cyrilzakka/clinical-trials huggingface dataset:
Plasma Levels of Danger-Associated Molecular Patterns in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass

The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 will be measured at four time points (prior to the onset of CPB, Hour 6 postoperative, day 1 and day 3 after surgery). HLA-DR gene expression will be determined before surgery and at day 3 postoperative. The direct effect of DAMPs release and immune suppression will be assessed by in vitro experiments.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to pediatric intensive care at Nantes University Hospital after cardiac surgery with bypass graft
* Age ≤ 3 months corrected age. Control group: patients less than 3 months old following cardiac surgery without CEC or digestive surgery with a central venous catheter.

Exclusion Criteria:

* Futility of care with cessation of blood tests as part of a limitation of active therapies;
* Absence of parents for information
* Refusal of parents after information (Lack of parental consent)
* Blood volume collected for medical purposes incompatible with the needs of the research
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.

Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.

Eligibility Criteria:
Inclusion Criteria:

* Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
* Females of childbearing potential who:

  * Are not breast-feeding;
  * Do not intend to become pregnant for the duration of the study;
  * Are using adequate birth control methods and agree to continue for the duration of the study.
* Able to read, understand and answer questions by investigator.
* Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.
* History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction.
* Ocular health within normal limits as determined by the investigator.
* No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study.
* Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the test article or its components.
* Inability or unwillingness to follow all study instructions and complete study visits as required.
* Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.
* Ocular trauma within 6 months prior to Visit 1 in either eye.
* Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.
* Presumed or actual ocular infection within 30 days prior to Visit 1.
* Any severe or serious ocular condition or significant illness.
* Any abnormal slit-lamp findings at the time of the Screening Visit.
* Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study.
* Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period.
* Use of topical or systemic ocular medications requiring longer than a two-week washout period.
* Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study.
* Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures.
* Other protocol-defined exclusion criteria may apply.
CTNow: A Clinical Trials Education Program for Rural Cancer Patients and Oncology Providers

The overall goal of the project is to pilot test CTNow, a multilevel intervention designed to facilitate access and referrals to cancer clinical trials in rural areas through patient and provider education and teleconference resources.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with any cancer.
* Patients who have received treatment, are receiving cancer treatment at the time of enrollment, or estimated to start treatment within 90 days.
* Patients must be ≥ 18 years of age. Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.

Patients must be residents of Hawaii, Kauai, or Maui counties.

Exclusion Criteria:

* Patients must not have previously participated in a cancer clinical trial. Those who have participated in a cancer clinical trial are not eligible for the study.
Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses

This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire.

Before commencing the trial, all participants will undergo an anterior segment examination to ensure the eyes are in a healthy state, free from corneal diseases. Two parameters will be measured during this examination: Tear Break-Up Time (TBUT), which is a non-invasive method used to assess tear break-up, and the Schirmer Test, where a strip is placed on the lower eyelid for five minutes to evaluate tear wetting of the strip.

The level of comfort after wearing contact lenses for 8 hours will be assessed using the Contact Lens Discomfort Index questionnaire.

The sample size is determined using the formula by Daniel (1999). Ten percent of the total sample size represents the number of subjects for this study. Considering a dropout rate of 10%, this study requires 18 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Age 19-29 years old
* Refractive error is less than -6.00DS with astigmatism is less than -1.00DC
* Have experience wearing Contact Lenses but agree to stop wearing them for 2 weeks before the study starts

Exclusion Criteria:

* smokers (Ward et al. 2010)
* participants with ocular disease or trauma which includes Lasik patients and intra/extraocular surgery.
* pregnant females (Yenerel \& Kucumen 2015).
* participants taking medication for systemic diseases (Fraunfelder et al. 2012).
Cromoglicate in Mastocytosis

The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent has been obtained
* Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign
* Age between 18 and 70 years
* Either sex
* Any race or ethnicity
* Attending hospital outpatient clinic or the private practice of a dermatologist.

Exclusion Criteria:

* The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
* Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
* Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
* Evidence of severe renal dysfunction (creatinine \> 1,5 times upper reference value)
* Evidence of significant hepatic disease (liver enzymes \> 2 times upper reference value)
* Presence of active cancer which requires chemotherapy or radiation therapy
* Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
* Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
* Intake of oral corticosteroids within 14 days prior to randomisation
* Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
* Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
* Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
* Known or suspected hypersensitivity to component(s) of investigational products.
* Current participation in any other interventional clinical trial.
* Subjects who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
* Previously randomised in this clinical trial
* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
* Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
* Females of child-bearing potential with positive pregnancy test at visit 1.
* Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Management of Patients Who Claim to be Electrosensitive

Know qualitatively the ways to deal with these patients, in general medicine in Brittany, and the difficulties encountered, through thematic and lexicometric analysis of responses

The Ministry of Health instructed the French society of medicine work (Dr Pougnet for the Brest CHRU) to coordinate the drafting of practical guides for the management of people claiming to have IEI-CEM (Intolerance Environmental Idiopathic in the Fields ElectroMagnetic) for care physicians primary (general practitioners). To meet this mission, it is necessary to know qualitatively the difficulties encountered by general practitioners during the management of these people.

Eligibility Criteria:
Inclusion Criteria: The inclusion criteria will be to be general practitioners, to have practiced between 01/01/2018 and 12/31/2018.

Exclusion Criteria:

* be other practionners
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon

The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
2. The patient has been informed about the study and signed the patient consent form.
3. The patient reads, understands and is able to complete the study questionnaires in English.

Exclusion Criteria:

1. The patient has an ongoing infection of the soft tissues of the ankle.
2. The patient has evidence of severe ankle arthritis.
3. The patient has a multi-system or multi-limb trauma.
4. The patient has a major medical condition that would affect quality of life and influence the results of the study.
5. The patient is pregnant
6. The patient is not expected to complete the study according to the investigation plan.
Shockwave Therapy for Plantar Fasciitis RCT

Inflammation of the plantar fascia is known as plantar fasciitis and is commonly seen in active or overweight individuals. It can be treated via conservative or surgical therapies. Extracorporeal shockwave therapy has shown promise in the treatment of plantar fasciitis. Several studies have compared the effects of different types of extracorporeal shockwave therapy (radial and focused) with other forms of conservative treatment in patients with chronic plantar fasciitis. No study has yet compared the effect of radial vs. focused shockwave therapy on pain in this population.

Plantar fasciitis is a common foot problem that affects 3.8 per 1,000 persons in the United States. It is characterized by inflammation of the plantar fascia, a fibrous tissue which connects the calcaneus to the metatarsal heads, and is often seen in individuals who are overweight and/or participate frequently in weight-bearing endurance activities such as running. Pain is typically at its highest during the first steps in the morning, although it can also occur with prolonged weightbearing. Plantar fasciitis can be treated via conservative or surgical measures, although surgery is considered as the last resort. In recent years, extracorporeal shockwave therapy has emerged as an alternative conservative method for treating plantar fasciitis. There are two types -- radial and focused shockwave therapy. Focused therapy creates deeper-penetrating, higher-energy shockwaves, whereas radial therapy produces more superficial shockwaves that can treat a wider area of pathology.

Randomized controlled trials have compared focused and radial shockwave therapy to placebo and other conservative measures in the treatment of chronic plantar fasciitis and overall demonstrated benefit. Only one study has directly compared radial and focused shockwave therapy in this population, although pain was not an outcome of focus in the study. The current study aims to collect patient-reported outcomes on both pain and function following radial vs. focused shockwave therapy vs. control therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with a clinical diagnosis of chronic plantar fasciitis (\>3 months) that has been recalcitrant to other treatments
* Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing)
* English-speaking

Exclusion Criteria:

* Cortisone injection within the past 3 months
* Platelet-rich plasma injection within the past 6 months
* History of previous foot surgery
* Bilateral heel pain
* Coagulopathies or use of anti-coagulants
* Local and systemic neurologic or vascular insufficiencies
* Rheumatologic disorders
* Systemic inflammatory disorders
* Active or chronic infection in the area
* Lower extremity bone disorders (e.g., Paget's disease, osteomyelitis)
* Calcaneal fractures
* Nerve entrapment
* Ruptures in tendon
* Non-English speaking
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair

To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.


Eligibility Criteria:
Inclusion Criteria:

* \>18 \<65 years of age
* Diagnosis of Unilateral inguinal hernia
* Able to provide written consent
* BMI \< 35
* ASA I-II patients
* Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty
* Informed consent

Exclusion Criteria:

* Recurrent hernias
* Incarcerated hernia
* BMI \> 35
* ASA III-IV patients
* Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
* Hypersensitivity to any drug in study
* Patients with an intra-operative findings of different pathology will be excluded from the study
Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial

This study investigates the short-term effects of the MindEase app on anxiety levels.

Anxiety is a common symptom in the world's population (Whiteford et al., 2013). It occurs as a symptom within other mental disorders and as a disorder in itself (American Psychiatric Association, 2013).

There are several ways of dealing with anxiety, from short guidance for coping on a symptom level to professional health. (Emmelkamp \&amp; Ehring, 2014). Many people suffering from anxiety below a threshold indicating need for professional therapy may profit from strategies to calm down. (Helmchen \&amp; Linden, 2000). Among the strategies that are effective, there are guided interventions that people can use via a web-based interface on a computer or smartphone (Taylor et al., 2021). While it is known for most interventions that they are helpful, it is often unclear if they work also in web-based environments (Baumel et al., 2020). This is because most research regarding the topic investigates the effectiveness of mental-health apps as a whole, while research of specific interventions is missing (Domhardt et al., 2019). However, to develop effective apps, it is crucial to identify which specific interventions are most efficient in a web-based setting. (Domhardt et al., 2019; Firth et al., 2017). Therefore we want to identify interventions working effectively in an online format.

Mind Ease is an app that offers different established interventions within one framework to their users when they feel anxious. This framework makes the different interventions comparable to each other. For this reason, we will test the interventions that are used in the Mind Ease-app.

In a first study we will correlate the Mind Ease 3-sliders-score with the state-trait- anxiety-Inventory (SAI). In a second study we will measure participants'; acute anxiety (with the 3-sliders- score) before and after they performed a 10 minutes web-based cognitive or mindfulness-associated intervention. We will compare the anticipated reduction in anxiety to the reduction measured in participants in a control group.

Prospectively registered here: https://osf.io/36ukh

Eligibility Criteria:
Inclusion Criteria:

* anxiety score is above cut-off

Exclusion Criteria:

-
Improvement of Fitness in Obese Children

This study observes fitness level and health parameters in children ages 6-12 years old with obesity using an exercise class intervention.

The purpose of this study is to improve physical fitness and health parameters in elementary-aged children who participate in an academic weight loss clinic. Patients and their parents are randomly assigned to either take exercise classes or to continue standard care (control group). Exercise classes are run at a local church 3 times a week for 8 weeks and children and parents are expected to participate. Parents are expected to follow similar dietary and exercise recommendations which are given to their children. Vitals, lab work and fitness testing are done on children at beginning, middle and end of the 6- month study. Vitals are done on parents at the beginning, middle and end of the study. Children are given Fitbits to record sleep patterns and daily physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Child must be a patient at the Penn State Hershey Children's Hospital Pediatric Multidisciplinary Weight Loss Program
* Child must be ages 6-12 years old

Exclusion Criteria:

* Lack of transportation to exercise classes
* Parents do not agree to participate in the exercise classes
Comparison of Two Stapled Antimesenteric Anastomosis for CD: a Randomized Control Trial Study

The postoperative recurrence of Crohn's diseases (CD) remains high. Stapled anti-mesenteric functional end-to-end anastomosis was safe for CD patients. Its impact on the postoperative recurrence of CD was unknown. Whether it is superior than the conventional anastomosis (stapled antimesenteric isoperistaltic side-to-side anastomosis) needs explored. The trial aims to compare the different impacts of the two antimesenteric anastomosis configurations on the anastomotic recurrence following bowel resection.


Eligibility Criteria:
Inclusion Criteria:

* patients with Crohn's disease needing bowel resection and anastomosis;
* ileocolic anastomosis；
* written consent acquired

Exclusion Criteria:

* patients underwent enterostomy;
* small bowel anastomosis;
* anticipating other trial.
Rigid Versus Flexible Cystoscopy in Women

The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.


Eligibility Criteria:
Inclusion Criteria:

* Female

Exclusion Criteria:

* Minors
* Incarcerated individuals
Contact Force Sensing and Pulmonary Vein Isolation

Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.

Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.

Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.

Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug
* Age 18-75 yrs
* First catheter ablation

Exclusion Criteria:

* Left ventricle ejection fraction at echocardiography \<50%
* History of heart surgery