bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
Condition: Pharmacokinetics and Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the Pharmacokinetics and Pharmacodynamics of
      alogliptin after a single or multiple administrations, once daily (QD), of oral alogliptin in
      healthy Korean subjects.
    

Detailed description: 
      Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being
      developed by Takeda Global Research & Development Center, Inc. as a treatment for type 2
      diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2
      important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent
      insulinotropic peptide (GIP). These hormones are responsible for increasing insulin
      synthesis, regulating β-cell proliferation, inhibiting gastric emptying and inhibiting
      glucagon secretion.

      Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries
      including the United States and Japan. As development of alogliptin expands to other
      countries, additional studies are needed to bridge between the data previously acquired.

      The main objective of this study is to assess the pharmacokinetics and pharmacodynamics of
      alogliptin in healthy Korean participants.
    

Intervention name(s): Alogliptin; Alogliptin; Alogliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.; Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.; Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
Other intervention name(s): SYR-322; SYR-322; SYR-322
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Drug Therapy
The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients
Condition: Hemodialysis Patients
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether half-dose intradermal influenza vaccine is
      as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.
    

Detailed description: 
      Hemodialysis patients are at high risk of influenza infection due to suppress immune
      status.It is recommended to immunize them against influenza annually.in intradermal
      vaccination antigens directly present to the large numbers of antigen-presenting cells in the
      skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose
      intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and
      three groups of immunocompromized patients including Rheumatologic patients treated with
      anti-TNF, HIV-infected and stem cell transplanted patients.

      In this study we compare the efficacy of influenza vaccines in half dose intradermal and
      standard intramuscular methods among hemodialysis patients.
    

Intervention name(s): intradermal influenza vaccine; intramuscular influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.25ml ,intradermal; 0.5ml,intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intradermal influenza vaccine; hemodialysis patients
A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
Condition: Hyperparathyroidism
MeSH terms: Hyperparathyroidism
Study type: Interventional

Summary: 
      OBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild
      asymptomatic primary hyperparathyroidism.

      II. Assess the quality of life, morbidity, and mortality of these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by gender.
      Patients are randomized to receive surgery or follow up without surgery.

      Patients receive parathyroidectomy (current standard care) or long term follow up without
      parathyroidectomy.

      Quality of life is assessed before the study and then every 6 months. All patients are
      followed every 6 months until death.
    

Intervention name(s): parathyroidectomy; Observation
Intervention type(s): Procedure; Other
Intervention description(s): Standard parathyroidectomy with a bilateral approach; Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disease-related problem/condition; endocrine disorders; hyperparathyroidism; quality of life; rare disease
Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Foot muscle energy technique and conventional physical therapy program administered in
      patients with type 2 Diabetic Neuropathy.
    

Detailed description: 
      Foot muscle energy technique and conventional physical therapy program administered in
      patients with type 2 Diabetic Neuropathy.
    

Intervention name(s): Foot Muscle Energy Technique; Conventional Physical Therapy Program
Intervention type(s): Other; Other
Intervention description(s): Starting from the preparation position, at the restriction barrier, the patient is asked to exert a small effort (no more than 20% of available strength) towards plantarflexion, against unyielding resistance, with appropriate breathing. The patient produces isometric effort contracts either gastrocnemius or soleus (depending on whether the knee is unflexed or flexed). This contraction is held for 7-10 seconds together with a held breath. The exercise was repeated until the full range of movement was obtained.; Graduated active resisted range of motion exercises for both UL and LL and graduated gait training
Other intervention name(s): Foot MET
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Foot muscle energy technique; Isometric muscle strength; Motor nerve conduction velocity study
Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced
      Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.
    

Detailed description: 
      It is a multi-center , open-label, singer arm study to explore the safety and efficacy of
      Z650 in advanced ESCC patients who had experienced systematic chemotherapy. Approximately 45
      subjects will be enrolled, each subjects will receive oral Z650, at dose of 350 mg/d,
      repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined
      as 28 days.
    

Intervention name(s): Z650
Intervention type(s): Drug
Intervention description(s): receive oral Z650 once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
Other intervention name(s): Larotinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic
      hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon
      (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with
      ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12
      weeks.
    

Detailed description: 
      A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir
      coadministered with RBV treatment leading to sustained virologic response 12 weeks
      post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in
      peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.
    

Intervention name(s): ombitasvir/paritaprevir/ritonavir; dasabuvir; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ombitasvir/ABT-450/ritonavir tablets; dasabuvir tablets; ribavirin tablets
Other intervention name(s): ABT-267/ABT-450/ritonavir; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment naive; Interferon free; HCV; Chronic Hepatitis C; Hepatitis C Genotype 1a; Hepatitis C; pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and
      eliminated by the body of stable schizophrenic volunteers receiving treatment with an
      atypical antipsychotic.
    


Intervention name(s): ABT-126; Placebo for ABT-126
Intervention type(s): Drug; Drug
Intervention description(s): ABT-126 Low Dose & ABT-126 High Dose; Matching Placebo for Arms 1 & 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Assessment of the Stability of Immediately Loaded All-on-four Dental Implants in FFF Used for Reconstruction of the Jaws
Condition: Reconstructed Jaws; Free Fibula Flaps; All on Four Technique
Study type: Interventional

Summary: 
      The use of free vascularized fibula flaps for bony reconstruction has proved its success as a
      substitution for the resected bone and in some instances, the surrounding soft tissues

      The aim of this case series study is to evaluate the stability of the dental implants placed
      in free fibula flaps substituting a resected mandible and/or maxilla when they are
      immediately loaded with the All-On-Four technique along with the patient satisfaction.
    

Detailed description: 
      • Preoperative phase :

      Patients will be subjected to:

        -  Case history including personal data, medical, surgical and family history.

        -  Clinical examination

        -  Radiographic examination using computed tomography (C.T) bony and soft tissue window.

        -  Diagnostic studying casts.

        -  Operative phase :

      All cases will undergo surgery under local regional anesthesia. Injection of local
      anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential
      drilling then insertion of the dental implant fixtures and abutments on which the
      prefabricated temporary prosthesis will be fixed.

      • Postoperative care Proper postoperative instructions will be given to the patient such as
      strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative
      medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac
      potassium 50mg as needed). Adherence to follow ups will be also instructed
    

Intervention name(s): immediate loading with all on four technique in FFF
Intervention type(s): Device
Intervention description(s): All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repositioning Method for Left-sided Double Lumen Tubes
Condition: Airway Morbidity; Intubation Complication
Study type: Interventional

Summary: 
      The purpose of this study is to devise repositioning method of a left-sided double lumen tube
      into left mainstem bronchus in case of misplacement into right mainstem bronchus.
    


Intervention name(s): repositioning method for left-sided double lumen tubes
Intervention type(s): Procedure
Intervention description(s): When a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein
      convertase subtilisin/kexin type 9 (PCSK9).

      Primary Objective of the study:

      To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
      after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL
      (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.

      Secondary Objectives:

        -  To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment
           in comparison with placebo

        -  To evaluate the safety and tolerability of alirocumab

        -  To evaluate the development of anti-alirocumab antibodies

        -  To evaluate the pharmacokinetics of alirocumab
    

Detailed description: 
      The duration of study participation depended on the status of the participant at screening:
      21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment
      period of 12 weeks, followed by an 8-week follow-up period.
    

Intervention name(s): Alirocumab; Placebo (for alirocumab); Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two SC injections in the abdomen only; Two subcutaneous (SC) injections in the abdomen only
Route of administration: subcutaneous injection (1 mL) in the abdomen; Orally once daily at a stable dose of 5 to 20 mg as background therapy
Route of administration: oral administration in the evening
Other intervention name(s): SAR236553; RGEN727
Intervention MeSH terms: Atorvastatin; Alirocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A four-period study to evaluate if the grade glucose infusion procedure will be able to
      detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment
      in healthy subjects.
    


Intervention name(s): Comparator: Treatment A; Comparator: Treatment B; Comparator: Treatment C; Comparator: graded glucose infusion
Intervention type(s): Other; Drug; Drug; Procedure
Intervention description(s): No Treatment; single dose administration of exenatide 5ug by subcutaneous injection; single dose administration of exenatide 10ug by subcutaneous injection; A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Three New Ideas to Protect Special Forces From the Stress of High Altitude
Condition: Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of
      non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric
      pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS.
      Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and
      difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance
      and endurance exercise capacity are impaired. Therefore, the goal of this research is to
      identify effective pharmacological agents that will help reduce the symptoms of AMS and
      improve physical and cognitive performance at high altitude.

      The investigators will study the efficacy of the dietary supplement, quercetin, the drugs
      nifedipine (extended release) and methazolamide taken together, the drug metformin, and the
      drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at
      high altitudes.
    


Intervention name(s): Quercetin; Nifedipine extended release; Methazolamide; Metformin; Placebo; Nitrite
Intervention type(s): Dietary Supplement; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Nifedipine; Methazolamide; Quercetin
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise, Aerobic; Cognitive Function
The Relationship Between Cerebral State and Emotion in Anesthesiologist and Surgeon
Condition: Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Observational

Summary: 
      This study was designed to observe the cerebral state obtained via wavelet analysis
      (HXD-I,Beijing Easymonitor Technology Co.Ltd, China) and evaluate the emotion in various
      states in anesthesiologist and surgeon. And we also explore the association between the
      characteristic of cerebral state and the emotion.
    

Detailed description: 
      A total of 20 anesthesiologist (A group) and 20 surgeon(S group) in Ruijin hospital were
      enrolled for this study. Except had a medical history of mental illness or emotional disorder
      and pregnant woman. A group and S group completed emotional self-perceived questionnaire and
      then observe the characteristic of cerebral state via cerebral state monitor. They also
      completed anonymous questionnaire, including Maslach Burnout Inventory-General
      Survey(MBI-GS), Self-reporting Inventory-90(SCI-90), Burnout Measure(BM).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        anesthesiologist and surgeon in Ruijin hospital
      
Keywords: anaesthetists, surgeons, stress, burnout
Effects of Red Wine and Cognac on Coronary Circulation
Condition: Healthy
Study type: Interventional

Summary: 
      Red wine consumption is associated with reduced cardiovascular disease mortality, and the
      cardioprotective properties may be partly related to its ability to improve endothelial
      function. The purpose of this study was to determine whether moderate doses of red wine,
      de-alcoholized red wine and cognac improve coronary flow reserve.
    

Detailed description: 
      Moderate consumption of red wine is associated with reduced coronary artery disease
      mortality. Cardioprotective effects of red wine may be partly related to its ability to
      improve endothelial function. Red wine increases endothelium-dependent flow-mediated
      dilatation of the brachial artery acutely after ingestion. Moreover, a heavy dose of red wine
      (ethanol 1.0 g/kg) has been shown to increase coronary flow reserve (CFR) as measured with
      transthoracic Doppler echocardiography. CFR depicts the relative increase of coronary blood
      flow in response to maximal myocardial hyperemia induced by adenosine. It is reduced in
      atherosclerosis and various conditions associated with the dysfunction of coronary
      microcirculation, such as diabetes and hypercholesterolemia.

      Both ethanol and antioxidative polyphenols have been implicated in beneficial endothelial
      effects of red wine. However, their relative contributions remain uncertain in vivo. It has
      been suggested that red wine has stronger vasoactive properties than other alcohol beverages,
      and even de-alcoholized red wine may be sufficient to improve flow-mediated dilatation of the
      brachial artery. Cognac is also known to contain polyphenols, but its effects on coronary
      circulation have not been evaluated.

      The purpose of this randomized controlled cross-over study was to determine with
      transthoracic echocardiography whether moderate doses of red wine improve CFR in response to
      adenosine in healthy humans. We also studied contributions of ethanol and antioxidants by
      comparing the effects of equal doses of alcoholic and de-alcoholized red wine, and cognac on
      the plasma antioxidant capacity and CFR.
    

Intervention name(s): red wine and cognac consumption
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: transthoracic; echocardiography; red wine; cognac; coronary reactivity
A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety
      and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years
      old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2
      diabetes mellitus will be enrolled at approximately 40 investigational sites in the United
      States and Canada.
    


Intervention name(s): placebo; telbermin
Intervention type(s): Drug; Drug
Intervention description(s): Topically applied; Topically applied
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Dabetic Feet