cyrilzakka/clinical-trials huggingface dataset:
A Pilot Trial of Disposable Nitrous Oxide Canisters in Providing Pain Control During Burn Dressing Changes

Improvements in burn care have resulted in increased survival. Despite these improved outcomes one of the leading challenges of burn care remains providing adequate analgesia during routine wound care and dressing changes. The traditional use of narcotics is challenging as the therapeutic window between analgesia and suppression of breathing becomes narrow with the intense pain and high doses of narcotics needed for dressing changes.

The normal challenges of using narcotics are increased in burn patients, who have significantly altered metabolism. Unfortunately, the use of regular general anesthesia or conscious sedation is not a viable option due to the resources required, and as the hypermetabolism of burn injury would result in compromised wound healing with repeated periods of without eating related halting of nutritional intake. This has led to the use of a number of adjuncts ranging from nonmedical (virtual reality, mindfulness, hypnosis etc.) to medication (ketamine, anxiolytics etc.). Historically Nitrous oxide has been used in similar settings where severe procedural pain is of relatively shorter duration, such as tooth extraction, labor or minor surgical procedures. Nitrous oxide is a rapidly acting analgesic that takes effect seconds after inhalation, and lasts minutes. While a randomized trial of Nitrous oxide in burn care has been proposed, the only published information currently available is in a Chinese medical journal.

To address this a gap in knowledge, a pilot Randomized Controlled trial is proposed to evaluate if Nitrous Oxide in the form of limited dose inhaler canisters can be used to improve pain control during burn dressing changes compared to placebo canisters.

Eligibility Criteria:
Inclusion criteria

* adult burn patients admitted to the Health Sciences Centre
* total body surface area burned of 5-20%

Exclusion criteria

* admitted to intensive care unit
* unable to participate in the measurement outcomes (sedated, cognitively impaired, unable to understand English or visually impaired)
* medical condition that precludes using nitrous oxide (respiratory disease and significant cardiovascular disease 5).
* pregnant
* physically unable to hold the canister
* \<90% SaO2 on room air
* face burn
* pre-injury narcotics (relative exclusion)
* use of IV ketamine
* pre-existing lung injury
Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension

This study investigated the effect of 12 weeks of aerobic training on sleep quality and aerobic fitness in patients with Pulmonary arterial hypertension(PAH).

Thirty male PAH patients were included in the study. They were randomized into two equal groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP) measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire with the wrist worn actigraph used for the assessment of sleep disturbance, and Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max .All were measured before and after the study period for both groups.The training was a moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).

Eligibility Criteria:
Inclusion Criteria:

* Patients who were clinically stable and compensated under optimized medical therapy
* World health organization (WHO) Classification of functional class II to III PAH
* Patients with ejection fraction ≥ 40%
* Non-smokers
* body mass index ≤ 35 kg/m2

Exclusion Criteria:

* Any patient with respiratory failure
* unstable angina
* renal, hepatic or neuromuscular disorders
* history of syncopal attacks
* uncontrolled systemic hypertension
* peripheral vascular disease
* serious cardiac dysrhythmias on resting ECG
* evidence of severe COPD at pulmonary function testing,
* any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise
Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide, with a 5-year survival rate of less than 50%. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck squamous cell carcinoma, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%, and the distant metastasis rate is as high as 20%-30%. This is associated with a lower radiosensitivity in HNSCC. Our previous study has confirmed that type I collagen secreted by cancer-associated fibroblasts (CAFs) can enhance the radioresistance of head and neck squamous cell carcinoma. We also confirmed that pirfenidone could reduce type I collagen expression in CAFs and enhance radiosensitivity in vitro and in vivo. Therefore, we plan to translate the basic research into clinical practice and conduct a prospective interventional phase II clinical trial to investigate the safety and efficacy of pirfenidone as a radiosensitizer in HNSCC.


Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years old;
2. provide written informed consent;
3. head and neck squamous cell carcinoma confirmed by biopsy (2022 WHO criteria);
4. no previous head and neck radiotherapy;
5. The presence of measurable lesions: no surgical treatment or postoperative imaging evaluation indicated that the tumor was not completely resected;
6. ECOG PS: 0/1;
7. Laboratory confirmation of good organ function. It should be given within 10 days before the first dose of treatment; 8) expected survival time ≥3 months.

Exclusion Criteria:

1. no indications for or contraindications to radiotherapy after evaluation;
2. no oral medication;
3. pregnancy or lactation;
4. patients with known allergy to pirfenidone or other contraindications;
5. concurrent tumors (except cured basal cell or squamous cell skin cancer, and cervical cancer in situ);
6. patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. "For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor condition, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), and mental illness."
Balancing Lupus Experiences With Stress Strategies

Linking a psychosocial stress intervention with clinical measures of stress in African American lupus patients will assess the utility of this method in reducing perceived stress, and provide the necessary preliminary steps toward future investigations of potential mechanisms.

To begin to fill this research void, a stress intervention will be piloted and both biological specimens and questionnaire responses collected to assess changes in stress state following the intervention in patients who participated in the intervention compared to those who did not participate in the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* African American
* Diagnosis of Lupus

Exclusion Criteria:

* Previous participation in a disease self management program
Non Neutralizing Antibodies: Prevalence and Characterization

Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the molecule are named inhibitors whereas Abs directed towards non-functional epitopes are named non-neutralizing antibodies (NNA). These NNA are poorly studied and their prevalence is ill-defined.

In a recent retrospective study the investigators evaluated, in a cohort of 210 patients without inhibitor, the NNA prevalence and the NNA epitope specificity against the heavy chain (HC)or the light chain(LC). For the first time, the investigators used two x-MAP based assays: the first to determine the specificity of anti-FVIII Abs against the HC or the LC, the second to display Abs directed towards the B domain. NNA were found in 38 out of 210 patients (18).

Among this NNA positive population, 74% and 13% of patients had anti-FVIII Abs against both chains. The proportion of NNA directed towards the B domain was 18%.

Considering an approximate inhibitor prevalence of 30% and a NNA prevalence of 19% in severe HA patients, approximately 50% of severe HA patients develop an immune response against infused FVIII. Due to their unclear relevance, the NNA detection does not yet belong to the routine clinical practice.

However, in 2006, Dimichele advancedf a hypothesis concerning the influence of NNA on the variations in the kinectics of FVIII observed in certain patients.

The mechanism explaining the role of these NNA in the FVIII in the FVIII kinectics has not still been demonstrated.

The investigators propose to perform a multicentre prospective study with the aim to confirm, in severe, moderate and mild HA treated patietns, the NNA prevalence observed in our retrospective study, to study the evolution over time of the epitopemapping of these NNA and to explore the correlation between these NNA and clinical/biological parameters.


Eligibility Criteria:
Inclusion Criteria:

* male with Age \> 6 years
* Severe, moderate or mild treated HA patients with negative inhibitor titer (\<0.6UB)
* An information form will be presented to the patient or his/her legal representative by the physician who includes the patient in the study protocol
* Patient with national insurance

Exclusion Criteria:

* Patient without his agreement for this study
* Patient deprived of freedom
* Patient without national insurance
Telerehabilitation in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a progressive inherited disease that affects the muscles and causes functional limitations to varying degrees. It is vital to start physiotherapy follow-ups immediately after diagnosis. Patients with DMD are among the most vulnerable groups who have problems in accessing physiotherapy services during the COVID-19 pandemic. The aim of the study was to investigate the effects of the telerehabilitation program developed to protect the physical health of patients with DMD and not to interrupt their follow-up.

Forty two patients with DMD were included in the study. 30 of them were ambulant in group 1, and 12 were non-ambulant in group 2. Physiotherapy assessments were performed blindly before the program started. According to the functional levels of the individuals, 2 groups were formed. 9 physiotherapists applied the tele-rehabilitation program for 24 session (3 days in a week).

Eligibility Criteria:
Inclusion Criteria:

* Able to communicate verbally and visually
* Older than 5 years old

Exclusion Criteria:

* The children who had undergone any surgical operations in the past 6 months,
* Having a severe cognitive and breathing impairment
* Using mechanical ventilator continually or intermittent
* Having a febrile infection
Effect of Iron Source on the Growth of Enteric Pathogens

The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically \<10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children 5-12 y
* Willing to donate stool sample

Exclusion Criteria:

* Currently taking antibiotics
* Currently taking a vitamin and mineral supplement containing iron
* Wards of the state, including children in foster care
Rheum@Home: RA Remote Patient Monitoring

The goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with Rheum@Home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis.

Participants will be asked to

* complete questionaires every 4 weeks
* perform a walking test every 4 weeks
* routine lab
* routine disease activity measurement by a qualified assessor

Researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients;
* signed, written informed consent;
* 18 -75 years of age;
* clinical diagnosis of RA;
* ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist;
* able to read and understand simple Dutch language instructions;
* ownership or access to a smartphone, tablet or computer and having internet access;
* able to conduct a teleconsultation on a smartphone, tablet or computer.

Exclusion Criteria:

* severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.

A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.


Eligibility Criteria:
Inclusion Criteria:

* Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels.
* Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study.
* Parents willing to weigh and measure the height of their child throughout the study.
* Generally healthy - do not have any uncontrolled chronic disease.

Exclusion Criteria:

* Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia.
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Is undergoing or planning to undergo significant medical procedures in the next six months.
* A history of severe allergic reactions, including but not limited to any of the product's ingredients.
* Any child with a dairy allergy or lactose intolerance.
* Has undergone any surgeries or invasive treatments in the last six months.
* Has had any major illness in the last three months.
* Having any planned invasive medical procedures during the study period.
* Currently participating in any other clinical study.
* Unwilling to follow the study protocol.
* Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD).
* Any child currently taking or have taken in the last 3 months any prescription medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or Ritalin).
* Any child that is a 'fussy' eater or who the parent suspects may not tolerate consuming the test product daily for six months.
Prevalence of Spasticity in Adults With Mental Retardation Living in the Community

This survey aims to investigate the prevalence of spasticity among adults who live in community settings in Davidson County, Tennessee. The treatment of spasticity in those who live in community homes could significantly increase a person's quality of life by allowing them to participate more independently in activities of daily living, or by making assistance easier for caregivers.

The process of deinstitutionalization has transitioned a large majority of persons with developmental disabilities into the community over the past several decades, and that number will only increase going forward. There are 926 people in this region who are provided assistance through the Division of Mental Retardation Services (DMRS). People with developmental disabilities frequently have comorbidities such as spasticity that hinder their ability to participate in activities of daily living. Spasticity results from brain or spinal cord injury and can produce increased muscle tone, causing joint stiffness, contractures and pain that can interfere with recommended treatment. A previous survey conducted at Clover Bottom Developmental Center investigated care areas typically affected by spasticity, including splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Pfister et al. reported the prevalence of spasticity in the developmental center to be 35% (72/205); of those people, the Survey Physician felt that 75% (54/72) would achieve a functional benefit from treatment.

Primary endpoints will assess the prevalence of spasticity in adults who reside in the community, and whether or not spasticity impacts activities of daily living. When appropriate, potential care area goals will be identified, and treatment options will be recorded. Secondary endpoints will examine whether or not participants currently receive treatment for spasticity; if so, what treatment is being used; and which care areas are most impacted by spasticity.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 and over) with mental retardation
* Living in a community home in Davidson County, Tennessee.

Exclusion Criteria:

None.
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven rectal carcinoma.
2. Tumor located in the rectum.
3. Clinical Tis, T1, T2 N0 M0
4. Without multiple lesions other than carcinoma in situ
5. Tumor size \<8 cm.
6. Sufficient organ function.
7. No bowel obstruction.
8. No history of major colorectal surgery.
9. No history of chemotherapy or radiotherapy.
10. Provide written informed consent.

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
2. Pregnant or lactating women.
3. Severe mental disease.
4. Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
5. Continuous systemic steroid therapy.
Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines

The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.

In translation

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* Pregnant \<32 weeks of amenorrhea
* Answers yes to the following question: "do you feel alone facing the upcoming changes related to your child"

Exclusion Criteria:

* Intends to move outside the area in which she can receive the intervention
* Sees a psychologist or psychiatrist at least once per week
* Refuses to participate
COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM)

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.

Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for prognostic risk assessment by CCTA findings but were limited by small patient cohorts or single centers. The CONFIRM Registry is a large, prospective, multinational dynamic observational study of patients undergoing CCTA. The primary aim of CONFIRM is to determine the prognostic value of CCTA findings for the prediction of future adverse CAD events.

The CONFIRM registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in North America, Europe, and Asia. CONFIRM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. Patients comprising the present CONFIRM cohort include those with suspected but without known CAD, with known CAD, or asymptomatic persons undergoing CAD evaluation. A data dictionary comprising a wide array of demographic, clinical, and CCTA findings was developed by the CONFIRM investigators and is uniformly used for all patients. Patients are followed up after CCTA performance to identify adverse CAD events, including death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.

Eligibility Criteria:
All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of 64-detector rows or greater will be included within the CONFIRM registry.

Inclusion Criteria:

1. Age \> 18 years
2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
3. Interpretable CCTA
4. Prospective data collection for CAD risk factors.

Exclusion Criteria:

No explicit patient exclusion criteria are defined.