bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetics (including comparisons of different formulations
      and investigation of food effect)
    


Intervention name(s): BIBP 5371 CL tablet; BIBP 5371 CL solution; High fat, high caloric breakfast; Placebo tablet; BIBP 5371 CL tablet high dose; Placebo drinking solution; BIBP 5371 CL tablet low dose
Intervention type(s): Drug; Drug; Other; Drug; Drug; Drug; Drug
Intervention description(s): single rising daily doses
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Clinical Study of Patellar Resurfacing and Non-resurfacing in Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The literature regarding resurfacing of the patella in total knee arthroplasty has
      conflicting conclusions. This study assesses medium-term clinical results of total knee
      arthroplasties performed with and without the patellar resurfacing in patients undergoing
      single-staged bilateral total knee arthroplasty in a randomized controlled, clinical study at
      a minimum of 5 years follow-up.
    

Detailed description: 
      Sixty-six patients (132 knees) underwent primary single-staged bilateral total knee
      arthroplasty for osteoarthritis. Patients were randomized to receive resurfacing or retention
      of the patella. All patients received the Scorpio NRG knee prosthesis. Evaluations were done
      preoperatively and yearly, up to a minimum of 5 years postoperatively. Knee Society Score and
      Feller Score outcomes were measured. Anterior knee pain, the clunk of patella, and patient
      satisfaction questionnaires were completed.
    

Intervention name(s): the patella was resurfaced.
Intervention type(s): Procedure
Intervention description(s): Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Patellar resurfacing; Anterior knee pain
In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old
Condition: Activation of Primordial Follicles
MeSH terms: Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional

Summary: 
      This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA)
      treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh
      (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.
    

Detailed description: 
      The objectives of the study is as following;

        -  Validation of the previously defined In-Vitro Activation Protocol approach in Turkish
           patients under 36 years old with Premature Ovarian Insufficiency (POI).

        -  Giving an opportunity to young POI patient in Turkey for having genetically own baby.

        -  Primary outcome measure would be live birth.

        -  For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor
           and protein kinase B (AKT) stimulator will be used.
    

Intervention name(s): In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator
Intervention type(s): Procedure
Intervention description(s): After laparoscopic unilateral oophorectomy, ovarian medulla would be dissected from cortex. After fragmentation of 2 cm square ovarian cortex into smaller pieces they would be incubated PTEN inhibitor and AKT stimulator for 48 hours. Finally we will auto graft these fragments beneath to the fallopian tube peritoneal surface.
Other intervention name(s): Laparoscopic unilateral oophorectomy; Laparoscopic auto grafting of ovarian cortex fragments sub-peritoneally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center
      study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal
      disease.
    

Detailed description: 
      The primary objective of this study is to characterize the safety and tolerability of
      multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis
      patients and to assess the feasibility of conducting a full-scale, mortality-powered trial of
      SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters
      will also be analyzed. The primary efficacy parameter will be the change in the E'
      measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a
      surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be
      studied in the overall population or in sub-studies include heart rate variability,
      circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular
      function. These parameters are designed to broaden insight into the potential effects of SPL
      on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess
      the feasibility of conducting a full-scale, mortality-powered trial.
    

Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention description(s): The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemodialysis; spironolactone; cardiac fibrosis; diastolic function
The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy; Postoperative Pain; Respiratory Function
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of ultrasound guided erector spinae block in
      control of the postoperative pain and the respiratory functions after laparoscopic
      cholecystectomy.
    


Intervention name(s): Bilateral Erector Spinae Block; Control
Intervention type(s): Procedure; Other
Intervention description(s): A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).; Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erector Spinae Block; Laparoscopy; Respiratory Function
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
Condition: de Novo Liver Transplant Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the efficacy and safety between a group that has
      been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group
      that maintained Prograf twice daily therapy.
    

Detailed description: 
      De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive
      Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will
      be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while
      Prograf therapy will be continued in other group.
    

Intervention name(s): Prograf; Advagraf
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Tacrolimus; modified release Tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FK506; tacrolimus; immunosuppressant
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess immunogenicity, safety and reactogenicity of primary and booster
      vaccination.
    

Detailed description: 
      "There will be two groups in this study:

        -  one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib
           vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster
           vaccination

        -  the control group will receive a birth dose of hepatitis B vaccine and 3 doses of
           DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine
           as booster vaccination".
    

Intervention name(s): DTPa-HBV-IPV/Hib
Intervention type(s): Biological
Intervention description(s): GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
Condition: Recurrent Colorectal Carcinoma; Progressive Colorectal Carcinoma
MeSH terms: Carcinoma; Colorectal Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of
      Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan
      therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive
      colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
    


Intervention name(s): Safety and efficacy of escalating doses; Safety and efficacy of escalating doses.
Intervention type(s): Biological; Biological
Intervention description(s): Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle) and irinotecan on Day 1 of each week for 4 weeks with a 2-week rest. Number of Cycles: until progression or unacceptable toxicity develops.; Imprime PGG and Cetuximab on Day 1 of each week for 6 weeks (one cycle). Number of Cycles: until progression or unacceptable toxicity develops.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal; Carcinoma; Recurrent; Progressive; Cetuximab; Irinotecan; 5-Fluorouracil
Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the neutralizing antibody response against each dengue
      serotype post-vaccination.
    

Detailed description: 
      The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate
      (TDV). TDV is being tested to protect people against dengue fever. This study will look at
      the immunogenicity and safety of TDV in flavivirus-naïve and dengue-immune adults.

      The study will enroll approximately 44 patients. Participants will be categorized into two
      groups based on results from serological testing performed by the trial center outside the
      scope of this trial (up to 70 days [10 weeks] prior to Day 1 [Month 0]):

      Group 1: Flavivirus-Naïve Participants Group 2: Dengue-Immune Participants

      All participants will receive subcutaneous injection of TDV on Day 1 (Month 0) and Day 90
      (Month 3).

      This trial will be conducted in the United States. The overall time to participate in this
      study is 12 months. Participants will make multiple visits to the clinic, and 9 months after
      last dose of study drug for a follow-up assessment.
    

Intervention name(s): Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Intervention type(s): Biological
Intervention description(s): Tetravalent Dengue Vaccine (TDV) subcutaneous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with
      placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

      Secondary objectives:

      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and
      health-related quality of life compared with placebo.

      To investigate the safety, immunogenicity, and tolerability of SC administration of
      tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18
      years) with moderate-to-severe AD.
    


Intervention name(s): Tralokinumab; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.; Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To propose a feasibility study of introducing a smoking cessation program in head and neck
      cancer patients with planned radiotherapy. The study will feature the feasibility, safety,
      and efficacy of a prospective smoking cessation program during head and neck irradiation.
    

Detailed description: 
      Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute
      and late complications but also poor clinical tumor response, poor local control, and poor
      overall survival. However, smoking cessation has not been included into the standard
      intervention in treating head and neck cancer patients in Taiwan. We propose a prospective
      study of introducing a smoking cessation program in head and neck cancer patients receiving
      radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective
      smoking cessation program during head and neck irradiation. The primary outcome is to test
      the feasibility of the smoking cessation intervention, and the secondary outcome is to test
      the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor
      response, patterns of relapse, and overall survival.
    

Intervention name(s): Smoking cessation
Intervention type(s): Behavioral
Intervention description(s): Refer for smoking cessation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiation therapy,Smoking pattern,head and neck cancer
A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine
      (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster
      immunization of children at the age of 18 months, and the simultaneous immunization with
      other vaccines of children at the age of 2 months and older, so as to provide reference for
      the improvement of immunization strategy.
    

Detailed description: 
      This study is an open and observational phase Ⅳ clinical trial of Sabin Inactivated
      Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated
      Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2
      months and booster immunization of children at the age of 18 months, and the simultaneous
      immunization with other vaccines of children at the age of 2 months and older, so as to
      provide reference for the improvement of immunization strategy.A total of 3200 subjects
      including 2000 subjects aged 2~3 months in primary immunization group,1200 subjects aged 18
      months in primary immunization group will be enrolled and will receive sIPV vaccine or sIPV
      vaccine and other vaccines simultaneously.
    

Intervention name(s): sIPV vaccine /DTaP vaccine; sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine
Intervention type(s): Biological; Biological
Intervention description(s): All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.; All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
Condition: Spinal Anesthesia
Study type: Observational

Summary: 
      Anesthesia alters microcirculation and tissue oxygen saturation (StO2). We sought to examine
      changes in StO2 using near-infrared spectroscopy and a vascular occlusion test (VOT) during
      spinal anesthesia. This prospective observational study was included 51 patients without
      comorbidities who underwent elective surgery under spinal anesthesia. We measured the StO2 in
      the lower extremity during VOT before and after intrathecal injection.
    

Detailed description: 
      The vascular occlusion test (VOT) procedure was conducted twice in each patient, before and
      15 min after intrathecal injection. An near-infrared spectroscopy (NIRS) sensor (INVOSTM
      5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the
      patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System;
      Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50
      mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min.
      After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The tissue
      oxygen saturation (StO2) data was continuously recorded during the VOT procedure. After
      confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in
      the same manner as mentioned above. The occlusion slope and recovery slope were calculated
      based on the measured StO2 data. The occlusion slope was defined as the descending slope of
      StO2 value until it reached the minimum value. The recovery slope was calculated from the
      deflation of the tourniquet until the recovery of StO2 to the maximum value.
    

Intervention name(s): Vascular occlusion test
Intervention type(s): Diagnostic Test
Intervention description(s): The VOT procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An NIRS sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The StO2 data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients, 18<age< 60 years old, scheduled for spinal anesthesia
      
Keywords: Microvascular Circulation; Spectroscopy, near-infrared; Spinal anesthesia
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced
      by current process and the NN2000 process in healthy Japanese subjects.
    


Intervention name(s): biphasic human insulin 30
Intervention type(s): Drug
Intervention description(s): Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment