cyrilzakka/clinical-trials huggingface dataset:
Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants

The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:

1. Decreasing cleft gap.
2. Attaining columellar length.
3. Effect on maxillary growth.
4. Treatment Duration.
5. Parents acceptance.


Eligibility Criteria:
Inclusion Criteria:

1. The age range from 14 -30 days after birth.
2. Has complete cleft lip and palate.
3. Parents acceptance.
4. Medically free infants.

Exclusion Criteria:

1. Syndromic patients.
2. Medically compromised patients contradicting operation.
Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adults over the age of 18
* Diagnosed obstructive sleep apnea (defined as an RDI \> 5 events per hour \& ≥ 90% of disordered breathing events classified as obstructive)

Exclusion Criteria:

* Total sleep time from previous sleep study \< 4 hours (240 minutes)
* Severe bilateral nasal obstruction (apparent mouth breathing at rest)
* Documented history of lung diseases, as defined below:
* Daytime hypercapnia (PaCO2 \> 45 mmHg)
* Baseline SaO2 ≤ 92%
* Chronic lung disease except mild intermittent or mild persistent asthma
* Cor pulmonale
* Documented clinical cardiovascular disease, as defined below:
* Myocardial infarction in past 3 months
* Revascularization procedure in past 3 months
* Implanted cardiac pacemaker or ICD
* Unstable arrhythmias
* Congestive heart failure with ejection fraction \< 40%
* Uncontrolled hypertension (BP \> 190/110)
* History of end stage renal disease (on dialysis)
* History of end stage liver disease, such as:
* Jaundice
* Ascites
* History of recurrent gastrointestinal bleeding
* Transjugular intrahepatic portosystemic shunt (TIPS) ;
* Sleep disorders other than obstructive sleep apnea, such as:
* Narcolepsy
* Restless leg syndrome
* Periodic limb movements causing an arousal index of \> 5 per hour
* Transportation industry worker (commercial truck or bus drivers, airline pilots)
* Known pregnancy (by self report)
* Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.
* Allergy to lidocaine
Collaborative-care Rehabilitation After Dysvascular Amputation

The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes and/or Peripheral Artery Disease
2. Unilateral transtibial amputation \< 6 months prior to screening
3. Household ambulation using definitive prosthesis prior to baseline testing
4. Participation in physical rehabilitation at time of baseline testing
5. Live within 45 minutes of a participating clinic

Exclusion Criteria:

1. Require wheelchair for mobility (use prosthesis for transfers only)
2. Ankle-level or above amputation on contralateral limb
3. Traumatic or cancer-related amputation
4. Uncontrolled heart condition
5. Acute systemic infection
6. Pregnancy
7. Decisionally challenged
8. Prisoners
Kyphoplasty With Structured Titanium Spheres

The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).

Randomized controlled open trial with P.R.O.B.E. design (Prospective Randomized Open, Blinded End-point)

Objective:

The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).

All consecutive eligible patients, belonging to the Neurosurgery Unit of A.R.N.A.S. Civico Hospital, in Palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm.

* Patients aged between 18 and 80 years.
* Diagnosis of vertebral body fracture, type A (according to Magerl classification) in particular A.1, A.2 and A.3.1.
* Absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by RX TC and NMR.
* Refusal to sign informed consent,
* Diagnosis different from those established by inclusion criteria.
* Age under 18 years.
* Age over 80 years.
* Presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by RX, TC and NMR.

For each patient will be evaluated:

* Spine RX
* CT of the spinal layer (or Spine CT)
* Spine MRI
* Roland Morris Disability (for the assessment of low back pain)
* EQ-5D (health questionnaire)
* Denis Work Scale (for the assessment of working conditions)
* VAS (for pain assessment)
* The statistical analysis will be performed using the SPSS software vers. 12.0 (SPSS Inc., Chicago, IL, United States). The study data will be collected pursuant to and for the purposes of articles 13 and 23 of the D. L.gs. n. 196/2003.

The study will be performed according to the rules established by the principles of Good Clinical Practice (as per Ministerial Decree of 07/15/97) and according to the principles gathered in the Helsinki Declaration (52 nd WMA General Assembly version, Edimburgh, Scotland, October 2000 ).

The clinical practices are performed according to the most recent recommendations of the World Medical Assembly (Declaration of Helsinki, 1964, and subsequent amendments).

Eligibility Criteria:
Inclusion Criteria:

* Magerl Type A Thoracolumbar fracture with no neurological deficits
* Age\>18yy and \< 80yy
* No ligament lesions

Exclusion Criteria:

* age \< 18yy or \> 80yy
* Ligament lesions
* refusal to sign informed consent
The Cardiovascular Effects of Nitrogen Dioxide Exposure

Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. It has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. Recent studies using an inline retrofit particle trap to reduce the particulate component of exhaust have shown that filtering particles leads to a reversal of the endothelial dysfunction seen after diesel exhaust exposure, and have even suggested an augmentation of vascular function. This raises the question of the cardiovascular effects of the gaseous pollutants, the most abundant of which is nitrogen dioxide. In this study we plan to investigate the cardiovascular effects of nitrogen dioxide exposure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current smokers
* Significant occupational exposure to air pollution
* Regular medication use
* Intercurrent illness
The Influencing Factors and Mechanism of High Incidence of Thrombotic Events in Patients With MN and DKD

Influence factors and preliminary mechanism of high incidence of thrombotic events in patients with idiopathic membranous nephropathy and diabetes kidney disease

According to the results of renal biopsy, the patients were divided into three groups: membranous nephropathy group (MN), non-membranous nephropathy group (non-MN) and diabetes kidney disease group (DKD). Collect the basic data and TEG test results of the enrolled patients. (1) ① According to TEG results, the enrolled patients were divided into two groups: hypercoagulable group (CI \> 3) and non-hypercoagulable group (CI ≤ 3). The basic data and related laboratory indicators of the two groups were compared - to explore the influencing factors of hypercoagulable (objective X); ② Compare the parameters related to TEG and coagulation routine between MN group and non-MN group, DKD group and non-MN group respectively - find out the coagulation index (target Y) of the difference between groups; ③ Build regression models for different target Y - explore the influencing factors of grouping variables (MN vs non MN or DKD vs non MN) on Y after adjusting other covariates; (2) ① According to whether the patients in the group had thrombotic events or not, all the patients in the group with thrombotic events were divided into MN thrombotic events group and non-MN thrombotic events group according to pathological diagnosis, and the TEG, coagulation and other related laboratory results and basic data between the two groups were compared (explore the unique factors and processes that affect the occurrence of thrombotic events in MN group compared with non-MN group); ② According to whether the patients in the MN group who were hospitalized for many times had thrombotic events, the patients were divided into the MN group with thrombotic events and the MN group without thrombotic events. The TEG, coagulation and other related laboratory results and basic data between the two groups were compared (to explore the factors and processes that affect the occurrence of thrombotic events in the MN group).

Eligibility Criteria:
Inclusion Criteria:

1. Primary glomerular disease patients with renal biopsy results (without hormone or immunosuppressive therapy) and patients with clinical diagnosis of diabetes kidney disease;
2. Age 18-70;
3. The liver function is normal.

Exclusion Criteria:

1. Other secondary kidney diseases except diabetes; Acute renal injury; Chronic kidney disease stage 5;
2. There are risk factors of hypercoagulability, such as acute infection, recent trauma, surgery or cancer, pregnancy;
3. Anticoagulant and antiplatelet drugs were given within one week;
4. Plasma infusion, plasma exchange or hemodialysis within one month;
5. There is a history of thrombotic disease or hemorrhagic disease before renal puncture;
6. Participated in other clinical studies within three months.
Validation of a Hypertension Education Program

The primary purpose of this study is to assess the effect of participating in the interactive hypertension education program of the German Hypertension League (DHL©) "My blood pressure - OK!" on office systolic blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* \> 21 years of age
* Primary arterial hypertension
* Office blood pressure between 140/90 mmHg and 160/100 mmHg

Exclusion Criteria:

* Participation in another clinical study
* Unstable clinical condition
* Secondary arterial hypertension
* Dementia
* Major disability (modified Rankin-Scale \> 4)
* Severe chronic kidney disease (serum creatinine \> 2.0 mg/dL or estimated glomerular filtration rate \< 40 ml/min/1.73m2)
* Liver disease including history of hepatic encephalopathy, esophageal varices or portacaval shunt
* History of gastrointestinal operation or disease with a potential influence on drug absorption
* Allergy or other contraindications against drugs given during the study
* History of non-compliance
Multisensory Telerehabilitation for Visual Field Defects

Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements.


Eligibility Criteria:
Inclusion Criteria:

* Acquired homonymous visual field defect (HVFDs) due stroke, traumatic brain injury, tumor, surgery for epilepsy in a chronic stage of illness (time from the lesion \>6 months)
* Normal hearing
* Normal or corrected-to-normal visual acuity

Exclusion Criteria:

* cognitive decline (adults)
* intellectual disability (children)
* major neurological or psychiatric disease
* being enrolled in another therapy for HVFDs

not being enrolled in another VFDs therapy.
Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis

This clinical trial will compare antibiotic therapy with laparoscopic appendectomy in the treatment of pediatric chronic appendicitis in china. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive antibiotic therapy with intravenous Ceftazidime sodium, while the other half will have a laparoscopic appendicectomy.

In recent years, nonoperative treatment has challenged appendectomy as a first-line treatment of acute uncomplicated appendicitis by demonstrating its safety and short-term efficacy in adults. Several randomized controlled trials comparing appendectomy to antibiotics alone in children with acute uncomplicated appendicitis have been reported from other countries. These studies reveal that non-operative management of appendicitis is a safe treatment for appendicitis and is associated with a significantly lower risk of complications than appendectomy. However, the success rate of nonoperative management was 75% at 1year. Chronic appendicitis has been described as a possible cause of persistent right lower quadrant (RLQ) pain and laparoscopic appendectomy has been shown to benefit a large number of children，but there are no high-quality clinical trials. There are more than 200 million children in China. According to preliminary clinical data, the incidence of pediatric appendicitis in China is higher than Europe and America. Due to the Chinese parents have different cultures and educational backgrounds, more high-quality clinical trials are needed to guide parents to choose appropriate treatment for chronic appendicitis in children. Therefore, the investigators propose a multi-institutional trial in which patients and their families choose between antibiotics therapy (AT group) or laparoscopic appendectomy (LAAPT group) to chronic appendicitis in children aged 3-15 years. The investigators hypothesize that laparoscopic appendectomy will be successful in 90% of patients at 1 year follow-up and will be associated with fewer disability days, higher quality of life scores, and higher pain reduce scores than antibiotic therapy. This study will enroll 200 patients, age 3-15 years, with chronic appendicitis at 8-10 hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were eligible if they were between 3 and 15 years of age, and they suffered from chronic appendicitis.
2. US showing hyperemia and fecalith, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no phlegmon or CT showing hyperemia and fecalith, fat stranding, ≤ 1.1 cm in diameter, no abscess, no phlegmon.

Exclusion Criteria:

1. Exclusion criteria consisted of (a history of) chronic back pain
2. previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization)
3. specific gastro-intestinal entities (such as inflammatory bowel disease) 4.gynaecological disease (all female patients consulted a gynaecologist)
School Based Malaria Control in Ugandan Schoolchildren

The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 6 - 14 years
* Pupils enrolled at participating school
* Willingness of the parent/guardian to provide consent
* Provision of assent by pupil (those above 8 years)

Exclusion Criteria:

* Known allergy or history of adverse reaction to study medications
* Intention of changing of schools during the follow-up period
* History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care
Study of Influenza Virus Infection in Children Hospitalized in Spain in Two Consecutive Influenza Seasons

This is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed

A better knowledge in our environment of the characteristics of the Influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls under 15 years of age.
* With a clinical diagnosis of influenza virus infection.
* With infection by influenza virus confirmed microbiologically.
* Hospitalized more than 24 hours

Exclusion Criteria:

* Age equal to or greater than 15 years.
* That the clinical diagnosis is not influenza virus infection.
* Influenza virus not confirmed by microbiological diagnosis.
* Not hospitalized or hospitalized for less than 24 hours.
bIosimilar of aDalimumab, an European evAluation

The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male or female.
2. Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
3. Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
4. Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
5. Patients able to understand and complete the study questionnaires in local language during the study visits.
6. Patients willing to sign informed consent to meet data protection requirements

Exclusion Criteria:

1. Unwillingness to provide written informed consent.
2. Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
3. Patients not expected to be available for study visits during 12 months.
The Effect of Olive Oil and Centaury Oil on Rash

Diaper dermatitis is a preventable health problem. No study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. This study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis.

Diaper dermatitis is estimated to have an incidence of between 7% and 35%, although the prevalence cannot be determined precisely because it is not usually seen as a disease by parents and most patients are treated at home. Prevention of diaper dermatitis should be the main approach in treatment and care. Once it occurs, the aim of treatment is to accelerate the healing of the damaged area and prevent its spread. In the prevention and treatment of diaper dermatitis, practices such as ventilating the baby's diaper, changing the diaper frequently, keeping the area dry, cleaning with appropriate methods, using barrier creams and not tying the diaper tightly have been reported to be beneficial.

In the literature, studies using methods such as water, herbal cream (chamomile cream, calendula cream, aloe vera cream), barrier cream (zinc oxide) and herbal mixture (honey, beeswax, olive oil) were found in the treatment of infants with mild to moderate diaper dermatitis. It has been stated that the rates of diaper dermatitis will continue to increase if parents are not given adequate information about appropriate care and which products are beneficial or even harmful. In conclusion, diaper dermatitis is a preventable health problem. No study evaluating the efficacy of olive oil and centaury oil in diaper dermatitis was found in the literature. This study will be conducted to examine the effect of olive oil and centaury oil in the management of diaper dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* The baby has mild diaper dermatitis according to the diaper dermatitis severity rating scale
* The baby receives antibiotic treatment
* The baby gets additional food
* The baby is between 6-18 months

Exclusion Criteria:

* Infants with moderate or severe diaper dermatitis according to the diaper dermatitis severity rating scale
* Babies with open wounds on the perineum,
* Babies with any skin disease
* Babies who use barrier creams or special oils in routine care
How Useful is the Advice: "Fill up a Handful of Sunscreen and Spread it All Over Your Body"

The advice: "Fill up a handful of sunscreen and spread it all over your body" is used in several sun safety campaigns. The hope is that users in swimwear following the advice will apply a sunscreen quantity of 2 mg/cm\^2 to all accessible skin. The present study is the first to investigate how this advice works in practice.


Eligibility Criteria:
Inclusion Criteria:

- European descent

Exclusion Criteria:

* Skin disease
* allergy to the content in sunscreen
* Pregnancy
* Breastfeeding
Oral Health and Psychosocial Factors During the Covid-19 Pandemic

This prospective observational study examines the effects of the Covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in Covid-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Residence in Germany
* Understanding of study participation and consent

Exclusion Criteria:

* \<18 years old
* Residence outside of Germany