rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Relaxation and Guided Imagery as an Intervention for Asthma
Status: Not yet recruiting

The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  At least 8 years of age and no older than 80 years of age Have clinical levels of anxiety Report having asthma Have asthma symptoms become triggered or exacerbated by anxiety  Exclusion Criteria:  Under 8 years old or older than 80 years old No clinical levels of anxiety No asthma symptoms triggered or exacerbated by anxiety - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 80 Years - StdAgeList: Child, Adult, Older Adult
Laparoscopic Ultrasound Examination: Analysis of Feasibility
Status: Recruiting

This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.

The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology. Women affected by gynecological pathologies undergoing elective laparoscopic surgery such as endometrial cancer, cervical cancer at early stage, or benign pathologies. All women will be required to sign written informed consent to enter the study.  Exclusion Criteria:  Patients affected by gynaecological pathologies undergoing emergency surgeries. Refusal to sign written informed consent. Patients with previous hysterectomy or salpingo-oophorectomy. Uterus and adnexa not visualised at LPS examination. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Eligible population includes 5 fellow surgeons with EFSUMB level 1 experience of ultrasound in gynecology (11) and 150 women satisfying inclusion criteria - SamplingMethod: Probability Sample
Focal Muscle Vibration in Parkinson's Disease
Status: Recruiting

Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.

The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations.

Eligibility:
- EligibilityCriteria: Inclusion criteria:  diagnosis of Parkinson's disease according to the criteria of the Brain Bank of London; Hoehn and Yahr stage II-III; absence of cognitive impairment (MMSE > 24/30); e effective pharmacological control of the pathology; being part of the PD group-rehabilitation program of our ward for at least one year; - acceptance and signature of informed consent.  Exclusion criteria:  comprised: a diagnosis of atypical Parkinsonism; poor pharmacological compensation of the disease; diagnosis of other neurological diseases; diagnosisof neuromuscular diseases; diagnosis of osteo-articular pathologies; cognitive impairment (MMSE < 24); visual impairment; vestibular disorders; not being part of our PD group-rehabilitation for at least one year; denial of informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Months - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients affected by Parkinson's disease, who refer to the Physiatry clinic of the Gemelli University Hospital Foundation in Rome. - SamplingMethod: Probability Sample
Pelvic Exenteration and Laterally Extended Pelvic Resection
Status: Recruiting

Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent.  Anterior/total pelvic exenteration Laterally extended endopelvic resection (LEER) Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure With or without stoma formation  Exclusion Criteria:  Radical hysterectomy without lateral resection Rectal resection only (posterior exenteration) - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients undergoing pelvic evisceration and lateral pelvic resection - SamplingMethod: Non-Probability Sample
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
Status: Recruiting

The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Willingness to participate and ability to understand and sign an informed consent. 18 years of age or older. Healthy subjects, patients with PACS or angle closure as defined by the EGS Guidelines. The right eye will be included in the study for all patients, unless a clinical contraindication to the examination is present.  Exclusion Criteria:  Inability to understand and sign an informed consent. Any prior ocular surgery or laser treatment with the potential to alter the natural anatomy of the anterior segment of the eye. Corneal or conjunctival abnormalities that preclude an adequate view of the anterior chamber. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes
Status: Recruiting

The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico.

The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs.

nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10.

Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients).

Eligibility:
- EligibilityCriteria: Inclusion criteria:  Patients with type 2 diabetes. Enrolled as beneficiaries of the Mexican Social Security Institute. With HbA1 greater than 7% and less than 13%. With and without pharmacological treatment for diabetes (hypoglycemic agents or insulin).  Who can read and write. With ≤ 60 years of age7. With ≤10 years of diabetes diagnosis.  Exclusion criteria. With severe complications of the disease (chronic renal failure, blindness or amputation) that prevent them from attending their appointments at the first level of care.  Those with morbid obesity BMI ≥35 kg/m2. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult
Psychological Factors Influencing Cancer Post-traumatic Growth
Status: Recruiting

The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients over 18 years of age Patients in the initial phase of curative treatment for a 1st solid cancer At the start of neo-adjuvant or adjuvant chemotherapy (1st course or 2nd course) At less than 6 months from the initial diagnosis Patient having given written consent to participate in the study  Exclusion Criteria:  Patients with a previous history of cancer Patients with cancer progression, recurrence or relapse Metastatic, brain, hematological or skin cancer Patients who have difficulty understanding written French Patient psychologically or physically unable to answer questionnaires - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma
Status: Recruiting

Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum) Metastatic or locally advanced unresectable tumour with curative intent Patient who never received first-line chemotherapy Measurable lesion according to RECIST 1.1 criteria ECOG status < or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years Life expectancy estimated at over 3 months Patient over 18 years of age Patient able to understand and sign the information and informed consent note Women of childbearing age and men who have sex with women of childbearing age must agree to use contraception during the trial treatment and for at least 9 months after stopping the experimental treatments.  Exclusion Criteria:  MSI/dMMR tumor Adenocarcinoma of the ampulla of Vater Neutrophils < 1500/mm3, platelets < 100 000/mm3 Hemoglobin < 9 g/dL, total bilirubin > 1.5x normal, alkaline phosphatase > 2.5x normal (or >5x normal if liver metastases), creatinine clearance > or = 40 ml/min. according to MDRD Hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment. Adjuvant chemotherapy completed less than 6 months ago History of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure Severe renal failure Peripheral sensory neuropathy with functional discomfort Active and/or potentially severe infection or other uncontrolled conditions Treatment with a cytochrome P450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "Contraindicated treatments" of the protocol) Patients currently undergoing treatment using St John's Wort Treatment with brivudine within 4 weeks prior to the administration of protocol - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS
Status: Recruiting

This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 18 - 65 years old; Diagnosis of F20, F25 or F21 according to ICD-10; Signed informed consent form.  Exclusion Criteria:  Age younger than 18 or older than 65 years old; Did not sign the informed consent form; Legally inactive person Patients with a comorbid or primary diagnosis of mental retardation according to ICD-10 (F70 - F79); Patients with a comorbid or primary diagnosis of mental and behavioural disorders due to psychoactive substance use (F10 - F19) Patients with a comorbid of primary diagnosis of organic, including symptomatic, mental disorders (F00 - F09) - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Inpatients between 18 and 65 years old with a diagnosis of F20, F25, or F21, according to ICD-10, who sign the informed consent form and do not have any exclusion criteria, will be included in the study. We will not devide patients who have active psychotic symptoms and those who do not. - SamplingMethod: Non-Probability Sample
Resection or Ablation of Small Kidney Tumors
Status: Recruiting

Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 - 99 years Patient suitable based on clinical status for both ablative treatment and surgery Primary kidney tumor Tumor size ≤ 3 cm Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion) Tumor location suitable for both ablative treatment and resection Absence of radiological signs of metastasis Biopsy with malignant pathological analysis (PAD) ISUP grade I-III"  Exclusion Criteria:  Radiological signs of metastasis Synchronous kidney tumors ISUP grade IV or sarcomatoid growth in the biopsy Other metastasized cancer in the last 5 years Patient unable to make an informed decision to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
Status: Recruiting

According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.

The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with Early infantile developmental and epileptic encephalopathy or Epilepsy of infancy with migrating focal seizures or infantile spasms syndrome or severe myoclonic epilepsy of infancy or Epilepsy with myoclonic-atonic seizures Diagnosed with drug-resistant epilepsy according to ILAE 2010 criteria Age at the start of participating in the study ranged from 0 to 23 months old Relatives agree to participate in the research There is no medical history of any diagnosis of hypoxic encephalopathy or inflammatory encephalopathy or traumatic encephalopathy or cerebral infarction or cerebral hemorrhage.  Exclusion Criteria:  Patients were removed from the study when they were lost to follow-up at 6 months  - - Gender: All - MaximumAge: 23 Months - StdAgeList: Child - StudyPopulation: The study population was patients with severe, early-onset epilepsy, suspected of having a genetic etiology - SamplingMethod: Non-Probability Sample
Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery
Status: Recruiting

Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant women followed-up in Brugmann University Hospital will be eligible to participate if:  Scheduled for cesarean delivery (business days and daily working hours) Singleton pregnancy Cesarean section scheduled at or after 37 weeks gestational age  Exclusion Criteria:  Fetal anomalies (congenital malformations, anemia, growth restriction with abnormal Dopplers) Abnormal placentation (placenta previa) Signs of fetal distress necessitating an emergency cesarean section Spontaneous labor before cesarean section Maternal health issue including severe anemia (defined as hemoglobin level < 7 g/dL), preeclampsia, and bleeding disorders Maternal refusal of the use of blood products. General anesthesia for cesarian section Planned cord blood banking Total language barrier without possibility of translation - HealthyVolunteers: No - Gender: All - MinimumAge: 37 Weeks - MaximumAge: 42 Weeks - StdAgeList: Child
Sexual Nursing Care in Stroke Patients
Status: Recruiting

The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.

The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.

Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.

In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical and neuroradiological diagnosis of ischemic or hemorrhagic stroke. Age between 18 and 70 years. Patients in the subacute phase (1-3 months post-event).  Exclusion Criteria:  Pre-existing neurodegenerative diseases (e.g., multiple sclerosis). Endocrine-metabolic and psychiatric pathologies that may interfere with sexual function. Global aphasia or other cognitive impairments that hinder active participation in training. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult