rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC
Status: Not yet recruiting

To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women >/=15 years visiting a pharmacy to buy ECP for her own use Has a smartphone with an electronic identification and ability to scan a QR code Ability to read Swedish or English Willing and able to provide informed consent Willing to participate in the follow-up  Exclusion Criteria:  * Ongoing pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult
PTCy and ATG for MSD and MUD Transplants
Status: Not yet recruiting

Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).

Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.

This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).

Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.

The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.

Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial remission after salvage therapy Who will receive a related or unrelated, HLA-compatible transplant; Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu conditioning; Peripheral blood source; Age between 18 and 60 years.  Exclusion Criteria:  Renal dysfunction (Cr > 1.5 mg/dL) Hepatic dysfunction (transaminases x2 the normal value) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement
Status: Recruiting

Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  above the age of 18years presence of non-restorable maxillary anterior tooth had intact socket walls following tooth extraction the gingival biotype was thick.  Exclusion Criteria:  history of systemic condition history of using bisphosphonates or other drugs that might impact bone turnover a history of smoking during the previous five years, a history of any acute infections at the surgical site, teeth having root resorptions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 40 Years - StdAgeList: Adult
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Status: Not yet recruiting

Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients aged between 18 and 90 years of age Diagnosed with heart failure with reduced ejection fraction (LV ejection fraction ≤ 40%) Can safely hold direct oral anticoagulant (DOAC) vitamin K antagonist (VKA) for 48 hours prior to the procedure  Exclusion Criteria:  Unable to interrupt VKA anticoagulation Point of care International Normalized Ratio (INR) > 1.5 Pregnant patients Acute hospitalization or decompensation within 2 weeks prior to study date Participation in a study involving an investigational drug within 4 weeks prior to study date Inability to lie flat in the supine position Symptomatic hemodynamic instability at rest or during the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will include patients who have heart failure with reduced ejection fraction, defined by a left ventricular ejection fraction less than or equal to 40%. - SamplingMethod: Non-Probability Sample
Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients
Status: Recruiting

Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged more than 18 years old. Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis. Patients scheduled for elective intestinal resection.  Exclusion Criteria:  Diagnosis of Undetermined Colitis. Recurrent disease. Concomitant diagnosis of malignancy. Established diagnosis of major depressive disorder or anxiety disorder. Diagnosis of ventricular or supraventricular arrythmia. Active pharmacological treatment with β-blockers or other drugs affecting the heart rate. Known hypersensitivity to cotton or silver. Emergent surgery. Planned open surgery. Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Status: Not yet recruiting

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy male and female subjects between 18 and 50 years old (inclusive); BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg; Willingness to remain in the hospital research unit for the duration of the inpatient period.  Exclusion Criteria:  Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy; Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or pulse rate > 100 bpm or < 45 bpm at Screening; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study; Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners); Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
The Use of Voice-Based AI in 988 Crisis Counseling
Status: Not yet recruiting

Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must be employed at Protocall Services, Inc.  Exclusion Criteria:  Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
Status: Not yet recruiting

This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female aged ≥18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Resectable non-small cell lung cancer harboring driver gene mutations. At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1. Have adequate organ function. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception. Voluntarily comply with the treatment protocol.  Exclusion Criteria:  Previously treated with any anti-tumor therapy; Subject with known autoimmune disease Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C. Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites). Subject with severe liver and kidney dysfunction. Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study Subject with previous malignancies within 5 years, except for cured in situ cancer. Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function. Subject with uncontrolled hypertension. Prior organ transplantation including allogenic stem-cell transplantation. Known hypersensitivity to the study drug or any of its excipients. Other situations that the investigator considers unsuitable for the enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
Status: Not yet recruiting

This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ≥18 years of age at the time of consent Therapy within GINA/NVL steps 4 or 5 and uncontrolled disease in the previous 12 months as per the healthcare provider's assessment Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate Able to read, understand, and speak German sufficiently to complete all the questionnaires  Exclusion Criteria:  According to the assessment of the study physician: cognitive impairment, psychiatric diseases, severe hearing or vision impairment, insufficient knowledge of the German language, if these factors could influence the ability to provide written consent and correct completion and assessment of the questionnaires. Current participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 30 days. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population is composed of severe asthma patients within GINA/NVL (Global Initiative for Asthma/ Nationale Versorgungsleitlinie) steps 4 or 5 with uncontrolled disease (including patients on biologics but without any prescribed oral corticosteroids). - SamplingMethod: Non-Probability Sample
The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children
Status: Not yet recruiting

The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed.

MATERIAL AND METHOD:

Evaluation will begin by applying demographic information and the Physical Activity Survey for Children.
The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task.
To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied.
Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test.
Walking speed will be evaluated with the 10m walk test.
Balance parameter will be evaluated with functional reaching test.
Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10.
Walking speeds will be normalized by measuring lower extremity lengths.
The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes.
After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator.

As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being between the ages of 7-15, Not having a chronic disease Volunteering to participate in the study and signing a consent form.  Exclusion Criteria  Experiencing a health problem that will affect the musculoskeletal system in the last year, Having a condition that prevents participation in physical education class. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 15 Years - StdAgeList: Child
The Effect of Dual Task on Manual Skill Performance in Children and Adolescents
Status: Not yet recruiting

The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18.

MATERIAL AND METHOD:

Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children.
The evaluations will primarily evaluate the child's performance on a single cognitive task
The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent.
Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.
the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.
Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph.
In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.

As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Be between the ages of 7-18, Not having a chronic disease.  Exclusion Criteria:  Participants must have had a health problem or had an operation that would affect the musculoskeletal system or dexterity performance in the last year (EX: Distal radius fracture). Having concentration problems such as attention deficit hyperactivity disorder (ADHD). Not volunteering to participate in the study and not signing a consent form. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Placebo Effect About Fatigue in Obesity
Status: Recruiting

Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  • Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).  Exclusion criteria:  • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital - SamplingMethod: Non-Probability Sample
Is Sensorimotor Training Effective Following a Distal Radius Fracture?
Status: Not yet recruiting

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Distal radius fracture with volar plate fixation Understand English 18 years or older Available to attend skilled occupational therapy visits a minimum of 1x per week.  Exclusion Criteria:  Prior surgery to the involved wrist/hand Cognitive impairment Distal radius fracture managed by casting or by another means of fixation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult