rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects
Status: Recruiting

This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, Marburg Virus glycoprotein [MARV GP] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:

Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?
What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?

Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years Given written informed consent No clinically significant health problems Negative test for SARS-CoV-2 Agree to avoid conception through Day 29 Agree to minimize blood and body fluid exposures to others after vaccination through Day 29 Agree to avoid exposure to immunocompromised persons after vaccination through Day 29  Exclusion Criteria:  Prior infection with Marburg virus, related filovirus, or Ebola virus Prior infection with vesicular stomatitis virus (VSV) Received any VSV-vectored vaccine BMI of ≥ 35 Household contact who is immunodeficient, or on immunosuppressive medication Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder History of severe reactions to any vaccine or history of severe allergies Receipt of investigational product up to 30 days prior to randomization Receipt of licensed or authorized non-live vaccines within 14 days of planned study immunization (30 days for live vaccines). Known allergy to components of PHV01 Injection sites obscured by tattoos or physical condition Significant psychiatric or medical condition or laboratory abnormality on screening History of Guillain Barre Syndrome or any chronic or acute neurological disorder Alcohol or illicit drug abuse within past 5 years Pregnant or lactating female Administration of blood or IgG within 60 days preceding study Administration of systemic chronic immunosuppressants (defined as more than 14 days) or other immune modifying drugs within 6 months of study entry History of blood donation within 60 days of study Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject Elective surgery planned during the study period - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not
Status: Not yet recruiting

The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.

The main questions it aims to answer are:

Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform

Gait analysis
Stair performance test
CT based Micromotion analysis of the implant micromovement

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Severe osteoarthritis Ahlbäck grade 3 or 4 affecting 2-3 compartments Ability to preoperatively walk 30 m independently without support before surgery Ability to give written consent. CPAK (Coronal Plane alignment of the Knee) I, II or III  Exclusion Criteria:  Previous cruciate ligament surgery in affected knee Previous osteotomy in affected knee, Posttraumatic arthritis in affected knee History of infectious arthritis Rheumatoid arthritis Significant preoperative varus or valgus deformity >15º Evidence of damaged Anterior Cruciate Ligament and/or Posterior Cruciate Ligament Flexion contracture > 10 º, - Planning reveals the need for a complex implant ( stem, augment or higher level of constraint). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy
Status: Recruiting

Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Older than 18 years of age. Admitted at the Department of Obstetrics at Erasmus MC - Sophia for suspicion of preterm birth with a gestational age of 23+5 weeks until 33+6 weeks. Understanding of Dutch in speaking and reading.  Written informed consent.  In order for the neonate to be able to participate in this study, the parent must meet the following criteria:  Older than 18 years of age. Admitted at the Department of Obstetrics at Erasmus MC - Sophia for suspicion of preterm birth with a gestational age of 23+5 weeks until 33+6 weeks. Understanding of Dutch in speaking and reading. Written informed consent for the neonate.  Exclusion Criteria:  Women unable or unwilling to agree with the procedures. Women unable or unwilling to give written informed consent. Women with acute obstetric complications requiring immediate delivery at time of admission. - Gender: Female - GenderBased: Yes - GenderDescription: pregnant women - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pregnant women admitted at the Department of Obstetrics at Erasmus MC - Sophia for suspicion of preterm birth with a gestational age of 23+5 weeks until 33+6 weeks. Postpartum, the neonates will also be included in the study. - SamplingMethod: Probability Sample
An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
Status: Recruiting

The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:

Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Attending a symptomatic clinic or other appointment at a participating breast clinic site Assigned female sex at time of birth Aged 18 years or older at time of scan Willing, able and mentally competent to read, understand, and provided informed consent in English  Exclusion Criteria:  Participants who have undergone biopsy less than 14 days before the Z-scanner scan Participants with implanted electronics Participants with breast implants Participants with nipple piercings (unless they are removed prior to the scan) Participants who are lactating Pregnant participants by verbal confirmation Participants with pacemakers Participants with open breast wound Participants who had previous breast surgery (mastectomy, lumpectomy) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions - SamplingMethod: Non-Probability Sample
A Phase 1 Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
Status: Not yet recruiting

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the investigator.  Dose Escalation:  Ovarian cancer Endometrial cancer Gastric cancer or gastroesophageal junction cancer Small cell lung cancer Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen receptor, progesterone receptor negative) Estrogen receptor/progesterone-receptor + human epidermal growth factor receptor 2 negative (HER2-) breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy) Other solid tumors with CCNE1 amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next generation sequencing by local liquid or tissue biopsy.  Dose Expansion:  a. Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with cyclin E amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next-generation sequencing by local liquid or tissue biopsy.  Measurable disease per the RECIST v1.1 An Eastern Cooperative Oncology Group performance status of 0 to 1 Able to swallow oral medications.  Exclusion Criteria:  Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy. History of another malignancy with exceptions Visceral crisis, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE) Clinically active interstitial lung disease History of uveitis, retinopathy or other clinically significant retinal disease Has known human immunodeficiency virus (HIV), active hepatitis B or C infection Prior CDK2 inhibitor, WEE1 inhibitor, or protein kinase membrane associated tyrosine/threonine 1 inhibitor. Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis
Status: Not yet recruiting

The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).

This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Fulfil the American College of Rheumatology hand osteoarthritis classification criteria Symptomatic hand osteoarthritis with a pain visual analogue score (VAS) equal to or more than 40/100mm within 2 weeks of study entry  Exclusion Criteria:  Secondary hand osteoarthritis from inflammatory arthritis including rheumatoid arthritis, spondyloarthropathy, psoriatic arthritis, gouty arthropathy or connective tissue diseases; Receive systemic corticosteroids (other than topical or inhalational) within 6 months of study entry Inability to sign informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction.
Status: Not yet recruiting

Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.

Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun & Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.

Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult women (18-65 years) accessing services in Jane's Place who consent to participation.  Exclusion Criteria:  Any person not meeting the age eligibility criteria. Any person identifying as a male. Any person lacking capacity to give consent. Any person with major physical/medical or cognitive challenges which would preclude ability to safely complete the assessment or Any person with insufficient English language ability to give fully informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: any person identifying as female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Interdental Guided Creeping Technique
Status: Not yet recruiting

The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy patients having interdental papilla deficiency. Good Oral Hygiene. Age range: 18 - 50 years.  Exclusion Criteria:  Pregnancy or lactation. Smokers. Alcoholic patients and drug abusers. Handicapped and prisoners. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Peripheral Bypass Trial for Completion Control
Status: Not yet recruiting

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  CLTI as defined by presence of PAD in combination with rest pain, gangrene, or a lower limb ulceration>2 weeks duration (ref Global Guidelines) Atherosclerotic infra-popliteal PAD Adequate distal anastomotic target (crural, tibial or popliteal BTK with one single run-off) between knee and ankle distal to the stenotic/occluded segment. Available autogenous vein conduit based on preoperative vein mapping. Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.  Exclusion Criteria:  Bypass with artificial conduit or cryopreserved allografts Bypass for non-atherosclerotic lesions Life-expectancy less than 2 years Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up. Any condition that the investigator believes should exclude participation. Excessive risk for adverse events during open surgery as judged by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
3D Visualization System in Highly Myopic Cataract Operation
Status: Not yet recruiting

This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  High myopia (axial length of 26 millimeters or more). Presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the International Classification System for Cataract (Lens Opacities Classification System III, LOC III), with a graded score indicating nuclear cataract (LOC III NC/NO grade 3-5). Participants must be 20 years of age or older.  Exclusion Criteria:  The target eye has undergone vitrectomy surgery. The target eye has undergone corneal refractive surgery. Presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery. Complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards LOCIII NO/NC6 or C4-C5 or P4-P5. Presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
Status: Not yet recruiting

This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer Volume difference between affected and healthy arm ≥ 10% Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided. Signed informed consent prior to any study-mandated procedure.  Exclusion Criteria:  Stage I lymphedema or located in several places. Patients for whom compression is contraindicated. Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis. Motor and sensitive neurological deficiency / psychiatric or addictive disorders Pregnant or breastfeeding patient Patient intolerant to MOBIDERM Autofit or known allergies to the components used. Participation to any other clinical study which has an impact on the different endpoints Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Risk Factors for Progressive Suction Loss Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery
Status: Recruiting

The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years; Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D; Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D; Best Corrected Visual Acuity (BCVA) ≥ 16/20; No use of corneal contact lenses two weeks before surgery.  Exclusion Criteria:  Eye diseases or histories beyond myopia and astigmatism, such as keratoconus; Previous eye surgeries or histories of systemic illnesses; Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: all - SamplingMethod: Non-Probability Sample