bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section
Condition: Caesarean Section; Anesthesia; Reaction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effects of different anesthetic techniques on QT, QTc, and Pwd in
      cesarean section. Half of participants received general anesthesia, while the other half
      received spinal anesthesia Electrocardiography (ECG) recordings were performed at
      preoperative, 5, 15, 30 min after initiation anesthesia and 30 min post-operatively.
      Hemodynamic state were also recorded at the same time intervals. QT, corrected QT (QTc), QT
      dispersion (QTd), QTc dispersion (QTcd), P-wave dispersion (Pwd), corrected JT interval, T
      wave (Tp-e), transmular dispersion of repolarization durations were measured from ECG records
      at predetermined time intervals of spinal or general anesthesia.
    

Detailed description: 
      The anesthetic drugs used according general or regional anesthesia techniques can display
      proarrhythmic and antiarrhythmic effects by inducing cardiac electrical signals with
      different pathways.In addition, comorbid disease, hormonal changes, surgery procedures, and
      drug therapy can all cause arrhythmia in the intraoperative period. Likewise, pregnancy
      causes many changes hormonal and physiological in women. Hemodynamic and hormonal changes
      during pregnancy can cause effects proarrhythmogenic that cause premature atrial and
      ventricular beats to develop.
    

Intervention name(s): Bupivacaine; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): 2 ml of hyperbaric bupivacaine (0.5%) was given intrathecally to patients in a sitting position by midline attempt between the L3 and L4 intervertebral space.ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.; General anesthesia was maintained with 2-3% sevoflurane. ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
Other intervention name(s): Marcaine Heavy 0.5%; Sevofluran
Intervention MeSH terms: Bupivacaine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spinal anesthesia; General anesthesia; P wave dispersion
OxyNorm Capsules in Post-Operative Pain Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized
      patients with moderate to severe pain following surgery.
    

Detailed description: 
      To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with
      morphine immediate-release tablets in hospitalized patients with moderate to severe pain
      following surgery.
    

Intervention name(s): OxyNorm Capsules; Morphine tablet
Intervention type(s): Drug; Other
Intervention description(s): dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours; dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
Other intervention name(s): OxyNorm; Morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Oral Apremilast in the Treatment of Alopecia Areata at the Tertiary Care Hospital, Karachi.
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 4

Summary: 
      Alopecia areata (AA) is a disease characterized by hair cycle dysfunction and the presence of
      peribulbar and perifollicular mononuclear cell infiltrate.1 The majority of patients report
      the rapid onset of one or several well-defined, usually round, 1 to 4 cm areas of scalp hair
      loss. A common feature is the presence of "exclamation-mark" hairs that are broken and short
      hairs that taper proximally.

      Commonly used treatment modalities are steroids (intra-lesional, topical or systemic),
      contact immunotherapy, anthraline, minoxidil, calcineurine inhibitors, topical retinoids,
      systemic immune modulating agents, photo-chemotherapy, dermatography wigs and hypnotherapy
      etc Apremilast is a newer drug. It is an oral small-molecule inhibitor of phosphodiesterase 4
      (PDE4), this may be effective treatment for a variety of inflammatory skin disorders such as
      alopecia areata.
    

Detailed description: 
      Due to its increasing prevalence and lack of local data on its long term management, the
      investigators designed current study On Efficacy of Oral Apremilast in Alopecia areata
      in-order to evaluate its effectiveness.
    

Intervention name(s): Apremilast 30mg
Intervention type(s): Drug
Intervention description(s): Patients will be given Oral Apremilast 30 mg twice daily after 05 days titration dose.
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the
      effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male
      and/or female participants will be enrolled in the study.
    


Intervention name(s): Caffeine; Ritlecitinib
Intervention type(s): Drug; Other
Intervention description(s): 100milligram (mg) tablet taken orally in period 1 and period 2; 200 milligrams (mg) taken orally once a day(QD) for 8 days
Other intervention name(s): PF-06651600
Intervention MeSH terms: Caffeine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy Study of AI LVEF
Condition: Heart Failure, Systolic; Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      To determine whether an integrated AI decision support can save time and improve accuracy of
      assessment of echocardiograms, the investigators are conducting a blinded, randomized
      controlled study of AI guided measurements of left ventricular ejection fraction compared to
      sonographer measurements in preliminary readings of echocardiograms.
    


Intervention name(s): Automated annotation of the left ventricle through deep learning; Sonographer Measurement of LVEF
Intervention type(s): Other; Other
Intervention description(s): A semantic segmentation deep learning model will identify the left ventricle and label the left ventricle. The AI model will produce an assessment of LVEF using video based features.; Standard practice sonographer measurement of left ventricle and assessment of LVEF
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Studies will be randomized 1:1 to either sonographer preliminary report finding or AI preliminary report finding with final adjudication by the cardiologist. With AI preliminary report, the preliminary interpretations will be generated by AI (artificial intelligence) technology [a semantic segmentation model] and the PACS system's native EF calculation workflow will be used to calculate LVEF. The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Echocardiogram; Artificial Intelligence
Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Condition: Recurrent Pregnancy Losses; Preeclampsia; Intervillositis
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Justification:

      We have recently demonstrated that maternofetal alloimmunization was not limited to blood
      cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the
      placenta can induce neonatal membranous glomerulonephritis.

      Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical
      pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not
      yet fully understood; nevertheless the hypothesis of an incompatibility between mother and
      child is often mentioned. The aim of this project is to detect and study the cases of
      recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by
      tissular maternofetal alloimmunization.

      Materials and methods:

      Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or
      intervillositis will be included in this project. Mothers' sera will be studied by indirect
      immunofluorescence and Western Blot on placental biopsies from different origins and
      gestational ages. This stage will enable us to detect possible maternal allo-antibodies.
      After detecting and revealing antibodies, nature of the target antigen will be identified by
      immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will
      be followed by a mass spectrometry analysis of detected proteins.

      Expected results:

      This study will enable us:

        -  to detect new cases of tissular maternofetal alloimmunization

        -  to improve our knowledge of mechanisms leading to anomalies of placentation

        -  to carry out a specific, preventive therapeutic approach for cases induced by tissular
           alloimmunization.

      Key words:

      Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neonatal pathologies can be caused by an alloimmunisation maternal fetal tissue, it's
        conceivable that certain pathologies. Obstetrics may be part of the same mechanism. Among
        these pathologies placentaires, for whom a "maternal-fetal incompatibility" is often
        mentioned, could be secondary to tissue alloimmunization against antigens independent of
        the immune system
      
Keywords: recurrent pregnancy losses; preeclampsia; intervillositis; maternofetal alloimmunization
The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
Condition: Chronic Disease
MeSH terms: Inflammation; Chronic Disease
Study type: Interventional

Summary: 
      The investigators have designed a three dose level, cross-over vegetable feeding study using
      expertise from nutritional sciences and plant sciences to:

        1. Implement a randomized vegetable feeding trial among overweight post- menopausal women

        2. Produce, in a controlled environmental setting, vegetable crops which provide a selected
           variety and quantity of carotenoid and nutrient exposure

        3. Assess changes and hopefully demonstrate a significant reduction in oxidant stress and
           inflammation in this population at risk for developing chronic disease
    

Detailed description: 
      Women were randomly assigned a vegetable feeding dose order of consuming 2,5 & 10
      servings/day of vegetables for 3 week periods, with feeding periods separated by 4 week
      washout periods, during which time a limited number of low biological value fruits and
      vegetables were eaten.

      This research will provide important and relevant information to fill several gaps in our
      current knowledge including a more thorough description of the oxidant stress and
      inflammatory status of overweight, postmenopausal women, assessment of the relevant daily
      "dose" of vegetables necessary to modulate biomarkers of oxidant stress and inflammation in
      overweight postmenopausal women and evaluation of the association between plasma nutrient and
      carotenoid levels in relation to changes in oxidant stress and inflammation in this
      population. Our long-term goal is to reduce chronic disease risk among "at-risk"
      post-menopausal females.
    

Intervention name(s): 2, 5 & 10 Vegetable doses
Intervention type(s): Other
Intervention description(s): 2,5 & 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers & tomatoes consumed for 3 week intervals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Probiotics (L. Gasseri, B. Bifidum, B. Longum) on Immune and Intestinal Health in Healthy Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years,
      consuming a probiotic each day for three weeks will have improved immune strength and
      digestive health. It is hypothesized that older adults consuming the probiotics will see a
      shift in their microbiota towards the "healthy" bacteria resulting in a greater proportion of
      immune cells, decreased inflammation, and better digestive health.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled crossover design with two 3-week
      interventions and a 5-week washout period in between. Thirty-six participants will be
      enrolled. With informed consent, the daily questionnaire will be administered and a baseline
      stool sample will be obtained during the week before the start of each intervention period.
      Blood and saliva will be collected on the first and last day of each intervention period to
      assess immune function. A final stool sample will be obtained in the last week of the
      intervention period. Nutritional status, which can impact immune function, will be assessed
      using the Mini-Nutritional Assessment, Block Fiber Screen, and the Block 2005 Food Frequency
      Questionnaire. Daily questionnaires will record intake of the probiotic or placebo, level of
      stress, hours of sleep, visits to the physician, new medications, number of stools, etc. The
      Gastrointestinal Symptom Response Scale, which records gastrointestinal symptoms, such as
      bloating, gas, diarrhea, and constipation, over the past week will be completed at baseline
      and weekly during the interventions and the week following the interventions.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration); 2 capsules daily containing 348.25 mg of potato starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: adults; probiotics; immune function; microbiota; digestive health
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total
      radioactivity and to assess the elimination of total radioactivity from a single oral dose of
      [14C]-olinciguat.
    

Detailed description: 
      OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that
      will be conducted at a single center in the US. Safety assessments will be performed
      throughout the clinic period and multiple PK samples will be collected. Subjects will be
      confined to the clinical research center for at least 8 days.

      The purpose of the study is to determine the absorption, metabolism, and excretion of
      [14C]-olinciguat and to characterize and determine, where possible, the metabolites present
      in plasma, urine, and feces after a single oral dose. The study will help identify and
      characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney
      impairment on the disposition of olinciguat, and assess the likelihood of drug-drug
      interactions with olinciguat.
    

Intervention name(s): [14C]-olinciguat
Intervention type(s): Drug
Intervention description(s): oral capsule
Other intervention name(s): 14C-IW-1701
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that prophylactic E-selectin inhibition via administration of
      uproleselan during melphalan conditioning will reduce the gastrointestinal (GI) toxicity in
      multiple myeloma (MM) patients undergoing auto-transplant, as assessed via diarrhea severity
      scoring per CTCAE v5.0, while potentially increasing chemosensitivity of malignant MM cells
      to high-dose melphalan.
    


Intervention name(s): Uproleselan; Placebo; Melphalan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Provided by study; Provided by study; -Standard of care
Other intervention name(s): GM-1271
Intervention MeSH terms: Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
Condition: Dental Cervical Non-carious Lesion
Study type: Interventional

Summary: 
      A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin
      based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious
      cervical lesions.
    

Detailed description: 
      This is a prospective, randomized, monocenter parallel group study on restoration of tooth
      with non-carious cervical restorations. Each patient receives cervical restoration(s) either
      with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme
      XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one
      experienced operator. One of two independent examiners will evaluate the restorations at
      baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria.
      Reliability of examination will be assessed on a random sample of 30 restorations.
    

Intervention name(s): Equia Forte; Filtek Supreme XT/Clearfil SE Bond
Intervention type(s): Other; Other
Intervention description(s): Restoration of cavities with a Glasshybrid material (Equia Forte); Restoration of cavities with a composite resin based material after placing an adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.
Condition: Antibody; Vaccine; Maternal; Cord
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective clinical study aiming to investigate on the transplacental antibody
      transmission post Covid-19 infection during pregnancy.
    

Detailed description: 
      Covid -19 infection has been a significant public health burden as it shifted the paradigm of
      infectious diseases aiming to control the spread and enhance public immune protection. The
      introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus
      tremendously helping to flatten the disease worldwide. Channeling the vaccine for the
      obstetrics field is one of the hallmark strategies to reduce maternal morbidity and
      mortality. The efficacy of vaccination for the pregnant lady has been established. However,
      fetus protection via transmission of the antibody during pregnancy is still uncertain.
      Therefore, this study aims to consolidate further evidence of transplacental antibody
      post-maternal vaccination aiming for fetal protection following delivery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All vaccinated pregnant women at term with or without a history of covid-19 infection
        admitted in labour
      
Biospecimen description: 
      Maternal and cord blood samples taken to measure the antibody levels for Covid-19 at
      delivery.
    
Keywords: Covid-19; antibody; pregnancy
Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's
      disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,
      resting state, functional brain connectivity (Aim II), and determine the number of subjects
      needed for a future, randomized clinical trial to test the efficacy of our novel, Agility
      Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches
      to these aims are cutting edge and will allow us to develop sensitive behavioral and brain
      biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: freezing of gait (FOG); balance; gait; exercise