bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease
Condition: Healthy Study Participants; Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of
      UCB0022 and food effect.
    


Intervention name(s): UCB0022; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.; Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
Other intervention name(s): PBO
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study consists of a crossover design part (Part A) and two parts (Part B and Part C) with a parallel design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Study Participants; Parkinson's Disease; Phase 1; escalating cohorts; UCB0022
Comparative User Experiences With BD Nano™ PRO 32G Extra Thin Wall Pen Needle vs the Terumo Nanopass® 34G Pen Needle
Condition: Diabetes
Study type: Interventional

Summary: 
      This is a subject single blinded, block randomized, prospective, single-visit, multi-center
      study to compare user experiences with BD Nano™ PRO pen needle vs. the thinner commercially
      available Terumo Nanopass® pen needle. The study will include a minimum of 55 Japanese
      American study subjects with Type 1 or Type 2 diabetes.
    

Detailed description: 
      Study conduct will consist of one 60 to 120-minute Site visit in which pre-set doses of
      saline will be abdominally delivered by Subjects via a reusable insulin pen device. All pen
      needles will be attached by Study Staff and pen needle outer cover and inner shield will be
      removed for subjects. Subjects are to perform 12 injections into the abdomen (6 pairs of
      injections). Pairs of injections will be evaluated and each pair will contain one BD Nano™
      PRO and one Terumo Nanopass® pen needle. The order of the two pen needles in each pair will
      be randomized.

      The intent of this comparative use study is to determine whether Japanese American patients'
      experiences are different when using the BD Nano™ PRO 4mm x 32G extra thin wall, 5-bevel pen
      needle vs the Terumo Nanopass® 4mm x 34G pen needle in the Japanese American population.
      These experiences include the perceived force to deliver dose, the ability to deliver the
      full dose (measured by leakage), injection pain and bending.
    

Intervention name(s): Terumo Nanopass® 34G pen needle; BD Nano™ PRO 32G pen needle
Intervention type(s): Device; Device
Intervention description(s): Insulin pen needle; Insulin pen needle
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: BD Nano™PRO (Test Device) will be compared to the Terumo Nanopass® through a series of randomized abdominal saline injections
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab
      when given directly into a vein in Chinese subjects.
    

Detailed description: 
      This is an interventional, randomized, open-label, parallel-group, single-dose study
      investigating the safety, tolerability and pharmacokinetic properties of eptinezumab
      administered by intravenous (iv) infusion.

      The study will consist of 20 healthy Chinese subjects, who will be randomized into two
      single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10
      subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a
      total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.

      Safety and tolerability will be assessed throughout the study. Blood samples for plasma
      quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day
      84)/Withdrawal Visit.
    

Intervention name(s): Eptinezumab
Intervention type(s): Drug
Intervention description(s): single iv infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Newborn Screening for Critical Congenital Heart Disease
Condition: Congenital Cardiovascular Malformation
MeSH terms: Heart Diseases; Heart Defects, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to
      screen for left-sided cardiac lesions. These studies have shown that the occurrence of
      critical congenital cardiac malformations among asymptomatic newborns is high; the technique
      of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to
      operate(requires little time and can be done in the newborn nursery) and is cost effective;
      there is effective follow-up test (heart ultrasound) and available interventions have an
      effect on outcome for diagnosed newborns. The importance of this research project is to
      examine the overall helpfulness of measuring oximetry in newborn infants using somatic
      oximetry, as well ast to prepare for a population based study in the state of Florida.
    

Detailed description: 
      This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart
      disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop
      computer which computes the difference between central and lower extremity peripheral values,
      upper and lower body peripheral values, and records all data. This information may
      differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse
      oximetry as a newborn screening for congenital cardiovascular malformations.
    

Intervention name(s): Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
Intervention type(s): Device
Intervention description(s): Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.
Other intervention name(s): Healthy Newborns with Pulse oximetry
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy newborns and newborns diagnosed with congenital cardiovascular malformations
      
Keywords: congenital cardiovascular malformation; newborn
Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population
Condition: Pulmonary Congestion; Congenital Heart Disease; Post-Op Complication
MeSH terms: Heart Diseases; Heart Defects, Congenital; Postoperative Complications
Study type: Observational

Summary: 
      Increased extravascular lung water (EVLW) may increase mortality and morbidity in
      cardiopulmonary pathology. Many factors can cause increased extravascular lung water and
      pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral
      regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right
      shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS)
      and sepsis.

      The clinical assessment of lung water ranges from auscultation to radiological methods to
      invasive measurements like dye dilution or thermodilution studies.

      Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung
      water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as
      well as the bedside gold standard, transpulmonary thermodilution in adults.

      Critically ill children are more susceptible to complications and worsened outcomes from
      increased EVLW.

      Lung ultrasound correlates with clinical and radiological endpoints, but has not been
      validated against invasive objective measures like transpulmonary thermodilution.

      Evaluation of transpulmonary thermodilution setups in the pediatric population has shown
      different normal values and cutoffs compared to adults, possibly due to differential rates
      growth and development.

      It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular
      lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and
      evaluate their sensitivity and specificity.
    


Intervention name(s): Lung ultrasound and EVLW measurement by transpulmonary thermodilution.
Intervention type(s): Diagnostic Test
Intervention description(s): Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.
      
Keywords: Lung ultrasound; Transpulmonary thermodilution
Human Sperm Markers of Cryodamage Resistance
Condition: Fertility
Study type: Observational

Summary: 
      Sperm freezing has been employed for decades for male fertility preservation in cases of
      foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a
      complement of assisted reproduction techniques.

      Sperm quality after thawing is highly variable, even among consecutive samples from the same
      individual, with mean survival rates around 40%. To date, the molecular basis of the adequate
      resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can
      lead to improvement in the selection of the samples to be frozen and also in the adequate
      supplement of cryopreservation media. Microarray analysis provides a powerful tool to address
      the molecular explanation beyond this behaviour, yielding results about comparative messenger
      ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and
      suboptimal survival.

      Then, the aim of the investigators' study is to determine the genomic profile of sperm
      samples depending on their survival resistance to cryopreservation, to determine genes
      involved in cryodamage sensitivity.
    

Detailed description: 
      Nested cases and controls design, with donor sperm samples frozen under conventional
      protocols, categorized depending on their good (GSR, n=20) (less than 20% motility decrease)
      or bad (BSR, n=20) (more than 20% motility decrease) survival rates. Sperm mRNA was extracted
      using Trizol protocol, suspended in diethylpyrocarbonate (DEPC)-treated water and frozen at
      -80 degrees until the microarray experiments were performed. RNAs were analyzed on Agilent
      Bioanalyzer 2100. Samples were pooled in 4 (5 samples/pool and 4 pools/group). Finally, 8
      Agilent One colour Whole genome microarray (44K) were performed with pooled samples, 4
      microarrays per group.

      The results will be evaluate to detect those genes differentially expressed.
    

Intervention name(s): Sperm cryopreservation
Intervention type(s): Other
Intervention description(s): Sperm from the different groups are cryopreserved to evaluate their resistance to preservation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men from 18-35 years, included in the donation program of IVI Alicante. Any transmisible
        clinical pathology, viral infection or genetic disease should be ruled out by family
        history records.

        In addition, seminal samples from donors must meet the seminal criteria considered by our
        laboratory:

          -  sperm concentration> 40 million sperm / ml;

          -  percentage of progressive motility> 50%

          -  percentage of normal forms> 4%.

        For pregnancy rates after IUI, only women< 40 years without tubal pathologies and IUI
        indications will be included.
      
Keywords: Cryodamage; microarrays; Insemination; sperm
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, open-label, randomized, active-controlled study to compare DR-2011
      to progesterone vaginal gel for luteal phase replacement.
    

Detailed description: 
      This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare
      the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel
      over an 18-day treatment period. Patients will also be required to use an estrogen patch
      during the course of the study. The overall study duration for each patient will be
      approximately 1½ months.

      Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In
      addition, serum hormonal levels will be measured at screening and at designated times from
      Cycle Day 14 to 31.
    

Intervention name(s): DR-2011; Progesterone 8% Vaginal Gel
Intervention type(s): Drug; Drug
Intervention description(s): Administered vaginally from Day 14 to Day 31; Administered vaginally from Cycle Day 14 to Day 31
Other intervention name(s): Crinone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: luteal phase replacement; oocyte donation; infertility; progesterone
Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults
Condition: Endothelial Dysfunction; Aging
Study type: Interventional

Summary: 
      Aging is the primary risk factor for cardiovascular disease (CVD) largely due to vascular
      endothelial dysfunction, a major initial step in the development of atherosclerosis.
      Endothelial dysfunction is characterized by impaired endothelium-dependent dilation and is
      primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and
      inflammation. Interventions that improve endothelial dysfunction are important for improving
      endothelial function and reducing CVD risk in this high-risk population. Aronia melanocarpa,
      commonly known as aronia berries or chokeberries, are rich in polyphenols such as
      anthocyanins, proanthocyanidins, and phenolic acids. These compounds, and derivatives
      resulting from gut microbial and phase II metabolism, have been shown to attenuate oxidative
      stress and inflammation, and to improve endothelial function. Aronia berries and other
      berries have been shown in numerous studies to have diverse cardiometabolic health effects
      including modulation of endothelial function, arterial stiffness, blood pressure, oxidative
      stress, and inflammation. In addition, berries, dietary fiber, polyphenols have been shown to
      exert positive effects on the gut microbiota, which may mediate improvements in
      cardiovascular health. Recently, we have demonstrated that modulation of the gut microbiota
      is associated with improvements in vascular dysfunction. The primary goal of the currently
      proposed research is to assess the efficacy and dose-dependent response of an aronia full
      spectrum dietary supplement to improve endothelial function in middle-aged/older men and
      postmenopausal women. A secondary goal is to determine whether aronia full spectrum
      modulation of the gut microbiota is associated with improvements in endothelial function.
      Other functional and biochemical measures of cardiovascular health, oxidative stress,
      inflammation, and polyphenol metabolism will be assessed.
    


Intervention name(s): Aronia full spectrum - half dose; Aronia full spectrum - full dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Powdered whole fruit obtained from aronia berries (Aronia melanocarpa); Powdered whole fruit obtained from aronia berries (Aronia melanocarpa); Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Polyphenols; Anthocyanins; Vascular function; Gut microbiome; Gut health; Berries
Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus Erythematosus
Condition: System; Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of mesenchymal stromal cells (MSCs)
      obtained from umbilical cords for the treatment of adults with active systemic lupus
      erythematosus (SLE).
    

Detailed description: 
      This open label trial will evaluate the safety of allogeneic MSCs for the treatment of adults
      with moderate to severely active systemic lupus erythematosus (SLE). MSCs will be derived
      from healthy donor umbilical cord cells and 1 dose of MSCs will be tested. MUSC has a good
      manufacturing practice (GMP) quality Clean Cell Facility to ensure the quality and safety of
      the MSCs prior to infusing into study participants. The goal of this study is to determine
      the safety of MSC infusion in patients with SLE when added to standard of care for SLE.

      The MSCs used in this trial are cells that are obtained from the umbilical cords of healthy
      donors having an elective Caesarean section and who have been screened to be sure that they
      are free of any infectious diseases. These investigational cells will be collected and
      processed so that they can be used as an infusion treatment. An infusion is when a drug (in
      this case the MSCs) is administered directly into the blood stream via a vein, usually
      located in the arm or hand. All participants will receive standard of care and their safety
      will be monitored throughout the study.
    

Intervention name(s): Low Dose Mesenchymal Stem Cells (MSCs)
Intervention type(s): Drug
Intervention description(s): Mesenchymal stromal/stem cells (MSCs) are cells that can be derived from umbilical cords, bone marrow, adipose tissue, and dental pulp, among other sites. MSCs have the ability to mediate a range of immuno-modulatory actions for both the innate and adaptive immune systems.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus; Stem Cell; Systemic Lupus Erythematosus
Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular
      weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e.
      post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been
      introduced worldwide the last two decades. Reports have suggested a beneficial effect of this
      costly treatment, but there are no randomized clinical trials documenting its short- and
      long-term efficacy and safety. This multi-center study will randomize patients with acute
      iliofemoral vein thrombosis to either conventional treatment or CDT in addition to
      conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence
      of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will
      increase patency of the affected segments after 6 months from <50% to >80%. The main
      long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS
      after 2 years from >25% to <10%.
    


Intervention name(s): catheter-directed venous thrombolysis
Intervention type(s): Procedure
Intervention description(s): catheter-directed continuous intravenous infusion of alteplase 0.01mg/kg/h and low-dose heparin. Max dose 20mg/24 h and up to 96 hrs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thrombolytic therapy; Postphlebitic syndrome; Venous thrombosis
Hyaluronic Acid and Uterine Synechiae
Condition: Uterine Synechiae After Scraping for Natural Miscarriage
MeSH terms: Abortion, Spontaneous; Gynatresia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to compare efficiency of a non-stick gel application
      after scraping surgery for natural miscarriage with no non-stick gel application after
      scraping surgery.

      Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8
      weeks after surgery.
    

Detailed description: 
      Women patients coming for natural miscarriage will be compared according to whether a
      non-stick gel will be applicated or not after scraping surgery.

      6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical
      hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study
      without knowing the randomization arm.

      Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick
      gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery
      using questionnaire asked by post, mail or phone.
    

Intervention name(s): Gel
Intervention type(s): Drug
Intervention description(s): Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Uterine synechiae Scraping surgery Natural miscarriage
Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to analyse prospectively if highly purified hMG compared
      with increased dose of clomiphene citrate has different outcomes in folliculogenesis in
      ovulation induction cycles.
    


Intervention name(s): clomiphene citrate; gonadotropins
Intervention type(s): Drug; Drug
Intervention description(s): ovulation induction; ovulation induction
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ovulation induction; clomiphene citrate; gonadotropins