bioihbjkbjnl/mcl2 huggingface dataset:
"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Condition: Anesthesia Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective Randomized non inferiority Trial involving adult patients undergoing elective
      surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose
      sugammadex vs half dose sugammadex for reversal of NMB.
    

Detailed description: 
      The investigators' aim is to prove that half dose sugammadex in combination with neostigmine
      0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep (
      absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in
      patients undergoing surgery under general anesthesia.
    

Intervention name(s): Sugammadex; Sugammadex; Neostigmine; glycopyrrolate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): half dose; full dose; IV = 50mcg/kg
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Iron Sucrose Versus Ferrous Bis-glycinate for Treatment of Iron Deficiency Anemia
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      Iron deficiency may result from inadequate dietary intake, achlorhydria or excessive
      ingestion of proton pump inhibitors, parasitic infestations, chronic infections and repeated
      pregnancies. Iron supplementation of antenatal patients is a basic tenet of antenatal care
      programmes in numerous developing and underdeveloped nations.

      Postpartum anemia is defined as hemoglobin of less than 11.5 gm% during the postpartum
      period. The prevalence of postpartum anemia varies from 4 - 27%. Chronic iron deficiency due
      to inadequate intake/ lack of iron supplementation during pregnancy, repeated pregnancies and
      postpartum hemorrhage are important causes of postpartum anemia
    


Intervention name(s): Iron Sucrose Injection; Ferrous Bisglycinate
Intervention type(s): Drug; Drug
Intervention description(s): iron Intramuscular injections; oral iron tablets
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
Condition: Bird Flu; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and immunogenicity over a 9-month period
      of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of
      the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in
      all Household Contacts residing with the vaccinated volunteers.

      Vaccinees also may participate in a substudy in which they receive a booster vaccination with
      the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
    

Detailed description: 
      At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each
      consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly
      assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56
      days. Volunteers will be followed for 168 days post-third vaccination.
    

Intervention name(s): Placebo; Ad4-H5-Vtn; Sanofi Pasteur Influenza Virus Vaccine, H5N1
Intervention type(s): Other; Biological; Biological
Intervention description(s): enteric coated capsule containing no vaccine virus; a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration; Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
Other intervention name(s): Placebo for Ad4-H5-Vtn; Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine; FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1; licensed H5N1 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Virus Diseases; Respiratory Tract Diseases; Vaccine
Psychoeducational Approach to Improve Health in Lupus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      We will study the relationships among patient/partner communication, social support, and
      self-efficacy (a person's belief in the ability to manage his or her disease) as they affect
      the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are
      assigning 150 people with lupus and their partners to either (1) receive counseling to
      improve self-efficacy, partner support, and patient/partner problem solving or (2) see an
      informational film about lupus. We will follow study participants for 12 months to find out
      about their physical and mental health, disease activity, beliefs that they can take steps
      that help them feel better, coping, social support, and couples communication.
    

Detailed description: 
      Studies have shown that patient self-efficacy in disease management and social support
      predict physical and mental health and disease activity in lupus. We wished to study the
      relationships among patient/partner communication, social support, and self-efficacy as they
      influence patient health longitudinally. We are randomizing 150 lupus patients and their
      partners to either (1) participate in a counseling intervention to improve self-efficacy,
      partner support, and patient/partner problem-solving in lupus management or (2) see an
      informational film about lupus (control). The counseling intervention includes an initial
      in-person session followed by five monthly telephone calls to monitor and reinforce
      problem-solving. We will follow patients for 12 months for self-reported physical and mental
      health, disease activity, self-efficacy, coping, social support, and couples communication.
    

Intervention name(s): Counseling intervention; Informational film
Intervention type(s): Procedure; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLE; Lupus; Educational intervention; Health education; Social support network; Outcomes research; Self-help
Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Stem cells have promising potential in treating diabetes. However the therapeutic outcome in
      diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to
      label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem
      cells will be given through different routes (intravenous and intraarterial)and tissue
      distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated
      C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be
      calculated.
    

Detailed description: 
      Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell
      tracking. The labeled stem cells will be given through different routes (intravenous and
      intraarterial)and tissue distribution studied. Patients will be followed up for the next 6
      months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA
      IR and HOMA beta will be calculated.
    

Intervention name(s): stem cells
Intervention type(s): Procedure
Intervention description(s): stem cell will be injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Hepatic Metabolic Changes in Response to Glucagon Infusion
Condition: Non-Alcoholic Fatty Liver Disease; Total Pancreatectomy; Diabetes Mellitus
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The objective of the study is to investigate how exogenously administered glucagon affects
      hepatic lipid, glucose and protein metabolism as well as appetite, food intake and resting
      energy expenditure.
    

Detailed description: 
      Most research has focused on the role of the pancreatic hormone, insulin, and insulin
      signalling (or lack of) in the development of NAFLD. However, increasing evidence suggest
      that the other major gluco-regulatory pancreatic hormone glucagon is also implicated in lipid
      metabolism and recent human data from studies investigating the effect of glucagon receptor
      antagonism suggest that glucagon signalling may be essential for maintaining a fat-free
      liver. This, combined with observations of increased degree of hepatic steatosis in patients
      after total pancreatectomy, who are devoid of pancreatic glucagon and typically are lean and
      peripherally insulin sensitive, suggests that glucagon may play a hitherto unrecognised role
      in the pathophysiology of NAFLD.

      The hypothesis of the study is that exogenously delivered glucagon will drive hepatic
      metabolism in a lipolytic direction and increase resting energy expenditure without affecting
      appetite and food intake.

      The acute effects of exogeneous glucagon infusion on hepatic lipid metabolism will be
      evaluated in patients after total pancreatectomy (no endogenous pancreatic hormones), in
      patients with type 1 diabetes (no endogenous insulin production) and in healthy controls
      (preserved endogenous pancreatic hormones).
    

Intervention name(s): Glucagon; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon (4 ng/kg/min); Placebo
Other intervention name(s): GlucaGen
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Glucagon; Stable isotope; Energy expenditure; Lipid metabolism; Glucose metabolism; Appetite
The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The twilight phase between being asleep and awake during recovery from anesthesia is a
      precarious time fraught with risks to the post-operative patient. Hyperventilation
      accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations
      which delays their resumption of spontaneous breathing. We previously showed that our method
      of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates
      the rate of emergence from anesthesia with isoflurane. In this study we will study the effect
      of IH on the rate of emergence from Sevoflurane anesthesia.
    


Intervention name(s): Isocapnic Hyperponea
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea
Narcotic Use After Minor Hand Surgery
Condition: Pain, Postoperative; Minor Surgical Procedures; Narcotics Use
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study evaluates the effect of larger or smaller opioid prescriptions following minor
      surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and
      leftover narcotic.
    

Detailed description: 
      Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg
      hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to
      request additional medication as needed. Patients are contacted by phone 10-14 days after
      their surgery to answer a questionnaire regarding number of pills taken, number of refills
      requested, number of remaining pills, their satisfaction with their pain control and their
      surgery, and their opinion regarding the appropriateness of the prescription size.
    

Intervention name(s): Initial prescription for 10 narcotic tabs; Inital prescription for 30 narcotic tabs
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Reduced number of pills in initial prescription post-operatively
Intervention MeSH terms: Narcotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
Condition: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to
      investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart
      surgery.
    


Intervention name(s): catridecacog; catridecacog; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute; Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute; Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus
      Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.
    


Intervention name(s): Doxycycline; Levofloxacin 500mg
Intervention type(s): Drug; Drug
Intervention description(s): Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid; Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
Other intervention name(s): Tinadizole; Esomeprazole; Bismuth subsalicylate; Amoxicilline; Esomeprazol; Tinadiole
Intervention MeSH terms: Amoxicillin; Doxycycline; Levofloxacin; Esomeprazole; Bismuth; Bismuth subsalicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Doxycyclien; Bismuth Subsalicylate; Helicobacter Pylori; levofloxacine; tinadizole
Changes of NLF in Serum of Long COVID Patients
Condition: Clinical Syndrome
MeSH terms: Post-Acute COVID-19 Syndrome
Study type: Observational

Summary: 
      The study investigates the blood NFL levels in Long-COVID patients.
    

Detailed description: 
      The study investigates the blood NFL levels in Long-COVID patients.
    

Intervention name(s): Bloot testing
Intervention type(s): Diagnostic Test
Intervention description(s): NFL measruments in serum
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Long-COVID-Syndrome
      
Biospecimen description: 
      Serum
A Comparison Study of PF708 and Forteo in Healthy Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (blood levels) of two
      teriparatide products, PF708 and Forteo, in healthy subjects.
    

Detailed description: 
      This is a double-masked, randomized, two-treatment cross-over study in healthy adult
      subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second
      (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence
      (Sequence B),
    

Intervention name(s): Teriparatide
Intervention type(s): Drug
Intervention description(s): Single subcutaneous injection
Other intervention name(s): PF708
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating Potential Pharmacokinetic (PK) Interaction Between Lecozotan and Digoxin
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To evaluate the effects of multiple doses of lecozotan SR on the PK profile of a
      single dose of digoxin in healthy adult subjects.

      Secondary: To assess the safety and tolerability of the coadministration of lecozotan SR and
      digoxin.
    


Intervention name(s): Lecozotan
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure
      require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved
      preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral
      antiviral medication. In the first 6 months after liver transplantation, patients receive
      treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody
      concentrations above 100 IU/L, the level considered safe for preventing hepatitis B
      reinfection.

      Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the
      'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver
      transplantation for hepatitis B induced liver failure'. The purpose of this study is to show
      that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can
      prevent hepatitis B reinfection.

      Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of
      patients and is more convenient for patients compared to intravenous treatment that must take
      place in the hospital setting.

      Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy
      and Spain. Patients who are eligible for the study will receive treatment with Zutectra for
      24 weeks.

      During the study, the safety and effectiveness of Zutectra will be assessed by checking for
      symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs
      antibodies and hepatitis B surface antigen (HBsAg).
    


Intervention name(s): Zutectra
Intervention type(s): Drug
Intervention description(s): Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
Other intervention name(s): Human hepatitis B Immunoglobulin; HBIg
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Hepatitis B virus re-infection; HBV-DNA negative; Liver transplantation
Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of single doses of therapeutic and
      supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy
      subjects compared with placebo.
    

Detailed description: 
      The secondary purposes of this study are to 1) determine if there is a relationship between
      the duration of the QTc intervals and the plasma concentrations of carmoterol; 2) expand the
      available information on plasma pharmacokinetics and urine excretion for inhaled carmoterol
      at the proposed therapeutic and supra-therapeutic doses; and 3) generate additional safety
      information.
    

Intervention name(s): CHF 4226 pMDI; CHF 4226 pMDI; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled solution, single therapeutic dose; Inhaled solution, single supratherapeutic dose; Inhaled solution, single dose of placebo; Tablet, oral, 400mg, single dose
Other intervention name(s): Carmoterol HFA; Carmoterol HFA; Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: QTc; CHF 4226 HFA; pMDI; Carmoterol
A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetics, safety, and tolerability of
      brivaracetam after a single dose and multiple doses in healthy adult Chinese Study
      Participants.
    


Intervention name(s): brivaracetam
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Film-coated tablets
Concentration: 100 mg tablets
Route of administration: Oral use
Other intervention name(s): Briviact
Intervention MeSH terms: Brivaracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epilepsy; Healthy participants; Phase 1; Brivaracetam