cyrilzakka/clinical-trials huggingface dataset:
Neighborhood Environments and Cardiovascular Disease

To investigate the contributions of neighborhood environments to the distribution of cardiovascular disease (CVD) risk across different age ranges and racial/ethnic groups, using data from three ongoing cohort studies of cardiovascular disease: the Coronary Artery Disease Risk Development in Young Adults (CARDIA) Study, the Atherosclerosis Risk in Communities (ARIC) Study, and the Cardiovascular Health Study (CHS).

BACKGROUND:

There is abundant evidence of persistent differences in cardiovascular disease morbidity and mortality by socioeconomic status (SES). The determinants of SES-related differences in CVD outcomes and risk factors have not been fully established. Previous work in this area has focused predominantly on individual-level SES indicators, but recently attention has shifted to the role of neighborhood or community-level variables in shaping health outcomes, independently of individual-level SES. Several epidemiologic studies have suggested that neighborhood characteristics may influence the distribution of disease risk, but the role of both neighborhood-level and individual level SES variables in shaping individual-level outcomes and risk factors has been rarely addressed in epidemiologic studies of CVD.

DESIGN NARRATIVE:

Associations of neighborhood socioenvironmental characteristics with CVD prevalence and incidence in middle-aged and elderly populations were investigated using data from the ARIC Study and CHS. Associations of neighborhood socioenvironmental characteristics with CVD risk factors and risk factor trends in young and middle-aged adults were investigated using data from the CARDIA and ARIC studies. CARDIA and ARIC data were also used to explore the contributions of neighborhood characteristics to racial differences in CVD risk factors. Census defined areas were used as proxies for neighborhoods. Participants were linked to their census-tract and block-group of residence using their home address, and neighborhood characteristics were obtained from the 1990 U.S. Census. The three data sets were analyzed separately. After exploratory and descriptive analyses, regression models were used to investigate associations of neighborhood characteristics with the outcomes before and after controlling for individual-level SES and other relevant covariates. Appropriate statistical methods (mixed effects models) were used to account for the multilevel structure of the data (individuals nested within neighborhoods and repeated measures nested within individuals), and the potential violations of the assumption of independence of observations that might arise from it.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Long-Term Evaluation of BIIB067 (Tofersen)

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 (tofersen) in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), biomarker effects, and efficacy of BIIB067 administered to participants with ALS and a confirmed SOD1 mutation.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have diagnosis of superoxide dismutase 1-amyotrophic lateral sclerosis (SOD1-ALS), and must have completed the End of Study Visit for either Parts A, B, or C of Study 233AS101 (NCT02623699) (i.e., were not withdrawn).
* If taking riluzole, participant must be receiving a stable dose for ≥30 days prior to Day 1.
* If taking edaravone, participant must have initiated edaravone ≥60 days (2 treatment cycles) prior to Day 1. Edaravone may not be administered on dosing days during this study.
* Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.
* For female participants of childbearing potential must agree to practice effective contraception during the study and be willing and able to continue contraception for 5 months after their last dose of study treatment.
* Participants from Study 233AS101 Parts A and B must have a washout ≥16 weeks between the last dose of study treatment received in Study 233AS101 and the first dose of BIIB067 received in the current Study 233AS102.

Key Exclusion Criteria:

* History of allergies to a broad range of anesthetics.
* Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally and could place a participant at an increased risk for bleeding during or after a Lumbar Puncture (LP) procedure. These risks could include, but are not limited to, anatomical factors at or near the LP site (e.g., vascular abnormalities, neoplasms, or other abnormalities) and underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease).
* Presence of an implanted shunt for the drainage of CSF or an implanted central nervous system (CNS) catheter.
* Prior or current treatment with small interfering ribonucleic acid (RNA), stem cell therapy, or gene therapy.
* Treatment with another investigational drug, biological agent (excluding BIIB067), or device within 1 month or 5 half-lives of study agent, whichever is longer.
* Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.
* Current or recent (within 1 month) use, or anticipated need, in the opinion of the Investigator, of copper (II) (diacetyl-bis(N4-methylthiosemicarbazone)) or pyrimethamine.
* Female participants who are pregnant or currently breastfeeding.
* Current enrollment in any other interventional study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Behavioral Support Techniques on Anxiety and Physical Reaction From Dental Treatment

Application of deep touch pressure (DTP) has been suggested to provide positive effects on anxiety modulation. However, empirical and theoretical evidence linked to the clinical effects of DTP is relatively rare in the behavioral and physiological aspects. The aim of this intervention trial study designs to investigate the effect of DTP in dental treatment by quantitative analysis of behavioral assessments and physiological measurements, including the electrodermal activity and heart rate variability, were conducted to understand the modulation of the autonomic nervous system (ANS), the orchestration of sympathetic (SNS) and parasympathetic (PsNS) nervous systems.

The subjects were recruited through word-of-mouth and by posted sign-up from the Department of Dentistry, National Taiwan University Hospital (NTUH), Taiwan. Informed consent was obtained prior to participation. The study protocol was approved by the Human Research Ethics Committee of NTUH. Before the testing, the experimental protocol was explained to the subjects. The subjects with normal overnight sleep quality were recruited to prevent the influences in both physiological and physical fatigue. All potential subjects receive independent examinations by an occupational therapist and a dentist to determine the eligibility for inclusion as well as were blind to the study hypotheses. Both electrodermal activity (EDA) and heart rate variability (HRV) were recorded continually through the entire testing procedures. Since the EDA and HRV are sensitive indicators for autonomic nervous system modulation, a standardization procedure that ensures the integrity of data is accessed. The power of the testing is preset at 0.80, and the significant level is 0.05. The quasi-experimental design of clinical trial for repeated measures will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patients who requiring tooth extraction were potentially selected to recruit.

Exclusion Criteria:

* with a history of systemic diseases that would contraindicate surgical treatment
* pregnant and lactating
* smoking of more than 10 cigarettes per day
* poor overnight sleep quality
* refusal to sign the inform consent agreement
Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

This study will assess the efficacy and safety of modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)


Eligibility Criteria:
Inclusion Criteria:

* Males and Females 30-80 years old
* Use of highly effective methods of contraception during study in women of childbearing potential
* Outpatients
* Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria
* Score of \>/= 2 on UPDRS items 32 and 33
* Dyskinesias for at least 3 months before baseline
* On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline
* Demonstrate capacity to complete accurate diary ratings
* Patients who have a primary caregiver willing to assess the condition of the patient throughout the study in accordance with protocol requirements
* Group 2 only: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study

Exclusion Criteria:

* Atypical/secondary form of Parkinson's disease
* History of surgical treatment of PD, including deep brain stimulation
* A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
* Advanced, severe, or unstable disease other than PD
* Evidence of dementia
* Treatment with certain prohibited medications
* Amantadine within 2 weeks prior to BL1 visit (applies to Group 1 only)

Other protocol-defined inclusion/exclusion criteria may apply.
Preoperative Supine Time for Adrenal Venous Sampling

This study aim to understand whether the length of preoperative supine time would affect the AVS outcome.

Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for 5% of hypertensive patients and 17-23% in patients with resistant hypertension. Compared to the primary hypertension, PA is more prone to cause severe organ damage and even early death. Adrenal venous sampling (AVS) is an effective confirmatory test for subtyping unilateral and bilateral adrenal hyperplasia, helping doctors to make an accurate decision between surgery or medication. Supine in bed before AVS is recommended for a desirable result of AVS according to guidelines. However, investigating study about the most optimal preoperative supine time before AVS is lacking. This is a single-center prospective randomized controlled study. 120 patients diagnosed as PA and with willing for further AVS examination will be included. Participants will be randomly allocated to 15-min supine time group or 2-hours supine time group. The primary outcomes are the degrees of clinical and laboratory remission (blood pressure, type and dose of antihypertensive drugs, serum potassium, orthostatic ARR). The secondary outcomes are the technical success rate and adverse event of AVS (selective index≥2 is considered as successful surgery without corticotropin stimulate). Discussion: Primary aldosteronism is an intractable public health problem, and many techniques including AVS have been developed to correctly identify this disease. This study will help to understand whether the length of preoperative supine time would affect the diagnostic efficacy of AVS, and thus help to formulate a more reasonable AVS procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are clinically diagnosed as primary aldosteronism with ARR≥37 (PAC showed as pg/ml, renin showed as μIU/mL) and passed through PA confirmatory tests (PAC-post CCT\>110pg/ml, PAC-post SSIT \>80pg/ml, or PAC-post FST\>60pg/ml). PAC: plasma aldosterone concentration;
2. Patients with willing for AVS;
3. Age 18 or above, male or female, with legal capacity.

Exclusion Criteria:

1. Patients with suspected adrenocortical carcinoma or pheochromocytoma;
2. Patients with high risk of adrenal surgery;
3. Patients have been subtyping to glucocorticoid-suppressible hyperaldosteronism or familial hyperaldosteronism type III;
4. Patients were diagnosed as Cushing syndrome or subclinical Cushing syndrome;
5. Patients were treated with glucocorticoids recently;
6. Patients with whole body or venipuncture area infection;
7. Patients with venous access thrombosis;
8. Patients are allergic to iodine;
9. Patients with X-ray contraindications;
10. Patients with coagulation dysfunction;
11. Patients are unable to cooperate and follow-up.
Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, CPIC guidelines, precision dosing, clinical safety, and personalizing analgesia

Aim 2. Implement and evaluate PPAP in children undergoing major inpatient surgery, posterior spinal fusion (PSF)

1. Determine genetic factors predisposing children to immediate and long-term postoperative methadone and oxycodone related adverse effects including RD, PONV, opioid dependence, and CPSP The investigators postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and CYP2D6 variants identify children at risk for poor pain relief, RD, PONV, opioid dependence, and CPSP in the postoperative period.
2. Determine genetic variants-based perioperative dosing and outpatient prescribing of opioids

The investigators hypothesize that CYP2B6 and CYP2D6 variants will explain pharmacokinetic variations of methadone and oxycodone, determine the right doses, and implement precision opioid use for optimal clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* Children ages 10 to 21
* ASA physical status 1 to 3
* Undergoing Posterior-Lateral Spinal Fusion
* Receives in-patient opioids
* Prescribed opioids at discharge

Exclusion Criteria:

* Serious illness
* Preoperative severe pain
* Preoperative opioid use or misuse
Forgotten Joint Score After Reversed Gap Technique

A new operation technique was established ("reversed gap technique" for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional "gap technique" as control in a RCT study.


Eligibility Criteria:
Inclusion Criteria:

* indication for implantation a total knee arthroplasty

Exclusion Criteria:

* indication for a constrained implant
* secondary type of arthritis (rheumatoid, post traumatic, post infectious)
* former "open" surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)
Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Adequate liver function
* Adequate performance status

Exclusion Criteria:

* Significant extrahepatic disease
Parents InformaTion in Child REHABilitation

In France, approximaly 3 million children have a chronic disease and require regular care such as paediatric rehabilitation. These cares are provided over long periods of time, most often throughout childhood and often into adulthood. Paediatric rehabilitation care involves multidisciplinary team working closely with families. During follow-up rehabilitation, communication between the children, families and the professionals is essential. To this end, digital health solutions can be helpful.

Digital health solutions are rapidly emerging in the field of paediatric rehabilitation. In this context of emergence of digital health solutions, it is essential to identify the needs and expectations of families of children with a chronic disease.

This project aims to identify the key points in terms of information exchange on rehabilitation monitoring. To identify these needs, a mixed study will be carried out from June 2022 to June 2023 involving focus groups to gather qualitative informations on parent's needs in terms of information exchange through digital apps and quantitative research with a survey that will allow to prioritise these needs.

For the first part of the study, the researchers will conduct focus groups and interview parents about their experiences and perceptions of information exchange with rehabilitation professionals. All the participants will be parents of a child with a chronic disease, aged between 0 and 18 years and receiving paediatric rehabilitation care. The objective of this first part is to collect qualitative information on the needs of parents in terms of information exchange through digital applications.

With the analysis of the focus group, the researchers will define the hypothesis.

Then, a survey will be built and shared online in France during 3 months (2nd semester 2022).

With this survey, the objective is to identify the key points for the development of paediatric rehabilitation apps in terms of information exchange.

Quantitative data will be described with frequency, mean and standard deviation.

Eligibility Criteria:
Inclusion Criteria:

- parents of a child (0-18 years) with a chronic condition and with a rehabiilitation follow up

Exclusion Criteria:

* parents who do not speak french
* parents with an intellectual disability (for the first part : focus group)
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)

This is a retrospective study to review the current experience of USG-MVA in Hong Kong and also evaluate the effectiveness of USG-MVA in cytological analysis in the management of first trimester miscarriage.

Miscarriage can be managed expectantly, medically or surgically. In cases where cytogenetic analysis is wanted, surgical evacuation is the ideal option as the POC is difficult to be obtained after medical evacuation. However, traditional surgical evacuation requires the procedure to be performed under general anesthesia using an electric vacuum aspiration (EVA). Moreover, the chorionic villi obtained via POC is often less intact and dispersed, making the identification and analysis difficult. Manual vacuum aspiration (MVA) was first introduced in 1973. The procedure is performed using a hand-held 60ml syringe to create the suction force and the intrauterine contents are aspirated using either a flexible or rigid cannula attached on it. The procedure can be performed in an outpatient setting with simple oral analgesics or conscious sedation given beforehand.

The investigators have previously evaluated the acceptability and feasibility of the addition of ultrasound guidance during the procedure. The investigators found that ultrasound-guided manual vacuum aspiration (USG-MVA) is an effective alternative treatment modality to medical and traditional surgical evacuation under general anesthesia for the management of first trimester delayed or incomplete miscarriage. The procedure has been introduced in our locality since 2015. Since then, the investigators have performed more than 200 cases of USG-MVA locally. However, the subsequent local experience of USG-MVA and culture failure rate in the POC during cytological analysis obtained via this method remains limited in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years old or above
* Women with miscarriage who are suitable candidates for USG-MVA
* first trimester delayed miscarriage ≤ 12 weeks of gestation
* incomplete miscarriage with POG ≤ 5cm
* hemodynamically stable
* tolerates well with speculum examination

Exclusion Criteria:

* Women who are not feasible for the USG-MVA
* cervical stenosis
* fibroid uterus ≥12 weeks in size
* known uterine malformation
* bleeding disorder
* suspicion of active infection
* inability to tolerate pelvic examination
* History of allergy to misprostol or same group of medications
Olympus - 19-gauge Needle

The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node \>0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity.
* Participants must lack bleeding disorders

Exclusion Criteria:

* Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
* Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
* Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
Prediction of Abatacept Discontinuation Using Test Reflecting Immunological Remission in Rheumatoid Arthritis

The objective of this study is to identify a panel of immunological molecular and cellular biomarkers able to predict the success of major dose-reduction or discontinuation of abatacept in rheumatoid arthritis patients

Parameters studied at different time points (before initiation of abatacept if sample is available in our biocollection; prior to dose tapering; prior to discontinuation) ACPA (anti-citrullinated proteins antibodies) repertoire

-IgG (Immunoglobulins G) and/or IgA auto-antibodies repertoire directed against major epitopes of well-known autoantigens

B cell repertoire B cell repertoire and transcriptome of regulatory B lymphocytes, memory B cells and B cells targeting specific autoantigens.

Analysis of type I interferon signature Expression levels of 7 type I interferon (IFN) response genes will be determined to calculate on type I IFN score

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (RA) patients (\> pr = 18 years) fulfilling the 2010 ACR/EULAR criteria
* Associated to high levels (\> 3 x upper limit of normal in UA/ml) of ACPA measured by the usual anti-CCP(cyclic citrullinated proteins)2 test at the start of abatacept treatment
* Receiving IV (intravenous) or SC (subcutaneous) abatacept alone or in combination with a conventional Disease Modyfying AntiRheumatic Drugs (cDMARD) (methotrexate, leflunomide, sulfasalasin in monotherapy or in combination) according to the usual scheme or in tapering phase
* Without intra-articular injections of corticosteroids during the last 6 months prior to down-titration of abatacept
* Having discontinued corticosteroids at he time of entrance in the study
* In deep remission (Disease Activity Score (DAS) 28 ESR (or CRP) \< 2.6 without clinical synovitis) since at least 1 year
* In sonographic remission at the time of enrollment (absence of PD (Power Doppler)-positive synovitis on 28 joints defined by a score \< 2 on a 0-3 semi-quantitative scale for each joint)

Exclusion Criteria:

* Age \< 18 years
* RA negative for ACPA (anti-citrullinated proteins antibodies) or not fulfilling ACR/EULAR criteria
* Abatacept discontinuation due to serious adverse event, loss of efficacy or pregnancy project