12, and to assess if yearly overall disease-free response factors predict overall
      disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded
      Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To
      identify prognostic factors at Baseline that predict clinical disease-free status at Month
      12, and to assess yearly clinical disease-free response factors that predict clinical
      disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate
      the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the
      following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week
      sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,
      36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with
      Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on
      the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity
      Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,
      36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]),
      capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality
      of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])
    


Intervention name(s): natalizumab
Intervention type(s): Biological
Intervention description(s): Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
Other intervention name(s): BG00002; Tysabri
Intervention MeSH terms: Natalizumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be recruited by participating neurologists from among their MS
        patients who opt to begin treatment with Tysabri.
Effects of Intraarterial Octreotide on Pancreatic Texture
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional

Summary: 
      The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg
      Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy
      in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.

      A primary end-point of the study is a change in pancreatic texture.

      A secondary end-point is the rate of postoperative pancreatic fistula.
    

Detailed description: 
      Soft pancreas is an established risk factor for the development of postoperative pancreatic
      fistula in patients undergoing pancreatoduodenectomy. Octreotide is believed to harden the
      pancreas. This theory is based on the results of a single animal experiment and a small case
      series in humans. This hardening effect of octreotide has not quantitatively been proven in
      humans and its mechanism is not clear. Histomorphologic correlates of pancreatic hardness are
      unknown.

      In this study all patients who are eligible for pancreatoduodenectomy and sign the informed
      consent for participation in the study will be recruited. Those of them who prove to have a
      soft pancreas intraoperatively will receive a single bolus of 500 µg Octreotide in the
      gastroduodenal artery after its proximal division. Pancreatic hardness in the region of the
      resection margin will be quantitatively assessed by a Shore durometer before the intervention
      and at several time-points after it. The suture-holding capacity of pancreatic tissue at the
      resection margin will be quantitatively assessed by a dynamometer. Histomorphological
      features of pancreatic tissue will be characterized in details at the Institute of Pathology
      in order to define possible correlates of pancreatic hardness.
    

Intervention name(s): Intraarterial application of Octreotide; sterile NaCl (sodium chloride) 0,9% solution
Intervention type(s): Drug; Drug
Intervention description(s): 500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.; a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery
Other intervention name(s): Sandostatin (Novartis Pharma, Switzerland); Bendatreotid; Octreo; Siroctid; Octreotid; Sodium chloride 0,9% solution
Intervention MeSH terms: Octreotide; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: octreotide; intraarterial; pancreatic hardness; pancreatoduodenectomy; durometer; dynamometer
Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM)
      despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have
      benefited from additional control of blood glucose levels. The study assessed the metabolic
      effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c),
      and lowering glucose while fasting, and following a meal (postprandial).

      Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were
      stratified by HbA1c ≤ 7.5% or > 7.5%. Enrollment was to include no more than two-thirds of
      participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results
      remained blinded during the study; for safety purposes, the investigator was to be alerted of
      severe hyperglycemia or hypoglycemia.

      Participants were instructed to maintain logs of their physical activity/exercise (Subject
      Activity Assessment) and study drug dosing (Dosing Log).
    


Intervention name(s): Ranolazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily; Placebo to match ranolazine administered orally twice daily
Other intervention name(s): Ranexa®
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; T2DM; Ranolazine; Ranexa; HbA1c
Mass Balance and Absolute Bioavailability Study of RO7049389 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to characterize the mass balance, absolute bioavailability,
      route and rates of elimination of RO7049839.
    


Intervention name(s): [12C] RO7049389; [13C] RO7049389; [14C] RO7049389
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive oral [12C] RO7049389.; Participants will receive IV [13C] RO7049389.; Participants will receive an oral suspension of [14C] RO7049389.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy
Condition: Atrioventricular Block; Atrioventricular Dyssynchrony
MeSH terms: Atrioventricular Block
Study type: Interventional

Summary: 
      This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV)
      resynchronization with His bundle pacing in patients with symptomatic first degree AV block.
    

Detailed description: 
      The term AV dyssynchrony was introduced by Salden F. and coauthors in 2018. It stands for the
      adverse effects of AV dyssynchrony due to PR interval prolongation. According to the ESC and
      ACC guidelines, severe first degree AV block is an IIa indication for permanent pacemaker
      implantation, yet data on these patients' clinical outcomes are scarce. To independently
      determine the impact of AV resynchronization, His bundle pacing will be used to avoid
      intraventricular desynchronization.

      Symptomatic patients with severe first-degree AV block and echocardiographically proven AV
      dyssynchrony will be included in the study.

      All patients will receive a dual-chamber pacemaker with an atrial lead positioned in the
      right atrium and ventricular lead placed on the bundle of His. In a single-blind cross-over
      design, patients will be randomized to AV sequential His bundle pacing with echo-guided AV
      optimization or back-up VVI pacing mode. Each study period will last for three months. At the
      end of both periods, cardiopulmonary exercise testing, complete echocardiographic study, and
      clinical evaluation will be performed.

      Peak oxygen uptake and echocardiography-based hemodynamic parameters in both periods will be
      compared.
    

Intervention name(s): His bundle pacing, AV optimized; Backup VVI pacing
Intervention type(s): Device; Device
Intervention description(s): A Select Secure 3830 (Medtronic, MN, USA) pacing lead will be placed on the bundle of His. In case of unsuccessful His capture, left bundle branch area pacing is going to be targeted. Pacemaker will be programmed to a low base rate and a high tracking rate to allow for intrinsic sinus rhythm. AV delay will be optimized with echocardiography to the shortest AV delay without truncation of the A wave on transmitral pulse wave doppler.; Pacemaker will be programmed to VVI (ventricular only) mode with low base rate as to allow for intrinsic sinus rhythm without AV optimization.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AV block; His bundle pacing; AV dyssynchrony; AV optimization; AV dromotropathy; First degree AV block; Peak oxygen uptake
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
Condition: Papillomavirus Infections; Dysplasia; Cervix Cancer
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This study aims to compare the expression of matrix metalloproteinases and their tissue
      inhibitors between 4 groups of patients defined according to the severity of the cervical
      lesion.
    

Detailed description: 
      Cervical cancer is the second most common cancer among European women under 45 years old. It
      is secondary to cervical dysplasia induced by persistent human papillomavirus infection. The
      involvement of matrix metalloproteinases in carcinogenesis of the cervix is real, but their
      expressions vary according to the published series. An association between the expression of
      MMPs and that of the human papillomavirus deserves to be explored, as this can have a
      prognostic influence in the case of gradual expression demonstrated in the development of
      (pre) cancerous lesions of the cervix.

      This study aims to compare the expression of matrix metalloproteinases and their tissue
      inhibitors between 4 groups of patients defined according to the severity of the cervical
      lesion.
    

Intervention name(s): Vaginal samples (biopsies + vaginal smear)
Intervention type(s): Other
Intervention description(s): Two types of samples are envisaged: tissue (large biopsies, coin of conization or hysterectomy) to affirm the diagnosis and detect the matrix metalloproteinases and their tissue inhibitors by immunohistochemistry; cell sample (monolayer smear type) to evaluate the expression of oncogenic Human papillomavirus.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Matrix metalloproteinases
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of
      patients with bipolar I depression.
    


Intervention name(s): lurasidone + (lithium or divalproex); Placebo + (lithium or divalproex)
Intervention type(s): Drug; Drug
Intervention description(s): lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.; 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Intervention MeSH terms: Valproic Acid; Lithium Carbonate; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar I; Latuda; Lurasidone
Health Enhancement And Resilience Training
Condition: Stress; Aging; Well-being
Study type: Interventional

Summary: 
      The purpose of this research study is to examine whether a stress reduction intervention can
      improve health, mood and biological markers of cellular stress and aging in a group of
      chronically-stressed maternal caregivers and healthy maternal controls.
    

Detailed description: 
      This stress-reduction intervention was added into an ongoing observational study in May of
      2013. The parent study is a prospective cohort study of the effects of chronic stress in a
      group of maternal caregivers with children on the autism spectrum and healthy controls whose
      children have no diagnosis. Study participants are being invited to enroll in a 12-week
      stress reduction course based on the principles of mindfulness. They will attend four
      six-hour workshops and participate in 12 weekly hour-long web video conferencing calls to
      reinforce what is taught in the workshops.

      At the beginning and the end of the intervention, they complete self-report measures of
      psychological well-being and give saliva samples. Since the women are also participating in
      the longitudinal study, we have other before and after data for them. These include
      psycho-social measures, body measurements, psycho-physiology measurements, cognitive tests,
      actigraphy (for sleep), as well as saliva (for hormones), hair (for hormones) and blood (for
      telomeres, telomerase, gene expression, circulating hormones, inflammation and oxidative
      stress).
    

Intervention name(s): Stress-reduction class
Intervention type(s): Behavioral
Intervention description(s): Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness. They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops. We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment. Both groups received similar instruction.
Other intervention name(s): mindfulness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Telomerase; Telomere length; Psychological Sress; Mindfulness
Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The aim of this study is to investigate the amino acid kinetics in blood after a bout of
      strength training and ingestion of different milk protein supplements (native whey, whey
      protein concentrate 80, hydrolysed whey, microparticulated whey and milk) The investigators
      hypothesize that native whey will give a faster and higher rise in blood concentrations of
      leucine compared to the other milk protein supplements.
    

Detailed description: 
      Increasing or maintaining muscle mass is of great importance for populations ranging from
      athletes to patients and elderly. Resistance exercise and protein ingestion are two of the
      most potent stimulators of muscle protein synthesis. Both the physical characteristic of
      proteins (e.g. different digestion rates of whey and casein) and the amino acid composition,
      affects the potential of a certain protein to stimulate muscle protein synthesis. Given its
      superior ability to rapidly increase blood leucine concentrations to high levels, whey is
      often considered the most potent protein source to stimulate muscle protein synthesis. Native
      whey protein is produced by filtration of unprocessed milk. Consequently, native whey has
      different characteristics than WPC-80, which is exposed to heating and acidification. Because
      of the direct filtration of unprocessed milk, native whey is a more intact protein compared
      with WPC-80. Of special interest is the higher amounts of leucine in native whey.

      The aim of this double-blinded randomized 5-arm cross-over study is to compare amino acid
      kinetics in blood after a bout of strength training and ingestion of 20 grams of high
      quality, but distinct, dairy protein supplements (native whey, whey protein concentrate 80,
      hydrolysed whey, microparticulated whey and milk). Furthermore, the investigators investigate
      whether differences in amino acid kinetics affect acute blood glucose and urea response, as
      well as recovery of muscle function after a bout of strength training.

      The investigators hypothesize that native whey will give a faster and higher rise in blood
      concentrations of leucine compared to the other protein supplements.
    

Intervention name(s): Strength Training; Milk 1%; Whey protein concentrate 80 (WPC-80); Microparticulated whey; Hydrolyzed whey; Native whey
Intervention type(s): Other; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): Protein supplementation; Protein supplementation; Protein supplementation; Protein supplementation; Protein supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science