cyrilzakka/clinical-trials huggingface dataset:
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension

This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.


Eligibility Criteria:
Inclusion Criteria:

* Parental consent must be granted
* Patient age: 1y - 18 y
* Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
* No reversible cause found on diagnostic work-up for hypertension
* Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension

Exclusion Criteria:

* Pregnancy
* Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
* Following abnormal laboratory values: Hyperkaliemia (serum potassium \> 5.3mmol/L); Anemia (hemoglobin \< 8g/dL); AST or ALT \> 3 times the upper limit of reference range; Total bilirubin \> 3 times the upper limit of reference range
* Abnormalities of the oral cavity that can influence intake of medication
* Known sensitivity to ACE-inhibitors
* Known lactose intolerance
* History of angioedema
* Unilateral or bilateral stenosis of the renal artery
* Diagnosis of heart failure (NYHA Class II-IV)
* History of coarctation of the aorta
* Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

The occurrence of bone loss in Crohn's disease patients is an important clinical problem for both patients with and without active disease. While therapy does exist for treatment and prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with adequate calcium and vitamin D supplementation.

The primary objective of the study is to assess the efficacy of risedronate, compared to placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years of age, or older.
* Crohn's disease, as documented by clinical, radiologic, endoscopic or histologic examination.
* Osteoporosis (T score less than -2.5) or osteopenia (T score between -1.0 and -2.5), as determined by dual energy X-ray absorptiometry.

Exclusion Criteria:

* Known bone disorders other than osteoporosis (such as hyperparathyroidism, Paget's disease, renal osteodystrophy and documented osteomalacia)
* Abnormal thyroid function. Those patients on thyroxine replacement must not have had a change in dose in the two months prior to prospective data collection program entry
* Clinically significant renal impairment (serum creatinine ≥ 2x normal).
* Clinical Short Bowel Syndrome
* Patients on total parenteral or enteral nutrition
* Spinal anatomy that would not allow adequate assessment of lateral spine using DEXA
* Patients who had received:

  1. previous bisphosphonate therapy
  2. fluoride supplement in the 24 months prior to entry
  3. calcium supplements of more than 1.0g/day in the 6 months prior to entry
  4. vitamin D supplements greater than 1000 IU/day in the 6 months prior to entry
  5. calcitonin in the 3 months prior to entry
* Females on hormone replacement therapy who do not agree to continue the therapy for the duration of the prospective data collection program
* Men on testosterone who do not agree to continue it for the duration of the prospective data collection program
* Pregnancy or women who are breastfeeding
Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included.

Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007
* Patients come to follow up

Exclusion Criteria:

* inability in verbal and written communication
* impairment in cognitive functions
Risk Assessment Strategies in Pulmonary Embolism

The aim of this study is to evaluate different scores of risk assessment in patients with pulmonary embolism. This study aim to compare the accuracy of these scores in predicting mortality during hospital admission.

Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate.Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (≥13%) short-term mortalities that occur either in hospital or within 30 days.

Some studies have demonstrated that PE may indicate increased 1-year mortality rates up to 25%,,. Therefore, PE is considered a potentially fatal disease, although patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage5.

Risk stratification of patients with acute PE is mandatory for determining the appropriate therapeutic management approach. Risk classification of PE can discriminate low-risk patients, who can be medicated as outpatients, from others at high risk, in whom a profit from intensive care unit admission or even in-hospital thrombolytic therapy is expected.

Eligibility Criteria:
Inclusion Criteria:

-

All patients will be subjected to the following:

1. Complete history taking and clinical examination.
2. Chest x-ray
3. ECG and echocardiography.
4. Arterial blood gases.
5. Multislice CT angiography of the chest.
6. Laboratory tests and biomarkers.

Exclusion Criteria:

* 1- Patients with unexpected or accidental diagnosis of PE (patients undergoing diagnostic tests for another suspected disease.

  2- Patients with acute left heart failure or acute respiratory failure responsible for symptoms.

  3- Patient with recurrent PE (only the first event was included in the analysis).
Enteral Nutrition Infusion Rate and Gastric Function

A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation.

Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* At least 18 years old
* BMI between and including 18 and 30
* Understand and able to read Dutch
* In good health on the basis of medical history
* Female subjects of childbearing potential are willing to use adequate contraception
* Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria:

* Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
* Using any medication that might affect gastric function or visceral sensitivity
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
* Metal or other MRI incompatible implants
* Contra-indications for MR (checked by MR safety questionnaire)
* Pregnancy
* Claustrophobia
* Have a known allergy or intolerance to cow milk, soy, saccharose or any other ingredient of Isosource Standard.
A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
2. Adequate hepatic, renal and pancreatic function.
3. Age ≥ 18 years.

Exclusion Criteria:

1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.
2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
3. Extramedullary disease only.
4. Major surgery or radiotherapy within 14 days of randomization.
5. History of clinically significant or uncontrolled cardiac disease.
6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.
7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
9. Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.
Maternal Diet, Body Mass Index Trajectories and Cardiometabolic Risk in Early Childhood

This study focused on evaluating the association between adherence to the Mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. This study is part of a secondary data analysis of the INMA (INfancia y Medio Ambiente-(Environment and Childhood)) Project.


Eligibility Criteria:
Inclusion Criteria:

* to be resident in one of the study areas
* to be at least 16 years old
* to have a singleton pregnancy
* to wish to deliver in the reference hospital

Exclusion Criteria:

* to not be fluent in Spanish or other regional languages.
* to have followed a programme of assisted reproduction
Normative Brain Volume Profiles From Multicenter Fetal MRI

Fetal brain MRI is an essential diagnostic tool to inform parents about the prognosis of abnormalities detected on routine ultrasound. Recent work has shown that brain MRI measurements at the antenatal stage are predictive of the child's postnatal development. However, this work remains limited to basic research, in part because of the lack of normative curves of brain tissue volume evolution from fetal MRI acquired in clinical routine. This project aims to fill this gap. For this purpose, the project will exploit fetal MRI scans acquired in 4 French hospitals (Marseille, Nice, Montpellier and Paris): MRI scans without abnormalities will be centralized for analysis, and families who have undergone these scans will be contacted to evaluate the development of their children after birth. Normative curves will be established by applying a set of treatments developed by the laboratory in Marseille collaborating in the project. Ultimately, these curves will help to clarify the diagnosis of fetuses by providing a quantitative characterization of the normality of brain measurements.


Eligibility Criteria:
Inclusion Criteria:

Child who has had, more than 3 years ago, a cerebral MRI during the fetal period in one of the 4 partner centers

Exclusion Criteria:

* Child suffering from a commissural malformation (anomaly of the corpus callosum)
* Child with a genetic syndrome and/or chromosomal abnormality and/or deleterious mutation
* Child with syndromic extra-cerebral malformations (including cardiac malformations)
* Child with intrauterine growth restriction reported in the obstetrical record
* Child with maternal-fetal infection (TORCH, parvovirus or other) confirmed by amniotic fluid test or neonatal urine test
* Multiple pregnancy
* Mother with diabetes treated during pregnancy (including gestational diabetes, if treated)
* Mother with antiepileptic medication during pregnancy
* Alcohol or drug use
* Presence of a sustentorial arachnoid cyst
* Presence of an arachnoid cyst with mass effect
* Objection from parental authority holders to participate in the study
Correlation of Volumetric Brain Analysis With Development at 18 Months

The study will correlate the volumes of the brain obtained from magnetic resonance imaging (MRI) scans done at term gestation for infants born prematurely who weighed less than 1000 grams at birth with their corresponding development at 18 months corrected age.


Eligibility Criteria:
Inclusion Criteria:

* All premature infants born \< 1000 grams who had MRI scans of the brain at term gestation

Exclusion Criteria:

* Any known genetic or chromosomal abnormalities
Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome

To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* History of AD for at least 3 years
* Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
* IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

* Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Baclofen for the Treatment of Alcohol Dependence

There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
* An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
* Last alcohol consumption within 7-21 days before randomisation
* Sufficient German language capabilities

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinical significant medical conditions or observed abnormalities
* Psychiatric illness undergoing treatment with psychoactive drugs
* Epilepsy or epileptiform convulsions
* Addiction to drugs other than nicotine
Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for avoidant/restrictive food intake disorder (ARFID) in one study for children and adolescents (ages 10-17 years) and one study for adults (ages 18-65 years).

This study is designed to pilot the CBT-AR treatment in youth with ARFID to determine treatment acceptability and efficacy.This includes evaluating the efficacy and acceptability of CBT-AR in reducing primary ARFID symptoms from pre- to post-treatment, and to assess whether improvement in individual symptoms is related to the timing of relevant interventions. The investigators hypothesize that from pre-treatment to post-treatment, subjects with ARFID will decrease severity of self-reported ARFID symptoms, decrease self-reported anxiety and depression, and improve psychosocial functioning. The investigators further hypothesize that overall, subjects with ARFID will have reduced phobic avoidance, sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Males and females; ages 10-17 years AND 18-65 years with avoidant/restrictive eating disorder or avoidant/restrictive eating patterns, characterized by either (i) Eating Disorder Assessment-5 (EDA-5) (ii) Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (KSADS-PL)

Exclusion Criteria:

* Use of systemic hormones, pregnancy or breastfeeding within eight weeks
* History of psychosis by KSADS-PL
* Substance or Alcohol Use Disorder active within the past month by KSADS-PL
* Active suicidal ideation
* Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* Any feeding or eating disorder other than ARFID determined by EDA-5
* Any clinically significant disordered eating as evidenced by EDE-Q global \> 4.0 or self-induced vomiting, laxatives, diuretics, purposeful fasting, or compensatory exercise in past 28 days
* Medical history of intellectual disability (IQ\< 70)
* Has previously received more than 4 hours of CBT for ARFID in the past
* Is currently receiving another form of psychosocial treatment for ARFID (e.g., occupational therapy, speech therapy, another form of psychotherapy) and is unable to discontinue that treatment for the duration of this study.
Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational Study.

Mechanical ventilation is likely lifesaving in patients with coronavirus disease 2019 (COVID-19) but may also result in adverse events. Only few studies describe the strategies used and adverse effect of mechanical ventilation in an unselected population of ICU patients with COVID-19.

This study is designed to be a retrospective study focusing on all mechanical ventilated ICU patients with COVID-19 included in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e. a total of 1,193 patients. The investigators will register the use of the core interventions around mechanical ventilation and its potential adverse event, including barotrauma and prolonged ventilation.

This study will provide important data on the ventilation strategies used and its potential adverse events in unselected ICU patients with COVID-19 and thereby inform clinicians, patients, policy-makers, and future research in this area.


Eligibility Criteria:
Inclusion Criteria:

All mechanical ventilated patients registered in the national Danish COVID ICU database between 10.03.2020 - 02.04.2021 i.e.

1. Admitted to an ICU in Denmark
2. Laboratory-confirmed SARS-CoV-2 infection
3. Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at any time during the ICU stay

Exclusion Criteria:

None
Study of Hemostasis in Case of Severe COVID-19

The COVID-19 outbreak has led to a significant increase in the number of patients admitted to intensive care for respiratory distress. Early data indicate a particularly high risk of thrombotic risk to viral lung disease, particularly in the most severe patients, with a particularly high incidence of pulmonary embolism. Catheter thrombosis and extra-renal purification filters are also abnormally common. These thrombotic complications could contribute to the mortality observed in this pathology. The introduction of early curative anticoagulation in the most severe patients has just been proposed by the perioperative hemostasis interest group

Biologically, a significant proportion of patients hospitalized in intensive care have a marked biological inflammatory syndrome, associated with signs of activation of clotting (a frank increase in D-dimers). The presence of circulating anticoagulants is common. Interestingly, thrombocytosis, normally observed in such inflammatory syndromes, is absent.

In this context, it seems legitimate to explore these patients from a hemostasis perspective to identify the factors that cause this thrombotic over-risk, in order to minimize the occurrence of these complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\<18y)
* With a SARS-CoV-2 infection confirmed by RT-PCR
* Hospitalized in intensive care

Exclusion Criteria:

* Patients under guardianship/curator
* Anemia at 7 g/dL at inclusion