rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome
Status: Not yet recruiting

EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to < 48 months. The study follows and open-label, dose-escalation design.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant has a predicted loss of function pathogenic or likely pathogenic SCN1A variant Participant must have experienced their first seizure between the age of 3 and 15 months Participant must have a clinical diagnosis of Dravet syndrome or the treating clinician must have high clinical suspicion of a diagnosis of Dravet syndrome Participant is receiving at least one prophylactic antiseizure medication  Exclusion Criteria:  Participant has another genetic mutation or clinical comorbidity which could potentially confound the typical Dravet phenotype Participant has a known central nervous system structural and/or vascular abnormality (indicated by an MRI or CT scan of the brain). Participant has an abnormality that may interfere with CSF distribution and/or has an existing ventriculoperitoneal shunt. Participant is currently taking or has taken antiseizure medications (ASMs) at a therapeutic dose that are contraindicated in Dravet syndrome, including sodium channel blockers. Participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent. Participant has previously received gene or cell therapy. Participant is currently enrolled in a clinical trial or receiving an investigational therapy. Participant has clinically significant underlying liver disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 47 Months - StdAgeList: Child
Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.
Status: Recruiting

Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.

After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Symptomatic patients Patients able to give informed consent and to follow the protocol of the study (i.e. able to use a smartphone) Patients >18 years BMI <35 and >18.5 Patients with a smartphone with Android or iOS as operative systems  Exclusion Criteria:  Patients unable to follow the protocol of the study (i.e. unable to use a smartphone, not owning a smartphone or unwilling to download or use the application) Patients with a diagnosis of a musculoskeletal injury but without symptoms Patients without a radiological examination confirming the diagnosis of musculoskeletal disease Patients with planned surgery in the following 60 days Pregnant or lactating woman Patients with other diseases causing pain in the involved joint (e.g. rheumatoid arthritis or other rheumatologic diseases). Surgical treatment in the last year and intra-articular injection in the last 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients with musculoskeletal chronic pain with a clinical and imaging diagnosis of an orthopaedic disease such as knee osteoarthritis, hip osteoarthritis, shoulder osteoarthritis, ankle osteoarthritis, rizoathrosis, meniscectomy treatment, rotator cuff tendinopathy, low-back pain, Achille tendinopathy, patellar tendinopathy,and tennis elbow. - SamplingMethod: Probability Sample
Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals
Status: Not yet recruiting

This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Asymptomatic subjects aged between 18 and 64 years.  Exclusion Criteria:  Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies. History of epilepsy. Pregnant Pharmacological treatment. Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult
Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy
Status: Not yet recruiting

Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.

The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.

Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients scheduled to undergo elective pancreaticoduodenectomy Non-opposition of the subject to participate in the study. Affiliated to the French social security system (CMU included).  Exclusion Criteria:  Emergent surgery. Pregnant patients. Refusal to participate or inability to provide informed consent. Patient under legal protection (individuals under guardianship by court order). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be made of adult patients scheduled to undergo elective pancreaticoduodenectomy in the University hospital of Besançon (France) - SamplingMethod: Non-Probability Sample
Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care
Status: Not yet recruiting

The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.

Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):

RAMP Knee-OA group
Usual care group

Outcomes will be measured at baseline, week 16, week 32, and week 52.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of Knee OA based on clinical criteria of the American Rheumatology College Moderate to severe Knee pain for 3 months or longer (average score of 4 or greater on a 0-10 pain scale in the past 3 months)  Exclusion Criteria:  Participants with potential serious knee pathology (e.g. inflammatory arthritis, acute trauma, malignancy) Previous Knee replacement Scheduled knee joint replacement surgery within 1 year Participants who are unable to reliably participate (e.g. those who do not speak Chinese or unable to attend study intervention) - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - StdAgeList: Adult, Older Adult
A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
Status: Not yet recruiting

This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female, age≥ 18 years； Patients with a diagnosis of gastric cancer by histopathology or cytology, accompanied by peritoneal metastasis, without systemic therapy, or for patients who have received neoadjuvant/adjuvant chemotherapy before, the time from last treatment to disease recurrence > 6 months; Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-). At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors （RECIST) 1.1; WBC≥3.0×10^9 /L; ANC≥1.5×10^9 /L; HB≥90 g/L; PLT≥75×10^9 /L; ALT and AST≤3×ULN (≤5×ULN with liver metastasis); ALB≥20g/L; Cr≤1.5×ULN or CCr>50 mL/min; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR or PT≤1.5×ULN (without anticoagulation therapy) LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms; ECOG 0~1； Expected survival ≥ 3 months; Consent to contraception； Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.  Exclusion Criteria:  History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration; Patients with central nervous system metastases with clinical symptoms; Patients who have been treated with high-dose systemic corticosteroids (prednisone > 10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the first dose of BioTTT001; Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001; Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001; Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia ); Patients with primary immunodeficiency; Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia); Patients with active infection requiring systemic anti-infective therapy; HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active syphilis; Patients with active tuberculosis or drug-induced interstitial lung disease； Patients with active inflammatory bowel disease ； NYHA≥ grade 3； Known allergy to the investigational drug or its components; Patients with prior organ transplants; Pregnant or lactating women; Other reasons judged by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Gurney Journey: Virtual Reality Distraction
Status: Recruiting

The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ages 5-17 years old. Patients undergoing general anesthesia with mask induction for dental procedures.  Exclusion Criteria:  Cognitive impairment that will impact the use of the VR headset or interaction with the game. Participants who cannot comfortably wear the VR headset. Visual impairment that would hinder use of software program. Patients receiving general anesthesia via IV. Parent accompanies patient back for anesthesia induction. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 5 Years - MaximumAge: 17 Years - StdAgeList: Child
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
Status: Recruiting

The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients. Body mass index < 30 kg/m2 (weight /height in m2) Mild to moderate OSAS Sagittal collapse of the lateral pharyngeal walls proved by Drug induced sleep endoscopy (DISE).  Exclusion Criteria:  • Refusing enrollment into the study.  Pregnant women. Refusing the surgery Contraindication to anaesthesia Patients with multilevel of obstruction. Serious psychiatric, neurological and cardiopulmonary (COPD or corpulmonale) diseases. Uncorrected hypothyroidism. Severe OSAS. Craniofacial anamolies. Central& mixed apnea Morbid obesity. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene
Status: Not yet recruiting

Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.

Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.

Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.

Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).

The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Presenting an heterozygous mutation on AGXT Presenting symptoms (presence or history of stones, nephrocalcinosis) or not  Exclusion Criteria:  Individuals unable to provide 24-hour urine samples. Individuals unable to free up a morning for day hospital appointments Individuals deprived of liberty by a judicial or administrative decision. Adults under a legal protection measure (guardianship, trusteeship). Individuals placed under judicial protection. Participants enrolled in another study with an ongoing exclusion period Pregnant women. Individuals not covered by social security - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters
Status: Recruiting

The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations  Exclusion Criteria:  inability to fill in the questionnaire inability to provide informed consent unwillingness to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants / patients (both adults and children from 6 years of age) who are referred by their General Practitioner to the Exercise Medicine Unit of the IRCCS Istituto Auxologico Italiano for an internal medicine visit, or other clinical examinations such as evaluation of the autonomic nervous system through spectral analysis of the variability of cardiovascular parameters, or bioimpedance analysis.  Only those persons who voluntarily provide their consent will participate in the study. - SamplingMethod: Probability Sample
Investigation of Walking Training With Different Slope Types in COPD Patients
Status: Not yet recruiting

Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with COPD (A, B, E groups according to GOLD assessment) Ambulate on your own Not having any contraindications for exercise To be mentally appropriate (score 24 points and above in the mini mental test)  Exclusion Criteria:  Being in GOLD 4 stage in spirometric evaluation Presence of hypoxemia Participation in another pulmonary rehabilitation program within the last 6 months Having an exacerbation in the last 1 month Being diagnosed with additional respiratory disease (asthma, bronchiectasis, etc.) Having had pulmonary surgery Having an orthopedic, neurological or cardiac disease that affects exercise Having uncontrolled hypertension or diabetes Presence of malignancy - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult
Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury
Status: Not yet recruiting

The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).

The main questions this trial aims to answer are:

Is Angiotensin (1-7) safe?
Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?

Participants will:

Complete 21 days of study treatment consisting of a once-daily injection.
Provide blood samples.
Undergo two magnetic resonance imaging (MRI) scans of the brain.
Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.

Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant or representative willing to provide informed consent. Age 18 years or older at time of enrollment. Traumatically induced head injury resulting from insult to head from an external force. Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available. Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness > 24 hours and GCS ≤ 9. Enrollment within 48 hours of TBI.  Exclusion Criteria:  Time of injury cannot be determined. Neurosurgery within the last 30 days. History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing. Contraindication to having an MRI. Pregnant or lactating female. Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug. Participation in another clinical study involving investigational product within 30 days prior to study enrollment. If in the opinion of the investigator, candidate is unsuitable for participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult