cyrilzakka/clinical-trials huggingface dataset:
Iron Bioavailability From Fortified Food

Determination of fractional iron absorption from bouillon fortified with 3 labeled iron compounds.

This single center trial will be single-blind to the subject, controlled, fully randomized with crossover design in 22 healthy females aged 18-40 years old.

Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after last stable isotope intake blood sampling (V7).

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-40 years old
2. Healthy, based on the medical screening visit including a blood formula
3. Normal BMI for age (18.5-25.0 kg/m2)
4. Weight less than 65 kg
5. Able to understand and to sign written informed consent prior to trial entry
6. Informed consent signed

Exclusion Criteria:

1. Anemia or polycythemia respectively evidenced by one of the following criteria from a standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or Ht 35-55%. Subjects outside of this range will be excluded.
2. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood donation and other causes to be appreciated by the investigator).
3. Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.
4. Any therapy or medication taken for any infectious and inflammatory disease in the past two weeks.
5. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease, as determined by the screening visit and by self-report from the subjects.
6. Diagnosed food allergy.
7. Pregnancy (tested in plasma at screening) and/or lactation.
8. History of cancer within the past year.
9. Significant weight loss during the last 3 months (10% and more)
10. Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion of the investigator).
11. Iron supplementation therapy or perfusion in the last three months.
12. Smokers (\> 5 cigarettes per day).
13. Have a high alcohol consumption (more than 2 drinks/day).
14. Consumption of illicit drugs (anamnesis only).
15. Subject having a hierarchical link with the investigator or co-investigators.
16. Subject who cannot be expected to comply with treatment or study procedure.
17. Currently participating or having participated in another clinical trial during the past month prior to the beginning of this study.
18. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
New Method to Close Nasal Septal Perforation

The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria:

* Patients with known allergy to polycaprolactone.
* Pregnancy or lactation.
Diet in Twin Pregnancy: the Wellness of Mother and Babies.

The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular:

* incidence of maternal obstetric complications:

  * gestational diabetes
  * gestational hypertension or preeclampsia
  * intrahepatic cholestasis (ICP)
* fetal growth, development and birth weight of the babies

Study design

At the time of recruitment, each patient will perform an initial clinical nutrition examination, during which will be evaluated, on the basis of BMI and specific anthropometric parameters, the necessary nutritional intake.

Patients included in the study will then be classified, on the basis of pre-pregnancy BMI, into 2 classes:

* normal weight (BMI 18-25)
* overweight (BMI 25-30) A specific diet will be developed for each patient, which will also take into account any food allergies or intolerances.

Each diet will be then eventually modified and revised throughout the pregnancy, according to the evolution of the same.

Patients will then continue their regular obstetrical examinations at the Obstetrical Day Hospital, every 4 weeks in case of uncomplicated dichorionic twin pregnancy and every 2 weeks in case of uncomplicated monochorionic twin pregnancy.

Once a month, in coincidence with the appointment at the Obstetric Day Hospital, the enrolled patients will be evaluated by the dedicated team of nutritionists.

Eligibility Criteria:
Inclusion Criteria:

* dichorionic-diamniotic twin pregnancies
* monochorionic-diamniotic twin pregrancies
* monochorionic- monoamniotic twin pregnancies
* spontaneous onset or by homologous PMA techniques
* Age between 18 and 40 years
* Gestational age between 8 weeks+0 days and 25 weeks+6 days

Exclusion Criteria:

* Pregestational diabetes mellitus (type I and II)
* Chronic hypertension
* Previous bariatric surgery
* Chronic gastrointestinal disease (Celiac disease, Crohn's disease, Ulcerative Rectocolitis)
* Age less than 18 years or more than 40 years
* Gestational age less than 8 weeks or more than 26 weeks
* Fetal structural and/or genetic abnormalities
* Heterologous PMA
* Maternal eating disorders
* Drug and/or alcohol use
* Multiple pregnancies with more than two babies
Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

Depression and obesity are very common among adolescents and young adults with attention-deficit/ hyperactivity disorder (ADHD). However, intervention programmes to prevent these comorbid disorders rarely exist. In a pilot randomized-controlled study we test two newly developed intervention programmes that do not involve medication: bright light therapy and physical exercise. Both interventions will be supported by a mobile Health application to monitor and feedback intervention success and booster patients' motivation.

The risk for comorbid major depressive disorder and obesity is increased in adolescents and adults with attention-deficit/ hyperactivity disorder (ADHD), and adolescent ADHD predicts adults major depressive disorder and obesity. Nonpharmacological interventions to prevent these comorbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm and is an established therapy for major depression in adolescents and adults. Exercise prevents and reduces obesity in adolescents and adults and also improves depressive symptoms. Interestingly, a reinforcement-based intervention using a mobile health app (m-Health) resulted in improved effects on weightloss in obesity. The aim of the current pilot randomized-controlled phase-IIa study is to establish feasibility and effect sizes of two kinds of interventions, BLT and exercise, in combination with m-Health based monitoring and reinforcement in adolescents and young adults aged 14 to 45 years old with ADHD, targeting the prevention of depressive symptoms and obesity. In addition, immediate and long-term treatment effects on ADHD specific psychopathology, health related quality of life, fitness and body related measures, neurocognitive functions and chronotype are explored. Furthermore, saliva samples are taken in a subgroup of adult patients to explore the effects of BLT and exercise on concentrations of hormones. This subgroup of adult patients will also participate in an additional neuroimaging study of the reward system in order to explore intervention effects on striatal reward reactivity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
* Stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise)

Exclusion Criteria:

* Intelligence Quotient (IQ) below 75
* Any severe (comorbid) psychiatric disorder with necessary additional psychopharmaco or daycare/ inpatient therapy beyond treatment as usual
* Severe medical/ neurological condition not allowing bright light therapy or exercise
* History of epilepsy
* Use of antipsychotics, antiepileptic or photosensitising medication
* Substance abuse/ dependency
Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas

A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.

Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.

All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-pedunculated colorectal adenomas who had provided written informed consent

Exclusion Criteria:

* known coagulopathy.
* polyposis of the alimentary tract.
* inflammatory bowel disease.
* malignant polyps.
* associated diseases in the stage of decompensation
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features

The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female age 30 years or older
2. Able and willing to give consent and able to attend all study visits
3. A confirmed diagnosis of Parkinsons Disease
4. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
5. Able to localize subthalamic nucleus on MRI for treatment
6. Able to communicate sensations during the ExAblate MRgFUS procedure

Exclusion Criteria:

1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
2. Presence of severe dyskinesia as noted by MDS-UPDRS scores
3. Presence of other central neurodegenerative disease
4. Parkinsonian symptoms are a side effect from neuroleptic medications
5. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
6. History of a bleeding disorder or receiving anticoagulant
7. Subjects with advanced kidney disease or on dialysis
8. Subjects with known intolerance or allergies to the MRI contrast agents.
9. Presence of unknown or MRI unsafe devices anywhere in the body.
10. History of multiple strokes, or a stroke within past 6 months
11. Subjects with a history of seizures within the past year
12. Subjects with malignant brain tumors
13. Women who are pregnant or nursing
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Serum C-peptide maximum 0.4 ng/mL
* Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
* BMI (Body Mass Index) maximum 32 kg/m\^2
* HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
* Non-smoker

Exclusion Criteria:

* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg/day
* Current treatment with IAsp (insulin aspart) products
* A history of drug or alcohol abuse within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Severe, uncontrolled hypertension
Enhancing Memory to Facilitate Weight Loss: Tracking, Recording and Coaching

The objective of this application is to pilot test and evaluate the acceptability and efficacy of a program to facilitate weight loss by enhancing memory for a recently consumed meal.

Once enrolled, all participants will receive behavioral weight loss treatment. Treatment will be 12 weeks in duration and will consist of 7 sessions. The content of sessions will provide the main elements described in behavioral therapy programs for obesity, based on empirical literature. Participants will be provided handouts, and the handout content will be based on our clinic treatment manual and published behavior therapy protocols. The program will be administered in individual 30-60-min sessions with a behavioral coach meeting every other week. This program emphasizes self-monitoring of food intake. It also emphasizes gradual weight loss, increasing physical activity, and improving diet through permanent lifestyle changes. Program topics include: self-monitoring of eating behavior, physical activity, changing the home environment and nutrition education. All treatment sessions will be conducted by licensed clinical health psychologists or psychology doctoral level students with experience in leading weight loss interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be overweight (BMI between 25-40)
2. Participant must be between the ages of 18-55
3. Participant can read at a minimum of an 5th grade level in English
4. Participant is willing to participate and to commit to 12 weeks of treatment and attendance at assessments

Exclusion Criteria:

1. Participant is unable to exercise (ex., due to physical or medical reasons)
2. Major psychiatric disorder diagnoses, including an eating disorder
3. Diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet is needed
4. Participant who takes medications that would influence weight and eating, or cognitive functioning, such as attention, concentration, or mental status
Psychosocial Factors and Central Sensitization in Chronic Pelvic Pain

The purpose of this study is to determine if the psychosocial factors in women with chronic pelvic pain are predisposing, precipitant or maintenance factors, and relate these factors with central sensitization and dysfunctional pain.

This study pretends clarify the psychosocial factors presents in women with chronic pelvic pain, and determine if this factors are predisposing, precipitant or of maintenance, through an interview and a series of validated questionnaires. In addition, these findings will be related to the presence of central sensitization, as measured by quantitative sensory testing.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years
* Chronic pelvic pain diagnosis, defined as persistent pain in pelvis related structures
* Pain duration ≥6 months
* Average pain intensity ≥3/10 in NRS during the previous week
* To understand the objectives of the study

Exclusion Criteria:

* Suspicion or knowledge of current organic pathology that requires medical or surgical treatment
* Pain as a consequence of surgery known
* Pending litigation or financial compensation
* Psychiatric disorders: major depression, bipolar syndrome, etc ..
* Cognitive difficulties
* Not sign the informed consent
Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 ;
* Diagnosis of acute ischemic stroke eligible for thrombolytic therapy;
* Thrombolytic therapy with the drug "non-immunogenic staphylokinase" is planned or has already been performed.

Exclusion Criteria:

* Individual intolerance or known hypersensitivity to a recombinant protein containing the amino acid sequence of staphylokinase;
* The presence of a contraindication to thrombolytic therapy of ischemic stroke;
* Pregnancy or lactation.
Impact of Chronic Ankle Instability on Gait Loading Strategy

compare the dynamic foot print outcomes in subjects suffering from chronic ankle sprain to heathy subjects


Eligibility Criteria:
Inclusion Criteria:

* subjects were suffering from chronic ankle sprain.
* age ranged from 20-30 years old.
* Normal BMI (ranged from 18 to 24.9 Kg/m2)

Exclusion Criteria:

* not suffering from any neuromuscular disorders , deformities
High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning

* High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated and humidified medical gas at up to 60 L/min of flow and is considered to have a number of physiological effects: reduction of anatomical dead space, positive end expiratory pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification
* Noninvasive positive-pressure ventilation is a safe and effective means of improving gas exchange in patients with many types of acute respiratory failure . for example, adding noninvasive ventilation to standard therapy decreased the need for endotracheal intubation...For patients assigned to noninvasive ventilation, the ventilator was connected with conventional tubing to a clear, full-face mask with an inflatable soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to 10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the disappearance of accessory muscle activity (as evaluated by palpation of the sternocleidomastoid muscle), and patient comfort
* The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory failure (ARF) are controversial. The investigators aimed to further determine the effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)

Eligibility Criteria:
Inclusion Criteria:

* All patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning
* Age \>18 years old

Exclusion Criteria:

* In patients less than 18 years old
* Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx
* Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration
Multicenter Retrospective Database on Prognostic and Predictive Factors in Patients With Neuroendocrine Tumors

Multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older and with histologically confirmed neuroendocrine tumors;
* Metastatic or inoperable disease;
* Patients with clinical information about the therapies received, including exclusive palliative care.

Exclusion Criteria:

* Lack of data on survival outcomes and/or details on treatments received.
Resect and Discard Approach to Diminutive Colonic Polyps

Resect and discard (RD) is a new paradigm for management of diminutive colorectal polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review. The aims of this study were to compare the surveillance recommendations between RD and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an RD program for management of diminutive polyps.

Introduction: Diminutive (≤5 mm) colorectal polyps are prevalent in the screening population but have low risk for harboring advanced villous or dysplastic components and for developing into colorectal cancer. "Resect and discard" (RD) is a new paradigm for management of these diminutive polyps wherein histology is determined by real-time endoscopic imaging; polyps are then resected and discarded rather than sent for histopathological review.

Aim: The aim of this study were to compare the surveillance recommendations between RD and the standard of care where polyps are sent for histopathological review in a mixed setting of academic and community gastroenterologists and to evaluate the diagnostic performance of an RD program for management of diminutive polyps.

Methods: This is a prospective, observational study conducted in a single outpatient endoscopy center over 12 months. Screening and surveillance colonoscopies were performed by four academic and two community gastroenterologists. All diminutive polyps (defined as ≤5 mm) were endoscopically imaged and histology predictions (adenoma vs. non-adenomatous polyp) were made using high-definition white light (HDWL) with/without narrow band imaging (NBI) at the discretion of the endoscopist. Diagnostic performance and accordance of recommended surveillance intervals from endoscopic imaging were compared to histopathological review of the polyps.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if diminutive polyps (defined as ≤5 mm) were identified at colonoscopy.

Exclusion Criteria:

* indication other than screening or surveillance
* no diminutive polyps were found
* an optical or histopathological diagnosis of the diminutive polyp could not be made
* the polyp was resected but not retrieved for histopathology
* a synchronous colorectal cancer was identified at the time of the colonoscopy
* polyposis syndrome
* inflammatory bowel disease
* colonoscopies not complete to cecum
* fair or poor bowel preparation