rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer
Status: Recruiting

The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligible for FET in a programmed- or stimulated cycle immediately following a fresh embryo transfer or freeze all cycle Oligo-anovulatory women (cycle length > 35 days) Ovulatory women (cycle length 21-35 days) At least one vitrified day 5 or 6 blastocyst with Gardner score of ≥ 3BB at the day of vitrification  Exclusion Criteria:  Uterine malformation Presence of hydrosalpinx, submucosal uterine myomas or uterine polyps Allergies or contraindication to standard fertility medication Male or female HIV or Hepatitis B or C Preimplantation genetic testing (PGT) in the fresh cycle Testicular sperm aspiration (TESA) Severe OHSS with hospital admission and ascites drainage during the fresh cycle Oocyte donation - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
Open Versus Laparoscopic Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial
Status: Recruiting

The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment.  Exclusion Criteria:  Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants
Status: Recruiting

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study. Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception. Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized.  Exclusion Criteria:  Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. Major surgery ≤ 4 weeks before the Baseline Visit or planned major surgical procedure during the study. Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose. Drug or alcohol abuse. Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose. Hepatitis B, hepatitis C, or human immunodeficiency virus infection. Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection. Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit. Hypersensitivity to study treatment or other biologics Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment
Status: Recruiting

The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.

A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.

A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children being treated according to our Short-Term Enteral Nutrition Protocol  Exclusion Criteria:  Parents refusal - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Weeks - MaximumAge: 1 Year - StdAgeList: Child - StudyPopulation: Inclusion of all infants under one year old presenting a bronchiolitis with exclusive nutritional impairment and treated in the emergency room of the Hôpital Femme Mère Enfant according to the Protocole de prise en charge de la bronchiolite avec forme digestive prédominante à l'accueil des urgences de l'HFME (Protocol for the management of bronchiolitis with a predominantly digestive form at the HFME emergency department)- ZSBCD. This population will constitute a restrospective cohort in a pediatric tertiary care hospital during the 2022-2023 bronchiolitis season. - SamplingMethod: Non-Probability Sample
Yoga on Cognitive, Mental and Functional Abilities in Older Adults
Status: Recruiting

Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To participate in the study, participants will be required to:  Who are over 60 years old Who do not participate in any physical exercise program Have sufficient physical autonomy to participate in the physical activities required by the study and are able to understand the instructions, programs and protocols of this project.  Exclusion Criteria:  All participants with contraindications for performing the physical tests will be excluded. Diseases that limit cognitive performance and physical activity. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Yoga for Physical and Mental Health
Status: Recruiting

In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  University students who do not participate in any physical exercise program Sufficient physical autonomy to participate in the physical activities required by the study That they are able to understand the instructions, programs and protocols of this project.  Exclusion Criteria:- University students who have serious physical or mental conditions  Lack of commitment to regular attendance Extensive previous experience in yoga - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult
Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
Status: Not yet recruiting

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)  Exclusion Criteria:  Participants requiring a surgical intervention Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure. Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions Participants with pathologic fractures e.g., presence of bone cyst Participants who smoke Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion) - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
Status: Recruiting

This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Patients must be 18 years of age or older at the time of enrollment. Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma. Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria. Patients must have clinical performance status of ECOG 0-2. Patients must have adequate vital organ function as defined by: Hemoglobin ≥8 g/dL Absolute neutrophil count > 1000/ mm3 Platelets > 50,000/mm3 ALT/AST levels lower than 3-fold of normal Creatinine clearance ≥45 mL/min/1.73 m2 Normal cardiac and pulmonary function No thromboembolic events in the past 3 months No heparin allergy or active infection  Exclusion Criteria  Patients who have any active and uncontrolled infection. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent). Patients who have active central nervous system disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador
Status: Not yet recruiting

ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.

In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.

At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.

Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):

AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test
ELISA protein detection: only available comparison test

In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):

• HPV DNA Mole Bioscience test

Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  have a previous abnormal pap smear/recent diagnosis of cervical dysplasia (<4 months) and therefore have a colposcopy appointment, or a positive HPV test (<4 months) and therefore have a colposcopy appointment, and able to understand the study materials (questionnaire) and informed consent form  Exclusion Criteria:  women with heavy bleeding at consultation women with known pregnancy at consultation women who are undergoing or have completed chemotherapy in the six months prior to the enrollment, or received LEEP, cryotherapy or another treatment in the six months prior to enrollment women who do not consent - HealthyVolunteers: No - Gender: Female - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy
Status: Not yet recruiting

Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with LARC (cT3c-4, N1-2, M0); Written informed consent is obtained; (We aim to include only patients who consent to both study procedures, however if some patients (n<9) do not consent to the first or second procedure or withdraw their consent for the second procedure after the first procedure, they can still be included) Be at least 18 years old; Speak the Dutch language.  Exclusion Criteria:  Concurrent uncontrolled medical conditions according to treating medical physician; Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); Prior irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor. Received an investigational drug within 30 days prior to administration of nivolumab-800CW and durvalumab-680LT according to the patient's medical history; History of infusion reactions to nivolumab, durvalumab or other monoclonal antibodies according to the patient's medical history; Active episode of inflammatory bowel disease; Use of immunosuppressive agents; Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture
Status: Recruiting

The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.

The main questions aim to answer:

how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered
what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture

Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Undergone surgery for hip fracture and admitted to department M1, Bispebjerg-Frederiksberg Hospital  Living in Frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality  Exclusion Criteria:  Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult - StudyPopulation: Patients will be recruited from Bispebjerg Hospital, department M1 - SamplingMethod: Probability Sample