rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Nerve Transfer to Improve Function in High Level Tetraplegia
Status: Recruiting

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.

Participants will:

undergo standard of care pre- and post-op testing and study exams
complete pre- and post-questionnaires
undergo standard of care nerve transfer surgeries
follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
attend therapy at local therapist for up to 2 years postop.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-80 years of age High cervical SCI (motor level C1-C4) Motor complete SCI AIS grade A-B Plateaued spontaneous recovery for at least 6 months of non-operative therapy SCI greater than 6 months and fewer than 60 months since injury At least MRC 4/5 donor strength Mentally and physically willing and able to comply with evaluations  Exclusion Criteria:  Active infection at the operative site or systemic infection Any return or ongoing recovery of distal motor function Significant joint contractures and/or limitations in passive range of motion in the arm Mentally or physically compromised making it impossible to complete study activities Immunologically suppressed Currently undergoing long-term steroid therapy Active malignancy Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with high-level SCI injury (C1-C4) with complete lack of upper extremity function. Occurrence of injury should be greater than 6 months but fewer than 60 months - SamplingMethod: Non-Probability Sample
Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
Status: Recruiting

Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female patients, aged 18 years and above Scheduled for elective total or hemi thyroidectomy Normal liver and renal function No known hypersensitivity for iodine or ICG Able to understand the nature of the study procedures Willing to participate and give written informed consent  Exclusion Criteria:  Age < 18 years Liver or renal insufficiency Known ICG, iodine, penicillin or sulfa hypersensitivity Pregnancy or breastfeeding Not able to understand the nature of the study procedure Not willing to participate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Assessing Patient Engagement in Keratoconus Clinical Research
Status: Not yet recruiting

This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Signed Written Informed Consent Aged ≥ 18 years old No prior treatment for keratoconus  Exclusion Criteria:  Participant is actively receiving study therapy in another Inability to provide written informed consent Women of childbearing potential without a negative pregnancy test; or women who are lactating. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with keratoconus who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization. - SamplingMethod: Probability Sample
MOdifiable facTors to Improve VentilAtion ThErapy in ICU
Status: Not yet recruiting

ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.

Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.

Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Invasive mechanical ventilatory support initiated anywhere within the study hospital i.e., emergency room, normal ward or in the operating room, or in the ICU at any time during admission.  Exclusion Criteria:  Successful extubations within two calendar days of intubation Admissions for end-of-life care and/or ICU palliative support Patients transferred from ICUs not participating in the study 24 hours after initiation of MV. Refusal or Withdrawal of consent - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients ≥15 years receiving invasive mechanical ventilation within the ICU - SamplingMethod: Non-Probability Sample
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Status: Not yet recruiting

Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  >18 years old Maintained on a stable methadone or buprenorphine dose for >1 month prior to the study Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5 Participants receiving psychotropic medications must be maintained on a stable dose for >1 month prior to enrollment.  Exclusion Criteria:  Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975) Enrolled in another ongoing evidence-based treatment for PTSD. Pregnancy as verified by pregnancy test No access to cellular service - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Understanding Patient Engagement Trends in TBI Clinical Research
Status: Not yet recruiting

Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ability to understand and the willingness to sign a written informed consent document Participant must be 18 years of age or older Confirmed diagnosis of TBI  Exclusion Criteria:  Enrolled in another research study Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study Inability to provide written informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with TBI who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization. - SamplingMethod: Probability Sample
Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intracranial Pressure Monitoring
Status: Not yet recruiting

ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The diagnosis of aSAH is established through the presence of SAH symptoms, confirmed by computed tomography (CT) scan or lumbar puncture, and further substantiated by cerebral angiography (CTA) or digital subtraction angiography (DSA) to identify the rupture of an intracranial aneurysm as the etiology. It is resolved to perform microsurgical clipping or endovascular therapy within 72 hours of the acute phase, along with the treatment of the ruptured aneurysm in phase I stage (excluding patients with exacerbated SAH due to intraoperative aneurysm rupture and occlusion of feeding arteries). Be aged 18 years or older; The onset of symptoms should occur within 72 hours; The GCS score should range from 6 to 12 points; Obtain the consent of the patient and their family members, and have them sign an informed consent form.  Exclusion Criteria:  Pregnancy or lactation period; Patients presenting with bilateral dilated pupils upon admission; Patients lacking spontaneous breathing or suffering from shock; Patients with concurrent tumors, hemorrhagic diseases, or other severe underlying conditions (such as chronic obstructive pulmonary disease, multiple organ dysfunction syndrome, severe diabetes mellitus, congestive heart failure, and chronic kidney disease); Patients with a history of brain disorders or previous brain surgeries; Hemorrhage attributable to causes other than aneurysm; Aneurysmal rupture bleeding concurrent with moyamoya disease; Other underlying conditions that impact prognosis; Patients volunteering for ICP monitoring; Participants in other ongoing clinical trails; Other circumstances deemed inappropriate for inclusion (to be determined by two physicians). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer
Status: Recruiting

The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.

Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.  Exclusion Criteria:  Patients are not eligible if they are currently receiving treatment for lung cancer. Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.  Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:  Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling; Consume alcohol (including mouthwash) at least 8 hours before breath sampling. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Study participants in all cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria. This study will enroll 30 patients from 3 different cohorts (confirmed NSCLS, stable pulmonary nodules, screened and negative controls). Additionally, a second breath sample may be taken from the 30 patients with lung cancer, totalling up to 120 breath samples. - SamplingMethod: Non-Probability Sample
Cardioneuroablation for Bradyarrhythmia
Status: Recruiting

This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any of the following variants of bradyarrhythmia in patients aged 18-65 years:  (1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient.  (1.2.) Severe asymptomatic sinus bradycardia with a rhythm frequency of <30 beats/min.  (1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree.  (1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury).  (1.5.) Rhythm pauses >6 seconds.  In combination with the following two criteria:  Positive reaction to physical activity and/or atropine test:  (2.1.) Increase in sinus rhythm frequency ≥25% or >90 beats/min. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or complete normalization of atrioventricular conduction at the sinus rhythm.  Sinus rhythm at the time of switching on  Exclusion Criteria:  Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his own reasons in writing; Constant intake of antiarrhythmic drugs (for PVC, AF, etc.); The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator; Drug-induced sinus bradycardia and/or atrioventricular block; Bradycardia due to electrolyte imbalance (e.g. hyperkalemia); Bradycardia due to hypothyroidism or other reversible conditions; No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg); Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome; Clinically significant coronary artery disease; Postinfarction cardiosclerosis; Hemodynamically significant congenital heart defects, including operated ones; Stroke or transient ischemic attack <3 months; Open heart surgery in the anamnesis; Catheter interventions on coronary arteries or for cardiac arrhythmias <3 days; Conditions after percutaneous coronary angioplasty <3 months; Anamnesis of stable ventricular tachycardia on the background of bradycardia; Pregnancy or breastfeeding period - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer
Status: Recruiting

Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  female patients aged 18-70 years; patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy; the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography), breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) were performed at the same time, and the difference of the largest diameter between breast US and MRI was less than 0.5 cm; the single tumor without other suspicious lesions (BI-RADS (the Breast Imaging Recording and Data System) score ≥4) evaluated by breast US, X-ray and MRI; the tumor without adhesion to chest wall, nipple or skin; patients without distant metastasis; Karnofsky performance status greater than 70%.  Exclusion Criteria:  multicentric or multifocal breast tumor; the tumor located on nipple and areola area; signs of extensive intraductal carcinoma on imaging examination (diffuse malignant calcification on breast X-ray or segmental distribution, non-mass enhancement, ductal or linear enhancement > 2.5 cm on MRI); extensive intraductal component in invasive cancer (more than 50% of the tumor volume) confirmed by pathology; invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosing adenosis; patients who were pregnant or breastfeeding; patients with evidence of coagulopathy, chronic liver diseases or renal failure; patients with previous treatment including chemotherapy, targeted drug therapy, or local radiation therapy, etc; patients with substance abuse, or mental or psychological disorders that may interfere with study compliance; any condition that is unstable or likely to compromise the patient's safety and compliance; patients enrolled in other clinical trials; diseases or symptoms that other investigators consider unsuitable for participation. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability
Status: Not yet recruiting

The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Minimum Education Level: Participants are required to have at least a primary school education to ensure comprehension of the study materials. Smartphone Ownership Regular Smartphone Access PTSD Diagnosis Risk: Participants must have a PCL-5 score at or above the diagnostic threshold of 31, indicative of PTSD.  Exclusion Criteria:  Risk of Suicide Neurological or Psychiatric Conditions: Participants should not have neurological or psychiatric conditions that would impede the use of the "TraumaRelief" mobile application. Current Medication Use: Participants who are on psychotropic medications that could influence the study's outcomes will be excluded to prevent interactions with the intervention. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Participants of any gender identity are eligible to enroll in this study, reflecting our commitment to inclusivity and recognition of the diversity of gender experiences. - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
U Shaped Toothbrush in Removing Plaque in Children
Status: Recruiting

The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.

Children accepted in the study will be randomly divided into two groups:

The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.  Exclusion Criteria:  Children with limited ability to communicate. Children with motor disabilities. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 4 Years - MaximumAge: 5 Years - StdAgeList: Child
Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting
Status: Not yet recruiting

This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion ASA physical status I and ll.  Exclusion Criteria:  patients with a previous history of PONV. Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension patients with cardiac, renal or hepatic dysfunction. patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery patients who have abnormal blood glucose on the night before surgery patients who are unable to understand and use the verbal rating scale (VRS);Growth developmental, and motor-mental retardation. - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult