cyrilzakka/clinical-trials huggingface dataset:
A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

Eligibility Criteria:
Inclusion criteria:

* Children suffering from primary nocturnal enuresis with no organic pathology.
* Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
* Children with a minimum of 6 wet nights in 2 weeks.

Exclusion criteria:

* Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
* Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
* Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
* Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients

The aim of the study is to provide clinical decision support to healthcare professionals using a wearable for non-invasive multimodal monitoring, allowing early detection of disease progression to severe forms, as well as the detection of significant clinical events.

For the development of the study, 500 individuals with COVID-19 in home confinement will be randomly assigned to form part of the control group, which will be followed conventionally by Primary Care Professionals, or to the experimental group, which will also be provided with the wearable device for non-invasive multimodal monitoring linked to an App for transfering data. Furthermore, the patient will be able to interact with the application on three times daily by indicating the symptoms contemplated and answering the decision clinical questions. In this way, alarms can be generated in the presence of symptoms or significant alterations in the parameters monitored by the device, which the health professionals of the Primary Care teams included in the study will evaluate at the appropriate time, taking the best decision in each case.

As variables to be considered in order to compare the effectiveness of the system against the conventional monitoring protocol, complemented with real-time patient notification of symptoms, certain variables will be collected, such as:

Baseline variables:

* Age, sex, date of COVID-19 positive diagnosis (PCR or antigen test).
* Stage of clinical progression of the disease: according to the Primary Care COVID-19 management
* Information collected in the telephone clinical assessment questionnaire in the home follow-up of the patient with SARS-CoV-2 infection

Variables generated by the study follow-up:

* Vital signs covered by the Bakeey E66 smartwatch device: temperature, respiration rate (RR), heart rate (HR) and oxygen saturation (SatO2)
* Clinical symptoms covered by the Home App for submission by the patient: cough, fever, chest pain, respiratory distress (dyspnoea), vomiting and diarrhoea.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of SARS-CoV-2 disease, detected by PCR or antigen test, performed 72 h prior to patient inclusion in the study.
* Acceptance to sign the informed consent document.
* Possession of a Smartphone or Tablet with Internet connection.
* Possession of mental faculties to participate in the study.

Exclusion Criteria:

* Age below the age of health majority (16 years).
* Lack of digital skills to use the Home App.
* Cognitive impairment that prevents the patient from participating in the study.
* Disabling pathology of the upper limb.
Investigation Of Transcutaneous Auricular Vagus Nerve Stimulation Efficacy In Female Fibromyalgia Patients

This study aimed to examine the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, depression, anxiety, functionality, and autonomic function in fibromyalgia syndrome (FMS).

primary hypothesis: TAVSS application is not an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.

secondary hypothesis: TAVSS application is an effective treatment for depression, physical limitation, functional disability, anxiety, pain and autonomic nerve system in female FMS patients.


Eligibility Criteria:
Inclusion Criteria:

* Female volunteer participants
* Aged 18-45 with regular menstrual cycles
* Diagnosed with FMS (Widespread Pain Index≥ 17
* Symptom Severity Scale≥ 21) according to the 2013 ACR diagnostic criteria by a specialist physician.

Exclusion Criteria:

* Neurological deficits,
* Diabetes
* Neuropathic disorders
* Chronic inflammation
* Immune deficiencies
* Cardiac diseases
* Pregnancy
* Being in the perimenopausal or postmenopausal stages,
* Menstrual cycles of less than 28 days,
* Started new medication within the last 3 months,
* Modifications to their existing treatment apart from taVNS.
Evaluation of Immunoregulatory Cells in Hematopoietic Stem Cell Transplant

The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease.

The investigators' hypothesis is that the graft-versus-tumor effect can be enhanced while minimizing the complications of graft-versus-host disease (GVHD) by determining the qualitative and quantitative changes in T regulatory cells throughout the transplant process. Their understanding of this can lead to new treatment strategies and improved clinical therapeutic implications.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-70 years old undergoing either autologous transplant or allogeneic transplant for various hematologic conditions

Exclusion Criteria:

* Patients \< 18 or \> 70 years old undergoing either autologous transplant or allogeneic transplant
Effectiveness of the Educator Well-being Program

Using a stepped wedge design (prospective cohort with concurrent controls) among six paired, elementary schools, investigators will implement and evaluate the Educator Well-being Program. The investigators will evaluate whether the process improves organizational-level factors, teacher mental well-being (stress, depression and anxiety symptoms).


Eligibility Criteria:
Inclusion Criteria:

* All staff aged 18 years or older at the time of survey administration within the three school districts will be eligible for participation.

Exclusion Criteria:

* None.
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole

Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile


Eligibility Criteria:
Inclusion Criteria:

* All primary and secondary. Infertility due to anovulation

Exclusion Criteria:

* Male factor infertility, tubal factor.
* Endocrineopathy
* Hypothyrodism
* Morbid obesity
* Under weight
* Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.
Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis

The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. With pericapsular nerve group block (PENG), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint. Intra-articular injection of corticosteroids; It is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method. The investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of post-procedural pain scores and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Hip pain NRS \> 4
* No pathologies in the laboratory and coagulation parameters

Exclusion Criteria:

* Rheumatological disease with hip involvement
* Systemic active infection
* Malignancy
* History of hip joint surgery
* History of traumatic hip injury
* Platelets values \< 150.000 / µl
* History of bleeding disorder
Platelet Transfusions in Critically Ill Patient

Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).

Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.

International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.

This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit

Exclusion Criteria:

* Age less than 18
Vulvar Disease in Nigeria Observational Study

Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria


Eligibility Criteria:
Inclusion Criteria:

* biological females - afab

Exclusion Criteria:

* none-afab
Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival.

CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.

A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR).

Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged.

The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse.

This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)

Exclusion Criteria:

* The patients not included or discharged prematurely from the STIM1 Study can not participate to the study
Establishing Czech Norms of Selected Standardized Tests

The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.

The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.

The Czech updated manuals for those tests were made by back-translation method and updated for unification of recommended three trials of each subtest administration and interpretation of tested individuals performance.

At least 540 individuals (20-65 years old) will be tested by the updated Czech manuals till the end of 2023 by those three tests. The Czech norms will be established from acquired data.

Eligibility Criteria:
Inclusion Criteria:

* Czech language as a mother tongue
* age from 20 to 65 years

Exclusion Criteria:

* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague
Assessing a New Proforma for Maternal Cardiac Arrest

During the Multidisciplinary Obstetric and Midwifery Simulation (MOMS) course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link.

The delegates observing the cardiac arrest scenario will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma.

The use of standardised proformas can improve the quality and completeness of data collection in healthcare settings. In a previous study we have found that medical records examined by the Confidential Enquiries into Maternal Deaths (CEMD) 2009-2012 were variable in their quality, often poor and in need of improvement. In view of this, we have developed a proforma to assist the quality of record-keeping during maternal cardiac arrest, using a modified Delphi process amongst a multidisciplinary group of CEMD assessors. The present application is for a study evaluating clinicians' views of this proforma and its usefulness in a simulator setting (as maternal cardiac arrest is so rare, evaluation in actual cases would be a very lengthy and expensive venture; such a study would have to be multicentre and would require a preliminary evaluation such as the one being proposed here, anyway).

One hundred participants will take part in the study during the routine Multidisciplinary Obstetric and Midwifery Simulation (MOMS) training course at the Chelsea and Westminster Hospital. During the course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link. A brief information sheet and explanation will be provided before consent is sought to take part in the study.

During the cardiac arrest scenario, the delegates observing will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. Delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma. All of the data will be collected pseudo-anonymously.

Eligibility Criteria:
Inclusion Criteria:

* Delegates taking part in the routine Multidisciplinary Obstetric and Midwifery Simulation training course at the Chelsea and Westminster Hospital.

Exclusion Criteria:

* Unwillingness to participate and provide written consent.
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older)
* Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
* Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
* Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
* Bilateral thumbs included

Exclusion Criteria:

* \<18 years age
* Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
* Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
* History of opioid dependency or current chronic opioid use
* Contraindication to acetaminophen use
* Contraindication to NSAID use
* Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
* Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
* Contraindication to multivitamin use
* Liver dysfunction
The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children

the investigators hypothesis is that milk consumption, either in the acute phase and through prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation. the investigators aim to objectively prove this by examining respiratory symptoms and signs and objectively measuring parameters of airway inflammation and hyper responsiveness after consumption of cow milk or soy milk substitute.

In this prospective single blinded placebo controlled trial, acute milk consumption will be evaluated. 50 asthmatic and 50 healthy children aged 6-18 will drink 240 ml of cow milk or soy milk substitute. Respiratory symptoms by questionnaire and physical examination will be evaluated. Airway response and inflammation will be assessed by fraction of exhaled Nitric Oxide (FENO) and spirometry before and after the exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Asthmatic children

Exclusion Criteria:

* Known allergy to cow milk
* Children had upper / lower respiratory disease in two weeks prior the study.
* Children who had been treated in systemic steroids in the month prior the study.
* Intolerant children to cow milk.
Cardiac Output Monitoring in Aortic Aneurysm Surgery

To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair

Exclusion Criteria:

* Patients not giving informed consent.
* Patients under the age of 18 years.
* Patients who may be pregnant
* Patients with learning disabilities.
* Rhythm other than sinus rhythm.
* Patients on oral lithium therapy.
* Patients less than 40kg
* Patients with severe mitral regurgitation
"Sport on Prescription" in Primary Care for Patients With Long-term Illnesses

Adapted Physical Activity (APA) helps to prevent chronic diseases identified as major causes of mortality, particularly cardiovascular diseases and some cancers, according to the World Health Organization (WHO). However, in general population, physical activity levels are below recommendations for nearly 40% of french adults. In France, general practitioners are now authorised and encouraged to prescribe APA to long-term illness patients.

In Var department in France, the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA on a regular basis. This program helps long-term illness patients to restart physical activity by considering their pathology.

The aim of this study is to evaluate " Maison Sport-Santé 83 " APA program effectiveness using a rigorous scientific methodology.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a long-term illness of any type, or a chronic illness, or risk factors (such as hypertension or obesity), or persons with decreasing independance and a stabilised clinical condition
* Aged 18 years old or over
* Able to express his/her consent prior to participation in the study
* Understanding french language
* Affiliated to or beneficiary of a social security regimen

Exclusion Criteria:

* Patient with a contraindication to physical activity
* Pregnant women
* Patient under judicial protection (guardianship, curatorship...) or safeguard of justice
* Any other reason that, in the opinion of the investigator, might interfere with the evaluation of the study objectives