rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder
Status: Recruiting

The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having more than 18 years old Having experienced the death of a close person (i.e., relative, partner, friend) in the palliative and oncological context Having sufficient cognitive abilities and proficiency in the Portuguese language Participants will be considered if the death has occurred up to 12 months, considering that the time criterion in diagnosis for prolonged grief disorder is 12 months (and the focus in this study is on prevention)  Exclusion Criteria:  individuals with a pre-existing severe or active mental disorder predating the loss (e.g., schizophrenia, bipolar disorder, major depression) individuals with suicide risk assessed during the intervention individuals undergoing other psychological interventions before the loss of the loved one - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Children Born Preterm: Sustainable Health Monitoring
Status: Recruiting

Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children born preterm (gestational age below 37 weeks at birth) in Tuscany Region Acquisition of the informed consent  Exclusion Criteria:  Residing outside Tuscany region - Gender: All - MinimumAge: 20 Months - MaximumAge: 66 Months - StdAgeList: Child - StudyPopulation: Preterm infants who were born and reside in the Tuscany region. - SamplingMethod: Non-Probability Sample
Stockholm Mammography Risk Stratified Trial
Status: Not yet recruiting

SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have read, understood and signed the informed consent Perform breast cancer screening at Södersjukhuset Females in the age range 40 - 74 years at baseline mammography Using a smartphone or tablet with BankID  Exclusion Criteria:  Pregnant, breast feeding or planning to become pregnant. Previous breast cancer A medical condition that according to the responsible physician would negatively affect the health of the women. Cognitive impairment and / or language ability that would make it difficult for the participant to understand the implication of study and to perform a contrast mammography.  For women that will be offered contrast enhanced mammography the clinically accepted and applied exclusion criteria will be used. Women who cannot perform a contrast mammography will be offered an automated ultrasound. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Registered as a woman in the Swedish social security number system. - MinimumAge: 40 Years - MaximumAge: 74 Years - StdAgeList: Adult, Older Adult
Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects
Status: Not yet recruiting

The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?

200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree >I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients should present with at least one surgically accessible molar (in tooth position 6 or 7) diagnosed with a single furcation defect degree II (at any aspect).  Following initial periodontal therapy, teeth to be included should present with one site with furcation defect degree II in combination with:  Bleeding on probing Probing pocket depth of ≥6 mm Soft tissue coverage of the furcation entrance Patients should present with a full mouth plaque score ≤25%.  Exclusion Criteria:  Multiple deep furcation defects (degree II - III) at the same tooth Vertical attachment loss >50% at aspects not facing the furcation defect Defects presenting with apico-marginal communication Intake of systemic antibiotics within 6 months Systemic conditions/medication impeding surgical intervention (e.g. uncontrolled diabetes, immunosuppressive medication) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The COSP-RBD Study
Status: Not yet recruiting

The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).

The main questions it aims to answer are:

What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?
Is this proportion higher to that in control patients without a diagnosis of RBD?

Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.

Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ.

Eligibility:
- EligibilityCriteria: Inclusion criteria group with RBD:  Patient at the SDC with diagnosis of RBD (Guy's and St Thomas' NHS Foundation Trust). 50 years of age or above (patients below this age would not be expected to have a RBD related to a synucleinopathy and other causes of RBD would need to be considered instead - e.g. narcolepsy, post-traumatic stress disorder).  Inclusion criteria control group:  Patients who have undergone a v-PSG at the SDC (Guy's and St Thomas' NHS Foundation Trust) and who do not have history of suspected RBD or RBD confirmed by v-PSG. 50 years of age or above This group will be age- and sex-matched to the RBD group.  Exclusion criteria group with RBD:  Age < 50 years of age. Diagnoses of narcolepsy or post-traumatic stress disorder. Subjects lacking capacity or literacy. Non-English speakers.  Exclusion criteria control group:  Age < 50 years of age (in order to match RBD group). REM sleep without atonia or confirmed RBD on v-PSG. Diagnosis of neurological diseases, cognitive complaints or motor complaints. Clinical history suggestive of parasomnia that may be included in the differential of RBD. Subjects lacking capacity or literacy. Non-English speakers. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a diagnosis of RBD at the Sleep Disorders Centre (Guy's and St Thomas' NHS Foundation Trust) will be identified via the sleep clinics. Expected number of eligible participants are 100, from which we expect 80 to agree to participate.  An age- and sex-matched control group of 60 participants will be obtained also via the Sleep Disorders Centre clinics (Guy's and St Thomas' NHS Foundation Trust). - SamplingMethod: Non-Probability Sample
Modeling Tic Change During Behavior Therapy for Tics
Status: Not yet recruiting

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.

CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.

The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 12-21 years at time of enrollment. Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.  At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score  ≥14 (≥9 for those with motor or vocal tics only).  Full scale IQ greater than 70 English fluency to ensure comprehension of study measures and instructions.  Exclusion Criteria:  Active suicidality. Previous diagnosis of psychosis or cognitive disability. Substance abuse or dependence within the past year. Concurrent psychotherapy focused on tics. Neuroleptic/antipsychotic medications. Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period) - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult
Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients
Status: Recruiting

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized, FMA score of the upper extremity ≤42, adequate language and cognitive function to perform at least a 1-step obey-command, pre-stroke functional level of modified Rankin Scale (mRS) ≤1, aged ≥19 years old, patients willing to sign the informed consent.  Exclusion Criteria:  those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy, those with progressive of hemodynamically unstable medical conditions, those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease, those with major psychiatric disorders, such as major depression, schizophrenia, or dementia, those having contraindications to conduct an MRI study, those who are pregnant or lactating , patients who have refused to participate in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
Status: Not yet recruiting

The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must be 18 Years to 75 Years, both male and female. BMI ≤40 kg/m2. Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis. ≥2 acute gout flares within 1 year prior to screening. Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.  Exclusion Criteria:  Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc. Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. Presence of severe renal function impairment. Intolerance of subcutaneous injection. Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment. Live vaccinations within 8 weeks prior to the start of the study. Use of forbidden therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Medical Device for Airway Patency During Sedation
Status: Recruiting

OVERALL SYNOPSIS

PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants

of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position
of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.

PART B: Systematic evaluation (in the body position [normally supine] considered most optimal for the procedural intervention) of the cumulative duration

of adjuvant manual airway support and ventilation
of respiratory arrest (interrupted monitoring of endtidal carbon dioxide [ETCO2])
of hypoxemia (hemoglobin saturation of oxygen [SpO2] <95 %), and
of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.

Eligibility:
- EligibilityCriteria: INCLUSION CRITERIA:  PART A: Adult (18-65 years). No known allergy or hypersensitivity to drugs used for routine sedation or to materials (PP or EVA) comprising STAIRWAY. Medically healthy with no comorbidity according to careful investigation by senior anaesthesiologist in charge of the sedation. No in situ magnetic device or implant. No cognitive or psychosocial distress, particularly including claustrofobia. Complete dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Non-pregnant. No ongoing breast-feeding. Ability to communicate in Swedish. Oral and written informed consent to inclusion as healthy volunteer study participant.  PART B: Adult (18 years and above) scheduled for elective diagnostic or therapeutic procedures under PS with propofol. No known allergy or hypersensitivity to drugs used for PS or to materials (PP or EVA) comprising STAIRWAY. Medical comorbidity corresponding to ASA class I-III. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Ability to communicate in Swedish. Oral and written informed consent to inclusion as study participant.  EXCLUSION CRITERIA:  PARTS A-B: Withdrawal of informed consent. Suspected or manifest unforeseen severe allergic reaction. Inability to obtain enough useful study data for practical or medicotechnical reasons. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia.
Status: Recruiting

Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Alive newborns weighing ≤ 1250 grams and GA ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥0.3 between days 5 and 14 of life, with no immediate extubation foreseeable.  Exclusion Criteria:  Presence of another concomitant congenital pathology at the time of inclusion: pulmonary malformations with compromised pulmonary function, active pulmonary haemorrhage, severe pulmonary hypoplasia, renal malformations with systemic compromise, congenital heart disease, polymalformative syndromes, chromosomopathies. Presence of refractory haemodynamic instability of any cause at the time of inclusion. Presence of severe neurological damage at the time of inclusion (HIV grade III or higher). Patients who have required major surgery in the 72 hours prior to inclusion. Patients who have necrotising enterocolitis (NEC) grades ≥II at the time of inclusion, according to the Bell classification. Patients who are children of a mother with HIV - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Month - MaximumAge: 28 Weeks - StdAgeList: Child
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
Status: Recruiting

The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of signed and dated informed consent form prior to any study procedures Stated willingness to comply with all study procedures and availability for the duration of the study Skeletally mature males and females  1 painful VCF which meets all of the following criteria:  Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5 points) VCF between T6 and L5 VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI). Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.  Exclusion Criteria:  Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .  Patient presenting a loss of vertebral height >50% compared to estimated pre-fracture height Sclerotic fracture Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion Active infection (systemic or in the target vertebra) Patient suffering from a severe or uncontrolled systemic disease Patient presenting a pathological fracture with the presence of a mass within the spinal canal Patient presenting neurological damage caused by vertebral fracture Patient pregnant or likely to be so or breastfeeding Patient vertebral anatomy not compatible with the size of the implant or instrumentation Fracture geometry making the insertion of the implant impossible - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult