cyrilzakka/clinical-trials huggingface dataset:
Cap Assisted Colonoscopy for the Detection of Colon Polyps

This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.

The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.

Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.

Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.

Exclusion Criteria:

* prior surgical resection of any portion of colon,
* prior history of colon cancer,
* history of inflammatory bowel disease,
* use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure,
* poor general condition or any other reason to avoid prolonged procedure time
* inability to give informed consent,
* inadequate bowel preparation.
* history of polyposis syndrome or HNPCC,
The United Kingdom Facioscapulohumeral Muscular Dystrophy Patient Registry

Facioscapulohumeral Dystrophy (FSHD) is the third most common form of neuromuscular dystrophy worldwide with an estimated prevalence of one in 20,000. FSHD is an autosomal dominant genetic disease and is estimated to affect up to 3,000 people in the UK.

The patient registry facilitates a questionnaire based research study to better characterise and understand the disease in the UK, and helps to identify potential participants eligible for clinical trials.

The UK FSHD Patient Registry (https://www.fshd-registry.org/uk/) recruits any individual, from anywhere within the United Kingdom, with a diagnosis of FSHD. The registry is sponsored by Muscular Dystrophy UK. Participants may be referred to the registry by health care professionals, genetic testing/laboratory centres who are aware of the registry etc. Alternatively, a participant may have discovered the registry via promotional activities or by their own online searches. After completing the consent process, participants are able to enter information on to the registry platform (note all forms are available to view on the registry website before joining the registry). This is an ongoing database and all participants are invited to update their information on an annual basis.

The database is designed to be self reporting, however where specialised clinical or genetic information is required, the neuromuscular specialist in charge of the participants care can be invited to provide some additional information. The participant is able to select a health care provider from a pre-populated list at registration stage, if they wish to (optional feature). This information is included in the patient information and consent. Relevant R\&D approval has been recieved.

Eligibility Criteria:
Inclusion Criteria:

- All patients with a confirmed FSHD diagnosis (or pending diagnosis) who reside in the UK are eligible for inclusion.

Exclusion Criteria:

* Any confirmed NMD other than FSHD
* Living outside of the UK
Community Engagement for Early Recognition and Immediate Action in Stroke

The investigators plan to develop and adapt a community-partnered intervention using community health promoters ("Stroke Promoters") to deliver messaging regarding stroke symptom awareness and the need for calling 911 after stroke onset. The study investigators will implement this intervention in south side Chicago communities and measure the impact on symptom onset to hospital arrival times and EMS utilization using an interrupted time-series analysis.

The CEERIAS community-partnered research project has the following specific aims:

1. To examine personal, community, and cultural barriers to calling 911 after stroke onset and adapt a culturally-tailored intervention for delivery in multi-ethnic communities (African American, Hispanic, non-Hispanic White) surrounding a hospital on the south side of Chicago;
2. To implement a culturally-adapted stroke awareness and action program and monitor its penetration and adoption using the RE-AIM (Reach, Evaluate, Adoption, Implementation, Maintenance) framework in multi-ethnic communities on the south side of Chicago; and
3. To assess change in early hospital arrival and EMS use at a intervention hospital before and after the community intervention.

For aim 1, the investigators will explore and identify facilitators and barriers to calling 911 for stroke through focus groups conducted and involving key stakeholders including children and adults, stroke survivors, neighborhood alderman/legislators, spiritual and community leaders, school teachers, and stroke advocacy group members. The CEERIAS team will test and culturally refine our core community-partnered pilot intervention for implementation.

For aim 2, the investigators will identify and train Stroke Promoters from collaborating community organizations on the adapted intervention techniques and messages, provide materials for public dissemination, and evaluate and monitor adoption and implementation in the surrounding communities.

For aim 3, the investigators will perform an interrupted time-series analysis of EMS use and early hospital arrival among stroke patients before and after our intervention in south side Chicago communities. The research team will also compare time trends in EMS use and early hospital arrival for stroke with concurrent control PSCs on the north side of Chicago and PSCs in St. Louis.

If the intervention is successful, the effect will be an increase in EMS use for stroke which will translate into earlier treatment for stroke and reduced death and disability. The CEERIAS results will be generalizable to other urban communities in the US and should be salient to other health emergencies such as heart attack and cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Hispanic, African American, or Caucasian/White
* Reside within the following Chicago Zip Codes: 60617, 60619, 60620, 60621, 60628, 60629, 06032, 60639, or 60649

Exclusion Criteria:

* \< 18 years old
* Ethnic groups outside our targeted population
* Outside targeted catchment area
Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for robotic assisted laparoscopis surgery
* acceptance to participate

Exclusion Criteria:

* allergies to local analgetics
* daily use of strong opioids
Pre-anesthesia Imaging-based Respiratory Assessment and Analysis

This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.

Anesthesia respiratory assessment is an important issue for anesthesiologists to evaluate the respiratory status and airway management of patients before surgery. The American Society of Anesthesiologists (ASA) updated its guidelines in 2022, emphasizing the importance of comprehensive respiratory assessment in the guidelines.

Various risk factors have been proposed in past literature for discussion, and corresponding to these risk factors, there is currently no single factor that can predict difficult intubation completely. Existing investigations into difficult intubation factors mostly focus on high-risk populations, including patients with morbid obesity, where significant differences have been identified but not developed into predictive models.

With the rapid development of AI-related technologies in recent years, numerous image-related AI frameworks have been proposed. In recent years, attempts have been made to combine various clinical risk factors using machine learning methods to create automated prediction models for difficult intubation. However, their effectiveness has not met expectations, reflecting the significant clinical problem of difficulty in prediction that remains unresolved.

This study is an observational study aimed at analyzing and establishing patient image data, refining various data engineering techniques, and optimizing existing prediction model frameworks to enhance their medical value. Additionally, the focus of this project will be on establishing more prediction models to improve existing clinical decision support systems.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia
* Patients who can undergo pre-anesthetic consultation and airway examination.

Exclusion Criteria:

* Patients unable to undergo pre-anesthetic consultation and airway examination.
* Patients requiring emergency surgery.
* Vulnerable populations.
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children

This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children


Eligibility Criteria:
Inclusion Criteria:

* Children who require a systemic antifungal agent for the prevention of systemic fungal infection

Exclusion Criteria:

* Children who are receiving medications which cannot be taken concomitantly with voriconazole.
REACH (Restore Energy, Activity Can Help) Lupus Study

The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are:

1. Is the REACH program feasible and acceptable to participants?
2. What is the impact of the REACH program on fatigue?

Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.

Participants will:

* Use the REACH mobile health application to set weekly movement goals and log daily physical activity
* Meet weekly with their REACH peer coach (if they have one) to talk about their movement goals and progress
* Complete weekly symptom surveys
* Complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends
* Participate in an interview to provide feedback on the program


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus based on 2019 American College of Rheumatology classification criteria
* ≥ 18 years of age
* English-speaking
* Ownership of a smartphone
* Physician's permission to participate in the study (including engagement in physical activity)
* Fatigue Severity Scale score ≥ 4

Exclusion Criteria:

* Inability to consent or comply with the study protocol (cognitively impaired adults).
Comparative Effects of Gun Massager and Transverse Friction Massage in Patients With Plantar Fasciitis

to compare the effects of massage gun and transverse friction massage on management of pain and disability in patients with plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of morning heel pain with taking first step.
* Patients with limited range of motion and diagnosed with plantar fasciitis.
* Patients who are willing to participate.

Exclusion Criteria:

* Patient with heel fracture and surgeries will be excluded.
* Patient with sign of local and generalized infection or sepsis.
* Patient with foot deformities will be excluded
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.

The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.

Eligibility Criteria:
Inclusion Criteria for siblings:

* Siblings of very low birth weight or healthy, full-term infants
* age 4 years old or younger
* siblings and infants must live with the mother

Inclusion Criteria for mothers:

* no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse)
* age 18 years or older
* English speaking,
* living within 1 hour's travel distance from Duke University, for feasibility.
* Mothers at-risk for preterm birth who meet all other eligibility criteria

Exclusion Criteria:

Mother/sibling pairs of infants who:

* have congenital neurological problems (congenital hydrocephalus or microcephaly),
* are symptomatic from substance exposure,
* are hospitalized longer than 1 month after term, or
* are technology dependent.
A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.


Eligibility Criteria:
Inclusion Criteria:

* Participants with headaches that meet the diagnostic criteria for migraines according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura.
* Patients prescribed rimegepant by the attending physician for the treatment of migraines.
* Signed informed consent form.
* Age greater than 18 years.
* Not concurrently participating in other interventional clinical studies.

Exclusion Criteria:

* Patients diagnosed with secondary headaches.
* Patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up.
* Pregnant or lactating female patients.
* Patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up.
* Patients with a known history of hypersensitivity reactions to rimegepant or its components.
* Evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.
Nutritional Rehabilitation and Sleep Apnea in the Obese

In obese patients, the prevalence of obstructive sleep apnea (OSA) is around 40% in men and 30% in women. Weight loss after bariatric surgery significantly improves OSA, with 75% of patients having a reduction in OSA severity or becoming non-apneic. We hypothesize a similar effect on OSA of nutritional and psychocomportemental rehabilitation for obese patients. However, we expect weight loss and blood pressure reduction to probably be lower in obese patients who have OSA and nutritional rehabilitation alone than in those who are treated for their OSA or are without OSA. To address this question, we will conduct an observational study on obese patients, treated or not for OSA, following nutritional and psychocomportemental rehabilitation.

In obese patients, OSA prevalence is around 40% in men and 30% in women. Being overweight or obese are independent risk factors for OSA, and the prevalence increases with body mass index (BMI). Weight loss after bariatric surgery is one treatment for OSA, 75% of patients having a reduction in OSA severity or becoming non-apneic. OSA and obesity both induce type 2 diabetes, hypertension and/or nonalcoholic fatty liver disease (NAFLD). A randomized study (Chirinos et al. NEJM 2014) demonstrated a better improvement in blood pressure, triglyceride levels or insulin resistance with weight loss alone or weight loss associated with continuous positive airway pressure (CPAP) than with CPAP alone. We hypothesize a similar effect of nutritional and psychocomportemental rehabilitation on OSA. However, weight loss and blood pressure improvements could be lesser in untreated OSA patients than in treated OSA or non-OSA patients. It has been demonstrated that bariatric surgery reduces medication use such as antihypertensive or antidiabetic drugs, and thus a secondary objective is to determine whether nutritional and psychocomportemental rehabilitation similarly reduces medication use by the overweight and obese.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 kg/m² and/or waist circumference \> 80 cm in women or 94 cm in men
* Patients registered to follow a nutritional psychocomportemental reeducation program with the "Ethique et Santé" group

Exclusion Criteria:

- Subjects covered by articles L1121-5 to L1121-8 of French law