bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to compare human embryo in vitro development in sequential and
      single-step culture medium using time-lapse imaging.
    

Detailed description: 
      Objective: To study whether a culture medium that allows undisturbed culture supports human
      embryo development to the blastocyst stage equivalently to a well-established sequential
      media.

      Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization
      (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized
      into two study arms.

      Intervention(s): Embryos from each patient were randomly allocated into two study arms to
      compare embryo development on a time-lapse system using a single-step medium or sequential
      media.
    

Intervention name(s): Single-step medium; Standard culture medium
Intervention type(s): Device; Device
Intervention description(s): This medium will allow in vitro culture of human embryos for 5/6 days; This culture system needs media change on day 3 of culture.
Other intervention name(s): Single step culture medium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a two-arm, prospective, randomized, controlled clinical trial performed at four independent IVF clinics. Ovarian stimulation and oocyte collection and fertilization were performed as per each clinic's practice. If >6 oocytes from the patient were fertilized, the resulting zygotes underwent stratified randomization into the two different media.
Allocation was performed in a 1:1 ratio according to a computer-generated randomization list for each couple, which was provided in sealed and numbered envelopes to each clinic.
Zygotes randomized into G-1/G-2 underwent a media change from G-1 to G-2 on day 3 and subsequent culture until days 5-6. The zygotes randomized to G-TL were cultured continuously without any media change until days 5-6.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: embryo; culture
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee
Condition: Severity of OA Knee; Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph
MeSH terms: Osteoarthritis, Knee
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is assess the severity of osteoarthritic knee between one-leg and
      both-leg standing radiograph in primary OA knee
    

Detailed description: 
      All patients were performed digital radiographs which one-leg and both-leg standing
      anteroposterior view. Medial and lateral joint space width were measured. The severity of OA
      knee was identified by the Kellgren-Lawrence (KL) classification.
    

Intervention name(s): radiographic of standing knee
Intervention type(s): Procedure
Intervention description(s): the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the patients who came to our clinic which bilateral knee pain
      
Keywords: Osteoarthritis of the knee; Weight bearing radiograph; Kellgren-Lawrence classification; Joint space width; One-leg standing view
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
Condition: Metastatic Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety of a single dose of GB221 compared to
      Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary
      objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
    


Intervention name(s): Coprelotamab Injection; Trastuzumab Injection
Intervention type(s): Drug; Drug
Intervention description(s): The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.; The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
Other intervention name(s): GB221; Herceptin
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Translation and Validation of MPCOSQ in Urdu Language
Condition: PCOS- Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ)
      questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of
      modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).
    

Detailed description: 
      -  All statistical analyses will be conducted using the Statistical Product and Service
           Solution version 21 software.

        -  Continuous variables will be shown by mean and standard deviation and the categories
           will be demonstrated in frequency and percentage.

        -  In this study, factor structure of the (MPCOQ) will be analyzed using the principal
           component factor analysis with varimax rotation.

        -  Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for
           test-retest value and Cronbach's Alpha will be used for internal consistency analysis.

        -  Measurement error will be determined by calculating the standard error of measurement
           (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to
           determine the differences between groups
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with PCOS
Impact of Food Combination on Starch Digestion and Gastric Processing
Condition: Glycemic Index; Gastric Emptying; Appetite
Study type: Interventional

Summary: 
      The results of our in vitro studies strengthen the hypothesis that the contribution of
      salivary alpha-amylase to starch digestion has been underrated and that this enzyme can play
      an important role in this process. As a result, its inhibition could constitute an
      opportunity to reduce the glycemic response elicited by starch-rich foods. The main goal of
      this study is to verify whether inhibiting salivary alpha-amylase upon the consumption of
      starchy foods, can have an impact on the postprandial glycemic response, and/or satiety.
    

Detailed description: 
      The main objective of this work was to test the impact of adding black tea or lemon juice to
      a starch-rich meal on postprandial plasma glucose concentrations and on energy intake in
      healthy humans. This study was divided into two parts.

      The objective of part 1 was to determine the effect of pairing a starch-rich food with water,
      black tea or lemon juice on postprandial plasma glucose and energy intake in healthy humans.
      This study was conducted in semi-controlled conditions. The three test meals (equal portions
      of bread (100 g) and 250 mL of either water, black tea or lemon juice) were consumed as
      breakfast (after a 10-h fast) on independent days and in a randomised order. Capillary blood
      glucose concentrations were self-monitored using the finger-prick method at pre-defined
      time-points during 180 min. Ad libitum energy intake was assessed 3 hours later.

      The main objective of part 2 was to investigate whether the gastric emptying patterns remain,
      or not, the same when a bread meal is paired with water, tea, and lemon juice. Blood glucose
      response and satiety perceptions were also monitored. The test meals were similar to those in
      branch 1, except that the meals were supplemented with 20 peas, which the subjects were asked
      to swallow at the end (with half of the beverage provided) without chewing. These peas
      conferred a distinct contrast in MRI scans and could be used as stomach motility and gastric
      mixing tracers in MRI images. Capillary blood glucose concentrations were determined using
      the finger-prick method at pre-defined time-points during 180 min. Visual analogue scales
      were used to assess satiety-related perceptions.

      Volunteer recruitment was conducted independently for each part of the study and volunteers
      were allowed to participate in one part of the study only. Data collected in each part of the
      study was analysed independently.
    

Intervention name(s): Bread; Water; Lemon juice; Tea; Peas
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Serving of wheat bread providing 50 g of carbohydrates; 250 mL of water; 250 mL of lemon juice; 250 mL of tea; 20 peas
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT
Condition: GVHD, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide
      (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received
      low-dose ATG at Day +15.
    

Detailed description: 
      For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA
      matched sibling, unrelated (9~10/10) donor or hallo-identical donors. For all patients will
      receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan.
      For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide
      50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients
      receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.
    

Intervention name(s): PT-CY-FK +/-ATG
Intervention type(s): Drug
Intervention description(s): GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Other intervention name(s): RJH-Lym-2018
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: aGVHD, cGVHD, PT-CY
Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures
Condition: Triangular Fibrocartilage Complex Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to describe and stage lesions of the triangular fibrocartilage
      complex (TFCC) in association with distal radius fractures. 20 patients with dorsally
      dislocated AO type A fractures of the distal radius with sufficient displacement (based of
      cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is
      explored through a volar incision and injuries were documented and repaired from this
      approach.
    


Intervention name(s): Arthroscopy, surgery
Intervention type(s): Procedure
Intervention description(s): Ulno-volar wrist approach to the TFCC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: TFCC injuries; Distal radius fractures
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma
Condition: Carcinoma, Pancreatic Ductal
MeSH terms: Adenocarcinoma; Carcinoma, Pancreatic Ductal
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with inoperable pancreatic cancer have extremely poor prognosis with five year
      survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the
      only therapeutic option for these patients. This tumor is characterized by poor uptake and
      chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of
      treatment intensity. This severely limits clinical outcome. Increasing the local uptake of
      chemotherapy has potential benefits for patients in connection to side effects, survival and
      possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is
      proved promising to improve treatment response in animal and clinical trials. Ultrasound can
      induce biological effects deep inside the body without surgical intervention. This opens for
      local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has
      been reported to influence the delivery of drugs to tumors.

      In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after
      the administration of conventional chemotherapy. Primary aim of the trial is to investigate
      whether the effect of the cytostatic drug, measured in tumor volume, can be increased.
    


Intervention name(s): SonoVue; Chemotherapy
Intervention type(s): Combination Product; Drug
Intervention description(s): 1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only; FOLFIRINOX Regime according to Norwegian national guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Contrast agent BR; SonoVue; Ultrasonic therapy; Microbubbles
In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
Condition: Complications; Arthroplasty
Study type: Observational

Summary: 
      A better understanding of knee joint kinematics is important to explain the premature
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a
      prosthesis that most closely approximates the normal knee. Previously, most experimental
      studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the
      knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that
      permit error due to undesired motions between markers and the underlying bone. More recently,
      fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

      ConforMIS has attempted to follow a clearly different path than the major orthopaedic
      companies. They have chosen to offer patients a personalized knee implant based off of each
      patient's femoral and tibial bone geometry. The hypothesis is that these subjects will
      experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding
      during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the
      in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25
      patients implanted with a traditional TKA design to determine if there are any kinematic
      differences between these TKA designs.
    

Detailed description: 
      Each subject will be asked to perform five activities in one continuous sequence: (1) stand
      up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep
      knee bend. Subjects will be video recorded from the waist down while performing the
      activities. The speed level of each trial will be based on the comfort level of the patient.
      The fluoroscopic images will be stored digitally for subsequent analysis on secure servers
      and workstations at the University of Tennessee.
    

Intervention name(s): Conformis CR Total Knee Replacement; Off the Shelf
Intervention type(s): Device; Device
Intervention description(s): iTotal CR by Conformis; A standard knee replacement not using ConforMIS' iFit technology
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard
        total knee replacement who meets the inclusion/exclusion criteria
      
Keywords: kinematics; knee joint
Establishing a Controlled Human Hookworm Infection Model at Leiden University Medical Center
Condition: Necator Americanus Infection
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis
Study type: Interventional

Summary: 
      Four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus larvae
      once and will retain infection for up to 2 years.
    

Detailed description: 
      Four volunteers will be exposed to 50 Necator americanus L3 larvae. Volunteers will be
      followed on a weekly basis until week 12 after infection. If volunteers develop a patent
      infection, defined by detectable egg production in stool by microscopy at any timepoint
      within week 9 to 12, they will be scheduled to donate faeces on request.

      Two years after infection or if volunteers do not excrete eggs detectable by microscopy on
      week 9 to 12, volunteers will be treated with a 3-day regimen of albendazole to abrogate the
      infection. Retreatment with albendazole will be given to volunteers who remain positive for
      hookworm after treatment.

      Six months after the treatment, volunteers will undergo their last visit.
    

Intervention name(s): Necator americanus L3 larvae
Intervention type(s): Biological
Intervention description(s): 50 Necator americanus L3 larvae
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hookworm; controlled human infection model
Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Successful control of the HIV epidemic will require a safe and effective vaccine to be
      developed. A successful vaccine will need to stimulate a widespread immune response. The
      purpose of this study is to determine the safety of and immune response to an adenovirus
      serotype HIV vaccine in HIV uninfected adults.
    

Detailed description: 
      Control of the HIV pandemic can only be achieved with the development of a safe and effective
      preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune
      response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown
      to elicit just such a response. The purpose of this study is to determine the safety and
      immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine.

      This study will last 18 to 24 months. Participants will be randomly assigned to one of four
      arms that will receive vaccine or placebo administered via intramuscular injection.
      Participants in Arms 1, 2, and 3 will all receive 3 injections. Participants in Arm 4 will
      receive one injection. For most participants, there will be 10 study visits in this study;
      for participants in Arm 4, there will be only 7 visits. For Arms 1, 2, and 3, study visits
      will occur at baseline and on Days 0, 14, 28, 42, 56, 168, 182,196, and 365. Participants in
      Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. For participants in Arm 4,
      study visits will occur at baseline and on Days 0, 14, 28, 56, 168 and 365. Participants in
      Arm 4 will receive one injection only, on Day 0. Participants will be asked to record their
      temperature and other side effects in a symptom log for 3 days after each injection. Risk
      reduction/pregnancy prevention counseling and physical exams will occur at all visits. At
      most visits, blood, urine, and oral swab collection will occur. Samples collected will be
      stored for future testing. HIV testing and pregnancy testing will occur at select visits. At
      Years 2, 3, 4, and 5, participants will be followed-up by telephone, e-mail, or study visit
      to collect vital status, and information about any development of significant disability or
      incapacity, hospitalizations, or congenital anomalies. At these follow-up visits, blood
      collection will be optional.
    

Intervention name(s): Ad5.ENVA.48 HIV-1 vaccine
Intervention type(s): Biological
Intervention description(s): Recombinant adenovirus serotype 5 HIV-1 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.
Condition: Noninvasive Ventilation; Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of
      gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well
      as respiratory outcomes and possible secondary side effects.

      SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants
      that met intubation criteria) and also is used electively for extubation when nCPAP
      extubation has previously failed or infants with Prolonged mechanical ventilation (more than
      15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
    

Detailed description: 
      SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants
      that met intubation criteria) and also is used electively for extubation when nCPAP
      extubation has previously failed or infants with Prolonged mechanical ventilation (more than
      15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).
    

Intervention name(s): Preterm Infants treated with non-invasive ventilation.
Intervention type(s): Other
Other intervention name(s): (Giulia®, Neonatal Nasal Ventilator)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective observational study of SNIPPV use in preterm infants of less than 32 weeks of
        gestation from January 2012 to December of 2014.

        SNIPPV is used for:

          -  nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria
             (FiO2>50%; apnea spells more than 4/h or more than 1 that needs PPV) if they are in a
             stable situation. SAP (systemic arterial pressure)> P10 with preserved respiratory
             drive (no more than 6 apneas episodes per hour or more than 2 requiring PPI).

          -  Electively For extubation:

               -  Preterm infants in which nCPAP extubation has previously failed or Prolonged
                  mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP
                  > 10 cmH2O and FiO2>35%).
A Thorough QT Study of Telotristat Etiprate
Condition: QT Interval
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that telotristat etiprate does not differ from
      placebo in the mean change from Baseline QT interval corrected for heart rate.
    


Intervention name(s): Telotristat etiprate; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1500 mg telotristat etiprate (six 250 mg tablets); Matching placebo; 400 mg moxifloxacin (one 400 mg tablet)
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment