cyrilzakka/clinical-trials huggingface dataset:
Fiber Tolerability in Children

Assessment of the digestive tolerability of the PROMITOR® .

The trial will be multicenter, double-blind, placebo-controlled, randomized with a 4-arm parallel-design. The subjects wil be randomized to one of the four arms, i.e. four doses of investigational product balanced in maltodextrin, given at the doses of 6, 9 or 12 g (corresponding to 4, 6, or 8 g of fibers) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fibers) over one week of intake.

The total sample size is 40 healthy children from 8 to 12 years old, male and female.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children,
* Aged between 8 and 12 years old included
* Acceptance of the taste of the product
* Having breakfast on daily basis
* Consent and/or assent received according to regulation
* Informed consent of one of the parents/guardians (for the study to be conducted in Switzerland, in respect with the Swiss regulation) or Informed consent of both parents/guardians (for the study to be conducted in France, in respect with the French regulation)
* Parents/guardians affiliated to a health insurance (only for the study to be conducted in France, in respect with the French regulation)

Exclusion Criteria:

* Specific food regimen
* Intolerability or food allergy
* Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
* Chronic gastrointestinal disease
* Gastroenteritis in the 2 weeks preceding the study
* Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)
* Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking)
* Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
* Having participated in another clinical trial for 1 month, or currently participating in a clinical trial
* Under legal protection or deprived from his rights following administrative or judicial decision (only for the study to be conducted in France, in respect with the French regulation)
Confocal Laser Microendoscopy (CellTouch) for the Diagnosis of Early Gastric Cancer: A Multicenter Clinical Study

This study is A prospective, randomized, multicenter clinical trial: The study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. The subjects are divided into two groups by random envelopes, A and B, and the endoscopic diagnosis in different groups is performed in different order (including: White light endoscopy,CellTouch, Magnifying endoscopy with NBI(ME-NBI)). Finally, the gold standard of histopathology was used to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.The study hypothesized that the sensitivity and specificity of CellTouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.

Objectives:

1. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch in the diagnosis of early gastric cancer.

Secondary Objectives

1. Using histopathology as the gold standard, the diagnostic performance of CellTouch and ME-NBI in the diagnosis of early gastric cancer was compared and analyzed.
2. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch combined with ME-NBI and ME-NBI alone in the diagnosis of early gastric cancer.
3. Histopathology was used as the gold standard to evaluate the diagnostic performance of CellTouch and ME-NBI in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 70 years;
2. Patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(Suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. According to the Paris classification standard);
3. Patients who willing to provide written informed consent.

Exclusion Criteria:

1. Patients with absolute contraindications to gastroscopy;
2. Patients with advanced gastric cancer;
3. Patients who cannot undergo histopathological examination;
4. Patients who cannot be given general anesthesia;
5. Patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception；
6. Patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.
Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)

This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (aged between 21 and 65)
* Subjects fluent in written and spoken French
* Subjects enrolled in a 12-weeks cardiac rehabilitation program
* Subjects agreeing to participate
* Subjects that have signed the informed consent form

Exclusion Criteria:

* Subjects with tachycardia (heart rate at rest \> 120bpm)
* Subjects with atrial fibrillation
* Subjects with severe heart failure (LVEF\<35%)
* Subjects with severe renal dysfunctions (eGFR \< 30mL/min/1.73 m2)
* Subjects with pheochromocytoma
* Subjects with Raynaud's disease
* Subjects with trembling and shivering
* Subjects with interarm systolic difference \> 15 mmHg
* Subjects with interarm diastolic difference \> 10 mmHg
* Subjects with arm paralysis
* Women in known pregnancy
* Subjects with an arteriovenous fistula
* Subjects with arm amputations
* Subjects with the upper arm circumference \> 64 cm
* Subjects with the wrist circumference \> 22 cm
* Subjects with the exfoliative skin diseases
* Subjects with lymphoedema
Medication Adherence to Phone-supervised Pancreatic Enzyme Replacement Therapy

This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their Pancreatic Enzyme Replacement Therapy's Medication Adherence.

Pancreatic exocrine insufficiency (PEI) represents a significant complication in cases of chronic pancreatitis (CP), exerting considerable influence on patient quality-of-life outcomes. The latest iteration (2020) from ACG's guidelines emphasizes Pancreatic Enzyme Replacement Therapy (PERT) as pivotal in managing both symptomatic and asymptomatic cases among individuals with CP. PERT not only extends median survival but also substantially mitigates symptoms while averting digestive complications associated with malabsorption-ultimately enhancing overall well-being.

An analysis revealed varying levels of PERT compliance across different patient groups-48% for those with CP, 52% for pancreatic cancer sufferers, and another 52% following pancreatic resection-induced PEI-with these rates declining to approximately 20% within one year post-initiation. Furthermore, findings from a limited-scale survey involving 148 individuals demonstrated that merely half exhibited satisfactory medication adherence; notably attributed to inadequate comprehension regarding prescribed regimens.

Presently lacking are established protocols aimed at bolstering PERT medication adherence specifically tailored towards individuals affected by CP-a gap this investigation seeks to address through comprehensive educational initiatives coupled with sustained telephonic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients in the Department of gastroenterology who met the clinical diagnostic criteria of chronic pancreatitis in the 2002 Asia-Pacific Consensus Opinion in Changhai Hospital;
* at least 18 years of age;
* Have a mobile phone that can talk;
* Agree to complete the supervision and follow-up of pancreatic enzyme administration set up in this study through telephone communication.

Exclusion Criteria:

* Refusing to participate in the study;
* Exclusion of difficult differential diagnosis: diagnosis of pancreatic cancer, groove pancreatitis, and autoimmune pancreatitis within 2 years after diagnosis of chronic pancreatitis;
* Pregnant or lactating women;
* communication difficulties, mental and mental illness can not cooperate;
* There are other reasons that researchers believe should not be included (Alzheimer's disease, end-stage cancer, HIV, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, decompensated cirrhosis, renal failure, etc.);
Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants

The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

Eligibility Criteria:
Inclusion Criteria:

* 1. Gestational age (GA) is from 26 to 37 weeks;
* 2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* 3. Respiratory distress syndrome Silverman score \>5;
* 4. Informed parental consent has been obtained.

Exclusion Criteria:

* 1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* 2. Major congenital malformations or complex congenital heart disease;
* 3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* 4. Cardiopulmonary arrest needing prolonged resuscitation;
* 5. transferred out of the neonatal intensive care unit without treatment.
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin naive
* On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
* Body Mass Index (BMI) below or equal to 40.0 kg/m2
* HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)

Exclusion Criteria:

* Proliferative retinopathy
* Recurrent major hypoglycaemia
* Cardial problems
* Uncontrolled hypertension
* Impaired hepatic or renal function
The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF

This study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (Ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF).

The purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia following anterior cervical discectomy and fusion (ACDF). The medications include Ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. Eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a ACDF for radiculopathy or myelopathy. Participants will be recruited for a prospective, randomized, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (NSAID), (2) IV NSAID(1-time dose of 30mg of IV Ketorolac at time of closure), and (3) IV steroid (1-time dose of 10mg of IV dexamethasone at the time of closure. The primary outcome measures are patient questionnaires which include the EAT-10 and Bazaz classification for dysphagia and VHI-10 for dysphonia. In addition, the Neck Disability Index (NDI) and Visual Analogue Pain Scale (VAS) will also be collected. Research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age and older
* Undergoing anterior cervical discectomy and fusion (ACDF) for radiculopathy or myelopathy
* No known allergies or sensitivities to steroid or non-steroidal medications

Exclusion Criteria:

* Procedure is being done for revision, trauma, infection or tumor
* Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestinal bleeding...)
* Patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27
Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain

The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, aged 15 years or more;
* Participants who require extraction of impacted mandibular third molar;
* Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell \& Gregory (1933) class II position B or class III position A or B;
* Participants with acute pain of moderate or severe intensity after completion of surgery.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Participants whose surgery for molar extraction lasted more than 50 minutes;
* Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
* Participants who used sedatives or hypnotic agents before surgery;
* Anesthesia technical failure or need for more than three anesthetic tubes;
* Participants with temporomandibular joint dysfunction or limited mouth opening;
* Surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial;
* Postoperative complications such as, but not restricted to: neuropraxia and paresthesia;
* Participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial;
* Participants under chronic opioid treatment.
A Novel Iron-Based Supplement for Athletes Aged 14-17

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in endurance-trained adolescent females (aged 14-17) with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation, participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility Criteria:
Inclusion Criteria:

* cis-gendered female 14-18 years old
* sub-optimal iron status (ferritin ≤45mcg/ L)
* At least 1 year past the age of menarche
* Engage in moderate to vigorous endurance activity for at least 3 hours a week

Exclusion Criteria:

* Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months
* antibiotic use in last 3 months
* - Energy availability \>30 kcal/kg lean body mass
Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada.

Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program.

Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-17.5 years
* Diagnosed with IBD diagnosed using standard criteria
* Ability to speak/read English at a functional (Grade 8) level
* Intention to reside in Canada after transfer to adult care
* Ability to use a smartphone or personal computer for the virtual intervention

Exclusion Criteria:

* Do not speak English fluently
* Intention to leave Canada after graduation from high school
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c \>= 7%, but \< 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) \>40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT \> 1.5 times UNL, creatinine clearance \<60 mL/min
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS

This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.


Eligibility Criteria:
Inclusion Criteria:

* 13 to 65 years old at the time of screening
* has moderately severe or severe hemophilia A or B (FVIII/FIX level

  ≤2%), with or without transient inhibitors
* Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient currently prescribed RIXUBIS (FIX)
* previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX for ≥150 documented exposure days (EDs)
* is willing and able to comply with the requirements of the protocol
* is proficient in the English language to allow for use of the SPACE eDiary

Exclusion Criteria:

* inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor
* has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of this study
* is a family member or employee of the investigator
* elective major surgery is planned within 6 months after enrollment which may interfere with activities of daily living (at investigator's discretion)
* continuously require walking assistance devices (eg, wheelchair, crutches, etc.)
Anecortave Acetate Risk Reduction Trial (AART)

The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.


Eligibility Criteria:
Inclusion Criteria:

* Dry AMD in study eye, Wet AMD non-study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 50.
* Other protocol-defined exclusion criteria may apply.
Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Referring for upper GI endoscopy
* Age 18 to 65 years
* First experience of upper GI endoscopy
* Class I or II of American Anesthesiology Association
* Willingness to participate

Exclusion Criteria:

* Severe psychiatric, neurological, cardio-vascular, or renal disorders
* History of allergy or intolerance to benzodiazepines or lidocaine
* History of upper GI surgery
* Pregnancy or lactation
* GI anomalia during endoscopy
* Need for therapeutic procedures during endoscopy
* Active bleeding