cyrilzakka/clinical-trials huggingface dataset:
PAP for Children With DS and OSAS

Determine the efficacy of family-informed intervention (INT) vs standard clinical care over a period of twelve months in children with obstructive sleep apnea and Down Syndrome.

Evaluate the effect of PAP adherence on quality of life, neurobehavioral, and healthcare utilization in children with DS and OSAS. It is being hypothesized that, irrespective of study arm, increased PAP adherence will be associated with better quality of life, neurobehavioral, and healthcare utilization outcomes.

Evaluate the effect of PAP adherence in children with DS and OSAS on patient-centered outcomes and family-relevant outcomes identified during the R61 phase of this research. It is being hypothesized that irrespective of study arm, increased PAP adherence will be associated with better patient-centered outcomes, and family-relevant outcomes identified during the first year of this research.

Determine the efficacy of INT vs. CON in promoting PAP adherence. It is being hypothesized that that children receiving INT will show significantly increased objectively-measured PAP adherence at 6 months compared with those receiving CON (Aim 4A). As a secondary aim (4B), it will be evaluated whether the improved adherence is maintained over 12 months. It is being hypothesized that participants initially randomized to the INT arm will have better adherence at 12 months compared to those in the CON arm.

Use mixed methods during the randomized controlled trial to identify family perceptions, such as empowerment and self-efficacy, regarding PAP use in youth with OSAS and DS. It is being hypothesized that INT-PAP will be associated with more positive perceptions compared to CON.

Eligibility Criteria:
Inclusion Criteria:

* Clinical referral for PAP initiation to treat OSAS
* Ages 6-18 years
* Children are able to cooperate with testing
* Naive to PAP treatment

Exclusion Criteria:

* Major illnesses, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant.
* Family planning to move out of the city within the next year
* Children in foster care
* Child with previously treated with PAP
* Caregivers who do not speak English well enough to complete behavioral and performance measures.
Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade malignant de novo or recurrence.

The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to chemotherapy, regardless of their initial extension. The failure of treatment is most often correlated with an incomplete answer or lack of response to chemotherapy as a result chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics of fixing, which can be used in oncological imaging (fixation by glial tumors of high grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in a traditional way, without changes in treatment protocols used in routine. Patients with a negative MIBI scan, will be watched with particular attention in order to detect insufficient response to chemotherapy. The only change, the care of patients, only for the achievement of an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping of MDR1, MRP1 and MRP2 to the patient.


Eligibility Criteria:
Inclusion Criteria:

* initial Attainment: High-grade NHL or Hodgkin's disease all stages:I, II, III et IV.
* Relapse: High-grade NHL or Hodgkin's disease relapse in all stages:I, II, III et IV.
* Patients recruited by the Network of clinical hematology du Limousin
* Patients older than 18 years with or without brain damage

Exclusion Criteria:

* Pregnant women or nursing mothers or without effective contraception
* Patients without coverage by social security
* Patients who started steroids referred to antitumor
Does Medical Cannabis Reduce Opioid Use in Adults With Pain

The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.

This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* English or Spanish fluency
* Actively certified for medical cannabis
* Intends to have a soft-gel capsule product dispensed at Vireo
* Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"
* Joint or neuropathic pain
* Current severe pain
* Dispensed opioid analgesics within the last 60 days

To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete study visits over 14 weeks
* Terminal illness
* Current or prior psychotic disorder
* Buprenorphine or methadone treatment for opioid use disorder within the past year
* Allergies to tapioca or coconut
* Currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
* Condition that is considered by a pharmacist or medical provider to be a contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-use interaction)
3M Cavilon Advanced Skin Protectant for the Prophylaxis of Radiation Dermatitis

This study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18years.
* Patient has initial or recurrent disease
* Undergoing external beam radiotherapy at the Mayo Clinic Rochester campus Note: Patients who are undergoing concurrent chemotherapy are eligible
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide informed written consent
* Willing to consent for photography of radiation field
* Available to return to Mayo Clinic in within 1 week post treatment for assessment (+/- 7 days).
* At risk for developing ≥ grade 2 dermatitis radiation as determined by treating Radiation Oncology clinician
* Biologic effective dose of \>42 Gy10 as calculated using the web site EQD2.com.

Exclusion Criteria:

* Unable to provide informed consent
* Patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult
* Known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates
* Subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study
* Subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
* The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery

The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface.

The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions:

* if the usage of preservatives has an impact on the eye surface healing process after cataract surgery
* if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops.

Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state.

Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.


Eligibility Criteria:
Inclusion Criteria:

* cataract surgery required defined previously by the eye-care specialist
* good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity)
* consent to the study protocol

Exclusion Criteria:

* diagnosed glaucoma
* diagnosed previous allergy
* diagnosed diabetic retinopathy or maculopathy
* previously diagnosed dry eye disease that requires treatment with multiple artificial tears
* permanent usage of the eye drops other than artificial tears
* non-compliance to the study protocol
Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient treated in CHR Metz-Thionville between 2013 and 2020
* With a pathological impairment (suspected or confirmed) of a salivary gland
* With sialendoscopy indication for diagnosis and/or treatment

Exclusion Criteria:

* Opposed to use data
* Without sialendoscopy indication
* Without lithiasis salivary gland disorder
* With parotid gland lithiasis
The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021

The goal of this Retrospective Cohort Study is to compare the patients from before and after the implementation of the pre-convention for infants with feeding difficulties needing tube feeding or having received tube feeding in the past, but able to develop normal feeding behavior.

The main objectives it aims to compare are:

* To characterize the patients taking part in a multi-disciplinary follow-up for feeding difficulties over time and to evaluate their progress before and after the institution of a multidisciplinary team in the context of the pre-convention for feeding difficulties from the RIZIV/INAMI.
* To evaluate if the multi-disciplinary approach is more efficient for treatment and follow-up in infants with eating difficulties before and after the start of the pre-convention.
* To calculate the probability of reaching full oral intake after having feeding difficulties within two years.


Eligibility Criteria:
Inclusion Criteria:

* Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2000 and the 31st of December 2021 and receiving the label "feeding difficulties".

The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means.

* The infants need or have needed (enteral or parenteral) artificial nutrition.
* The infants are aged between 0 and 12 years at their first presentation.
* The infants are capable of developing normal feeding behavior.

Exclusion Criteria:

* Have no 6-months follow-up available.
* Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children.
Oxaliplatin and Capecitabine Versus Follow-up After Resection of Colorectal Liver Metastases

Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.

Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.

Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:

Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up

or

Arm B: follow-up

Randomization: stratification after Scores of Fong et al:

* number of metastases (1 vs. \>=1)
* maximal diameter of the metastasis (\<= 5cm vs. \> 5cm)
* disease free interval (\>= 12 months vs. \> 12 months)
* CEA (\<= 200ng/l vs. \>200 ng/l) in the strata 0-1, 2 and \>= 3,

Eligibility Criteria:
Inclusion Criteria:

* patients after R0-resection of colorectal liver metastases
* age: \>= 18 years
* Karnofsky-Index \>= 70%
* neutrophiles \>1,5 x10e9/l, thrombocytes 100 x10e9/l
* adequate contraception for male and female patients
* oral and written informed consent (GCP)

Exclusion Criteria:

* other prior malignancies, except treated in situ-carcinoma of cervix or tumours of skin without indication to a melanoma (or 10 years tumourfree)
* other participation in clinical trials within 30 days before randomization
* previous chemotherapy (except adjuvant chemotherapy with an interval of \>= 6 months)
* creatinine clearance \<50 ml/min
* hepatic insufficiency (ALAT, ASAT, Bilirubin, AP \>5 x upper limit)
* peripheral neuropathy \> CTC grade 1
* uncontrolled cardiac insufficiency or angina pectoris
* active infections
* severe neurological or psychiatric illness
* breast-feeding or pregnant women
* incapacity to take part in regular visits
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Oral AT-406 in Combination With Daunorubicin and Cytarabine in Patients With Poor-risk Acute Myelogenous Leukemia (AML)

The main purpose of this study are to determine the maximum dose of AT-406 that can be safely given in combination with cytarabine and daunorubicin to humans. Other purposes are to determine how the drug is broken down in the body, and to see if there are any molecular interactions that can help determine how AT-406 works. Side effects will also be studied in an effort to make sure that this drug is safe to take.

This is an open label, multi-center, dose escalation study to determine the MTD of oral AT-406 combined with daunorubicin and cytarabine in patients with poor-risk AML. Treatment with AT-406 will be administered to up to 60 patients at approximately 7 investigational sites in the US. Patients will be enrolled in open label sequential cohorts of up to 12 patients to determine the MTD of AT-406 in combination with daunorubicin and cytarabine. Dose finding will occur during the induction cycle of the regimen. AT-406 will not be administered in consolidation cycles. Patients who require re-induction during initial treatment will be removed from the study and replaced (if needed) in order to assess at least 3 evaluable patients at each dose level.

Clinical and laboratory parameters will be assessed to evaluate the toxicity of AT-406. In addition, pharmacokinetic (PK) and pharmacodynamic (PDy) blood samples will be analyzed for plasma concentrations and PDy effect of AT-406, respectively.

Eligibility Criteria:
Eligibility Criteria:

Inclusion:

* Male or females patients ages 18 to 74
* Morphological diagnosis of untreated or relapsed non-M3 AML according to WHO diagnostic criteria who exhibit at least one poor-risk feature and are not be known to exhibit any favorable cytogenetic features or variants.
* Patients with relapsed AML and patients with prior autologous or allogeneic hematopoietic stem cell transplantations are eligible if relapse occurred following a remission of ≥ 6 months.
* Patients must have an ECOG score of ≤ 2,
* Adequate cardiac, liver and renal function.

Exclusion:

* Must not have any evidence of CNS leukemia.
Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the toxicity and response to intensive chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with Hodgkin's disease or non-Hodgkin's lymphoma who have received prior chemotherapy and/or radiotherapy.

OUTLINE: Patients receive oral busulfan every 6 hours on days -9 to -6 and cyclophosphamide IV over 2 hours on days -5 to -2. Autologous peripheral blood stem cells are reinfused on day 0. Patients are followed monthly for 1 year.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease OR Histologically proven non-Hodgkin's lymphoma (NHL) Intermediate grade OR Large cell immunoblastic (high grade) Refractory to standard therapy or relapsed following initial complete remission Must have received radiotherapy to the extent that no longer eligible for involved field radiation, cyclophosphamide, or total body irradiation No CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Physiologic 65 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the last 3 months No significant arrhythmia requiring medication Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to NHL or Hodgkin's disease) Other: HIV negative No clinical evidence of AIDS

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
the Cogmed Program for Youths With ADHD

The primary objective of this study was to examine the effects of the Cogmed training program on working memory among youths 7 to 13 years old, while controlling presence and presentation of ADHD-related comorbidity. A secondary objective was to examine the generalization of effects to ADHD symptoms, non-verbal reasoning, attentional and executive functions, motor impulsivity, reading comprehension, and mathematical reasoning. Participants were under pharmacological treatment for ADHD combined type and a comorbidity. They were randomized into an experimental group that received the Cogmed program and an active control group that received a low-intensity comparison version of the training. They were evaluated at three time points: six weeks prior to intervention onset (T1), immediately prior to onset(T2), and one week following intervention completion (T3).

Participants completed the Cogmed WM training program at home.Each training session lasted from 30 to 45 minutes and was supervised by a parent. For five consecutive weeks, participants had to complete at least five sessions per week.

Eligibility Criteria:
Inclusion Criteria:

* (1) be 7 to 13 years old;(2) had to be diagnosed with ADHD combined type and present a comorbid learning disability, oppositional defiant disorder or Tourette syndrome;and (3) had to be medicated for ADHD,

Exclusion Criteria:

* Youths were excluded from the study if diagnosed with epilepsy, an internalizing disorder (anxiety or mood disorder), an autism-spectrum disorder or mental retardation.