cyrilzakka/clinical-trials huggingface dataset:
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).

The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 4 to 16 years with suspected uncomplicated OSAS

Exclusion Criteria:

* Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders)
* Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity
* Children who are exposed to second hand smoke for greater than 8 hours per day.
* Children with hypersensitivity to caffeine or dextromethorphan
* Children who are receiving corticosteroids or thyroid hormone
Comparison of Dietary Fats on Vascular Parameters

The purpose of the study is to examine the effect of consuming 50g of fat from 5 different sources (coconut, canola, grapeseed, chia, and butter) on arterial stiffness, blood pressure and blood glucose levels. It is hypothesized that butter will have the most detrimental effect on acute vascular function. Canola, grapeseed and chia oil with their decreased content of SFA are hypothesized to impair vascular function to a lesser extent.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18-65 years
* BMI \< 30 kg/m2
* Brachial systolic blood pressure ≤ 140 mmHg
* Brachial diastolic blood pressure ≤ 90 mmHg

Exclusion Criteria:

* Women of childbearing age must not be pregnant or breastfeeding at the time of the study
* BMI \>35kg/m2
* Hypertensive as defined by brachial SBP \>140mmHg and/or DBP \>90mmHg
* Sensitivity to the study product or its sources
* Presence of chronic conditions or illnesses
* Having any gastrointestinal complication or condition
* Chronic use of dietary supplements that alter fat absorption
Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery

The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR

Exclusion Criteria:

* diabetes mellitus,
* coronary stenosis ≥70%,
* renal failure (serum creatinine \> 2.0 mg/dL),
* upper arm peripheral vascular disease,
* LV ejection fraction \<50%
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.

Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping

Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump.

Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds).

Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR \> 100/min

Eligibility Criteria:
Inclusion Criteria:

Vaginally born, Singleton Term gestation (≥ 37 and \& \< 42 weeks), requiring resuscitation at birth

Exclusion Criteria:

* Major congenital anomaly (antenatally diagnosed or visible at birth)
* Rh negative pregnancy
* Hydrops
* Abruptio Placneta/ Placenta previa
* Fetus with absent and reversal of End Diastolic flow
* Cord avulsion
* Refusal of consent
Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Sepsis

The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
* Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
* In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.

Exclusion Criteria:

* Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
* Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.
Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients

AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed orthodontic appliances (FOA).

The null hypothesis is that neither incidence nor severity of lesions would differ from a control group using standard fluoride dentifrice.

SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4 Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the maxillary incisors, canines and premolars are taken. At debonding, remaining composite material on the surfaces is removed with a slow rotating carbide bur followed by polishing with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is thereafter exposed.

The primary outcome measure is the incidence and severity of WSL as registered separately by two blinded experienced and calibrated clinicians according to a validated index. A random sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The intervention is indended run throughout the full duration of the orthodontic treatment, varying between 18 and 24 months.

not desired

Eligibility Criteria:
Inclusion Criteria:

* healthy
* bi-maxillary treatment with fixed orthodontic appliances for at least 1 year

Exclusion Criteria:

* poor oral hygiene (not being able to brush their teeth)
* recent high caries activity
Outcomes Measures in Intellectual Disability

Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.

The aim of the study is to develop and validate quantitative interactive attention evaluation criteria by using games on touchscreen and or eye tracking in patients with intellectual disability. Tests will have to be suitable whatever severity and etiology of intellectual disability. Tests have to evaluate attention and concentration troubles in intellectual disability.Once validated, tests could be used as outcome measures in clinical trials and as cognitive reeducation tools in intellectual disability.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sex, with intellectual disability
2. Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients
3. Patients with more or less severe intellectual disability from various causes including Fragile X syndrome, Rett syndrome, Angelman syndrome and other etiologies of intellectual disabilities and intellectual disabilities without identified etiology
4. Affiliation to a social security system own or affiliated (excluding AME)
5. Presence of parents or legal representative
6. Informed consent signed by parents or legal representative

Exclusion Criteria:

1. Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
2. Uncontrolled seizure disorder despite treatment
Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Good general and oral health;
* Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

Exclusion Criteria:

* Presence of non-treated caries or periodontal disease;
* Prior tooth hypersensitivity;
* Presence of gingival recession;
* Teeth with cracked enamel or any hypoplasia;
* Patients using oral removable or fixed orthodontic appliances;
* Patients were pregnant or breastfeeding.
Impact of Tiotropium Add-on Therapy in Patients With Asthma

To evaluate the effectiveness of add on therapy with Tiotropium Respimat® compared to increasing the dose of ICS in patients with a diagnosis of Asthma and on ICS/LABA therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with least one asthma diagnosis in the inpatient setting or at least two separate instances of asthma diagnosis (separated by at least 30 days) recorded in the outpatient or emergency room setting will be included.
* Patients will be required to be already on Inhaled Corticosteroid/Long-acting beta-agonist (ICS/LABA).
* Patients will be required to have available records 12 months prior to the index date.

Exclusion Criteria:

* Patients below the age of 6 years on the Inhaled Corticosteroid/Long-acting beta-agonist initiation (ICS/LABAi) date will be excluded.
* Patients with a diagnosis of COPD at any time during the study period will be excluded.
* Those who are on biologics at baseline will be removed.
* After the PSM process, unmatched patients will be excluded.
ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.

PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

OBJECTIVES:

* Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer.
* Determine toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal).

Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage I or II primary operable breast cancer

  * Surgery planned within next 1-4 weeks
* Hormone receptor status:

  * Estrogen receptor positive or unknown
  * No known estrogen receptor negative tumor
  * Unknown progesterone receptor status eligible

PATIENT CHARACTERISTICS:

Age:

* Any age

Sex:

* Female

Menopausal status:

* Premenopausal or postmenopausal

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* No bleeding diathesis not compatible with an IM depot injection

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study
* No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix
* No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* At least 2 months since prior ICI 182780

Radiotherapy:

* No prior radiotherapy to primary tumor

Surgery:

* See Disease Characteristics

Other:

* No other concurrent preoperative therapy for breast cancer
Machine Learning Predict Renal Replacement Therapy After Cardiac Surgery

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a major complication which may result in adverse impact on short- and long-term mortality. The researcher here developed several prediction models based on machine learning technique to allow early identification of patients who at the high risk of unfavorable kidney outcomes. The retrospective study comprised 2108 consecutive patients who underwent cardiac surgery from January 2017 to December 2020.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years who underwent cardiac surgery

Exclusion Criteria:

* data miss greater than 10%
Study of Low Molecular Weight Heparins

DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.


Eligibility Criteria:
Inclusion Criteria:

* All patients with indication for low molecular weight heparin

Exclusion Criteria:

* Patients under the age of 18
* Patients who are incapable of understanding the written material received
* Patients who after being informed in writing chooses not to participate
* Patients with contraindications for low molecular weight heparins as described in the SmPC
Efficacy and Safety of BGG492 in the Treatment of Migraine

This study will assess the efficacy and safety of BGG492 used to treat migraine pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe migraine for at least 1 year
* At least 1 migraine episode, but not more 15 migraine days per month
* Past use of triptans
* Migraine onset before 50 years of age

Exclusion Criteria:

* Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
* More than 6 non-migraine headaches per month
* Patients receiving migraine prophylaxis treatment
* Patients receiving regular treatment with psychoactive drugs
* Smokers
* Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia

This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).

The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14 to 45, inclusive
* Episodes of prolonged penile erection in the absence of sexual interest or desire, with an average frequency of at least twice weekly, when averaged over the previous four weeks
* Able to provide informed consent or assent

Exclusion Criteria:

* Use of chronic nitrates or recreational use of nitrate containing products
* Use of a PDE5 (phosphodiesterase type 5)inhibitor within the previous two weeks
* Alcohol use exceeding two standard drinks daily
* Hypersensitivity to sildenafil
* Estimated glomerular filtration rate \<50ml/min
* Known cirrhosis
* Retinitis pigmentosa
* Necessary use of a P450 3A4 inhibitor (a drug which can increase plasma levels of sildenafil when taken together)
Bone Mineral Density in Children With Graves' Disease

to evaluate bone mineral density in children with graves' disease


Eligibility Criteria:
Inclusion Criteria:

* age at enrollment ≥2 years to \< 18 years
* both sexes
* the patients should be diagnosed with graves'

Exclusion Criteria:

* patients less than 2 years
* patients more than 18 years
* Controlled GD patients on antithyroid
* patients with other endocrine diseases
Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Primary outcome:

The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a well-documented line of therapy namely narrow band ultra violet B (nbUVB).

Secondary outcomes:

1. To identify the possibility of streptococcal throat infection as a possible underlying etiology in PLC.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with classic papular eruption of PLC (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions
2. Age: \> 6 years
3. Both sexes.

Exclusion Criteria:

1. Patients presenting with only hypopigmented macules whom their skin biopsy revealed PLC.
2. Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.
3. Patients with PLC associated with classic MF.
4. Patients with known absolute contraindications to NB-UVB.
5. Patients with impaired liver and/or kidney functions.
6. Patients with history of any heart disease.
7. Patients with known hypersensitivity to Azithromycin

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Metacognitive Therapy for Patients With Obsessive-Compulsive Disorder

Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. However, the majority of treated patients remain symptomatic. The metacognitive therapy by Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis: obsessive-compulsive disorder
* German-speaking
* Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

* Current or past diagnosis of substance dependence, psychosis, neurological conditions
* Mental retardation