bioihbjkbjnl/mcl2 huggingface dataset:
Location of Injection of Local Anesthetics in the Adductor Canal Block
Condition: Anesthesia; Adductor Canal Block
Study type: Interventional

Summary: 
      The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate
      Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the
      subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests
      that different injection sites within the canal may produce different degrees of analgesia
      and quadriceps motor block. This trial seeks to determine the effects of various ACB
      injection sites on postoperative analgesia and motor power following ACL repair.
    

Detailed description: 
      Adductor canal block (ACB) is replacing femoral nerve block (FNB) as the peripheral nerve
      block of choice for knee surgery. The ACB aims to inject local anesthetics (LA) within the
      neurovascular sheath in the subsartorial adductor canal around the femoral nerve. The point
      where the sartorius muscle crosses over the femoral artery is generally the accepted site for
      performing ACB. Clinically, injecting LA in the adductor canal blocks the sensory innervation
      of the knee and thus offers pain relief that is similar to FNB while conserving motor power
      around the knee. While these benefits are desirable, the exact location for performing ACB
      that ensures these benefits, remains debatable. The subsartorial adductor canal itself is
      7-10cm long and the anatomical location of the sensory and motor nerves that innervate the
      knee and its surrounding muscles in this canal may vary. This randomized controlled trial is
      designed to identify and refine the ACB technique by clinically determining the effects of
      various ACB injection locations on postoperative analgesia and quadriceps motor power
      following ACL repair.
    

Intervention name(s): lidocaine; ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Local anesthetic; Local anesthetic
Other intervention name(s): Xylocaine; Naropin
Intervention MeSH terms: Lidocaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study
      to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection
      Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy
      Male Subjects.
    

Detailed description: 
      CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will
      be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio
      to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect
      preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a
      1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed
      Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will
      be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1
      and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all
      subjects will receive a study drug subcutaneously via PFS. The randomization to treatment
      assignment will be stratified by study center and body weight as measured at baseline to
      balance subject weight across treatment groups. Subjects will be confined to the study center
      until all required 24-hour post-dose assessments have been completed and will be discharged
      on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.
    

Intervention name(s): CT-P43; EU-approved Stelara; US-licensed Stelara
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 45mg single dose; 45mg single dose; 45mg single dose
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Condition: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the maximum tolerated dose (MTD) of
      blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r)
      DLBCL.
    

Detailed description: 
      The study was planned as 2 parts:

        -  Part 1 will test the safety of up to 3 different blinatumomab target dose levels in
           combination with pembrolizumab in a rolling 6 design. A Dose Level Review Team (DLRT)
           will review the safety data to evaluate possible drug effects and dose-limiting
           toxicities (DLTs).

        -  Part 2 will consist of an expansion cohort to assess pharmacokinetics (PK), safety, and
           preliminary efficacy data at the chosen target dose. The part 2 dose will be determined
           by the totality of the clinical data from part 1 as determined by the DLRT.

      Based on the results from Part 1, a decision was made not to proceed with Part 2 of this
      study.

      Secondary objectives of the study are to evaluate the safety, efficacy, and pharmacokinetics
      (PK) of blinatumomab in combination with pembrolizumab. Tumor response will be evaluated
      according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al, 2007). With
      implementation of Protocol Amendment 5, response will also be assessed according to the
      Lugano Classification (Cheson et al, 2014). Only participants enrolled after implementation
      of Protocol Amendment 5 (03 December 2019) will have tumor assessments using the Lugano
      criteria.
    

Intervention name(s): Blinatumomab; Pembrolizumab
Intervention type(s): Drug; Drug
Intervention description(s): Up to 2 cycles of blinatumomab may be given, where cycle 1 lasts 8 weeks, and cycle 2 lasts 28 days. The treatment is given as a continuous intravenous infusion.; One cycle of pembrolizumab is a 200 mg IV injection lasting 30 minutes. One cycle will be given every 3 weeks until disease progression, or for a maximum of 35 cycles.
Other intervention name(s): Blincyto; AMG 103; Formerly known as MT103 or bscCD19xCD3; Keytruda; MK-3475
Intervention MeSH terms: Pembrolizumab; Blinatumomab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Antibodies; Bispecific in combination with PD-1/PD-L1 inhibitor
First in Human Clinical Trial of ApTOLL in Healthy Volunteers
Condition: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, first-in-human, dose ascending, randomized, placebo-controlled clinical
      study to assess the tolerability and pharmacokinetics of ApTOLL in healthy volunteers. ApTOLL
      is an aptamer able to antagonize TLR4 receptor and, therefore, to reduce the inflammatory
      response.
    

Detailed description: 
      This Phase I clinical trial is divided in two parts: the first part (part A) is a single dose
      escalation study and the second (part B) is a multiple dose study. Both are performed in
      healthy volunteers.

        -  First part: a single dose, i.v. administration (slow infusion), dose escalation with a
           maximum of 7 single dose levels, randomized, double-blind, placebo-controlled (saline
           solution), in healthy subjects.

        -  Second part: a multiple dose, i.v. administration (slow infusion), randomized,
           double-blind, placebo-controlled (saline solution), in healthy subjects.

      The main objectives of this study are:

        1. To evaluate the tolerability and pharmacokinetic characteristics of ApTOLL in healthy
           volunteers, after single dose administration in fasting conditions, following an
           ascending dosing scheme.

        2. To evaluate the tolerability and pharmacokinetic characteristics of ApTOLL in healthy
           volunteers, after multiple dose administration in fasting conditions.
    

Intervention name(s): ApTOLL; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatoryy response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.; 100 mL 0.9% Sodium Chloride solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; ApTOLL
Iyengar Yoga for Young People With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms
      include discomfort in the abdomen, along with diarrhea and/or constipation and other
      gastroenterological symptoms, which can significantly impact quality of life and daily
      functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that
      mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced
      to childhood and adolescence, making the early manifestation of IBS important to understand.
      The current study focuses on young people aged 14-26 years of age with IBS. The study will
      test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual
      functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and
      spiritual benefits to practitioners and has been associated with reduced stress and pain.
      Through its focus on restoration and use of props, IY is especially designed to decrease
      arousal and promote psychospiritual resources in physically compromised individuals.
      Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week
      biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group.
      The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life
      and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will
      include visceral pain sensitivity assessed with a standardized laboratory task (water load
      task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and
      mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20%
      attrition; and the IY group will demonstrate significantly improved outcomes compared to
      controls, with physiological and psychospiritual mechanisms contributing to improvements;
      clinical treatment gains will be maintained at 2 months following yoga.
    


Intervention name(s): Iyengar yoga
Intervention type(s): Behavioral
Intervention description(s): Iyengar yoga twice/week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to conduct a comparative trial to further evaluate the safety,
      immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,
      given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2
      through 10 years of age.
    


Intervention name(s): MenACWY-CRM
Intervention type(s): Biological
Intervention description(s): The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of meningococcal disease, children, vaccine
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of
      GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
    


Intervention name(s): Pandemic influenza vaccine GSK2340272A
Intervention type(s): Biological
Intervention description(s): Two primary intramuscular (IM) injections and a booster IM injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A
Entereg Laparoscopic Colon Resection Study
Condition: Laparoscopic Colonic Resection
Study type: Interventional
Phase: Phase 2

Summary: 
      Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been
      shown to increase postoperative bowel function in patients after open bowel resection
      surgery. It has been proven safe and effective for short-term in-house treatment. At the
      present there are several Drug Use Utilization Evaluation studies reporting results involving
      the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However, this study
      will be the first randomized, prospective, double-blind, placebo-controlled trial looking at
      this population. We propose that Entereg will decrease the length of stay by one day in the
      laparoscopic colon resection patient. We wish to perform a voluntary, double-blinded, placebo
      controlled study. We plan an enrollment population of 250 patients. Twelve milligrams of
      Entereg will be administered 30 minutes to 5 hours pre-op followed by 12 mg BID, up to 7 days
      or 15 total doses. The primary endpoint of the study will be length of stay. The time of GI-2
      recovery (toleration of solid food and first bowel movement) and time to GI-3 recovery
      (toleration of solid food, and flatus or bowel movement) will be secondary endpoints.

      Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion Date:
      May 2012, Estimated Primary Completion Date: Nov 2011.
    


Intervention name(s): Entereg; Entereg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis.; oral, 12 mg 30-300 min pre-op then BID up to 7 days (or 15 total doses); 12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses)
Intervention MeSH terms: Alvimopan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: laparoscopic; colon; resection; Entereg
Incidence of Dyschromatopsia in Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Incidence of dyschromatopsia
    

Detailed description: 
      Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control
      population. However, the actual incidence rate is not investigated.
    

Intervention name(s): Color Vision Test
Intervention type(s): Procedure
Intervention description(s): Farnsworth Panel D15/Hue test plus Ishihara charts
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of glaucoma from a university outpatient department
      
Keywords: Glaucoma, Dychromatopsia
Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of
      valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight
      stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with
      hypertension (SSBP ≥ 95th percentile for age gender and height).
    


Intervention name(s): Valsartan; Enalapril
Intervention type(s): Drug; Drug
Intervention description(s): Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Intervention MeSH terms: Valsartan; Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan; enalapril
Coadministration of Measles-rubella and Rotavirus Vaccines
Condition: Measles Antibody Seroconversion; Rubella Antibody Seroconversion; Rotavirus Geometric Mean Titer (GMT); Rotavirus Immunoglobulin A (IgA) Seropositivity
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aim to establish the non-inferiority of concomitant administration of
      measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of
      measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate
      as defined by the percentage of children seroconverting to measles with a measles serum
      antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant
      administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained
      when measles-rubella vaccine is given alone in children 9 months of age who have received a
      primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at
      least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
    


Intervention name(s): Rotarix vaccine; measles-rubella vaccine
Intervention type(s): Biological; Biological
Intervention description(s): one 1.0 ml dose of oral rotavirus vaccine at 9 months of age; one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Other intervention name(s): rotavirus vaccine; Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: rotavirus
Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing
      clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and
      Thioctic acid after oral administration in healthy male volunteers.
    


Intervention name(s): Pregabalin 300mg, Thioctic acid 600mg
Intervention type(s): Drug
Intervention description(s): A: Pregabalin - Pregabalin 300mg will be administered orally twice a day for 3 days
B: Thioctic acid - Thioctic acid 600mg will be administered orally once a day for 3 days
C: Pregabalin plus Thioctic acid - Pregabalin plus Thioctic acid same way as A and B
Intervention MeSH terms: Thioctic Acid; Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Prevention of Lifestyle-related Ill-health With Early Functional Examinations and Individualized Risk Profiles
Condition: Lifestyle Risk Reduction
Study type: Interventional

Summary: 
      Background: Many lifestyle-related health disorders are influenced by physical activity level
      and physical function. Health examinations which focus on musculoskeletal function of people
      who have risk factors for lifestyle-related disorders, combined with person-centered advice
      based on risk profiles can give people knowledge and guidance to manage their own lifestyle
      priorities.

      Aim: To investigate the feasibility of a protocol for a randomized controlled trial (RCT)
      which will examine the preventive effects of musculoskeletal function examinations and
      person-centered advice on inactive middle-aged people.

      Methods: Physically inactive middle-aged people will be invited to participate in a two-part
      health examination with follow-up after three months in a pilot study. Part 1 is a standard
      health examination including blood tests and Part 2 is a functional examination of fitness,
      strength, mobility, balance and posture according to our protocol based on validated tests.
      The intervention group receives feedback based on both parts of the examination while the
      control group receives feedback only from Part 1. Physical activity level will be measured
      objectively with accelerometers at inclusion and follow-up.

      Expected results: The pilot study is expected to show whether the planned RCT is practically
      feasible and to give relevant support for the power analysis for a later full-scale RCT.
      Better understanding of personal physical function and risk factors can facilitate lifestyle
      decisions on the individual level which can reduce the risk for later ill-health and need of
      health-care. Preventive interventions may contribute to reduce the ever-increasing level of
      lifestyle-related ill-health.
    


Intervention name(s): Risk profile
Intervention type(s): Behavioral
Intervention description(s): Compiliation of risk profile based on fitness, strength, mobility, balance, posture, physical activity level, weight and pain. Advice based on the above and support in goal-setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Prevention; Lifesyle-related condition; Physical function; Physical activity
Effect of Body Composition and Metabolism on Oocyte Gene Expression
Condition: Healthy
Study type: Observational

Summary: 
      The investigators will test the hypothesis that obese women have a unique oocyte gene
      expression profile that differs significantly from that of normal weight women.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women of childbearing age undergoing fertility treatment
      
Biospecimen description: 
      oocytes and follicular fluid
    
Keywords: healthy women; oocytes; in vitro fertilization; pregnancy; childbearing-age