cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
* Negative screening test results
* Notified associated factors
* Menopause, surgically sterilized women or women using effective contraceptive method
* Good understanding and predictable adherence to the protocol
* beneficiary/affiliated to French social security/social healthcare
* signed Informed Consent Form

Exclusion Criteria:

* Predictable poor adherence
* Pregnant or breastfeeding women
* Myasthenia
* Treatment with aminoglycosides
* Major mental disorders
* Underlying etiology
* Vulnerable subjects (particularly adults under guardianship)
* Any reason deemed relevant by the investigator
* Current or former (in the last 3 months) participation to another clinical trial
Dental Safety Profile of High-Dose Radioiodine Therapy

We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.

Sialadenitis and xerostomia are the most frequent adverse events of high-dose radioiodine therapy. Saliva has vital functions in maintaining periodontal and oral health. Therefore, xerostomia not only impairs quality of life permanently, but may also increase the risk of caries and tooth extractions. Nevertheless, despite more than 6 decades of radioiodine therapy for thyroid cancer, large studies on long-term oral adverse events are still lacking. In the present study, we investigate the influence of high-dose radioiodine therapy on the long-term oral health.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed differentiated thyroid cancer
* status after total thyroidectomy
* status after subsequent high-dose radioiodine treatment
* regular follow-up by a board-certified dentist
* a minimum follow-up of 1 year after radioiodine therapy.

Exclusion Criteria:

* anaplastic thyroid cancer
ATtention Test and Executive Functions After STroke to Predict Depression.

The purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression.

1. Baseline visit: after neurologic stability, 14 days or less after stroke and before discharge.
2. First assessment :

   1. Neurologic data: morphologic data (MRI of the brain), stroke severity (NIHSScore), aphasia assessment (Boston Diagnostic Aphasia Examination) if NIHS verbal score ≥1, hemineglect assessment (Bells test).
   2. Personal data assessment :

   i. Socio demographic : age, gender, marital status, employment, level of education ii. Medical history: medical treatments, psychiatric and non psychiatric history.

   c. Psychiatric assessment i. Mini International Neuropsychiatric Interview - depression ii. Beck Depression Inventory iii. Clinical Global Impression iv. Standardized Assessment of Personality - Abbreviated Scale (SAPAS) v. Fageström-C vi. Alcohol Use Disorders Identification Test (AUDIT-C) d. Cognitive assessment: i. Verbal memory : Dubois's five words ii. Clock drawing test iii. D2test (computerized) iv. Verbal fluency (Cardebat) v. Working memory (digit span WAIS 3) vi. Brixton (computerized)
3. Assessment 3 months after the first assessment. Phone call and psychiatric assessment: MINI depression, Beck Depression Inventory. Barthel index and Quality of Life assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Ischemic or hemorragic stroke, diagnosed with radiology : cerebral CT or MRI, 14 days or less after stroke
* Signed Consent
* Social insurance regime affiliation

Exclusion Criteria:

* Death
* No possibility of follow-up
* No French-speaker : insufficient command of French
* Deprivation of liberty : judicial or administrative decision
* D2 test assessment impossibility
* Aphasia with major disorder of the understanding (Boston \<8)
* Antidepressant treatment during stroke
* Depression during stroke
* protected people
Cranial Electrotherapy Stimulation in Burned Patients

To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to some or all of those symptoms.

The purpose of this research study is to systematically determine if CES therapy is effective in managing post traumatic stress disorder (PTSD) in the burn patient. Cranial Electrotherapy Stimulation (CES) is the delivery of low-level electrical stimulation across the head, delivered with ear lobe electrode clips or self-adhesive electrode pads. CES in the current form has been used for the past 30 years to successfully treat anxiety, depression, insomnia and pain in a variety of patient populations. This FDA approved medical device is non-invasive and has no reported significant side effects. It will be used on patients undergoing outpatient rehabilitation in our burn center.

Eligibility Criteria:
Inclusion Criteria:

* burned patients requiring outpatient physical or occupational therapy in the USAISR Burn Rehabilitation Gym or Center for the Intrepid
* Able to read and speak English
* Between ages of 18-65 years
* Screen positive (score greater than 44) on the PCL-M/C instruments

Exclusion Criteria:

* pregnant patients
* patients with implantable pacemakers or electronic stimulators
* patients scoring below 44 on the PCL-M/C instrument
* patients who previously used CES therapy
Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)

The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.

Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied.

The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs
* Receiving invasive or noninvasive mechanical ventilation
* Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV

Exclusion Criteria:

* Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
* On home BiPAP or CPAP
* Depressed sensorium as evidence by Glasgow Coma Score \< 10, need for continuous sedation with Riker Score \< 2 and inability to follow verbal commands for sustained 3 hours
* Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
* Severe hemodynamic instability (BP\< 90 mmHg despite vasopressor therapy) and sepsis
* Recalcitrant hypoxemia (inability to sustain SaO2 \> 88%)
* Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)
Studying Genes in Samples From Younger Patients With Relapsed Acute Lymphoblastic Leukemia

This laboratory study is looking into genes in samples from younger patients with relapsed acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

OBJECTIVES:

I. To identify global changes in the epigenome and various underlying histone modifications that characterize relapsed acute lymphoblastic leukemia (ALL).

II. To identify specific transcription factor-binding sites associated with histone alterations.

III. To correlate gene expression changes of differentially regulated genes at relapse with underlying chromatin modifications.

OUTLINE:

Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of B-cell acute lymphoblastic leukemia

  * Paired diagnosis-relapse primary patient samples obtained from the Children's Oncology Group (COG) cell bank
Sequential and Personalized PK-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allo-HSCT in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning

Because the anti-leukemic activity of busulfan, this dug is largely used in graft conditioning but in elderly and/or cormobid patienth an excess of toxicity is observed. This study focus on the possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual PK parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient up to 65 years old
* Acute leukemia, myelodysplastic syndrome or myeloproliferative neoplasia eligible for an allogeneic transplant
* Chemosensitive disease, in complete or partial or stable remission
* Allograft from an identical HLA related donor, Haplo-identical or unrelated (HLA compatibility from 8/10 to 10/10 according to HLA-A, -B, -C, -DR, -DQ allelics)
* Signed consent to participate

  -. Affiliation to a social security regimen or beneficiary of this regimen
* Patient not eligible for standard myeloablative conditioning due to age\> = 45 years and / or the presence of an HCT-CI comorbidity score\> = 3

Exclusion Criteria:

* Pregnant woman, without effective contraception or breastfeeding
* Person in emergency situation, patient deprived of liberty or placed under the authority of a tutor,
* Impossibility of undergoing medical follow-up of the trial for geographic, social or psychological reasons
* Contraindications to performing an allogeneic transplant
* Previous allograft
* Placental blood allograft
Parenteral Injection Training Module

Injection practices are a legal obligation of healthcare professionals, but they are also ethically responsible, and the safe maintenance of these practices is extremely important for both patient and employee safety. Due to reasons such as the lack of knowledge and skills of healthcare professionals regarding safe injection, lack of experience, in-service training and periodic training for newly recruited personnel, situations that threaten patient and employee safety occur. Mistakes made in situations requiring technical skills related to injection practices lead to local complications such as ecchymosis, hematoma, pain, abscess, lipodystrophy, infection, and can result in life-threatening situations. In addition, lack of technical skills causes sharp-edge injuries in the world and in excess of their number, and causes blood-borne diseases for many healthcare professionals. In order to prevent these complications and injuries, the education of healthcare professionals requires an education system based on theory and clinical practice, supporting students' cognitive, sensory and psychomotor skills. In the education process, the aim should be to provide clinical skills as well as theoretical knowledge and to develop the acquired skills. Because clinical education allows students to integrate theoretical knowledge with practice in healthcare settings and learn by experience. Gaining competence in parenteral interventions in the clinic is a gradual process and is one of the most important issues in both undergraduate education and postgraduate in-service training. Although clinical practice training is one of the basic practices for learning and acquiring clinical skills in traditional medical and nursing education curricula, it is seen that it is insufficient and it is recommended to benefit from developments in the field of educational technologies in order for practice training to increase patient and student safety. Considering the increasing emphasis on the right of patients to receive care from well-educated health professionals and the right of employees to be safe in risky practices, it is thought that developing a tool that will provide students with the opportunity to practice repeatedly in parenteral injection practice training will be an effective tool in solving all the problems mentioned above. For this purpose, the parenteral practice (intravenous, intramuscular, subcutaneous) skill training module, which is targeted to be developed in the project, aims to improve students' injection skills, provide safe injection practices and ensure their own safety.


Eligibility Criteria:
Inclusion Criteria:

* Students who were 18 years of age or older,
* Enrolled in the Fundamentals of Nursing course,
* Fully participated in the assessments to be applied in the study,
* Volunteered to participate in the study were included in the study

Exclusion Criteria:

* Students who filled in the forms applied within the scope of the study with incomplete information
* Students who dropped out of the Fundamentals of Nursing course while the study was ongoing
Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction

Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea.

The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.


Eligibility Criteria:
Inclusion Criteria:

* indication for permanent cardiac pacing (third degree atrioventricular block, second degree atrioventricular block mobitz 2 type, symptomatic sinus node dysfunction including brady-tachy form of sick sinus syndrome or bradyarrhythmia)
* Diastolic dysfunction diagnosed at the transthoracic echocardiography

Exclusion Criteria:

* younger than 18 years old
* lack of informed consent form
* impossibility to fit in the scheduled study plan
* indication for cardiac resynchronization or left ventricular ejection fraction lower than 45%
* indication for epicardial pacemaker, known severe sleep apnea treated by continuous positive airway pressure
Effectiveness of Music During Cardiac Catheterization

The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.

Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.

During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.

"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.

This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18.

The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.

Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.

The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group.

During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.

"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research
* Being between 7-18 years of age
* Lack of communication problems (vision, hearing, mental)
* Being informed about surgical intervention
* Lack of prior surgical intervention experience
* Receiving sedoanalgesia during angiography

Exclusion Criteria:

* Intubation of the child during angiography
* Parent's refusal to take part in the study
Sympathetic Nerve Activity in Renal Failure

The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension.

A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease.

The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.


Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure stages I-IV

Exclusion Criteria:

* pregnancy and lactation
* severe heart failure or ischemic heart disease
* patients with NYHA III-IV
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease

The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.

This is a feasibility study that aims to investigate the safety and efficacy of dance classes via an online platform in people with and without Parkinson's Disease. The intervention will last 2 months and the classes will be conducted twice a week (60 minutes) using the Zoom platform. Evaluations will be performed before and after the intervention by means of the Zoom platform as well and will include questionnaires of quality of life, depression, anxiety, and activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with and without parkinson's disease according London Brain Bank Criteria
* Minimal cognitive ability to understand commands (MMSE)
* Able to stand at least 10 minutes with or without support
* Dopamine medication stable at least 6 weeks before the beginning of the study
* Portable device and internet connection

Exclusion Criteria:

* Severe visual or auditive disturbances
* Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities
Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen

The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which is verified more than 70% in our I/II phase study, there are also lots of patients cannot benefit from this treatment. On top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (ICB), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. The application of MOAP regimen to patients, who have a progressive disease after DP regimen, can bring high CR rate. MOAP can be the a rescue treatment for cHL resisted to DP treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 13 to 70 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received at least two prior chemotherapy regimen and four cycle of DP regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Chemomechanical Caries Removal Using Papain Gel

To evaluate the efficacy of a papain-based gel in caries removal.

Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
* The caries were located on the occlusal surface.

Exclusion Criteria:

* Children with pathological process of the dental tissue, with pulpal involvement