cyrilzakka/clinical-trials huggingface dataset:
Turkish Validation of The Drooling Impact Scale

The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy

Drooling is common among several neurologic disorders such as cerebral palsy, Parkinson's disease, amyotrophic lateral sclerosis, which are the main diseases that physiatrist are one of the leading physicians involved in whose management 1. Drooling can be seen either as anterior drooling, unintentional leaving of saliva from mouth to outside of the body, or posterior drooling, invisible spill of saliva from mouth through pharyngeal isthmus and then to respiratory or digestive tract, inside the body 2. Anterior drooling causes psycho-social impairment, skin problems, infections, bad odor, dehydration, dentation problems and wet clothes and tools while posterior drooling may result in morbidity by posing a risk for aspiration pneumonia. Despite the frequency and significance of the condition, there is still a paucity of research and inadequate evidence about the various treatments and valid and reliable outcomes available. A major problem for research into interventions to reduce drooling is that there is no valid and reliable measurement tool of saliva control. There is no questionnaire in Turkish to evaluate the effects of drooling as well as drooling interventions.The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unilateral or bilateral cerebral palsy at between the ages of 4-16
2. Spastic, dyskinetic or mixed type cerebral palsy
3. GMFCS level 3,4,5
4. Stable drooling within at least one month

Exclusion Criteria:

1. Active infection of salivary glands
2. Upper respiratory tract infection at the time of testing
3. History of anticholinergic drug intake in the past three weeks
4. Occurance of any above between test and re-test assessment that may interfere with the results
Remote Monitoring in Cancer Care: a Platform Study

This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.

PRIMARY OBJECTIVES:

I. Develop patient-specific algorithms to predict the trajectory of cytokine release syndrome (CRS) and or neurotoxicity and time to escalation of medical intervention is needed. (Arm 1) II. Establish the validity for the use of mobile technology to assess neurologic symptoms remotely. (Arm 1) III. Compare the time to escalation of potential medical intervention between remote monitoring (RM) and standard care (SC) based on retrospective analysis of clinical trial data. (Arm 1) IV. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 1) V. Define the range of physiologic variables associated with receipt of radiation and chemotherapy. (Arm 2) VI. Correlate PROs and physician rated CTCAE to biologic parameters. (Arm 2) VII. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 2)

OUTLINE:

ARM 1: Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks.

ARM 2: Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 60 to 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device.

Eligibility Criteria:
Inclusion Criteria:

* ARM 1: Age \>= 18 years
* ARM 1: Provide written informed consent
* ARM 1: Patients undergoing commercial CAR-T cell therapy in an outpatient setting
* ARM 2: Age \>= 18 years
* ARM 2: Provide written informed consent
* ARM 2: Patients with a plan to undergo radiation therapy for lung, gastrointestinal, or head and neck cancer

Exclusion Criteria:

* ARM 1: Non-English speaking
* ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
* ARM 2: Non-English speaking
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. Cough is assessed with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results.

A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has not been done so far, in very young children, especially in a time frame of 4 days. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.

Eligibility Criteria:
Inclusion Criteria:

* cough attributed to infection of the upper respiratory tract since less or equal than 7 days,
* children aged 1 to 5 years
* score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent,
* score of at least three of all questions assessing daytime cough considering the day prior to study entry
* written consent by a parent.

Exclusion Criteria:

* Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies,
* Children who received antihistamines or any cough medicine the day prior to study entry,
* The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry,
* Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the cough syrup.
Doctor-Patient Communication in Spanish

Does use of a translator or use of less than perfect Spanish diminish provider-patient communication compared to a native speaker.

Spanish speaking drop-in patients will be consented then randomized to receive care by a native Spanish speaker, an English speaker using a translator, or an English speaker with intermediate Spanish skills using Spanish. After the visit, the researcher will enquire about patient satisfaction, when the next appointment is, whether medication has been changed, and what instructions their provider gave them. Each provider will do a similar questionnaire. A blinded researcher will score a concordance of plans between provider and patient to see if there is a significant difference in retained information between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Spanish speaker

Exclusion Criteria:

-
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas

This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.


Eligibility Criteria:
Inclusion Criteria:

* Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \[RMS\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;
* Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy

Exclusion Criteria:

* Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);
* Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;
* Patients with no clinical indication for neoadjuvant therapy prior to surgery;
* Patients with chronic pulmonary disease;
* Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.
Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.


Eligibility Criteria:
Inclusion Criteria:

* Bed partners of patients with moderate to severe OSA

Exclusion Criteria:

* Bed partners with OSA using specific treatment.
Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair

The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

Traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. They cannot be repeated within a short period of time because of their invasiveness, and because the procedures themselves may include an inflammatory response. The need to monitor inflammation in the lungs has led to the exploration of exhaled gases and condensates. Noninvasive monitoring may assist in differential diagnosis of pulmonary diseases, assessment of disease severity and response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist
* Baseline IgE 30-700 IU/mL
* Exhaled nitric oxide greater than 13 ppb
* Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach
* Stable asthma at the time of enrollment

Exclusion Criteria:

* Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months
* Upper or lower respiratory tract infection within 6 weeks of screening visit
* Elevated IgE level other than atopy
* Known sensitivity to Xolair
* \< 3 months of stable immunotherapy
* Smokers
* Pregnant/nursing women
* Women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence
* Patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer
* Known sensitivity to study drug or class of study drugs
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days.
Effect of Omega-3 Fatty Acid on Vitamin D Activation

Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D \< 30 ng/mL

Exclusion Criteria:

* Patients with a history of active infection within 3 months,
* Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
* Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
* Patients with a history of hospital admission within 3 months,
* Patients with a history of bleeding within 3 months,
* Patients with thrombocytopenia,
* Patients with current use of warfarin,
* Patients with an albumin level \< 3.0 g/dL,
* Patients with malignancy and/or liver cirrhosis
Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study

Pupillary diameter monitoring is currently used routinely for assessment of the nociception / antinociception balance during surgery.

Pupillary diameter decreases reflexively in response to light flash, called photomotor reflex. The photomotor reflex is described by the latency between the light flash and the beginning of the decay expressed in milliseconds, the slope or decay rate expressed in millimeters per second, and the percentage of variation, corresponding to the ratio between the basal pupil diameter and the minimum diameter reached during the light stimulation.

The AlgiScan™ videopupillometer used includes a device for producing a flash light, designed for this purpose.

It has recently been shown that the slope (or rate) of pupillary diameter decrease during a light flash varies during anesthesia, independently of any nociceptive stimulus.

The hypothesis of this study is the variation of the decay slope of the pupil diameter is proportional to the depth of the anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Majors patients
* Score American Society of Anesthesiologists (ASA) 1 or 2
* Managed in the operating theater of the University Hospital of Saint-Etienne for a neurosurgical intervention.

Exclusion Criteria:

* Single or bilateral eye surgery modifying the possibilities of variation of the pupillary diameter
* Having been asleep under general anesthesia in the 7 days prior to the current surgery
* History of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomous stage
Mobile Application for Self-Management of Type 2 Diabetes Mellitus

The goal of this Randomized Controlled Trial is to study the effect of mobile Application on glycemic control of type2 diabetes mellitus. The main questions aim to answer are:

* The effect of mobile application on glycemic control and quality of life of diabetes mellitus patients
* The satisfaction of mobile application of diabetes mellitus patients who used it Participants will be received education about diabetes mellitus and separated into two groups, intervention group(using mobile application) and control group(not using mobile application but also receive standard treatment of diabetes mellitus.

Researchers will compare intervention group to control group about glycemic control including HbA1c, complications of diabetes mellitus etc. and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Type2 diabetes mellitus who have HbA1c above 7%
* Can use application on smartphone
* age 18 years old or more (relatives are accept if participants have age more than 65 years old and cannot use smartphone)
* consent to participate the research

Exclusion Criteria:

* refuse to participate the research
* pregnancy
* using continuous glucose monitoring system or insulin pump
* disability in sight or hearing
* have been using the mobile application(RAMAdiabetes) in the past
Mapping of Sentinel Lymph Node Drainage Using SPECT (SUSPECT) (SUSPECT)

This study aims to explore the feasibility, safety and outcome of a non-invasive sentinel node mapping (SNM) to individually tailor the elective nodal irradiation (ENI) to the ipsilateral neck only and to exclude the contralateral negative neck from the irradiation fields when there is no draining sentinel node. Subsequently the dose to the salivary glands, mucosal area and the swallowing and chewing muscles and structures involved in voicing and articulation will significantly be reduced


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with histopathologic proven primary HNSCC (T1 -3 N0 -1) located in the oral cavity, oropharynx, larynx (except T1 glottic ), and hypopharynx, not crossing the midline and planned for treatment with (chemo)radiotherapy in curative setting
* No chemotherapy or surgery prior to inclusion
* No distant metastatic spread at the time of inclusion
* Age ≥ 18 years
* WHO performance status 0 or 1
* Signed written informed consent

Exclusion Criteria:

* Patients with previously radiation treatment in the head and neck region, for any reason
* Patients with previous neck dissection
* Patients with recurrent or second primary tumor in the head and neck region
* Patients with head and neck malignancies arising from skin, lip, nose, sinuses, nasopharynx, salivary glands, thyroid gland or esophagus
* Previous history of cancer in the last five years (excluding basal cell carcinoma of the skin and in situ SCC of the cervix)
* Pregnancy or no active contraception for pre-menopausal women
* Known hypersensitivity to iodine or nanocolloid injection
* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow up schedules
Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).

A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.

Abbreviations for Mechanical Ventilation:

PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters

Eligibility Criteria:
Inclusion Criteria:

1. Invasive mechanical ventilation
2. PF ratio \<255
3. Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
4. Presence of ≥1 risk factor for ARDS as determined by review of the HER

Exclusion Criteria:

1. Age \<18 years
2. Pulmonary capillary wedge pressure \>18 mm Hg if a right heart catheter is present
3. Prisoner
4. Known to be pregnant
5. Death \<24 hours from initial intubation
6. Placed comfort care \<24 hours from initial intubation
7. Mechanically ventilated for \>7 days prior to meeting ARDS criteria
Blown Nasal Secretion Measurements in Rhinosinusitis: Repeatability and Validity Compared to Nasal Lavage

To process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen by nasal lavage. To investigate the reliability and validity of the measurements we will determine their repeatability and compare them with those of nasal lavage in the same subjects.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from rhinitis with our without sinusitis

Exclusion Criteria:

* unable to provide blown nasal sample