bioihbjkbjnl/mcl2 huggingface dataset:
Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
Condition: HPV Infection; CIN1
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of
      prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical
      lesions.
    

Detailed description: 
      The study consists of an open label, non-randomised, dose escalation Lead in phase. 9
      participants with high-risk HPV, in cohorts of 3 in 3 dose ascending groups, will be
      vaccinated after SMC safety data reviews.

      This is followed by a blinded, randomised Main phase with 96 participants with high-risk HPV,
      in parallel running dose cohorts (three different doses of ChAdOx1-HPV plus two different
      doses of MVA-HPV versus placebo plus placebo boost). At least 60 of these participants will
      take part in the immunogenicity sub-study.

      A blinded, randomised expansion phase investigating the effects of up to two different main
      phase doses against placebo will be further defined prior to commencing this phase of the
      study.
    

Intervention name(s): ChAdOx1-HPV; MVA-HPV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Trial vaccine; Trial vaccine; Saline placebo vaccine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
Condition: Locally Advanced Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      No comparative trial investigating the effect of preoperative chemotherapy for locally
      advanced pancreatic cancer on short-term postoperative outcome has been published so far. The
      aim of the present study is to assess the potential impact of preoperative chemotherapy on
      short-term postoperative outcome after pancreatic resection in a case-matched series of
      cancer patients.
    

Detailed description: 
      Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were
      treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was
      matched with the closest two patients with pancreatic cancer ( control group ) selected from
      our prospective electronic database who met the following match criteria: age (+/- 3 years),
      gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size
      (+/- 5 mm).
    

Intervention name(s): Pancreatic resection after preoperative chemotherapy; Pancreatic resection
Intervention type(s): Procedure; Procedure
Intervention description(s): Pancreatic resection after preoperative chemotherapy; Pancreatic resection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer, neoadjuvant chemotherapy
A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
Condition: To Determine Bioequivalence Under Fed Conditions
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets
      and IPR Pharmaceuticals, Inc. Zestril (R).
    

Detailed description: 
      To compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc.
      Zestril (R), 40 mg - Effect of Food Study
    

Intervention name(s): Lisinopril; lisinopril; Lisinopril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 40 mg, single oral dose; Tablets, 40 mg, single, oral dose; 50% of subjects received the Par formulated product.
Other intervention name(s): Zestril (R) Tablets, 40 mg, single, oral dose; Zestril (R) Tablets, 40 mg, single, oral dose; Zestril (R) Tablets, 40 mg, single, oral dose
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence, lisinopril, fed
Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to explore safety and tolerability of eteplirsen in
      participants with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon
      51 skipping.
    

Detailed description: 
      This is an open-label, multi-center study to explore the safety and tolerability of
      eteplirsen injection in participants with advanced stage DMD with confirmed genetic mutations
      amenable to treatment by exon 51 skipping.

      Participants will be evaluated for inclusion during a Screening/Baseline period of up to 4
      weeks. Eligible participants will receive once weekly intravenous (IV) infusions of 30 mg/kg
      eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks).

      Safety will be regularly assessed throughout the study via the collection of adverse events
      (AEs), laboratory tests, electrocardiograms (ECGs), echocardiograms (ECHOs), vital signs, and
      physical examinations.
    

Intervention name(s): Eteplirsen
Intervention type(s): Drug
Intervention description(s): Eteplirsen solution for IV infusion
Other intervention name(s): AVI-4658; EXONDYS 51®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD; exon 51; dystrophin; dystrophy; eteplirsen; Duchenne
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Condition: Allergy; Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Respiratory Tract Infections; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Hypersensitivity
Study type: Observational

Summary: 
      The objective of this study is to determine whether there is a relationship between
      interferon-gamma levels and the incidence of viral respiratory infections in allergic
      children treated with allergy immunotherapy as compared to those treated with standard
      medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be
      tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months
      in allergic children treated with allergy immunotherapy as compared to those treated with
      standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3,
      6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to
      those treated with standard medical care.
    

Detailed description: 
      This study will consist of five visits. Visit 1 will occur after subjects complete an initial
      clinical evaluation for allergy at this site. Subjects will select their treatment (allergy
      immunotherapy as compared to standard medical care) prior to enrollment in this study.

      Visit 1 will include informed consent, review of inclusion and exclusion criteria and
      phlebotomy for the determination of serum interferon-gamma levels. At the end of this visit,
      diary cards to capture the frequency of symptoms of viral respiratory infections will be
      distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include
      review/exchange of diary cards, and phlebotomy for determination of serial serum
      interferon-gamma levels.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and Female patients aged 6 to 18 years being treated for allergies.
      
Keywords: Allergy; Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
Condition: PCOS; Semaglutide; Taste, Altered; Tongue Tissue Transcriptome; Gastric Emptying; Central Neural Response
MeSH terms: Dysgeusia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to explore the effects of GLP-1 receptor agonist (GLP-1 RA)
      semaglutide on modulation of taste sensitivity, tongue tissue transcriptome, modulation of
      neural response in central reward processing regions and gastric emptying rate. In addition,
      we aim to investigate the associations between semaglutide induced modulation of taste
      sensitivity, neural responses and gastric emptying with changes in body mass, eating-
      behavioural pattern, food perception and food intake.
    


Intervention name(s): Semaglutide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks; once-weekly injection with placebo pen for 16 weeks
Other intervention name(s): Ozempic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, single-blind, placebo-controlled clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Condition: Obese But Otherwise Healthy Participants
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese
      but otherwise healthy participants.
    


Intervention name(s): BMS-963272; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose with varying frequency among groups; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia
Condition: Acute Myocardial Infarction; Persisting Ischemia; No Reflow
MeSH terms: Myocardial Infarction; Infarction; Ischemia
Study type: Interventional

Summary: 
      Patients presenting with large myocardial infarction and signs of persistent ischemia after
      successful percutaneous coronary intervention, have a poor prognosis with respect to outcome
      and development of heart failure in the future.

      The hypothesis of this study is that in patients in whom persistent ischemia is present, use
      of intra-aortic balloon pump will be beneficial and improve outcome.
    

Detailed description: 
      In some patients presenting with large myocardial infarction and poor hemodynamic condition,
      intra-aortic balloon counterpulsation is effective in alleviating cardiogenic shock. In
      others, the use of intra-aortic balloon pump has no effect at all. The investigators believe
      this is dependent on the presence of persisting ischemia after successful epicardial
      reperfusion, known as no-reflow.

      In the presence of persisting ischemia, the investigators believe us of the intra-aortic
      balloon pump will relieve ischemia and improve outcome.
    

Intervention name(s): Intra-aortic balloon pump
Intervention type(s): Device
Intervention description(s): The intra-aortic balloon pump is placed in the descending thoracic aorta and inflates and deflates in synchrony with the cardiac cycle, providing diastolic augmentation and improving coronary blood flow, while deflating before systole, providing afterload and workload reduction for the myocardium.
Other intervention name(s): IABP; Intra-aortic balloon counterpulsation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Persisting ischemia; No reflow; Intra-aortic balloon pump; Exhausted autoregulation
Safety Study of Oxaliplatin and 5-fluorouracil Followed by FUDR for Unresectable Colorectal Liver Metastases
Condition: Colorectal Liver Metastases
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerated dose and dose limiting
      toxicity of 5-FU in combination with Oxaliplatin delivered via isolated hepatic perfusion.
    

Detailed description: 
      Subjects who are planning to undergo surgery for placement of HAI therapy pump will be
      considered for enrollment. Standard HAI therapy requires a laparotomy and placement of an
      intrahepatic arterial catheter that is connected to one of several commercially available
      subcutaneous electronic pumps. The pump is then used to deliver FUDR directly to the liver,
      usually beginning four weeks after surgery and lasts on average for a period of six to twelve
      months after the study. Current HAI therapy regimens often alternate FUDR with systemic
      chemotherapy. This study will examine the addition of a one hour isolated hepatic perfusion
      with 5-FU and Oxaliplatin prior to this standard treatment. Subjects will be given the
      consent form to review and after sufficient time to review the information, interested
      subjects will have the opportunity to ask questions of the investigators. Subjects interested
      in enrolling in the trial will then sign informed consent and clinical data will be collected
      from their chart to ensure that they meet eligibility requirements. The study will consist of
      a one hour isolated liver perfusion that will be performed at the time of the laparotomy to
      place the HAI therapy pump. Following surgery subjects will be monitored in the ICU for 24-48
      hours and potentially in the hospital for an additional 5-7 days. Subjects will be free to
      start standard HAI therapy regimens four to six weeks following surgery. The duration of
      treatment, dose of HAI therapy and the decision to combine HAI with systemic chemotherapy
      will be at the discretion of the treating physician.
    

Intervention name(s): Drug: 5-FU; Drug: Oxaliplatin
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation (200 to 900 mg/m²) scheme, one hour isolated hepatic perfusion prior to standard treatment.; 40 mg/m², one hour isolated hepatic perfusion prior to standard treatment.
Intervention MeSH terms: Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal; liver; cancer; metastases
Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Condition: Schizophrenia; Mental Disorder; Nervous System Diseases
MeSH terms: Nervous System Diseases; Schizophrenia; Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and tolerability of multiple-dose administrations of aripiprazole
      intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
    

Detailed description: 
      This is a trial designed to assess the safety and tolerability of multiple-dose
      administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult
      subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day
      followup. The trial population will include male and female subjects between 18 and 64 years
      (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a
      prior history of tolerating aripiprazole per investigator's judgement.
    

Intervention name(s): Aripiprazole, OPC-14597
Intervention type(s): Drug
Intervention description(s): 5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OPC-14597; Aripiprazole; Schizophrenia
A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of three intra-articular injections, given 2 weeks
      apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.
    

Detailed description: 
      A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of
      repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis
      of the knee.

      The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20
      of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in
      improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).

      The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change
      in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.
    

Intervention name(s): 4 mL injection of Ampion; 4 mL Injection of Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 4 mL injection of Ampion
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; osteoarthritis of the knee
Long-Acting Reversible Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      In the proposed study, women aged 18-29 seeking oral or injectable contraception will be
      offered an opportunity to try LARC instead; the FDA-approved options include two types of
      intrauterine products and one type of subdermal contraceptive implant. Over a 24 month
      period, the experiences of LARC users will be compared to the experiences of those opting for
      their initial short-acting method.
    

Detailed description: 
      In this partially randomized patient preference study, women aged 18-29 seeking oral or
      injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved
      options include two types of intrauterine products and one type of subdermal contraceptive
      implant. Over a 24-month period, the experiences of LARC users will be compared to the
      experiences of those opting for their initial short-acting method. It is expected that 38% of
      the participants using short-acting methods will stop using them during the first year and be
      at risk of unintended pregnancy. In contrast, less than 20% of LARC users will want to have
      their contraceptive removed. Continuation rates will be measured and pregnancies will be
      tallied in the two groups to document any differences that emerge.
    

Intervention name(s): DMPA; oral contraceptives; Implanon®; ParaGard®; Mirena®
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.; Oral contraceptives (any variety of formulations are permitted); Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel); Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface); Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
Other intervention name(s): Nexplanon®
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially randomized patient preference trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AE-adverse event; FDA-(U.S.) Food and Drug Administration; GCP-Good Clinical Practice guidelines; ICH-International Committee on Harmonisation; IRB-Institutional Review Board; IU-International units; mg-milligram(s); mm3-cubic millimeter(s); LARC-Long-Acting reversible contraception; PPCNC-Planned Parenthood of North Carolina; SAE-serious adverse event; SARC-Short-Acting reversible contraception; µg-microgram; ULN-upper limit of the normal range; SubQ-subcutaneous
Effect of Amnion Membrane With and Without Taurine on GCF TNF α Level.
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites
      were divided into 3 groups as Group A, B and C.
    

Detailed description: 
      Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with
      subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival
      placement of Amnion membrane hydrated with Taurine.
    

Intervention name(s): Scaling and root planing; Amnion membrane; Taurine
Intervention type(s): Procedure; Biological; Drug
Intervention description(s): 15 sites with periodontal pockets ≥ 5mm received only SRP; 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.; 15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.
Other intervention name(s): SRP; AM; T
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; taurine; amnion membrane
Effectiveness of Modafinil in Improving Cognitive Performance of University Students
Condition: Attention; Memory, Short-Term; Executive Function
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether modafinil is effective in the improvement
      of mnesic performance and executive functions of university students from high academic
      performance.
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention description(s): Modafinil 200mg
Other intervention name(s): Modafinilo
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Modafinil; Memory; Executive Functions; Memory, Short-Term; Attention; University Students; Stroop Effect; Digit Span; Backwards Digit Span; Biber Cognitive Estimation Test