cyrilzakka/clinical-trials huggingface dataset:
Responding to Children and Adolescents With Tyrannical Behaviour

This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB).


Eligibility Criteria:
Inclusion criteria:

1. being the parent of a child aged 6 - 20 years who endorses the DSM-5 criteria of IODD. In fact, ODD is considered a necessary but not a sufficient condition for tyranny behavior
2. two or more positive answers to the custom quetions routinely used to identify STB in children/adolescents at the University Hospital of Montpellier), related to a 12 month period :

   * Are you afraid of your child?
   * Is your child physically or psychologically violent toward you?
   * Do you think that your child is the decision maker in the family?
   * Do you feel ashamed by your situation at home?
3. being able to attend half of the sessions.

Exclusion criteria:

1. predicted absence from at least half of the sessions
2. subject deprived of liberty
3. subject under guardianship or curatorship.
Bioavailability of Insulin Administered in Duodenum

A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers.

METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus Community Hospital at 8 a.m. A Gastrointestinal tube will be placed in Duodenum distal to papilla Vaterii with a pH of approximately 7.0 as measured by the pH meter distal in the tube. An indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be placed in an antecubital vein. In the contralateral anticubital vein a catheter will be placed for blood sampling. All subjects will have 4 tests with duodenal infusion of the insulin Aspart solution. The first 4 volunteers will receive 4 doses of insulin Aspart solution in 1 ml (150, 300, 600 and 1000 IU) with 3-6 hours apart. Blood sampling for Insulin Aspart, total insulin, and glucose (Beckmann apparatus) will be done every 10 minutes the first two hours, and then every 20 minutes. When final the subjects will receive a meal before leaving the hospital.

Based on data from the pilot a dose will be determined for the remaining 8 subjects. These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split. Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 5.5 (two different insulin concentrations but the same dose given at the two places in Duodenum). Frequency and interval of blood sampling in the second part will be determined by results from the pilot study. For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous (iv) bolus injection of 6 IU of insulin Aspart. The iv injection will be followed by blood sampling for three hours as above, but every 5 minutes the first two hours, and the sc injection will be followed by blood sampling for three hours as above, but again with 10 minutes interval the first two hours.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy Volunteers
* Age \>18 - \< 50 years
* BMI 18-30 kg/m2

Exclusion Criteria:

* Any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus)
* pregnancy or nursing
* suspected or known allergy towards the drug
* Participation in other research trials within 3 months before the study
Red Light Intervention for Myopia Prevention

To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.


Eligibility Criteria:
Inclusion Criteria:

* Students of grade 1-4 in the participating schools;
* Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） \>-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D \<cycloplegic SE≤0.50D;
* Students whose mother and/or father are in myopia status (SE \< -3.0D for either of eyes);
* Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.

Exclusion Criteria:

* Students whose parents do not sign informed consent;
* Students who have strabismus and/or other binocular vision abnormality;
* Students who have other eye diseases and/or systematic diseases;
* Students who have DC \<=-1.5D;
* Students whose difference of SE between the two eyes \>=1.5D;
* Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.
Circulating Exosome RNA in Lung Metastases of Primary High-Grade Osteosarcoma

The purpose of this study is to learn whether the profile of RNA from circulating exosomes can be used as a biomarker for lung metastases of primary high-grade osteosarcoma. Circulating exosomes plays roles in metastases in many kinds of cancer including osteosarcoma. By RNA profiling researchers may find lung metastases earlier than conventional work-up and predict the oncological outcomes.

Investigators have performed a 4 patients pilot study under the oversight of hospital's ethics committee, and investigator found that the levels and mutations of circulating exosome RNA from patients with or without lung metastasis have significant differences. Then investigators wish to register this study to do a further research, in order to reveal the roles of circulating exosome RNA in metastases of osteosarcoma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis by biopsy: primary high-grade osteosarcoma, including conventional osteosarcoma, telangiectatic osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma.
* Tumor located in the extremities or pelvis.
* Age 12-60 years.
* No prior history of cancer and no prior treatment elsewhere.
* No prior history of chronic diseases including autoimmune disease, chronic infection, etc. which may interfere the level of circulating exosomes.

Exclusion Criteria:

* Initial misdiagnosis confirmed by specimen of definitive surgery.
* Applying target drugs in the period of treatment which may reduce tumor derived exosomes
* withdraw from the study for any reason
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients

A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.

A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.

Eligibility Criteria:
Inclusion Criteria:

* Advanced brain cancer
* English Speaking
* Able to provide informed consent

Exclusion Criteria:

* Folstein mini mental status score of 23 or less
Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

About 65,000 Canadians develop acute respiratory failure requiring breathing machines (ventilators) to give oxygen to their lungs. Unfortunately, up to 50% of these individuals will not survive their illness.

Mechanical ventilation through breathing machines, though potentially lifesaving, may further injure the lungs and the respiratory muscles. In the patients with the most severe and life threatening forms of respiratory failure a breathing machine alone may not be able to provide enough oxygen to the lungs and vital organs. In these critical situations, patients may require an artificial lung machine, which is referred to as extracorporeal membrane oxygenation (ECMO) to temporarily replace the function of the patient's own lung and supply critical oxygen to the body, while protecting the damaged lungs. How to use the breathing machine safely while a patient is on ECMO is still unknown. Using conventional breathing machine settings while on ECMO can lead to large portions of the lungs or airway to remain collapsed, which can contribute to further lung damage.

The investigators have recently discovered a way of detecting if patients on a breathing machine suffer from collapsed airways. Knowing if the most severe patients on ECMO have airway collapse is a pivotal question that the investigators plan to answer in our study. The investigators will use our technique to determine how many patients on ECMO have airway closure and determine if this contributes to a longer time on ECMO and a longer time on a breathing machine, and if this impacts a patient's survival in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Acute hypoxemic respiratory failure
* VV-ECMO
* Less than 24 hours from ECMO cannulation

Exclusion Criteria:

* Air leak
* VV-ECMO as bridge to lung transplantation
* Status asthmaticus
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).


Eligibility Criteria:
Inclusion Criteria:

1. Age Range: Adult subjects (45 to 90 years of age inclusive)
2. Sex distribution: Men and women. Women of child-bearing potential (\<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. \[Women who are breast-feeding are excluded.\]
3. Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
4. A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
5. Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
6. The subject must be expected to complete the entire study.
7. Subjects must be sufficiently fluent in English.
8. Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
9. Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).

Exclusion Criteria:

1. Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
2. Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
3. Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
4. Subjects with uncontrolled hypertension (sitting systolic \>= 160mmHg and/or diastolic \>=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
5. Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
6. Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
7. Subjects who may not be able to comply with the protocol.
8. Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
9. Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of \>170mg/dl.
10. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
11. Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.

Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.

Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven breast adenocarcinoma
* Evaluable or measurable metastases
* HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH
* Previously treated with anthracyclines and taxanes
* Age \> = 18 y
* No more than two previous chemotherapy regimens for metastases
* No nervous central system involvement
* Hormonal therapy must have been stopped two weeks before enrollment
* Adequate biologic function
* Performance status OMS \< = 2
* Signed informed consent

Exclusion Criteria:

* History of other malignancies, except basocellular cancer, in situ cervix carcinoma
* Gastro intestinal disease that might affect absorption of capecitabine
* Cardiac failure or angina pectoris uncontrolled
* Hypersensitivity for capecitabine, fluorouracil, or one of their excipient
* Known dihydropyrimidine dehydrogenase (DPD) deficiency
* Concomitant anticancer therapy (included hormonotherapy)
* Concomitant radiotherapy
* Treatment with sorivudine and analogs
* Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required.
* Inclusion in an experimental protocol within 30 days
Genetic Modifiers of Cystic Fibrosis: Sibling Study

The purpose of this study is to identify modifier genes in cystic fibrosis (CF).

BACKGROUND:

CF is a highly variable but inevitably fatal single gene disorder. Several lines of evidence suggest that genetic background contributes to the variability of cystic fibrosis phenotypes. The study will develop CF as a model for the identification of modifier genes by capitalizing on the availability of a large motivated population of affected twins and siblings.

The study is in response to a Request for Applications titled "Genetic Modifiers of Single Gene Defect Diseases" released in August 2000 and co-sponsored by the National Institute of Diabetes, Digestive, and Kidney Diseases.

DESIGN NARRATIVE:

The study has four aims: 1. To identify heritable CF phenotypes by twin study. Intrapair and interpair variance will be determined for selected CF phenotypes, and interclass correlations (monozygotic versus dizygotic) will be performed to identify CF phenotypes with a substantial heritable component. 2. To determine the contribution of genetic and other factors to the variability of CF phenotypes by analysis of affected sibs. Variance component methods will be used to evaluate the CF phenotypes that appear to be heritable based upon other studies or the results of aim 1. 3. To identify biologic phenotypes that correlate with heritable CF phenotypes by clinical study of twins and sibs. Multivariate analysis will be used to find biologic phenotypes associated with CF phenotypes. 4. To identify modifier genes and loci responsible for heritable CF phenotypes by linkage approaches. Identity by descent and transmission disequilibrium methods will be used to test linkage between candidate genes/loci and heritable CF phenotypes. To identify novel loci, genome-wide scans will be performed upon sib pairs selected for extreme concordance or discordance for heritable traits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF
(MIST2)-Part2: AEs Following DC Care at DC Teaching Clinic: Electronic

This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.

Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data with an electronic platform for patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients at the Parker University Wellness Clinic
* Agreed to participate

Exclusion Criteria:

* none
Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).

To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and participants with relapsing and remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for all Participants:

* The subject has a clinically normal or acceptable medical history and physical examination at screening.
* The subject has an acceptable kidney function (eGFR \>60 mL/min/1.73m2) for administration of Gadolinium.
* The subject has a trans-locator protein (TSPO) platelet assay conducted with documented results.

Inclusion Criteria for all healthy volunteers:

* The subject has no clinical history or signs of neurological impairment.
* The subject has a normal MRI without central white white matter lesions.

Inclusion Criteria specific for participants with relapsing and remitting results sclerosis (rrMS):

* Subject with a previous diagnosis of rrMS, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion on MRI.
* The subject at screening has a MRI scan of sufficient quality for Volume of Interest (VOI) definition and co-alignment with Positron Emission Tomography (PET).

Exclusion Criteria:

General Exclusion Criteria for all participants:

* The subject has a contraindication for Magnetic Resonance Imaging (MRI).
* The subject has known allergies to Gadolinium contrast agent.
* The subject has received significant ionising radiation exposure from clinical trials or medical examinations in the last 12 months.

Exclusion Criteria specific for healthy volunteers:

* The subject has family history of multiple sclerosis (MS).
* The subject is undergoing monitoring of occupational ionising radiation exposure.

Exclusion Criteria specific for participants with remitting multiple sclerosis (rrMS):

* The subject has a past history of cerebrovascular disease or vasculitis.
* The subject has a history of head injury with prolonged coma.
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

Miltefosine efficacy will be \>85%


Eligibility Criteria:
Inclusion Criteria:

* 12 years or older
* nodules and papules consistent with post kala-azar dermal leishmaniasis
* parasitological confirmation of Leishmania infection

Exclusion Criteria:

* platelet count \<100x 109/l,
* leukocyte count \<2.5 x 109/l ,
* hemoglobin \< 8.0 g/100 ml ,
* liver function tests \>3 times upper limit of normal range,
* bilirubin \>2 times upper limit of normal range,
* serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range);
* any non-compensated or uncontrolled condition,
* lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
* treatment with any anti-leishmanial drug within the previous 12 weeks.
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains

The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion.

This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain

Exclusion Criteria:

* History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP\>140/90), coronary artery disease, or pregnancy
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)

In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.

40 adults with mild OSA (\< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age 18 - 100 years
* RDI between 5 - 15
* all races
* both sexes

Exclusion Criteria:

* craniofacial, syndromic, neurological abnormalities
* current or previous use of Singular, Rhinocort within last 6 months
* acute upper respiratory infections
* recent nasal trauma, nasal surgery, nasal septum perforation
* known immunodeficiency or under going immunosuppressant therapy
* current therapy with drugs that interact with Montelukast or Budesonide