cyrilzakka/clinical-trials huggingface dataset:
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.

In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female patient
* Age \>18 years
* Previous diagnosis of EoE, confirmed by histopathology, with the presence of \>15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies
* Current maintenance treatment for EoE with a PPI or swallowed topical corticosteroids or about to start with these maintenance medications as decided during regular clinical practice

Exclusion Criteria:

* Severe and clinically unstable concomitant disease that may interfere with the subject's ability to participate in the study
* Receive investigational treatment during the study
* Dilation of esophagus required
* Insufficient Dutch or English language skills to understand patient information leaflets
Increasing Documentation and Disclosure of Sickle Cell Trait Status: an Implementation Science Approach

The hemoglobinopathy newborn screen (NBS) performed on all neonates in the U.S. allows for early life-saving medical care for infants with sickle cell disease (SCD), an autosomal recessive genetic disorder. Because of its detection method, the NBS incidentally reveals hemoglobinopathy traits including sickle cell trait (SCT). In an effort to uphold the rights of the newborn to their medical data and preserve autonomy in medical decision making, pediatric and genetic society guidelines recommend disclosure and documentation of SCT results during infancy. Despite this guidance, a large guideline-to-practice gap exists: SCT status is grossly under-documented in the pediatric electronic health record and few adults report knowing their SCT status despite universal screening. We plan to evaluate the effect of a toolkit of SCT Documentation and Disclosure (SCT-DD) strategies on documentation and disclosure of SCT by pediatric primary care providers in a 2-arm randomized interrupted time series trial.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient pediatric primary care providers within Nemours and their patients

Exclusion Criteria:

* none
Validation of the Turkish Version of PTSD-RI-5

The aim of this study is to investigate the adaptation and validity of the DSM-5 PTSD-RI -5 scale in patients who have been exposed to traumatic events. Thus, a scale useful for the diagnosis and follow-up of PTSD will be presented to the Turkish population.

Children worldwide are at risk of experiencing psychological trauma. In addition, one in every four children experiences major traumatic events such as domestic, school, or social violence, abuse, vehicle accidents, serious medical diseases, terrorist incidents, and war. These difficult experiences increase the incidence of post-traumatic stress disorder in children. It is reported that approximately 30% of children who have been exposed to trauma develop post-traumatic stress disorder. Although it is sometimes difficult to diagnose post-traumatic stress disorder, it is important to detect symptoms of PTSD in children and adolescents early. Many internalizing and externalizing symptoms occur in PTSD; There may be separation anxiety, shame, guilt, low tolerance, overstimulation, impulsivity, outbursts of anger, hostility, defiance, aggression, irritability, and mood changes. Therefore, early evaluation of trauma experience and post-traumatic symptoms in children and adolescents seems important.

Eligibility Criteria:
Inclusion Criteria:

* Being a child or adolescent between the ages of 11-17
* To have experience a traumatic event in the past
* To have cognitive capacity to understand and complete the survey.

Exclusion Criteria:

-
Exploring Clinical Trial Experiences of People With Leiomyosarcoma

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient has been diagnosed with leiomyosarcoma
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
* ECOG score of 4
Shared Responsibility Between General Practitioners and Highly Specialized Hospitals in Spinal Cord Injury

It is an interventional study that aims to assess a new primary care model of collaboration between specialized centers and primary care physicians in Switzerland, in order to reduce morbidity and improve patients' and providers' experience with delivery of follow-up care in individuals with chronic spinal cord injury as compared to current best practice.

This model will lead to awareness, recognition and interactive communication between GPs and specialists and guidelines on the shared-role relationship.

The study interventions are educational modules on bladder, bowel, skin-care, and pain management which will be provided to participating GPs by Spinal Cord Injury specialists. In addition visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site.

Eligibility Criteria:
Inclusion Criteria:

Physicians

* GPs practicing in medium to large group practice
* The practice is wheelchair accessible and remote to SCI specialized centers
* Proficiency certificate in ultrasonography

Patients:

* Diagnosed with traumatic or non-traumatic, sensory or motor complete or incomplete, chronic SCI
* 18 years or older
* Permanently reside in Switzerland
* Reside farther than 25 minutes driving distance from a specialized SCI center
* Understand German, English, Italian
* Informed consent
* Additionally in treatment group: Patients with chronic SCI Living in the region of a participating GP irrespective if they visit the participating primary care practice.
* Additionally in control group: individuals with SCI who live outside the catchment areas

Exclusion Criteria:

Patients:

- Acute SCI or during first rehabilitation phase - Congenital conditions leading to paraplegia or tetraplegia, including spina bifida - Neurodegenerative disorders such as multiple sclerosis and amyotrophic lateral sclerosis - Guillain-Barré syndrome
Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol

examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.

Primary outcome:

Soft-tissue pathology

* Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
* Sinus tract or fistula will be assessed through visual examination by the operator

Secondary outcomes:

1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror
2. mobility will be assessed through the back of two mirrors
3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).

clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.

• These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.

Eligibility Criteria:
Inclusion Criteria:

* Medically fit and cooperative children.
* Pediatric patients aged 4-6 years.
* A deep carious lesion in vital primary molars.
* Absence of clinical signs and symptoms of pulpal exposure.
* Absence of radiographic signs and symptoms of people degeneration.
* Positive parental informed consent.

Exclusion Criteria:

Uncooperative children.

* Medically compromised children.
* Presence of clinical signs and symptoms of pulpal exposure.
* Presence of radiographic signs and symptoms of pulp degeneration.
* Physiologic root resorption more than one-third.
Trunk Oriented Exercises Versus Whole-body Vibration for Duchenne Muscular Dystrophy

The abdominal muscles play an important role in stabilizing the trunk and providing postural stability. Children with Duchene muscular dystrophy have weak muscles, which may impair postural adjustments. These postural adjustments are required for gait and dynamic balance during the daily living activities.


Eligibility Criteria:
Inclusion criteria:

* diagnosed as Duchenne muscular dystrophy,
* aged from 6 to 10 years,
* having grade 3+ muscle strength in lower limbs and trunk muscles.
* had functional range of motion for upper and lower limb joints,
* able to walk alone level I and II of Ambulation function classification system for DMD (AFCSD)
* Exclusion criteria:
* congenital or acquired skeletal deformities or cardiopulmonary dysfunction,
* had undergone previous orthopedic surgery in lower limbs,
* had abnormal motor development or neurological disease that affect balance
* and gait, and
* behavioral problems causing inability to cooperate during the study.
Almitrine in COVID-19 Patients With ARDS Treated by HFNO

The purpose of this study is to determine the effects of Almitrine administration on oxygenation in COVID-19 patients with acute respiratory distress syndrome treated by high-flow nasal canula oxygen therapy as first-line ventilatory support.

From December 2019, the emergent coronavirus SARSCoV-2 is responsible for the worldwide pandemic of coronavirus disease (COVID-19). Although SARSCoV-2 infection is mainly responsible for mild respiratory symptoms, up to 70% of hospitalized patients with COVID-19-related pneumoniae may develop severe respiratory disease, progressing to acute respiratory distress syndrome (ARDS). These patients may experience severe but well-tolerated hypoxemia, so-called "happy hypoxemia" which may be related to blunted hypoxic vasoconstriction. Almitrine is a selective pulmonary vasoconstrictor that has been reported to improve the oxygenation in ARDS patients by increasing hypoxic pulmonary vasoconstriction. Some small case series reported that the use of Almitrine in mechanically ventilated COVID-19 patients with ARDS improved oxygenation. Given the "happy hypoxemia" phenomenon, it has been suggested to use high-flow nasal canula therapy (HFNO) as first-line ventilatory support in COVID-19 patients with ARDS, since the risk of aerosolization with HFNO was similar to that with standard oxygen therapy and lower to that with non-invasive ventilation. However, the effects of Almitrine in spontaneously breathing patients with ARDS has not been reported so far. Thus, the main goal of this study is to investigate the effects of Almitrine on oxygenation of COVID-19 patients with ARDS treated by HFNO as first-line ventilatory support. The second goal of this study is to determine the effects of Almitrine on respiratory mechanics and hymodynamics.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated by high-flow nasal canula oxygen
2. Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs
3. Persistent severe hypoxemia after awake prone positioning defined by one or more of the following criteria:

   1. SpO2 \< 96% with FiO2 \> 80%
   2. PaO2/FiO2 ratio \< 100 with FiO2 \> 80%
4. Patients treated by Almitrine

Exclusion Criteria:

1. Age \<18 years old and pregnant women
2. Patients under legal protection
3. Patients with a do not intubate or do not resuscitate decision
4. Patients requiring immediate invasive mechanical ventilation
5. Contraindication to Almitrine
6. Poor echogenicity
Effect of Covid 19 Infection on Fetomaternal Outcome

The novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was discovered for the first time in December 2019 in Wuhan (China) and the disease it causes is called coronavirus disease 2019 (COVID-19). Now, this pandemic is rapidly spreading all over the world.

Pregnant have higher rates of COVID-19, associated with hospitalizations, and severe in-hospital outcomes. Immune responses may have a potential role in the diagnosis, treatment, and prognosis of patients with COVID-19. So we need of identifying biomarkers for disease severity and progression.

It is important to define whether a novel virus is transmissible from a mother to her infant, vertical infection, and there are three possible mechanisms for vertical infection - intrauterine infection (including transplacental and ascending infections), intrapartum transmission (during delivery), and postpartum infection. These mechanisms have important implications that can influence obstetrical management decisions, best practice delivery options, and neonatal care (3).

Aim of work To detect the effect of time of infection by COVID 19 on the fetomaternal outcome including vertical transmission, and the immunological and genetic changes during the disease course.

Patients and Methods:

* All pregnant women eligible for the study will undergo detailed medical history.
* Each patient will have the following data: • Patient name. • Age. • Past medical and surgical history. • Menstrual history and contraceptive history: especially emphasis on Last Menstrual Period to determine the exact gestational age.
* Clinical examination of the patients: - General examination of vital data (blood pressure, pulse, temperature, respiratory rate). CBC, PT, PTT, RBS, ALT, AST, serum creatinine), and ultrasound will be done.
* Abdominal examination: to detect any abnormality as intrauterine growth restriction, with serial ultrasound estimation.

Eligibility Criteria:
Inclusion Criteria: Pregnant pt with covid 19 infection (at any gestational age) diagnosis of infection based on any one of the following criteria:

1. Positive RT-PCR nasopharyngeal swab is taken (even if the result became available after labor);
2. Positive rapid antigen test performed before labor
3. Chest computed tomography (CT) scan performed before labor showing changes consistent with pneumonitis secondary to SARS-CoV-2 infection;
4. Positive pre-labor immunoglobulin G or immunoglobulin M antibody test; or
5. Clinical diagnosis made before labor (in the absence of negative RT-PCR swab results).

Exclusion Criteria:

1. Healthy individuals:
2. Acute or chronic infectious disease,
3. And any medication with known influence on immunological factors.
Functional Recovery in Critically Ill Children, the Wee-Cover Multicentre Study

When children suffer from a critical-illness, the investigators focus on resuscitating and saving lives. Once these children leave the pediatric intensive care unit, very little is known about what happens to them - how long it takes for them to recover, how families cope, and what factors that impede their recovery. The specific objective of this research project is to evaluate how children and their families recover after a critical illness.

Research Hypotheses: Following a critical illness in children, 1) the rate and degree of health and functional recovery is influenced by the following factors: age, pre-admission co-morbid status, critical illness severity, discharge functional status, and time to initiating acute rehabilitation; 2) functional recovery is influenced by caregiver burden and health-related quality-of-life (HRQoL).

The Specific Objective of this study is to evaluate the trajectory of health and functional outcomes in children following a critical illness, define poor functional recovery, and evaluate predictors of poor recovery.

The Research Questions for this study are: 1) What are the health and functional outcomes in children affected by a critical illness, at 3 and 6 months following Pediatric Intensive Care Unit (PICU) discharge? 2) What defines poor functional recovery? 3) What are predictors of poor functional recovery in critically ill children? 4) What are the most important and relevant outcomes in critically ill children, from the patient and caregiver's point of view?

Study Design: Prospective Observational Mixed Methods Longitudinal Cohort Study Study Setting: Two Academic Pediatric Centres in Canada - McMaster Children's Hospital and London Health Sciences Centre.

Eligibility Criteria:
Inclusion Criteria:

* Age over 12 months to 17 years
* Admitted to PICU for at least 48 hours
* ≥ one organ dysfunction on admission
* Informed consent of patient/substitute decision maker, and patient assent were appropriate

Exclusion Criteria:

* Patients transferred directly from a neonatal intensive care unit prior to discharge home
* Patients who are already mobilizing well, or are at baseline functional status at time of screening
* Previous enrolment into this study
* Language barrier (i.e. no access to translation services)
The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease

Background/Aims: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. The investigators aimed to evaluate whether tegoprazan would be more effective in controlling symptoms than placebo in patients with laryngopharyngeal reflux disease (LPRD). Methods: This double-blind, randomized, placebo-controlled trial randomly assigned 35 patients suffering LPRD symptom to two groups: Tegoprazan50mg once daily and placebo. The primary end point was complete resolution rate of LPRD symptoms after 8-week medication, and the secondary endpoints were complete resolution rate of LPRD symptoms after 4-week medication, change of reflux symptom index (RSI) and reflux finding score (RFS) from baseline at 4- and 8-week medication.


Eligibility Criteria:
Inclusion Criteria:

* At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks
* Reflux symptom index \> 13 and reflux finding score ≥ 7

Exclusion Criteria:

* Viral or bacterial laryngopharyngitis at present
* History of malignancy of head and neck region, esophagus and stomach
* Previous radiotherapy or endotracheal intubation within three months
* Previous anti-reflux surgery or gastroesophageal surgery
* Diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder
* Taking anti-psychotics, anti-depressants or anti-anxiety drugs
* Anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening)
* Need for continuous therapy with non-steroidal anti-inflammatory drugs
* Pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period
* Abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level \>1.5 upper limit of normal \[ULN\]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase \> 2 ULN) or
* Any other conditions or disease that an investigator considered not appropriate for this study
Effect of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients.

ICU-Protocol.Summary Profuse and tenacious tracheal secretions are a significant factor impeding the weaning process in mechanically ventilated patients in the intensive care unit (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological substances are used as remedies for the treatment of illness, which is based on the "Law of Similars" (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized, double-blind, placebo-controlled study found a statistically significant effect of this remedy on improving the amount of tracheal secretion, timing to extubation and discharge from the ICU among critically ill patients, with no side effects observed.

The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube or tracheostomy and receiving controlled mechanical ventilation in the ICU setting. The quantity of the secretions will be studied, as well as sputum neutrophil count (using direct microscopy). Time to extubation and the need for re-intubation will also be evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The preparations will be administered in the form of small pellet-like globules, which will be placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies administered twice daily with an interval of 12 hours, for a period of up to 14 days or until the patient is extubated. Any adverse event will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* endotracheally intubated or tracheostomy ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment, who is due for Spontaneous Breathing Trial (SBT).
* profuse tenacious, stringy tracheal secretions (from 2+ to 4+)

Exclusion Criteria:

* Unstable septic patients
* Concomitant disease of the larynx and trachea obstructing the airway or inhibiting the extubation process.
* active heart disease.
* Need for catecholamines.
* Pregnancy.
* underlying neuromuscular disorder or any other condition preventing patient cooperation with voluntary coughing and expectoration of secretions.
* underlying conditions requiring continuous therapy with bronchorrheic medications (i.e. myasthenia gravis)
* Patients on home ventilation or BIPAP support
* Failure of the patient or legal guardian to give written informed consent.
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women

The purpose of this study is t o evaluate levator ani morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) ultrasound, and to study the effect of mode of delivery on female sexual function.

1. transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
2. answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.

Exclusion Criteria:

* Refused consent. 2. Previous vaginal or cesarean delivery. 3. Severe mental illness. 4. Severe physical handicap or difficulties in communication. 5. Women without postpartum active sexual life or separate from their spouse. 6. Past history of sexual dysfunction.