bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one
      dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and
      expand immunogenicity and safety data to adults through age 65.
    

Detailed description: 
      This is a Phase 2a, randomised, double-blind study in 300 adults to compare the safety and
      immunogenicity of OVX836 to QIV (Influvac TetraTM). One dose of OVX836 at two dose levels
      will be administered intramuscularly, in comparison to Influvac TetraTM, quadrivalent
      seasonal influenza sub-unit vaccine in healthy subjects aged 18-65 years.
    

Intervention name(s): OVX836; Quadrivalent seasonal influenza vaccine (Influvac TetraTM)
Intervention type(s): Biological; Biological
Intervention description(s): One single administration intramuscularly at Day 1.; One single administration intramuscularly at Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized assignment to experimental vaccine (2 dosage levels or active control (commercial influenza vaccine) in a 1:1:1 ratio.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions
Condition: Uterine Fibroids; Myomas
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this study is to compare the outcomes of two uterine-conserving treatment
      alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global
      fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard
      step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating
      laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have
      equal access to valuable imaging information and to plan treatment accordingly. By
      randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one
      treatment or the other following the LUS is eliminated.
    


Intervention name(s): Global Fibroid Ablation; Myomectomy
Intervention type(s): Procedure; Procedure
Other intervention name(s): Halt Procedure; Acessa Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic Uterine Fibroids; Menorrhagia; Heavy Bleeding; Myomas; Radiofrequency Ablation; RFA; Leiomyoma; Fibroids
A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single increasing doses
      of intravenously administered rolapitant in healthy male and female subjects.
    

Detailed description: 
      Part 1 of the study is designed to evaluate the safety and tolerability of a SAD, up to 6
      cohorts,of rolapitant IV (2 mg/mL solution) administered as an IV infusion over 30 minutes.

      In Part 2 of the study, the safety and tolerability of the highest safe and well-tolerated
      dose established in Part 1 will be evaluated in an expanded cohort. The highest safe and
      well-tolerated dose established in Part 1 will be ascertained by the following criteria: an
      upper limit of 90% confidence interval (CI) for Cmax. A minimum of 40 subjects will be
      enrolled in Part 2.
    

Intervention name(s): Rolapitant
Intervention type(s): Drug
Intervention MeSH terms: Rolapitant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
Condition: Irreversible Pulpitis; Apical Periodontitis
MeSH terms: Periodontitis; Pulpitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP
      as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients
      needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus
      arm randomly. After root canal shaping and cleaning, the teeth were obturated according to
      their arms. Assessment of postoperative pain was done 1 week after root canal obturation
      using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were
      carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the
      arms.
    


Intervention name(s): Root canal sealer
Intervention type(s): Procedure
Intervention description(s): Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
Condition: Colorectal Cancer; Ulcerative Colitis; Polyps
MeSH terms: Colorectal Neoplasms; Colitis; Colitis, Ulcerative
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty
      acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.
    

Detailed description: 
      Epidemiological evidence from several countries supports a protective effect of fish
      consumption on cancer risk and gastrointestinal cancers in particular. Further evidence to
      support the idea that fish consumption is protective in relation to cancers of the GI tract
      is now emerging from the European Investigation into Cancer and Nutrition (EPIC).

      The FISHGASTRO project is headed by the Institute of Food Research and includes groups from
      the University of East Anglia, the University of Wageningen, Netherlands and the University
      of Jena, Germany. The project focuses on assessing the impact of fish consumption on a range
      of markers of gastrointestinal health associated with ulcerative colitis or colon cancer and
      on looking at bio-accessibility of a range of nutrients from fish. We aim to recruit a total
      of 270 patients with gastrointestinal problems in the UK and Netherlands and take biopsy and
      blood samples before and after asking them to eat two extra portions of fish per week. One
      group will receive oil rich fish such as salmon while another will be asked to eat white
      fish. Changes in cell proliferation, apoptosis, inflammatory markers, gene expression and
      plasma levels of n-3 fatty acids will be compared to a control group only given standard
      nutritional advice.
    

Intervention name(s): Increased dietary intake of salmon or cod
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Intervention; Adults; Colorectal cancer; Nutrition; Fish; n-3 fatty acids; Apoptosis; Ulcerative colitis; Polyps; Gastro-intestinal tract
Helicobacter Pylori Resistance
Condition: Helicobacter Pylori Resistance
Study type: Observational

Summary: 
      The main goal of the study was to characterize the morbidity, immunological, microbiolical
      and clinical phenotypes of patients with treated- resistance to Helicobacter pylori (HP)
      infection, and the effect of triple therapy including the levofloxacin. Control groups were
      newly diagnosed, previously infected and never infected HP patients
    

Detailed description: 
      See Nestegard O, et al. PLOS ONE | https://doi.org/10.1371/journal.pone.0238944 September 23,
      2020
    

Intervention name(s): levofloxacin, amoxicillin, clarithromycin
Intervention type(s): Drug
Intervention description(s): Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days
Intervention MeSH terms: Amoxicillin; Clarithromycin; Levofloxacin
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        1. Patients referred to Gastrointestinal (GI) unite in the time periode from 1990 to 2010
             and defined as resistant to triple Helicobacter pylori (HP) treatment

          2. Patients referred to GI unite in the time periode from 2010 to 2012 due to opper GI
             complaints. Included were patients a) newly diagnosed HP, b) previously successful
             triple HP therapy, and c) never HP infected
      
Biospecimen description: 
      RNA measure of mucosal transcripts, mucosal histology, cultures including antibiotic
      sensitivity to HP from mucosal biopsies
    
Keywords: Gastrointestinal Symptom Rating Scale, Helicobacter pylori resistance, levofloxacin, Sydney score
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to
      30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in
      high risk patients was considered a "standard" method to prevent PEP. However, the risk
      factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just
      for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to
      determine whether routine using of rectal indomethacin is more effective than the conditional
      strategy.
    


Intervention name(s): Pre-ERCP rectal Indomethacin; Post-operational Rectal Indomethacin
Intervention type(s): Drug; Drug
Intervention description(s): Rectal Indomethacin was administrated within 30min before ERCP in all patients.; Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Indomethacin, pancreatitis, ERCP
Cerebroplacental Ratio and Perinatal Outcomes in Mild and Moderate Idiopathic Polyhydramios Cases
Condition: Idiopathic Polyhydramios Cases
Study type: Observational [Patient Registry]

Summary: 
      This study aims to evaluate the predictability of fetal Doppler parameters in terms of
      perinatal adverse outcomes in singleton pregnancies with mild and moderate idiopathic
      polyhydramnios
    

Detailed description: 
      Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton
      pregnancies without polyhydramnios were included in the study one-on-one by matching their
      gestational ages. The diagnosis of polyhydramnios was made if the AFI was 24 cm and above.
    

Intervention name(s): doppler assesment
Intervention type(s): Diagnostic Test
Intervention description(s): In all cases, the measurement, including UA PI and MCA PI, was measured with a 6-4 MHz convex transabdominal probe. All measurements were made by an obstetrician (Ş.D.) with 28 years of experience. Doppler measurements were collected from the proximal third of the MCA and the free-floating segment of the umbilical cord, ensuring that the angle of insonation was as close to zero as feasible and that fetal movements were absent
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women diagnosed with mild-moderate IP and randomly selected low-risk singleton
        pregnancies without polyhydramnios were included in the study one-on-one by matching their
        gestational ages.
      
Keywords: polyhidramnios,cerebroplacental ratio
Sensitivity Diagnosing Traumatic Knee Injuries With and Without Injection of Blue Dye Into the Knee Joint
Condition: Traumatic Knee Arthrotomy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if adding blue dye improves the saline load test,
      which is a way to detect a traumatic intraarticular knee injury by injecting normal saline
      into the knee and looking for outflow through the wound.
    


Intervention name(s): Saline Load Test
Intervention type(s): Procedure
Intervention description(s): Intraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Melatonin and Nighttime Blood Pressure in African Americans--24 mg Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of oral melatonin supplementation (24 mg per
      night for 4 weeks) on nighttime blood pressure in African Americans with a history of
      elevated nighttime blood pressure.
    

Detailed description: 
      The main outcome of interest is the mean nighttime blood pressure. The investigator is also
      trying to see the mechanism of action of melatonin on blood pressure by analyzing data from
      sleep studies to see if melatonin lowers blood pressure by providing a better quality of
      sleep or is that independent of the quality of sleep.

      The investigator is also looking into the effect of melatonin on sympathetic nervous system
      by measuring urinary catecholamines.

      Finally, the investigator is looking into changes in vascular biology markers P-selectin and
      e-selectin) on Melatonin.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 24mg of time release melatonin pills (3 x 8mg) to be taken orally at night for 4 weeks.; Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Melatonin; Hypertension; Blood Pressure; Cardiovascular; Sleep; Nighttime; Nocturnal; Catecholamines; Sympathetic Nervous System; Endothelial Function; African American
Unicirc vs Open Surgical Circumcision
Condition: Circumcision, Male
Study type: Interventional
Phase: Phase 4

Summary: 
      RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical
      circumcision under local anesthetic with suturing.
    


Intervention name(s): Unicirc with tissue adhesive; Open Surgical
Intervention type(s): Procedure; Procedure
Intervention description(s): As above; As above
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young
      patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as
      IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show
      an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined
      with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated
      CLL and/or del(17p) and is associated with a high rate of clinical responses.
    

Detailed description: 
      Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young
      (age ≤65 years) patients with CLL. However, IGVH unmutated patients and patients with
      disrupted TP53 show an inferior outcome after FCR in terms of PFS and OS. Venetoclax as a
      single agent or combined with rituximab is an effective treatment for relapsed/refractory
      patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of
      clinical responses and MRD-negative responses. The achievement of a MRD negative response in
      CLL is the best treatment endpoint since it is associated with an improved PFS.

      In treatment-naive patients with unmutated IGVH and/or disrupted TP53 the venetoclax and
      rituximab combination could be a more effective regimen than FCR with a 15% increase in the
      CR rate.
    

Intervention name(s): Venetoclax; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Venetoclax and rituximab association; Venetoclax and rituximab association
Intervention MeSH terms: Rituximab; Venetoclax
Intervention model: Single Group Assignment
Intervention model description: Multicenter, prospective, interventional, single arm study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic myeloid leukemia; Umutated IGVH; Disrupted TP53
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to assess the safety and tolerability of GLPG1205 in
      single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study
      will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look
      at how the study drug is absorbed, broken down, and eliminated by your body.
    


Intervention name(s): GLPG1205; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG1205 film-coated tablets; placebo film-coated tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor
Condition: Maternal Oxygen Use in Labor
Study type: Interventional

Summary: 
      The objective of this study is to determine if a strategy of indicated compared to liberal
      oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is
      that women who undergo a strategy of indicated compared to liberal oxygen administration in
      labor will have lower rate of cesarean delivery and fetal acidemia at birth.
    

Detailed description: 
      This is a single-site before and after study comparing the strategy of liberal versus
      indicated use of maternal oxygen in the first and second stages of labor in the setting of a
      category 2 fetal heart rate tracing (FHR) tracing, as defined by American Congress of
      Obstetrics and Gynecology (ACOG) and National Institute of Child Health and Human Development
      (NICHD) guidelines. All patients who are at term and are undergoing labor at Memorial Hermann
      Hospital in Houston, Texas during the time frame of the study will be included in the study.
      The study will be conducted over 18 weeks. It will involve two 8 week time periods during
      which all patients will under either a strategy of liberal administration of oxygen use
      (current practice) in the "before" portion of the study and indicated administration of
      oxygen in the "after" portion of the study (new practice). There will be a transition period
      where training, education, and audit + feedback will be done to prepare for a strategy of
      indicated administration of oxygen.
    

Intervention name(s): Liberal use of maternal oxygen; Indicated use of maternal oxygen
Intervention type(s): Drug; Drug
Intervention description(s): Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician; Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Remifentanil on Rebound Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators will evaluate the influence of intraoperative remifentanil infusion on the
      postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus
      block for postoperative analgesia.
    

Detailed description: 
      The study will include 68 patients undergoing rotator cuff repair. All patients will receive
      brachial plexus block for postoperative analgesia, followed by general anesthesia. In the
      experimental group, remifentanil infusion will not be used intraoperatively, and in the
      control group, remifentanil will be infused. After surgery, both groups will be given the
      same postoperative pain management using patient controlled analgesia(PCA), and pain patterns
      will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The
      primary end point of this study is the total dose of PCA medication over 24 hours.
    

Intervention name(s): Not used remifentanil infusion
Intervention type(s): Drug
Intervention description(s): Remifentanil is not used during operation
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hyperalgesia; brachial plexus block; remifentanil