cyrilzakka/clinical-trials huggingface dataset:
Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome

Down syndrome can be characterized by global mental and physical dysfunction or isolated gait, cognition, growth, or sensory disturbances. This study was conducted to investigate the effect of the sensory integration approach on improving balance and motor coordination in children with Down syndrome.

Thirty children were enrolled in this study and randomly assigned to two groups: Group A received (sensory integration therapy program and training in physical therapy) and received group B (physical therapy training program only). Motor coordination and balance were assessed before and after exercise for all children using Bruininks - Oseretsky Test of Motor Proficiency - 2nd Edition.

Eligibility Criteria:
Inclusion Criteria:

* children with Down syndrome
* the ages of five and ten years who can walk
* their IQ is more than 75%

Exclusion Criteria:

* they had a serious neurological disorder (epilepsy), orthopedic problems, upper or lower limb surgery, vision or hearing problems, use of medications that impair behavior or attention, and suffered from advanced intellectual disability
Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients: ORION Trial

This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia.

The video laryngoscope, compared to direct laryngoscopy, provides better visualization of the laryngeal and glottic structures, a higher success rate for intubation on the first attempt, and a lower incidence of complications such as mucosal injury, dental injury, and esophageal intubations. Despite the advantages offered by video laryngoscopy, its use is not widespread in developing countries due to high costs. For this reason, the ORION video laryngoscope was developed as a low-cost, reusable device that can undergo high-level disinfection. It is designed using additive manufacturing and meets the standards for biocompatibility, rigidity, and resistance. Additionally, it has undergone preclinical testing in simulation models where anesthesiologists have approved its use in real clinical scenarios. In this study, patients scheduled for elective surgery under general anesthesia without predictors of difficult airway will be included and randomized to be intubated with either the ORION video laryngoscope or the King Vision video laryngoscope. The study will compare the success of intubation on the first attempt, the time taken for intubation, the level of visualization of the glottic structures, and the associated complications between the two video laryngoscopes.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age scheduled for elective surgery requiring general anesthesia.
* Patients without predictors of difficult airway.
* Patients with ASA I-II classification.
* Patients with BMI less than 35 kg/mts2.

Exclusion Criteria:

* Pregnant women.
* Patients requiring emergency surgery.
* Patients with chronic obstructive pulmonary disease.
* Patients with a history of chronic ischemic heart disease.
* Patients with a history of asthma.
* Patients who have not signed the informed consent to participate in the study.
Sleep Disorders in Transient Ischemic Attack and Stroke: SOMN'AIC Study

Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.


Eligibility Criteria:
Inclusion Criteria:

* Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3 month' rehabilitation examination
* TIA group: diagnosis of a TIA by a stroke specialist at the "SOS TIA" examination
* \> 18 years

Exclusion Criteria:

* Refusal to participate
* Severe cognitive impairment leading to inability to fulfil questionnaires
* For the TIA group: presence of an ischemic lesion on CT scan or MRI
Efficacy and Comparative of the Association Beclomethasone Clotrimzaol + Gentamicin in Patients With Acne Contaminated

The objective of this trial is to evaluate the comparative efficacy of the combination of Clotrimazole + Gentamicin + Beclomethasone in study subjects with a condition of contaminated dermatosis showing bilateral symmetrical lesions.

The specific objective is to evaluate, by means of analytical propedeutics medical improvement in clinical signs and symptoms related to acne infected, the use of the association: Clotrimazole, Gentamicin and Beclomethasone versus association: Clotrimazole and Gentamicin, which will first be randomized.

The study should be conducted with 20 research subjects aged over 18 years, of both sexes, showing the framework of bilateral lesions infected with acne, at any stage of evolution. The study subjects will receive treatment with both products, so they can use one in each lesion chosen at random, double-blind.

Thus, the proven efficacy and safety and taking all possible adverse events reported, the study sponsor hopes to obtain registration with the Ministry of Health of this new association in the country.

The association made a proposal was developed by the Laboratory Glenmark Pharmaceuticals Ltd..

Eligibility Criteria:
Inclusion Criteria:

* Subject search of both sexes, regardless of color or social class
* From age to 18, with good mental health
* Carriers of two outbreaks of acne contaminated
* Subjects who agree to return follow-up visits
* Research subjects who agree to participate and sign the Deed of Consent

Exclusion Criteria:

* Subject Research carriers of susceptibility to gentamicin
* Research subjects suffering from sensitivity to clotrimazole
* Research subjects suffering from sensitivity to beclomethasone
* Research subjects who are making use of steroids or steroidal anti-inflammatory and non-steroidal drugs or who made use of topical or oral 15 days ago
* Research subjects who are doing immunosuppressive treatment
* Research subjects with a diagnosis of eosinophilic folliculitis or Pseudo-folliculitis barbae and groin
* Pregnant and lactating
A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 in Subjects With DuchenneMuscular Dystrophy Carrying Eligible DMD Duplications.

This is an 48-week open-label study to determine the efficacy and safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 for the treatment of boys with duchenne muscular dystrophy who have a single exon duplication of either exon 45, 51 or 53, respectively. There will be weekly infusions and two muscle biopsies at baseline and at month 12.

DMD is a rare, serious, debilitating, and ultimately fatal, disease for which there is an urgent need to develop safe and effective therapies. In order to efficiently meet this urgency and the needs of the subject community, the study evaluates the efficacy and safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 administration over approximately 1 year in DMD subjects with duplication mutations amenable to treatment by exon 45, 51 or exon 53 skipping. Skipping of a single copy of the duplicated exon is expected to result in a wild-type (WT) DMD transcript allowing the expression of a WT, full length dystrophin protein. Successful skipping of a single copy of the duplicated exon in in vitro and in vivo models has been reported in the literature. AMONDYS 45, EXONDYS 51, VYONDYS 53 have the potential to be disease-modifying treatments for boys with DMD mutations amenable to exon 45, 51 and exon 53 skipping, respectively.

The totality of the non-clinical data with these PMOs as well as AVI-4225 (targeting exon 23) and EXONDYS 51 suggests that PMOs are well tolerated in the non-clinical setting. Moreover, treatment with EXONDYS 51(at 30 mg/kg and 50 mg/kg) has been well-tolerated by boys with DMD deletion mutations amenable to skipping exon 51. The relatively low expected risk for subjects exposed to AMONDYS 45, EXONDYS 51, VYONDYS 53 and the urgent medical need for a treatment for this subject population support the conclusion that the potential benefits of exposing subjects to AMONDYS 45, EXONDYS 51, VYONDYS 53 outweigh the potential risks.

Eligibility Criteria:
Inclusion Criteria:

* Is a male with DMD and has an out-of-frame duplication of either exon 45, 51, or 53, with a normal copy number of all other DMD exons.
* Is above age 6 months of age.
* Has sufficient muscle mass in a pair of bilateral muscles that will allow for pre- and post-treatment muscle biopsies per PI discretion.
* If the subject is ambulant and 4 years old or greater and has been on a stable dose or dose equivalent of oral corticosteroids for at least 12 weeks prior to Week 1 the dose is expected to remain constant (except for modifications to accommodate changes in weight) throughout the study.

Exclusion Criteria:

* Any additional missing exon for DMD that cannot be treated with study drugs.

Other inclusion/exclusion criteria apply
Antibodies Production After Covid-19 Vaccination Among Patients With Medical History of Cancer and Anti-CD-20 Treatment

This is a Phase II study designed to investigate if the Covid 19 vaccines are capable of eliciting production of antibodies against S protein of Sar-S-Cov-2 virus among patients with medical history of cancer previously treated with monoclonal anti CD-20 antibodies. The antibody production is defined based on the detection of antibodies in the serologic Covid-19 rapid test against S protein or with semiquantitative assay when it becomes available.


Eligibility Criteria:
Inclusion Criteria:

* All patients either diagnosed with cancer or with HIV positivity or treated with an antineoplastic regimen including anti CD-20 after Covid-19 vaccine will be registered on the study regardless of their type of cancer or type of antineoplastic regimen.
* Patients 21 years or older diagnosed with cancer treated with antineoplastic regimen or anti CD-20, or with HIV infection vaccinated with 2 doses of anti Covid-19 vaccine.
* Eligible patients will be registered on study after a Covid -19 vaccine has been scheduled.
* In order to be screened for Covid 19 antibodies, they must be tested at least two weeks after the second dose of Covid-19 vaccination.

Exclusion Criteria:

* Anyone who has not been treated with anti-CD20 antibodies or with chemotherapy who doesn't have HIV infection or who has not received chemotherapy for cancer.
Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer

The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.

Primary Objective:

The primary objective of the study is to measure the frequency with which DBT alters the surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional site of cancer or DCIS, will be taken into account when estimating the frequency of changes to surgical management.

Secondary objectives:

1. To measure the frequency and nature of additional findings like atypical pathology (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) , requiring surgical intervention).
2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from DBT.
3. To measure the proportion of patients undergoing additional work-up following the DBT, and the subset of these patients with benign findings (i.e. False Positives).

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of breast cancer
* New diagnosis if a previous breast cancer patient with negative surgical margins
* Patients willing to sign a written informed consent form

Exclusion Criteria:

* High risk benign lesions as the primary pathology diagnosis
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men older than 18 years old.
* Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
* Previous radical prostatectomy.
* Biochemical relapse with local or regional recurrence proven on PSMA PET.
* Five or less positive nodes on the PSMA PET.
* ECOG 0-1

Exclusion Criteria:

* Presence of para-aortic lymph nodes or distant metastasis.
* Chronic pelvic inflammatory disease.
* Contraindication for radiation treatment.
* Previous radiation treatment within the pelvis
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

* have symptomatic knee OA based on American College of Rheumatology clinical criteria
* have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain,
* can speak and read English
* have no plan to change medication regimens for pain throughout the trial

Exclusion Criteria:

* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
* systemic rheumatic disorders, including rheumatoid arthritis,systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
* pregnancy or lactation
* prosthetic knee replacement or non-arthroscopic surgery to the affected knee
* hospitalization within the preceding year for psychiatric illness
* no access to a device that can be used for secure videoconferencing for real-time remote supervision.
Low Dose Treosulfan Based Conditioning Regimen in HSCT for Nijmegen Breakage Syndrome

The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT in Nijmegen breakage syndrome

Nijmegen breakage syndrome (NBS) is a DNA repair disorder. The only curative option for combine immunodeficiency in NBS is allogeneic hematopoietic stem cell transplantation (HSCT). Standard myeloablative conditioning regimens in DNA repair disorders lead to increased morbidity and mortality after HSCT. Low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. The data of treosulfan usage in NBS are sparse. To evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in NBS, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, cyclophosphamide 40mg/kg, thymoglobulin (Genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion. The primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 3 months and \< 21 years
2. Patients diagnosed with NBS eligible for an allogeneic HSCT
3. Signed written informed consent signed by a parent or legal guardian
A National Registry of Patients With Hepatocellular Carcinoma

A registry of patients with the diagnosis of hepatocellular carcinoma.

The purpose of this research is to study the factors which might cause hepatocellular carcinoma (a form of cancer arising within the liver) and compare these factors in patients from different ethnic groups and from different parts of the United States. The researchers will also conduct a survey of the stage of the cancer (how far advanced it is) and what treatments are used for this difficult-to-treat tumor.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hepatocellular carcinoma

Exclusion Criteria:

* Patients can not be under 18 years of age
Pilot-testing a Perinatal Palliative Care Intervention Program

The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.


Eligibility Criteria:
Inclusion Criteria:

* Parents:

  * who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
  * who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
* Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth

Additional inclusion criteria for parents:

* Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
* Parents are older than 18
* Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
* Parents are deemed (emotionally) approachable for the current study by the treating physician

For each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* informed of the objectives of the project and signed consent
* non small cell lung cancer, stage IIIA, IIIB or IV
* PS (WHO performance status) \< or =2
* treatment based on immunotherapy (monotherapy or combination)
* at least one measurable target
* available results of PD-L1 expression

Exclusion Criteria:

* concomitant other type of cancer
* another cancer in the last 5 years
Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer

The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).


Eligibility Criteria:
Inclusion Criteria:

* Has confirmed biliary tract cancer
* Ability to understand and willingness to sign a written informed consent document.
* Age ≥18 years
* Have biopsiable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patient must have adequate organ function defined by the study-specified laboratory tests.
* Must use acceptable form of birth control while on study.

Exclusion Criteria:

* Has active autoimmune disease that requires systemic treatment.
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication.
* Has received a blood transfusion within 72 hours prior to first dose of study drug administration
* Unwilling or unable to follow the study schedule for any reason.
* Major surgery within 4 weeks prior to initiation of study treatment.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breastfeeding women.
* Have known history of infection with HIV, hepatitis B, or hepatitis C.
* Received any prophylactic vaccine within 30 days of first dose of study drug treatment.
* Has a history of allergy to study treatments or any of its components of the study.