bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Proximal Caries Infiltration
Condition: Dental Health; Caries
Study type: Interventional

Summary: 
      The goal of the project is to investigate the clinical efficacy of management of early caries
      lesions by resin infiltration and to further scrutinize the patient stress experiences.
    

Detailed description: 
      The aim of this study is to test the clinical efficacy of caries infiltration to arrest
      proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test
      lesions) will progress significantly less than non infiltrated lesions (control lesions).
      Additionally, it was hypothesized that dental anxiety and stress related to caries
      infiltration will be significantly less than dental anxiety related to a conventional
      restorative procedure. The study will be a controlled clinical trial with a split mouth
      design and blind evaluation of the outcome (caries progression). Caries progression will be
      evaluated annually, 12, 24, and 36 months after treatment.
    

Intervention name(s): Resin infiltration; Control
Intervention type(s): Device; Device
Intervention description(s): Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.; Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.
Other intervention name(s): Icon (DMG, Germany), Approximal resin infiltration kit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: caries infiltration; caries arrest; dental anxiety; dental stress; resin infiltration
Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to investigate the incidence and possible causes of obscured or
      disrupted cone outer segment tips line at fovea in spectral-domain optical coherence
      tomography images of normal eyes.
    

Detailed description: 
      Thirty-seven eyes of 37 individuals without eye diseases were included in this study. Optical
      Coherence Tomography (OCT) images were taken using Cirrus HD-OCT (Carl Zeiss Meditec) with 5
      line raster and high-definition 5 line raster modes. Images with signal strength weaker than
      5/10 were excluded. Distinction of COST line and the integrity of COST line, external
      limiting membrane, and the photoreceptor inner segment and outer segment junction at the
      fovea were recorded. Demographic data, refractive error of the eyes, signal strengths of the
      OCT images were acquired for analysis.
    

Intervention name(s): Optical coherence tomography
Intervention type(s): Other
Intervention description(s): Optical coherence tomography
Other intervention name(s): Cirrus HD-OCT (Carl Zeiss Meditec)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Thirty-seven eyes of 37 individuals without eye diseases
      
Keywords: cone outer segment tips line; Optical coherence tomography
Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F
Condition: Malaria,Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F
      administered intravenously or subcutaneously at escalating dose levels in healthy, malaria
      naïve, adults. This study will also evaluate the pharmacokinetics of TB31F and the functional
      activity of mAb TB31F in the standard membrane feeding assay.
    

Detailed description: 
      This phase 1 study aims to assess the safety and tolerability of monoclonal antibody (mAb)
      TB31F administered intravenously or subcutaneously in healthy, malaria naïve, adults at the
      Radboud University Medical Center (Radboudumc). Five groups will receive a single dose of mAb
      TB31F. Group 1 (n=5) will receive 0.1 mg/kg TB31F, Group 2 (n=5) will receive 1 mg/kg TB31F,
      group 3 (n=5) will receive 3 mg/kg TB31F, and group 4 (n=5) will receive 10 mg/kg mAb TB31F
      intravenously. Group 5 will receive 100mg TB31F subcutaneously. Twenty-five (n=25) subjects
      will be enrolled, as well as 1 reserve subject per group. Safety follow-up will be done at
      following times: baseline, end of infusion (EOI), 1, 3, 6 and 24 hours and 2, 7, 14, 21, 28,
      56 and 84 days after administration. Extra follow-up visits at 4 and 10 days after
      administration for collection of serum/plasma for pharmacokinetic and pharmacodynamic
      measurements will be performed in group 5.
    

Intervention name(s): TB31F
Intervention type(s): Biological
Intervention description(s): Monoclonal antibody
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Five groups will receive a single dose of mAb TB31F administered intravenously (groups 1-4) or subcutaneously (group 5). Group 1 (n=5) will receive 0.1 mg/kg TB31F, group 2 (n=5) will receive 1 mg/kg TB31F, group 3 (n=5) will receive 3 mg/kg TB31F, group 4 (n=5) will receive 10 mg/kg mAb TB31F, and group 5 will receive 100mg TB31F. Twenty-five (n=25) subjects will be enrolled.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malaria; monoclonal antibody; falciparum; TB31F; transmission blocking; gametocyte
A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women
Condition: Breast Cancer
Study type: Interventional

Summary: 
      A randomized, double-blinded study conducted in British Columbia, Canada, where there is a
      publicly funded, organized screening program and screening mammography is recommended at
      24-month intervals. Eligible women aged 51-73 years old and overdue for their screening
      mammogram by 6-24 months are identified in the database of the Screening Mammography Program
      of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the
      overdue women in their practices. The overdue women are randomized and mailed either the
      signed reminder letter and the standard reminder postcard, or the standard reminder postcard
      alone. The primary endpoint is the proportion of overdue women attending a screening
      mammogram appointment 6 months after the mailing.
    


Intervention name(s): Standard Reminder Postcard; Family Physician Reminder Letter
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: 6-24 months overdue; screening mammography
Clinical Validation of an Artificial Intelligence Algorithm to Help Interpret Mammograms
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This aims to clinically validate, on a large population, a tumor detection aid software which
      has already been trained on a representative French population (from several hospital centers
      and liberals from several departments in the west and east of France).

      This population consists of 1000 patients who have been treated for breast cancer
      (histologically proven by breast biopsy) and whose investigators have mammograms performed at
      the time of diagnosis. The control population consists of the unaffected breast of each
      patient (with the exception of the rare cases of bilateral cancers).

      This innovative software has the main feature of recognizing healthy breast tissue, allowing
      the radiologist to focus on breast tissue at risk, improving the management of medical time
      and the management of "difficult" files.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult woman (40 to 75 years old) treated at the University Hospitals of Strasbourg between
        2010 and 2020 for breast cancer
      
Keywords: Breast Cancer; Mammography; Artificial intelligence; Tumor detection on mammograms
Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy of intra-articular hydraulic distension
      (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and
      capsule-preserving IHDs.
    

Detailed description: 
      The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted
      joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension
      (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure
      within the joint space. Although IHD is one of the most common treatment options for the PSS,
      the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed
      as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS
      treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid
      rupture, thus producing less satisfactory outcomes. However, we devised in our previous study
      a novel technique that enabled a physician to infuse the possible largest volume without
      rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of
      capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.
    

Intervention name(s): Capsule-Preserving Intra-articular Hydraulic Distension; Capsule-Rupturing Intra-articular Hydraulic Distension
Intervention type(s): Procedure; Procedure
Intervention description(s): Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.; Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Injections, Intra-Articular; Range of Motion, Articular; Pain
Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The RALES study has shown that spironolactone reduces the risk of morbidity and mortality
      both from progressive heart failure and sudden death, in patients with NYHA III or IV heart
      failure. This favourable effect was clearly independent from a diuretic effect.
      Antialdosterone drugs may be effective because they opposes the effects of aldosterone on
      sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor
      function and vascular compliance. Antialdosterone treatment may also antagonize the effect of
      aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a
      marker of cardiac fibrosis synthesis showed an independent negative correlation with survival
      and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the
      effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in
      patients with mild heart failure assuming standard therapy.
    

Detailed description: 
      The protocol is sponsored by and independent organization and partially supported by Therabel
    

Intervention name(s): Canrenone
Intervention type(s): Drug
Intervention MeSH terms: Canrenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Study of Rifaximin in Minimal Hepatic Encephalopathy
Condition: Minimal Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome
      and metabolome.
    


Intervention name(s): Rifaximin; rifaximin
Intervention type(s): Drug; Drug
Intervention description(s): 550mg BID open-label; 550mg PO BID
Other intervention name(s): xifaxan; xifaxan
Intervention MeSH terms: Rifaximin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: minimal hepatic encephalopathy; cirrhosis; complications
Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
Condition: Pain
Study type: Interventional

Summary: 
      Low current electrical stimulation test, also called the Tsui test, has been used
      successfully to confirm the catheter location in the epidural space in various patient
      populations. The results of this study will show whether or not doing a Tsui test can predict
      inadequate epidural analgesia early in the course of placing the epidural, so that the
      appropriate measures could be applied immediately upon gathering unfavorable results.
    

Detailed description: 
      Despite its very high success rate, the epidural technique remains a rather blind technique,
      and failures continue to occur. The incidence and reasons for failure are not well
      understood. The Tsui test is not routinely performed with each epidural catheter insertion,
      but rather it is used when there is suspicion about the catheter location.

      In this study, the Tsui test will be performed twice during the epidural procedure, and
      bupivacaine consumption will be recorded for the first 2 hours.

      Information gained from this study could have great impact in clinical practice, since the
      incidence of inadequate labor analgesia is still relatively high (10-20%), leading to
      maternal distress and disappointing labor experience.
    

Intervention name(s): Tsui test
Intervention type(s): Procedure
Intervention description(s): The stimulator is set at frequency of 1Hz with 200ms pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tsui test; Epidural Analgesia
Safety Study of Chimeric Natriuretic Peptide(CD-NP) in Stable LVAD Patients
Condition: Left Ventricular Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The most promising chimeric natriuretic peptide designed and studied by our group has been
      CD-NP which has anti-fibrotic and cardioprotective properties in vivo, vitro and in normal
      volunteers and human heart failure patients. Since left ventricular assist device (LVAD) can
      not reverse remodeling of the heart whereas it can improve hemodynamics, CD-NP may be novel
      anti-fibrotic and anti-remodeling drug as co-therapy during LVAD support.
    

Detailed description: 
      This study is a double blind, placebo-controlled phase I trial of the safety and neurohumoral
      activity of CD-NP, in the treatment of heart failure with LVAD support. Subjects more than 3
      months after LVAD implantation will be screened at outpatient clinic visit appointments lists
      and interested qualified subjects will be either confronted at a visit or sent a letter in
      the mail to be consented and offered participation in this trial. Once consent has been
      obtained, baseline values will be established at day 1 and subjects will be given
      subcutaneous injection of placebo or CD-NP and stay overnight on two different visits in the
      Clinical Research Unit (CRU). Participant's will receive both placebo and the CD-NP during
      the study, one per visit. A final follow-up visit for clinical assessment will be conducted
      over the phone at the end of the study.

      Potential subjects who present to Mayo Clinic, Rochester, Minnesota for follow up clinical
      visit after LVAD implantation will be identified by the study coordinator. A $300
      remuneration per subject will be involved to compensate for the inconvenience to the subject.
      A $500 reimbursement of gas mileage will be provided for those who travel.
    

Intervention name(s): CD-NP; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CD-NP 5 ug/kg subcutaneous injection (SQ); Vehicle (D5W) SQ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Ankle/Brachial Non-Invasive Blood Pressure Difference During General Anesthesia
Condition: Surgery
Study type: Observational

Summary: 
      Brachial non-invasive blood pressure (NIBP) monitoring is recommended as part of the American
      Society of Anesthesiology (ASA) basic monitoring package. Although brachial NIBP is often
      practical, some surgeries and patients may require NIBP measurement elsewhere (e.g. the
      ankle).

      Several studies have shown that ankle NIBP overestimates brachial NIBP measurements.
      Algorithms have been proposed, based on correlation studies, to estimate brachial NIBP from
      ankle NIBP during general anesthesia and mechanical ventilation. These algorithms, however,
      are based on both heterogeneous populations and surgeries.

      Our aim was to determine if ankle brachial NIBP difference occurs in in young ASA physical
      status 1 patients undergoing general anesthesia in the supine position. We also aim to
      determine if this difference is constant during anesthesia or if it varies according to
      different predefined time points.
    


Intervention name(s): Ankle Non-invasive Blood pressure measurement; Arm Non-invasive Blood pressure measurement
Intervention type(s): Device; Device
Intervention description(s): Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).; Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient undergoing elective surgery requiring general anesthesia in supine position.
        American Society of Anesthesiology (ASA) pysical status score 1.
Pupil Dilation and Analgesia Nociception Index
Condition: Pain
MeSH terms: Mydriasis
Study type: Interventional

Summary: 
      Pain assessment is crucial in clinical practice. Currently, subjective self-report is
      considered the most appropriate method to evaluate pain. Although several methods to assess
      pain objectively exist, the lack of a golden standard still remains. This pilot study
      assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a
      measure of pain in healthy, conscious, male volunteers in a highly standardized and
      individualized environment. Nineteen subjects received three blocks of 4 individualized
      electrical stimulus intensities, ranging from no to severe pain. Subjects reported their
      perceived severity of each individual stimulus, enabling the comparison of changes in PD and
      ANI in relation to both administered stimulus intensities and perceived pain severities. PD
      and ANI were measured before and after each administration of a stimulus.
    


Intervention name(s): Measurement of pupil dilation and analgesia nociception index
Intervention type(s): Diagnostic Test
Intervention description(s): painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears
Condition: Achilles Tendon Tear
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To review the influence of patient derived PRGF on the healing process of Achilles tendon
      after a surgical correction of a complete tear.
    

Detailed description: 
      Autologous platelet-rich matrices may aid in post surgical patients by promoting and
      accelerating tissue healing because of the release of growth factors including transforming
      growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet
      alpha-granules.
    

Intervention name(s): PRGF; placebo
Intervention type(s): Biological; Biological
Intervention description(s): injection of 6cc into injured area of tendon; injection of 6 cc of saline into injured area
Other intervention name(s): platelet-derived preparation rich in growth factors; saline 0.9% nacl
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Achilles tendon
Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single arm dose escalation study of recombinant human keratinocyte growth factor
      given to patients undergoing allogeneic bone marrow transplantation who are at high risk for
      graft versus host disease (GVHD).
    

Detailed description: 
      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): recombinant human keratinocyte growth factor
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: graft versus host disease; bone marrow transplant; alternative donor