bioihbjkbjnl/mcl2 huggingface dataset:
EuroNeut41: Safety & Immunogenicity of Immunisations With HIV Vaccine
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives:

        -  To assess the safety of three priming immunisations by nasal route followed by two
           booster immunisations by intramuscular route

        -  To assess immunogenicity responses induced by the vaccine.
    


Intervention name(s): EN41-FPA2 HIV vaccine; EN41-FPA2 HIV vaccine; EN41-FPA2 HIV vaccine; EN41-FPA2 HIV vaccine; Na Cl Placebo vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL); Group 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL); Group 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL); Group 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL); Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety of this HIV vaccine
One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the double-lumen endotracheal tube or the
      standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one
      lung ventilation during thoracic surgery.
    

Detailed description: 
      The purpose of the study is to compare a double lumen tube versus the standard single-lumen
      tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung
      ventilation during surgery. The objects is to determine which device is best for intubation
      and is most effective in terms of optimal positioning of the device, of lung collapse, and
      quality of lung isolation.
    

Intervention name(s): Double Lumen Endotracheal Tube; Arndt Bronchial Blocker
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; One-Lung Ventilation; Anesthesia; Thoracic; One-lung ventilation in the morbidly obese patient
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study is designed as a prospective cohort study to determine whether standard
      subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5
      days in the treatment of relapses or attacks in multiple sclerosis (MS).
    

Detailed description: 
      Evaluations and treatment will be administered as an outpatient in the Neurology Clinic. Each
      subject will be seen for MS relapse or exacerbation in the Neurology Clinic during a routine
      or semi-emergent visit. Patients will be offered an FDA approved treatment (ACTHar Gel) for
      MS attacks under a standard 14 day SQ protocol (standard 14 day SQ protocol (80 IU x 14 days)
      or a 5 day SQ protocol - (5 day subcutaneous protocol (80 IU x 5 days). Both protocols are
      within package insert guidelines. The subjects will be evaluated for Extended Disability
      Status Scales (EDSS), a standardized measure of clinical status in MS and the initial visit
      and 28 days later (and 90 days later). We will compare the change in EDSS outcomes between
      day 0 and day 28 (day 90) to determine if the 14 days is superior to 5 day protocol may be
      clinically equivalent. Patients will also be evaluated for walking, upper extremity function
      (9 hole peg test), cognition and vision.
    

Intervention name(s): H.P. Acthar Gel (repository corticotropin injection)
Intervention type(s): Drug
Intervention description(s): Acthar Gel 80 IU
Other intervention name(s): Acthar; Repository Corticotropin Injection; ACTH Gel
Intervention MeSH terms: Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MS; Multiple Sclerosis
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with
      regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who
      have received the vaccine within the clinical study AFF002.
    


Intervention name(s): AFFITOPE AD02
Intervention type(s): Biological
Intervention description(s): s.c. injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics of midazolam with/without concomitant administration of
      crobenetine
    


Intervention name(s): Midazolam, tablet; Crobenetine, i.v. infusion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Masking: Single
Primary purpose: Treatment
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia
Condition: Post-operative Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal
      analgesia. This medication is generally safe, well tolerated and effective within recommended
      daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol
      Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the
      reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.
    


Intervention name(s): Paracetamol injection; Normal Saline injection; Morhpine PCA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.; 32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.; Morphine PCA will be connected upon the first dose of study drug(roughly 30min prior to the completion of would suture). Morphine PCA is set as follows:1mg bolus every 5min with background infusion of 0.25mg/h and maximal dose<25mg/4h.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: paracetamol; post-operative analgesia
Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer
Condition: Advanced or Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety
      and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal
      Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.
    

Detailed description: 
      This study will enroll patients with advanced or metastatic breast cancer to assess the
      safety and tolerability of Pelareorep at 1.5×10^10, 3.0×10^10, 4.5×10^10 (TCID50) combined
      with paclitaxel to fix the MTD or RP2D.
    

Intervention name(s): Pelareorep
Intervention type(s): Drug
Intervention description(s): Pelareorep at 1.5×10^10 TCID50, 3×10^10 TCID50, 4.5×10^10 TCID50 on Day 1/2/8/9/15/16 with Paclitaxel at 80 mg/m^2 on Day 1/8/15 per cycle
Other intervention name(s): Paclitaxel
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock
Condition: Cardiogenic Shock; Acute Myocardial Infarction; Complications
MeSH terms: Myocardial Infarction; Shock, Cardiogenic; Infarction; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      The study compares the therapies of instant multivessel balloon angioplasty plus stent
      implantation or the balloon angioplasty plus stent implantation of the infarct artery alone
      with any possible graduated later treatment of the other vessels in patients with acute
      myocardial infarction with cardioganic shock.

      The main study hypothesis is to explore if culprit vessel only PCI with potentially
      subsequent staged revascularization in comparison to immediate multivessel revascularization
      by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces
      the incidence of 30- day mortality and/or severe renal failure requiring renal replacement
      therapy.
    


Intervention name(s): Immediate multivessel PCI; Culprit Lesion only PCI
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiogenic shock; infarction; multivessel coronary artery disease; angioplasty
Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery
Condition: Elderly Patients Undergoing Spinal Surgery
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients
      undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides
      information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD
      after general surgery has been lacking. Especially, the prone position is used primarily for
      surgical access to the posterior spine, if there is any significant lowering of the legs or
      tilt of the entire table, venous returns may be decrease or augmented accordingly. The
      purpose of this study was to examine the relationship between POCD and intra-operative
      cerebral oxygen saturation after spine surgery in elderly patients.
    


Intervention name(s): Neurologic and neuropsychologic tests
Intervention type(s): Other
Intervention description(s): Cognitive functioning was assessed with the following test: Korean Mini-Mental State Examination (K-MMSE) and visuomotor test of D-LOTCA battery.
Regional cerebral oxygen saturation was continuously monitored using the INVOS 5100 (somatics,Troy, MI) with bifrontal placement of two sensors before the induction of the anesthesia until the end of operation.
Baseline rSO2 was defined as the average saturation value over a 1 min period before induction of general anesthesia, beginning approximately 3 min after the sensors were applied in supine position. After the induction, baseline prone rSO2 was defined over a 5min period after the change of position.
There is no intervention were made according to rSO2 values. Physiologic variables including BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature were measured every 1 hours during the surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Post-operative cognitive dysfunction; regional cerebral oxygen saturation; elderly
The Effect of Norepinephrine on Cardiac Output in Patients Undergoing Liver Transplant .
Condition: Liver Transplantation
Study type: Interventional

Summary: 
      Early administration of NE in liver transplant recipient might enhance cardiac output through
      an increase in cardiac preload .
    

Detailed description: 
      The derangement of circulatory blood volume in patients with liver cirrhosis makes
      intraoperative fluid management during liver transplant is challenging . Cirrhotic patients
      not only have large blood volume but abnormal blood volume distribution, with a substantial
      fraction of this volume in the splanchnic circulation (. These hemodynamic changes render
      volume loading in these patients has little impact on CO because a large proportion of
      infused fluid is shifted to the splanchnic system . In addition, patients with liver
      cirrhosis is similar to septic patients who have increased total vascular compliance which
      may cause pooling of blood in venous pool. Several studies in patients with sepsis found that
      use of low dose vasopressor may convert unstressed blood volume (i.e the amount of blood not
      causing pressure on the vessels) to stressed volume (i.e additional blood causing a
      distending pressure on the vascular walls and reflects the effective circulating volume) .
      However, no previous studies tested the effect of using norepinephrine (NE) on venous return
      and cardiac preload in patients undergoing liver transplant. An obvious advantage of this
      possibility is that NE will be used instead of true ﬂuid replacement which may minimize fluid
      replacement during operation.

      Recently, a method was described to estimate the changes in intravascular volume and vascular
      capacitance by calculating mean systemic ﬁlling pressure (MSFP) . MSFP is the driving
      pressure in venous return, and it allows calculation of the arterial and venous components of
      systemic vascular resistance .
    

Intervention name(s): Noradrenaline
Intervention type(s): Drug
Intervention description(s): Noradrenaline infusion for patients undergoing liver transplantaion from living donor .
Intervention MeSH terms: Norepinephrine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantaion , fluid management , noradrenaline
Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not known whether combining chemotherapy with surgery is more
      effective than surgery alone.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without
      combination chemotherapy in treating patients with cancer of the esophagus.
    

Detailed description: 
      OBJECTIVES:

        -  Compare survival in patients with operable adenocarcinoma of the lower third of the
           esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior to
           surgical resection.

        -  Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.

      OUTLINE: This study is randomized for neoadjuvant chemotherapy. Patients are stratified by
      performance status, tumor location, and randomizing center.

      Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with
      adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups
      recommended).

      Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4
      week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and
      cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is
      assessed after 2 courses; responding patients with no serious toxicity receive a third
      course. Surgery, as above, is initiated 4-6 weeks after the second or third course of
      chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant
      chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of 6
      courses). Patients whose best response was stable disease are assessed for postoperative
      radiotherapy.

      Patients on either arm with positive resection margins, positive lymph nodes, or equivocal
      complete resection are referred for postoperative radiotherapy. Further therapy for patients
      with incomplete resection is at the discretion of the physician.

      Patients are followed every 3-4 months for at least 5 years.

      PROJECTED ACCRUAL: A total of 250 patients will be entered.
    

Intervention name(s): cisplatin; fluorouracil; adjuvant therapy; conventional surgery; neoadjuvant therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I gastric cancer; stage II gastric cancer; stage I esophageal cancer; stage II esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus
The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available
      non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic
      alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy
      applied to articular branches (genicular nerves) in treating knee joint pain.
    

Detailed description: 
      The knee joint is innervated by articular branches of various nerves (femoral, common
      peroneal, saphenous, tibial and obturator) (Kennedy et al. 1982; Hirasawa et al. 2000). These
      articular branches around the knee joint are known as genicular nerves. Several genicular
      nerves can be easily approached percutaneously under fluoroscopic guidance. In our study,
      genicular nerves were effectively blocked with local anesthetics under fluoroscopic guidance,
      leading to a significant reduction in knee pain. Rf neurotomy is based on the theory that
      cutting the nerve supply to a painful structure may alleviate pain and restore function. we
      evaluate the efficacy of RF neurotomy in reducing pain and improving function in the elderly
      with chronic knee OA.
    

Intervention name(s): radiofrequency neurotomy for genicular nerve; radiofrequency neurotomy sham therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): RF cannula was advanced percutaneously towards areas connecting the shaft to epicondyle of femur or tibia. Lidocaine (1 mL of 2%) was injected before activation of the RF generator (NeuroThermTM, Morgan automation LTD, Liss, UK). RF electrode was inserted through RF cannula. The temperature of the electrode tip was raised to 70℃ for 90 seconds by radiofrequency generator.; The placebo (sham) group received the same procedure without activation of the RF generator.
Other intervention name(s): neuroablation or radiofrequency neurolysis; radiofrequency neurolysis sham therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: genicular nerve; osteoarthritis; knee; neurotomy
Family Lifestyle Actions and Risk Education Study
Condition: Melanoma; Child
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      The overall purpose of this study is to test the feasibility, acceptability, and preliminary
      efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family
      Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive
      behaviors among children at elevated risk for the disease.
    

Detailed description: 
      Test the feasibility and acceptability of FLARE, a family-focused behavioral intervention
      that is designed to improve and maintain adherence to photoprotection (e.g., use of
      sunscreen) and screening (e.g., implementation of self skin exams). We expect that the
      feasibility of the intervention will be supported by at least 75% of participants attending
      at least 3 intervention sessions. We also expect that the acceptability of the intervention
      (e.g., overall satisfaction, ease of participation, perceived utility of intervention) will
      be supported by mean ratings that indicate adequate levels of acceptability across
      participants (e.g., mean rating of "satisfied" or "very satisfied" for overall satisfaction).

      Pilot test the efficacy of the FLARE intervention with children at elevated risk for melanoma
      and their primary caregiver.

      We will also explore the potential impact of the FLARE intervention on melanoma preventive
      behaviors among siblings of the child who receives the intervention, as well as the child's
      other parent/caregiver (if another parent/caregiver is available).
    

Intervention name(s): FLARE
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Education; Prevention and Control; Behavioral Research
Operant H-reflex Down-conditioning of Rectus Femoris in Post-stroke Stiff Knee Gait
Condition: Training
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators performed a feasibility trial of operant conditioning of spinal reflex
      excitability on five healthy individuals and two post-stroke individuals. The investigators
      found that operant conditioning of rectus femoris reflex excitability was feasible in all
      participants.
    

Detailed description: 
      The investigators performed a cohort study on 7 individuals (5 healthy, 2 post-stroke) to
      examine the feasibility of operant down-conditioning of rectus femoris reflex excitability
      (i.e. H-reflex). Each individual performed 30 sessions, 6 baseline sessions with no operant
      conditioning (225 trials of surface electrical stimulation of the femoral nerve), followed by
      24 training sessions (20 baseline trials followed by 225 trials with feedback of H-reflex
      magnitude). The investigators' main outcome measure was rectus femoris H-reflex magnitude. We
      also examined H-reflex magnitude of other quadriceps muscles.
    

Intervention name(s): Operant RF H-reflex conditioning
Intervention type(s): Behavioral
Intervention description(s): Operant down-conditioning of rectus femoris H-reflex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment