cyrilzakka/clinical-trials huggingface dataset:
Hydrolyzed Egg and Tolerance Induction

The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral tolerance induction to egg in children allergic to egg as compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Child of any ethnicity aged between 12 and 66 months at the time of enrolment

  * Positive Skin Prick Test (SPT) to egg white within the last 3 months
  * Either positive oral challenge OR convincing history, defined as an immediate (\<1h) reaction following isolated ingestion of egg, positive SPT to egg white and positive sIgE (\> 0.35 kU/L) for at least one of the following: egg, egg white, ovalbumin, ovomucoid, within the last 12 months
  * Having obtained his/her signed legal representative's informed consent.

Exclusion Criteria:

* History of severe anaphylaxis to egg

  * Significant pre-natal and/or post-natal disease
  * Child on systemic drugs (e.g. antihistamines, beta-agonists, ACE-inhibitors) according to half-life at time of enrolment
  * Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
  * Child whose parents / caregivers cannot be expected to comply with treatment
  * Child currently participating in another interventional clinical trial
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain

In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.

Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as "continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain.

While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature.

This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life.

It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-55
* History of neck pain lasting at least three months
* Agreeing to participate in the study
* Being able to read and write Turkish
* Having a computer or tablet and an active internet connection at home
* To be able to use a computer, tablet and internet at a level to participate in video conference or to have a relative who can help in this regard.

Exclusion Criteria:

* History of spinal surgery
* Traumatic cervical injuries
* Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
* Tumor conditions
* Having vision and hearing problems
* Cognitive problems
* Receiving physiotherapy for neck and/or low back pain in the last 6 months
Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Removal of IgE through adsorption of IgE on a specially designed column after apheresis of blood has the potential to improve the severity of atopic dermatitis.

In this study the investigators will treat patients with a severe form of Atopic dermatitis not responding or having to much side effects to systemic imunosuppressive treatment with this modality.

Patients will be treated with immunoadsorption on 4 consecutive days week 1 and three consecutive days week 5 and week 9.

The clinical improvement and histological and serological tests will be evaluated.

Eligibility Criteria:
Inclusion criteria

1. Adults (\> 18 year) with severe atopic dermatitis (objective SCORAD \> 40)
2. Who's AD is persistent and stable since more than 1 year
3. Who signed the informed consent
4. Who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment
5. Who were treated in the recent past with phototherapy or immunosuppressive therapy ( one or more : cyclosporin A, methotrexate , azathioprine , mycophenolate , systemic corticosteroids ) and where this therapy was not sufficiently helpful, had unacceptable side effects or are contraindicated

Exclusion Criteria:

1. Patients who did not give an informed consent.
2. Patients with mild or moderate AD.
3. Patients with severe AD improving with, and tolerating, standard therapy (including phototherapy, short periods of corticosteroids, the above mentioned immunosuppressive therapies ) and having no contra-indications for these therapies
4. Pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after.
5. Having contra-indications for immunoadsorption:

   * Patients with a known allergy for the material used during immunoadsorption.
   * Severe cardiovascular diseases.
   * Severe bleeding during anticoagulation .
   * Treated with ACE-inhibitors.
   * Patients younger than18 years.
6. Having a malignant disease not under remission
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia

The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).

The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences. The study will enrol a total of 214 study participants including 190 preterm infants randomized controlled trial of HV feedings and 24 mothers of enrolled infants and healthcare workers for in-depth interviews. We will also screen mothers to study participants for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) screening tool.

Study aims are:

Aim 1: To evaluate the impact of high volume (HV) feedings using additionally expressed milk at the end of feeding (hind-milk) vs usual volume (UV) feedings on growth velocity from birth to discharge or 40 weeks' PMA, whichever comes first, among very preterm infants.

Through a 1:1 randomization, the study will enrol 190 preterm infants weighing between 1,000g - 1,999g in both study arms and follow them until hospital discharge or 40 weeks' PMA, whichever comes first.

Aim 2: To evaluate the impact of HV vs UV breastfeeding until 40 weeks' PMA on all-cause neonatal mortality and morbidity (including sepsis, NEC, intestinal perforation, and hypoglycaemia).

All study participants (n=190) will be until 40 weeks' PMA to estimate its impact on all-cause neonatal mortality and morbidity.

Aim 3: To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital and its feasibility by healthcare workers.

A total of 24 mothers and healthcare workers will be interviewed through in-depth interviews (IDIs) to better understand the acceptability of this intervention by the feeding mothers, the feeding tolerance by their newborns, and the feasibility of the same by the healthcare workers.

Eligibility Criteria:
Inclusion Criteria:

* Between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams,
* Admitted to the UTH NICU within 24 hours after birth, and
* Infants who have reached feeding volume ≥120 mL/kg/day at time of randomization

Exclusion Criteria:

* Who are deemed unstable by the neonatologist,
* With necrotizing enterocolitis or intestinal perforation
* Known gastrointestinal malformations,
* Major malformations or congenital anomalies, and
* Whose parents do not provide informed consent
A Study of LY3819469 in Participants With Impaired and Normal Renal Function

The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
* Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial

Participants with Normal Renal Function:

* Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

* Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis
* ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing

Exclusion Criteria:

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemia symptoms
* Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
* Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year
Impact of Salpingectomy on Ovarian Reserve

Epithelial cancer of the ovaries is the most severe form of gynecologic cancer; a significant proportion of ovarian cancers originate from the Fallopian tube. Guidelines therefore now recommend systematically associating prophylactic salpingectomy to benign hysterectomy. The principal objective of the present study is to assess the impact of salpingectomy on ovarian reserve by anti-Müllerian hormone (AMH) assay and calculating the Doppler index of vascular resistance in the ovarian vessels. The secondary objective is to compare ovarian reserve results between two coagulation techniques used in salpingectomy: bipolar electric energy versus ultrasound.

The study design is single-center, prospective, before-and-after, with open randomization between two groups defined by coagulation technique.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged 18
* Scheduled surgery: bilateral laparoscopic salpingectomy associated to hysterectomy for benign indication

Exclusion Criteria:

* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy, ongoing or planned during the study period
* History of bilateral salpingectomy
* Salpingectomy associated with pelvic cancer
* Oral hormonal contraception during the study period
* Menopause
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision.
The Leaky Lung Test

This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.

A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.

Eligibility Criteria:
Inclusion criteria: Asthma The diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. Consistent historical features of asthma include episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). Consistent physical findings of asthma include audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. Subjects will need to be free of asthma symptoms at time of challenge testing. Most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test.

Inclusion criteria: Non-asthmatic controls Healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. Healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. Healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test.

Exclusion Criteria:

1. \>5 pack year history of tobacco use or active smoking.
2. Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
3. History of significant renal insufficiency of liver disease
4. Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
5. Asthma subjects with a baseline FEV1\<65% predicted
6. Asthma subjects unwilling or unable to withhold medications prior to testing
7. Pregnant women.
Efficacy and Safety of Ultrasound Hyperthermia Combined With Chemotherapy on Oral and Maxillofacial-Head and Neck Cancer

The purpose of this study is to determine whether Ultrasound Hyperthermia is effective and safe in the treatment of Oral and Maxillofacial-Head and Neck Cancer.

As a non-invasive treatment, Ultrasound Hyperthermia has received increasing interest for the treatment of cancer.Many studies have shown that Therapeutic Ultrasound is safe and effective. Eligible patients were randomly assigned by using permutated blocks designed for each site to receive either Ultrasound Hyperthermia combined with chemotherapy (Arm A) or chemotherapy alone(Arm B).Chemotherapy will be conducted as follows. For Squamous cell carcinoma of head and neck,it will be administrated with Docetaxel(at a dose of 75 mg per square meter of body-surface area and intravenous infused in 1 hr at day 1rt), Cisplatin(at a dose of 75 mg per square meter of body-surface area and intravenous infused in 1 hr at day 1rt) and Fluorouracil(at a dose of 75 mg per square meter of body-surface area and intravenous infused last 5 days) . For other types of cancer,the treatments will be administrated in accord with the guideline.In addition,Ultrasound Hyperthermia will be conducted 5 times(day 1rt,3rd,5th,7th,9th) in Arm A. Patients in arm B will receive chemotherapy only. One cycle comprises a period of 3 weeks (21 days).All patients will receive 2 cycles in both arms. All the patients eligible for the operation will take surgery. After treatment，some patients with advanced unresectable cancer may be down-staged from stage IV, and will regain the opportunity of operation.

Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntary and signed informed consent form
* Age 18-75，both genders.
* Had histologically or cytologically confirmed advanced squamous cell carcinoma of the head and neck
* At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm .
* Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2.
* Life expectancy of more than 6 months.
* Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
* Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10\^9/L
* Hepatic function:ALAT、ASAT\< 2.5 x ULN, TBIL\< 1.5 x ULN
* Renal function: Creatinine \< 1.5 x ULN

Exclusion Criteria:

* Participation in other interventional clinical trials within 1 month
* Previous received other drug or operative treatment within 6 month
* Pregnant or breast-feeding women
* History of serious allergic or allergy
* Patients with the history of Serious lung or head disease
* Local skin ulceration
Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older

The purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back (relapsing). Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make leukemia cells grow.

The study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects, 60 years and older, with AML in complete remission (CR) after consolidation therapy. Prior to enrollment, patients will receive 1 or 2 cycles of induction chemotherapy. Patients who attain a CR will receive 1 or 2 cycles of consolidation chemotherapy. Patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study. Subjects enrolled in the study are treated with tipifarnib A dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events. Postconsolidation treatment with tipifarnib continues until the time of relapse, death, completion of 24 cycles of treatment, or discontinuation as advised by study doctor.

Tipifarnib, film coated, compressed tablets containing 100 mg active drug, will be administered orally at a dose of 300 mg (three 100 mg film coated tablets) taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed AML
* Leukemia in remission
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Acute Promyelocytic Leukemia (APL)
* Previous History of myelodysplasia or antecedent hematologic malignancy
* Previous therapy with a farnesyl transferase inhibitor
Obstructive Sleep Apnoea in Ehlers-Danlos Syndrome

Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in patients with EDS is unknown.

Aortic root dilation and dissection are common complications of EDS and little is known about the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not yet been investigated.

The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100) compared to a matched control group (100). The secondary objective of this pioneer study is to assess whether there is a relationship between OSA severity and aortic diame-ter/craniofacial abnormalities in EDS patients.

Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in patients with EDS is unclear.

Aortic dilation and dissection are complications associated with EDS and little is known about the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not yet been investigated.

The primary objective of this study is to assess the prevalence of OSA in EDS-patients compared to a matched control group. The secondary objective of the study is to assess whether there is a relationship between OSA severity and craniofacial phenotypes / aortic diameter in EDS patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Diagnosis of Ehlers-Danlos Syndrome (not for control group)

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Continuous positive airway pressure treatment for OSA during sleep study
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnant patients
Cost Evaluation of Venous Leg Ulcers Management

The purpose of this study is to evaluate direct costs of Venous Leg Ulcers (VLU) management when two different compression systems are used.

The purpose of this study is to evaluate direct costs of Venous Leg Ulcers management when two different compression systems are used. Micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages.

Perspective of costs will be Public Health Insurance. Time horizon will be 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* consent to participate
* ambulatory management
* 1 to 3 leg ulcers
* leg ulcers below the knee and above ankle
* no contra-indication to wear compression bandage
* not currently treated by one of the investigational devices

Exclusion Criteria:

* cognitive impairment
* opposition to wear compression bandage
* bedridden
* pregnancy