rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
Status: Recruiting

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.  Exclusion Criteria:  Substance use disorder requiring medical management; imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment; and impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clareon Toric Study (T2-T9)
Status: Not yet recruiting

The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Able to understand and sign the informed consent form. Willing and able to attend all scheduled study visits as required per protocol. Cataract in one or both eyes with planned extraction by conventional phacoemulsification. Astigmatism in the operative eye(s). Other protocol-defined inclusion criteria may apply.  Key Exclusion Criteria:  Women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing. History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve. Clinically significant corneal disease that may, according to the Investigator's medical opinion, adversely affect visual outcomes. Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion. History of prior intraocular or corneal surgery. Other protocol-defined exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Femoral Blood Gas and Prediction of Postoperative Bleeding
Status: Not yet recruiting

Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with major abdominal surgery Postoperative intensive care unit following Accepting to participate in research  Exclusion Criteria:  Age under 18 years old Pregnant patients Do not accept to participate of study - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit. - SamplingMethod: Probability Sample
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Status: Not yet recruiting

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Diagnosed with Parkinson's Disease in the past 4-10 years inclusive defined by the following:  Presence of bradykinesia PLUS any of the following:  Rigidity Rest Tremor Postural instability  Modified Hoehn and Yahr stage II-III in the practically defined OFF medication state (>/= 12 hours from last dose of anti-parkinsonian medications) MDS-UPDRS Part III score in the practically defined OFF state of 33 to 60 (inclusive) Presence of motor fluctuations with >/= 2.5 hours of absolute time in the OFF state averaged over 3 days as measured by the PD Motor Diary, and assessed at screening, and baseline visit 1 and 2 Stable anti-parkinsonian medication regimen for >/= 4 weeks prior to Screening and held stable throughout the baseline period o Responsiveness to levodopa as determined by change in modified H&Y stage or MDS-UPDRS Part III score from the practically defined OFF state to ON state after taking first daily dose of PD medication  Exclusion Criteria:  Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis Presence or history of significant vascular and/or cardiovascular disease Presence of significant cognitive impairment, poorly controlled depression/anxiety Presence or history of psychosis or impulse control disorder History of malignancy other than treated cutaneous squamous or basal cell carcinomas Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure Chronic immunosuppressive therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Short-Term Versus 6-Week Prednisone in The Treatment of Subacute Thyroiditis
Status: Not yet recruiting

The goal of this clinical trial is to compare the efficacy and safety of short-term versus 6-week prednisone in the treatment of moderate-to-severe subacute thyroiditis. The main questions it aims to answer are: Does the short-term medication regimen reduce glucocorticoid side effects while achieving similar efficacy as the guideline treatment group? Patients with moderate-to-severe symptoms were randomly assigned to receive either 30 mg/day prednisone for 1 week, followed by 1 week of nonsteroidal anti-inflammatory drugs, or the conventional 6-week prednisone therapy in the control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  We enrolled adult patients (age 18-70) with Subacute Thyroiditis (SAT) scores ≥3 points. SAT was diagnosed on the basis of diagnostic criteria. The severity of SAT was scored as follows: fever - none, <38℃, and >38℃ (0, 1, and 2 points, respectively); tenderness - none, mild, and severe (0, 1, and 2 points, respectively); goiter by ultrasonography or palpation - none and yes (0 and 1 point, respectively); and ESR - normal, 25-60 mm/h, and >60 mm/h (0, 1, and 2 points, respectively).  Exclusion Criteria:  Patients who were diagnosed with diabetes, an active peptic ulcer, benign and malignant tumors, hepatic dysfunction, recurrent SAT, and already on glucocorticoid therapy were excluded within 3 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Effect Evaluation of Different Blood Products Infusion on Neonatal Anemia
Status: Not yet recruiting

The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are:

Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy.
To provide objective basis for clinical rational use of blood in the selection of blood products.

Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. Diagnosis of Neonatal Septicemia:  The mother had chorioamnionitis infection or Premature rupture of membranes (PROM) ≥18 h. The clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ① blood non-specific examination ≥ 2 items are positive, ② cerebrospinal fluid examination is purulent meningitis change, and ③ pathogenic bacteria DNA is detected in blood. The diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture.  Exclusion Criteria:  Infants with necrotizing enterocolitis (NEC) (current or previous). Feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours). RBC transfusion in the past 72 hours; Children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Day - MaximumAge: 1 Year - StdAgeList: Child - StudyPopulation: Neonates who received blood transfusion at the Women's Hospital School of Medicine Zhejiang University from October 1, 2023 to September 30, 2025. - SamplingMethod: Probability Sample
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
Status: Recruiting

Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; Aged 18-80 years; Eastern Cooperative Oncology Group performance status of ≤2; Planning to receive definitive RT or postoperative adjuvant RT; Normal liver, kidney and bone marrow function; Sign informed consent.  Exclusion Criteria:  Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components; Those with poor compliance; Pregnancy or breastfeeding; History of head and neck radiotherapy; Taking antifungal or viral medications one week prior to the start of radiation therapy. Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
A Nurse-led Coaching Programme With Telemonitoring in Heart Failure
Status: Not yet recruiting

The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:

Are implementation strategies effective in facilitating participant fidelity?
What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?
Are the methods and tools established the most appropriate to ensure the completeness of the data collection?

Participants will follow a combined intervention consisting of:

pre-discharge educational meeting;
telephone nurse-led coaching sessions;
home telemonitoring of vital signs.

In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged 65 and over hospitalized for cardiac decompensation, regardless of ejection fraction (FE) value (preserved or decreased) expected to be discharged home will be considered eligible.  Exclusion Criteria:  Individuals who lack the cognitive and/or physical capabilities (Mini Mental State Examination score ≤ 24) for self-monitoring of vital signs, and without a caregiver available to assist them people who receive other medical services - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Evaluation of the Comprehensive Family Support Program (PAIF)
Status: Not yet recruiting

The goal of this study is to evaluate the effectiveness of positive parenting programs targeted to parents of toddlers, children and adolescents carried out in Cantabria (Spain).

We will collect information from the participants before the intervention, in the last session of the program and some months after, to verify if there have been some changes in the family dynamics of these parents, and if these changes continue after some time. Besides, we will compare these results with information from other families that are not taking part in the program. The main caregivers of the participating families and the practitioners in charge of the intervention will provide the information for the study.

We expect that families participating in the programs will improve their parenting competencies and their family dynamics, and that these change will stay after the program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being caregiver of at least one child under 18 years of age The child to be in the developmental stage appropriate for the corresponding arm If participating in a targeted program, meet the requirements: (1) be a father; (2) presenting bad health habits in the family according the evaluation of the pediatrician Motivated to improve parenting competences  Exclusion Criteria:  Not having sufficient command of the Spanish language to be able to communicate Experience family crisis that prevent for participating in a group intervention Experience mental health issue that prevent for participating in a group intervention - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Glycocalyx Monitoring in Major Abdominal Surgery
Status: Recruiting

The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  For the HIPEC group :  Adult patients Age < 75 years Receiving HIPEC for primary or secondary peritoneal carcinosis  For the CDP group :  Adult patient Age < 75 years Receiving CDP for pancreatic neoplasia Patient who has read and understood the information letter and does not object to taking part in the study Patient affiliated to a social security scheme  Exclusion Criteria:  Secondary distant peritoneal metastases Chronic heart failure Chronic liver failure at stage C of the Child-Pugh score Stage IV or V chronic renal failure Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation Patient refusal Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patient undergoing major abdominal surgery by cytoreduction combined with an intraperitoneal chemotherapy bath (HIPEC) or cephalic duodeno-pancreatectomy (CDP) with epidural analgesia planned in accordance with the department's usual practice - SamplingMethod: Probability Sample
Cardiovascular Metabolic Remodeling in Shock
Status: Not yet recruiting

The aim of the study is to increase our knowledge of energy dysfunction in the cardiovascular dysfunction observed during shock states by analysing the omics molecules involved.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient aged between 18 and 75. Patient admitted to intensive care for shock treated with a vasoactive or inotropic amine (adrenaline, dobutamine or noradrenaline).Patient undergoing invasive mechanical ventilation for less than 24 hours (or admitted to intensive care for less than 24 hours if the patient arrived intubated) and for a foreseeable duration of ventilation of at least 48 hours. Patient, or relative if the patient is not competent, who has read and understood the information letter and does not object to participation in the research, or emergency procedure in the absence of a relative. Urine or blood pregnancy test if a sample is taken as part of routine negative care (if woman of childbearing age).  Exclusion Criteria:  Moribund patient (death expected within < 24 hours) and/or decision to limit or stop treatment on admission to intensive care. Pregnant, parturient or breast-feeding woman. Patient not suitable for enteral calorie intake. Patient with a history of: advanced chronic renal failure ; advanced chronic liver failure. Incapacitated patient of full age (under guardianship, curatorship) or deprived of liberty by court order. Patient already taking part in an interventional study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients hospitalised in intensive care for shock, treated with a vasoactive or ionotropic amine, undergoing invasive mechanical ventilation for less than 24 hours - SamplingMethod: Probability Sample
Umbrella Study for Single Patient Treatments in Oncology
Status: Recruiting

The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria & Exclusion Criteria:  Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients have advanced and rare cancer with limited treatment options. - SamplingMethod: Non-Probability Sample
Depression in Youth Onset Type 2 Diabetes
Status: Not yet recruiting

The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Type 2 Diabetes diagnosis ≥ 3 months Age 12-17yr Elevated depression symptoms HbA1c ≥7.0%  Exclusion Criteria:  Currently receiving psychotherapy from a licensed counselor Psychotropic meds <8 weeks - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 17 Years - StdAgeList: Child