cyrilzakka/clinical-trials huggingface dataset:
Study on Out of School Nutrition and Physical Activity Environments

The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.

Nearly half of Boston's school age children (49%) participate in out of school time programs, a critical time to intervene on physical activity and nutrition. Previous research has mostly focused on during-school-day efforts, or on child care policies and practices for very young children, leaving a gap in the knowledge of what might work with programs serving school-age children during out of school time. OSNAP aims to implement low cost and sustainable policy and environmental interventions to improve physical activity and healthy eating/beverage environments. Data will be collected via observations, plate waste and accelerometers on program policies, environments, practices and behavioral outcomes related to physical activity, beverage, snack and screen time outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Afterschool programs in Boston MA serving at least 40 children ages 5-12 years operating the full school year between September and June
* Afterschool programs serving a snack to children
* Children between the ages of 5 and 12 years
Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Diabetes mellitus (pre-gestational)
* Hypertension (pre-gestational)
* Malformations on ultrasonography at 12 weeks
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia

The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).

Currently there are no recommendations on the use of anticoagulant and/or antiplatelet treatment in patients with Rendu-Osler Disease.

The main question this study aims to answer is:

• to better determine which anticoagulant and/or antiplatelet therapy are best tolerated or if they are equivalent in Rendu-Osler disease because this type of treatment is often used in urgent and/or vital situations.

Participants will have a 2-year follow-up with biological monitoring of ferritin and hemoglobin level and ESS (Epistaxis Severity Score) and QoL-HHT (Quality of Life Hereditary Hemorrhagic Telangiectasia) questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Rendu-Osler disease with an indication of antiplatelet and/or anticoagulant introduced for less than 3 months (inclusion period within 3 months of exposure)
* Age \> 18 years old
* Patient able to understand and agree to participate in the study
* Affiliation to a social security system

Exclusion Criteria:

* Patient with an indication of antiplatelet and/or anticoagulant but for whom treatment has not been introduced or introduced for more than 3 months
* Refusal to participate
* Pregnant woman or who are breast feeding
* Patients under maintenance of justice, wardship or legal guardianship
Somatic Tracking for Tinnitus

We are examining the effect of mindfulness meditation on attitudes towards tinnitus, as well as physical and psychological distress associated with the condition. The meditation is designed to promote neuroplasticity, fostering new neural connections to help you reinterpret tinnitus through a lens of safety and reduce the perception of threat. This approach integrates several techniques from various psychological therapies which have been promising in reducing tinnitusrelated distress. Therefore, the purpose of this study is to see whether a guided mindfulness meditation intervention is effective in improving the acceptance of tinnitus symptoms, as well as reducing tinnitus-related distress in people living with tinnitus.

Somatic tracking is one aspect of most mindfulness meditation protocols, involving paying attention to the present non-judgementally, and focusing on breath and bodily sensations (e.g., sounds in the case tinnitus). By encouraging individuals to observe and reinterpret distressing symptoms as benign, it aims to decrease the brain's reactivity and vigilance towards tinnitus symptoms, promoting acceptance instead of maladaptive avoidance behaviours that can inadvertently heighten awareness of symptoms (McKenna et al., 2020). Reduced tinnitus-related fear has appeared to improve CBT treatment effects (Cima et al., 2018), while greater tinnitus acceptance is associated with reduced tinnitus distress and improved mental well-being (Westin et al., 2008). This coping strategy has also reduced distress in other conditions, such as traumatic brain injury (Garland et al., 2009). In line with the greater goals of mindfulness, somatic tracking encourages sustained and flexible attention to the wider experience and environment, moving away from narrowed attention to tinnitus symptoms. In redeploying attention beyond tinnitus, awareness extends to other stimuli, and tinnitus-related distress should reduce alongside decreased resistance and selective attention which contribute to the perception of tinnitus (Marks et al., 2020b). This study aims to explore the effectiveness of a somatic tracking intervention - Tinnitus Tracking, for tinnitus sufferers. This intervention constitutes a mindfulness activity commonly part of meditation/mindfulness programmes, which will be tested as a standalone intervention. We aim to answer: What is the effect of Tinnitus Tracking compared to no intervention on (1) participants' positive and negative thoughts towards their tinnitus and (2) the physical and psychological distress associated with the condition?

Eligibility Criteria:
Inclusion Criteria:

* Experiencing distressing tinnitus
* Sufficient English language and hearing ability to take part
* Completed all relevant medical and audiological investigations and concluded ensuing treatment for any underlying disease
* Not be engaging in any other therapy for tinnitus.

Exclusion Criteria:

* Risk to self (scoring 'nearly every day' on PHQ-9 question "Thoughts that you would be better off dead, or of hurting yourself in some way?")
* Severe mental health difficulties (PHQ-9 score of 20 or more)
Efficacy And Safety of Pneumatic Trabeculoplasty

The purpose of this study is to evaluate prospectively the PNT safety and efficacy in term of IOP reduction in a group of previously or newly diagnosed glaucomatous subjects.

A group of subjects affected by Primary Open Angle Glaucoma (POAG) underwent 3 PNT treatments to evaluate one-year efficacy in term of IOP reduction and one-year safety in term of incidence of adverse events

Eligibility Criteria:
Inclusion Criteria:

* Subjects affected by primary open angle glaucoma

Exclusion Criteria:

* Any local or systemic contraindication to timolol topical therapy
* Chronic iritis and/or uveitis in one or both eyes,
* History of inflammatory glaucoma,
* Hemorrhagic glaucoma,
* Post-traumatic glaucoma,
* Phacolytic glaucoma,
* Acute glaucomatocyclitic attack,
* Closed angle/narrow angle glaucoma in one or both eyes,
* Previous corneal transplantation,
* Proliferative diabetic retinopathy with/without iris neovascularisation,
* Significative disk cupping (90% of complete disk area),
* Large and severe perimetric defects (I. e. a central perimetric residual not above 10 central degrees),
* Dry/wet age related macular degeneration in one or both eyes,
* Previous glaucoma surgery (Laser therapy was not considered)
* Keratitis
* Severe dry eye disease,
* Corneal dystrophies
* High myopia (more than 6 dioptres)
* Peripheral retinal degenerations with risk of retinal detachment
Effects of Oral Stimulation and Supplemental Nursing System

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.

Eligibility Criteria:
Inclusion Criteria:

* a birth weight of 1,000 gr and above,
* a gestational age between 30 and 34 weeks,
* no congenital anomaly,
* no severe asphyxia or chronic lung disease,
* spontaneous breathing,
* grades III and IV intracranial hemorrhage and no periventricular leukomalacia

exclusion criteria.

* congenital anomaly
* grades III and IV intracranial hemorrhage and periventricular leukomalacia
Progress Complication

Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)

The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. Systematic study of cardiac procedure complications can improve procedural safety and optimize short and long-term patient outcomes. The objectives of this multi-center observational registry are to

1-Examine the frequency and types of complications occurring during cardiac catheterization and PCI among participating sites, 2-Examine the procedural strategies (techniques and devices) utilized for complication management, 3-Evaluate the clinical outcomes (both immediate and during follow-up) after each complication type.

Eligibility Criteria:
* Over 18 years of age
* undergoing coronary angiography or PCI
* A complication occurred during or after the procedure
Performance Assessment of a Modified Daily Disposable Contact Lens

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form;
* Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
* Monocular (only one eye with functional vision);
* Other protocol-specified exclusion criteria may apply.
chemQbiosciences:Manual Liquid Based Cytology

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.

Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Eligibility Criteria:
Inclusion Criteria:

* Female ages 18 years or older
* English speaking
* Presenting for pap smear examination

Exclusion Criteria:

* Pregnancy
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients

After a stroke, most patients have poor ankle control and difficulty walking. Considering that proper foot placement will provide a more balanced and controlled gait, the aim of this study was to investigate the immediate effect of non-elastic ankle taping providing eversion support on gait balance in stroke patients.

The study included 30 stroke patients. Participants were randomly assigned to two groups: intervention group(n=15) and the control group(n=15). The control group received 45 min of conventional physiotherapy. The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support. The gait balance of both groups was evaluated using the Dynamic Gait Index before and after treatment. . Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* having a stroke diagnosis at least 6 months ago,
* being between the ages of 18 and 75,
* having a spasticity grade of 0, 1, 1+, 2 according to the Modified Ashworth Scale,
* having no cooperation problems and being mobilized without support.

Exclusion Criteria:

* orthopedic problems such as surgical intervention, fracture history, presence of cognitive, visual, or cardiovascular diseases
* skin sensitivity in the foot and ankle that may affect gait.
Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance

The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the search for strategies optimizing the results of antiviral therapy. Some factors associated with non response have been identified. Among the modifiable factors, numerous series have shown that insulin resistance adversely impacts the rate of sustained virological response. The aim of this study is to determine whether the pharmacological correction of insulin resistance through therapy with glitazones restores higher rates of viral eradication and to determine the impact on the kinetics of viral response. Patients will be randomized to receive pioglitazone or placebo starting 4 months before initiating pegylated interferon and ribavirin and continued throughout the whole antiviral treatment period.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6
* Naive Patient(never treated with antivirals for HCV)
* HOMA score higher than 2.5
* Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C

Exclusion Criteria:

* Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke
* Alcohol consumption exceeding 40 g / day
* Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following : bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy
* Hepatocellular carcinoma or any other neoplasm (except if in remission for \> 5 years)
* Other documented chronic liver disease
* Insulin treated diabetes
* HBV or HIV co-infection infection confirmed
* Thrombocytopenia below 50 000/mm ³; neutropenia below 750/mm ³ or hemoglobin below 11 g / dL
* Drug-induced steatosis(tamoxifen, glucocorticosteroids, amiodarone, tetracyclines).
* Bone marrow or solid organ transplantation
* Pregnancy or breastfeeding, or desire for pregnancy during the study period.
* Patients under legal protection or unable to express their consent
Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire

The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.


Eligibility Criteria:
Inclusion Criteria:

* Difficult peripheral IV access (2 failed attempts by nursing staff)
* Prior history of difficult IV access and patient request for ultrasound guided IV

Exclusion Criteria:

* Need for emergent access or central venous access
* Inability to provide informed consent
Non-Inferiority of Peer Comparison Interventions

The objective of this study is to test the hypothesis that the Peer Comparison intervention in the Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (BEARI) trial (Meeker et al. 2016) promoting antibiotic stewardship did not adversely impact physician job satisfaction as measured in the study exit survey at trial completion. Detrimental impacts on job satisfaction is a phenomenon that was observed in a randomized controlled trial using a Peer Comparison intervention with different characteristics from the BEARI trial. (Reiff et al. 2022) The BEARI trial sample size, intraclass correlation, and measurement of job satisfaction are comparable to Reiff et al. 2022.

This secondary analysis includes all providers from the Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (BEARI) trial who completed the exit survey following 18 month trial completion. The objective of this study is to test the hypothesis that the Peer Comparison intervention in the BEARI trial (Meeker et al. 2016) promoting antibiotic stewardship did not adversely impact physician job satisfaction. Detrimental impacts on job satisfaction is a phenomenon that was observed in a randomized controlled trial using a Peer Comparison intervention with different characteristics from the BEARI trial. (Reiff et al. 2022) The BEARI trial sample size, intraclass correlation, and measurement of job satisfaction are comparable to Reiff et al. 2022.

The differences in Peer Comparison interventions between BEARI and Reiff et al. include the following:

1. Differences in physicians' control and agency over patient adherence to screening recommendations vs. their own antibiotic prescribing
2. Relatedly, in the antibiotic stewardship study, there were achievable benchmarks for improvement, including a feedback and ranking framework allowing all physicians to attain the highest status and thus obtain positive feedback.
3. Differences in framing and presentation of messages

The investigators define a clinically significant detrimental effect on job satisfaction as 27% of individuals reducing job satisfaction ratings by one point on a 5-point likert scale. This shift is equivalent to a mean difference of 0.32 and a Cohen's d of 0.36. This difference corresponds to approximately a ⅓ reduction in job satisfaction on a 5-point likert scale.

H0: The BEARI Peer Comparison intervention had a clinically and statistically significant detrimental effect on physician job satisfaction. Control-PeerComparison\>=0.32

HA: The Peer Comparison intervention had no clinically significant negative impact on physician job satisfaction. Control-PeerComparison\<0.32

The investigators will conduct a traditional hypothesis test Control-PeerComparison= 0.0 as a secondary analysis.

Eligibility Criteria:
Inclusion Criteria:

* All providers included in the BEARI trial

Exclusion Criteria:

* N/A
The Impact of Post Discharge One-Time Home Visit: Bridging the Gap Between Hospital and Home.

A single post-hospital discharge home visit by a geriatric nurse practitioner or geriatric fellow can bridge the gap and ease the transition for elderly frail patients returning home after hospital admission. We believe this intervention will reduce medication errors, ensure follow-up discharge plans, decrease re-hospitalization rates, and decrease morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the ACE unit during the study time frame, age 65 and over, and residing in the community before and after discharge from the hospital. Selected patients will have complex discharge plans including referrals to home care agencies, poly-pharmacy, multiple co-morbidities, history of repeated hospitalizations, and poor social support systems in the community. In addition, eligible patients will have at least one of eight admitting diagnoses, chosen for their high likelihood of requiring post-discharge home care needs. These diagnosis include: CHF, COPD, coronary artery disease, diabetes mellitus, stroke, hip fracture, peripheral vascular disease or cardiac arrhythmia. The GNP or fellow will then request permission from the patient's primary physician to do a one-time post-discharge home visit.

Exclusion Criteria:

Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)
The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository

This study will investigate the association between clonal hematopoiesis and other conditions. Clonal hematopoiesis (CH) refers to the mutations in a person's stem cells which commonly affect people as they get older. These mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.

Objectives:

* To develop the CHIVE Registry with CH patients or patients with elevated risk for CH in order to better characterize associated clinical outcomes and co-morbidities in these populations
* To improve understanding of cardiovascular phenotypes and risk of patients with known Clonal Hematopoiesis of indeterminate potential (CHIP) or Clonal Cytopenias of undetermined significance (CCUS)
* To investigate prognostic significance of CH mutations for the development hematologic malignancies
* To generate a CHIVE Biorepository to acquire patient samples to study the natural history of CH, and to make available to CH investigators.

Eligibility Criteria:
Inclusion Criteria:

* Patient greater than or equal to 18 years old at time of consent
* Able to provide informed consent
* Idiopathic cytopenia (ICUS) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease)

Exclusion Criteria:

* Unable to provide consent
* Diagnosis of active hematologic malignancy. For example, a diagnosis of CMML, AML, MDS, MPN; History of hematologic malignancy is NOT exclusionary if in complete remission (e.g. previous myeloma or lymphoma)
Dynamic CT Imaging After Nellix Endoprosthesis Implantation

The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.


Eligibility Criteria:
Inclusion Criteria:

* Nellix implantation

Exclusion Criteria:

* Use of chimneys or combined with other stent graft material