rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Open Lung Protective Extubation Following General Anesthesia
Status: Not yet recruiting

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.

Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients (18 years of age or over) Elective intra-abdominal surgery under general anesthesia. Moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more) Planned postoperative hospitalization  Exclusion Criteria:  Expected or known difficult intubation according to the treating anesthesiologist Postoperative mechanical ventilation (planned or unplanned) General anesthesia performed outside the main operating room - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis
Status: Recruiting

Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Chronic in-center hemodialysis patients for at least three months  Exclusion Criteria:  Active Cancer. Active infection. Patients with pulmonary fibrosis. Patients with diffuse pneumonia. Patients with frequent hypotension episodes in HD Extreme weight gain between dialysis sessions demanding more than 13 ml/kg/h UF rate. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Status: Recruiting

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient is 18 years or older Patient is male Patient is due for a transperineal prostate biopsy Patient signed and dated informed consent form on Redcap agreeing to participate in the study  Exclusion Criteria:  Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion) Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure Patient has a history of reactions to noxious odors - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
Status: Not yet recruiting

The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria: pregnant women with the following characteristics:  nulliparous single pregnancy cephalic presentation of the fetus Italian language fluency  Exclusion Criteria:  multiparous age < 18 y, age > 40 y previous urinary or fecal incontinence contraindications to vaginal delivery (such as placenta previa, vasa previa, etc) twin pregnancy language barrier BMI at or > 30 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma
Status: Recruiting

The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed informed consent form. Age ≥ 18 years at the time of signing of the informed consent form. Documented diagnosis of multiple myeloma according to IMWG criteria  Measurable disease at screening:  M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or light chain myeloma: serum "involved" FLC level ≥ 10 mg/dL (100 mg/L) and abnormal κ/λ FLC ratio . At least a partial response according to IMWG criteria to at least 1 prior line of therapy. Subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy ECOG score 0-2. Not pregnant and willing to use contraception. Consent to bone marrow biopsy in the study.  Exclusion Criteria:  Prior treatment with daratumumab or other anti-CD38 therapy. Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization. Allogeneic hematopoietic stem cell transplantation, regardless of timing. Scheduled hematopoietic stem cell transplantation prior to progressive disease during this study. Plasma cell leukemia, POEMS syndrome or amyloidosis. Waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal IgM (M-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement. A history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the Investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years. Plasmapheresis within 28 days prior to randomization. Clinical signs of meningeal involvement of multiple myeloma. Pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial
Status: Not yet recruiting

Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeks

Trial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion; 7) being able to walk independently with or without aids.

Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.

The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged 18-85 years old, having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); having had a first stroke; having no more than 12 months of evolution since stroke; having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion; being able to walk independently with or without aids.  Exclusion Criteria:  medical conditions interfering with data interpretation; any contraindication to receiving BTX A or PS treatment; If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Exergames on an Unstable Surface in Stroke Inpatients
Status: Not yet recruiting

Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.

This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Prescription for inpatient rehabilitation due to a stroke Ability to provide a signed informed consent Mini-Mental State Examination (MMSE) score ≥ 20 Physically able to stand for at least 3 minutes without external support (self-report)  Exclusion Criteria:  Insufficient knowledge of the German language to understand the instructions and the games Conservatively treated osteoporotic fractures in the last 16 weeks Depending on assistance for ambulation (Functional Ambulation Categories <2), Mobility, cognitive, sensory and/or psychiatric limitations or comorbidities which impair the ability to play the exergames and/or conduct the pre-/post assessments - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult
Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care
Status: Not yet recruiting

To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Those who have been histologically or cytologically confirmed as adenocarcinoma among colorectal cancers Those with at least one measurable or evaliable lesion by RECIST v1.1 Those who fail standard treatment for metastatic colorectal cancer (failure of treatment is defined as failure of not only progression of the disease or recurrence after treatment, but also unacceptable side effects or maintenance of the treatment process) ECOG performance status 0 or 1 person  A person who can draw about 100 cc of whole blood for the manufacture of immune cells  Weight: More than 50 kg for men and more than 45 kg for women Hb: 9.0 g/dL or higher (registerable if hemoglobin levels recover to 10.0 g/dL or higher during the screening period); however, transfusions within 7 days prior to screening to meet this standard are not allowed) Appropriate contraceptive regimen up to 2 months after clinical research drug administration A person who voluntarily decides to participate after receiving a sufficient explanation for this clinical study and agrees in writing  Exclusion Criteria:  Brain Metastasis patients who have symptoms or need treatment [However, patients with stable brain metastasis who have no symptoms and do not need treatment (excluding anticonvulsants in maintenance therapy) can register] A person with a systemic disease that is inappropriate to administer anticancer drugs according to the researcher's judgment Those with the following cardio-cerebrovascular diseases as of the time of screening a person who is HIV-positive Those determined that the researcher was not suitable for participation in this clinical study as a result of the active infection (HBV, HCV) test a person with acute or severe infection Those who have autoimmune diseases or have a history of chronic or recurrent autoimmune diseases Those with a history of organ transplants a hematopoietic stem cell transplant patient - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome
Status: Not yet recruiting

The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Getting over 104 points from the PMS scale, Having regular menstruation, Not having any chronic disease, Not using any method to cope with PMS.  Exclusion Criteria:  Having irregular menstruation, Having musculoskeletal system and respiratory diseases, Having a diagnosed psychiatric disease, Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Since it is a study conducted on premenstrual symptoms with women, it concerns the female gender. - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Investigation of the Effectiveness of Different Physiotherapy Applications in Trigger Finger Treatment
Status: Recruiting

There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteering Being between the ages of 18-65 Being diagnosed with stage 1 or stage 2 (according to the Froimson classification) trigger finger Having the language and cognitive skills to answer the questionnaires used in the evaluation  Exclusion Criteria:  Being pregnant Having an inflammatory disorder Having had surgery on the hand/wrist Having a neurological disease NSAIDs, painkillers, etc. being on medication De Quervain's tenosynovitis, carpal tunnel syndrome - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease
Status: Not yet recruiting

Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease . Accept to participate in the current study -  Exclusion Criteria:  Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease). Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease. Patients with other comorbidities as diabetes, hypertension were excluded from the study.  Refused to participate in the current study.  - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: The study will include 80 participants:  Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014).  . Group 2: 40 healthy matched controls. - SamplingMethod: Probability Sample
The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis
Status: Not yet recruiting

The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with spastic diplegic CP Being diagnosed with scoliosis, To be between the ages of ten and eighteen, Being at I-II-III level according to GMFCS classification (18), Not having undergone scoliosis surgery, Cobb angle to be between 10-40 degrees, To be receiving physiotherapy appropriate to the functional status for at least 6 months.  Exclusion Criteria:  Psychiatric disorders, Having a communication problem at a level that cannot adapt to the physiotherapist's instructions, To have undergone scoliosis surgery, Uncontrolled epilepsy. - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Multimarker Approach in Acute Chest Pain
Status: Recruiting

Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.

The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years; Patients who came to the emergency department with chest pain of presumable cardiac origin and uncertain etiologic diagnosis ECG not diagnostic for ischemia cTnI ultra within limits  Exclusion Criteria:  STEMI Sepsis and viral infections Patients with ECG abnormalities that make it uninterpretable for ischemic purposes Patients with previous coronary events History of heart failure Known diagnosis of cardiovascular disease, acute or chronic, including pericarditis, myocarditis Conditions involving increases in sST2 and suPAR unrelated to cardiac causes, especially acute/chronic inflammatory or fibrotic conditions (inflammatory bowel disease, neoplasms, moderate-to-severe pulmonary fibrosis, chronic hepatopathy; autoimmune diseases) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients entering the emergency department with chest pain or other typical symptoms suspected of ACS will be included in the study if they are adults, not pregnant, and meet the predetermined inclusion criteria. Furthermore, patients who sign written informed consent to participate in the study and to the processing of personal data - SamplingMethod: Non-Probability Sample