cyrilzakka/clinical-trials huggingface dataset:
Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods

A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.

In this prospective, randomized study The investigators will include at least 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.

Eligibility Criteria:
Inclusion Criteria:

* patients with dislocation of IOL in the capsular complex who agree to participate in the study

Exclusion Criteria:

* patients with total dislocation of the capsular complex'
* patients with reduced general health
* patients who can't be randomized
The Effects of Vitamin E and Vitamin C and Exercise

Moderate exercise is thought to be one of the best known means to improve how insulin works in people. Taking vitamin C and vitamin E is also thought to have the same effect. This study is being done to see if taking vitamin C and vitamin E improves or hinders how insulin works when people do not exercise and when they do exercise.

The objective of the study is to determine in humans whether anti-oxidant supplementation with ascorbate (vitamin C) or R,R,R-α-tocopherol acetate (vitamin E) improves insulin sensitivity in the untrained state but blocks exercise-induced increases in insulin sensitivity and other adaptations to exercise. The results will provide new information on the roles of anti-oxidant supplementation in modifying insulin sensitivity, and will inform guidelines for anti-oxidant supplementation as an adjunct to exercise.

Eligibility Criteria:
Inclusion Criteria:

* 30 to 50 years of age
* Willing to not change eating habits
* Willing to not change physical activity habits
* Willing to complete the 28 week study
* Able to swallow pills

Exclusion Criteria:

* smoke or use tobacco or nicotine in any form including snuff, pills, and patches
* take any medication that makes you unable to do hard exercise
* have cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
* have uncontrolled high blood pressure
* have alcohol, anabolic steroids, or other substance abuse issues
* consume more than 3 alcoholic drinks/week
* have any joint or muscle injuries that affects your ability to exercise
* have cancer (other than skin cancer or carcinoma in situ of the cervix)
* are pregnant or nursing
Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.

Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease morbidity and mortality

This cross sectional study will be conducted to compare between the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as a non-invasive method for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms of both conditions.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis

Exclusion Criteria:

* Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease.
* Patients with heart failure.
* Patients with implantable cardiac pacemaker or defibrillator
Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up.Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18\~75,both gender.
* Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
* Patients are willing to receive eradication treatment.
* Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

* Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
* Contraindications to study drugs.
* Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
* Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
* Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
* Pregnant or lactating women.
* Underwent upper gastrointestinal Surgery.
* Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
* Evidence of bleeding or iron efficiency anemia.- Page 3 of 4 \[DRAFT\] -
* A history of malignancy.
* Drug or alcohol abuse history in the past 1 year.
* Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
* Patients who has psychological problem or poor compliance.
* Enrolled in other clinical trials in the past 3 months.
* Refuse to sign informed consent.
Promoting Early Diagnosis of Chronic Mesenteric Ischemia

CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.

Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia

Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing

Study design: Multicentre prospective cohort studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical suspicion of CMI referred to to Maagdarm Ischemie Centrum Rotterdam (MICR).
* Patients ≥ 18 years

Exclusion Criteria:

* Patients who are unable to give informed consent
* Patients with previous mesenteric artery revascularization
* No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
* Common origin of the celiac artery and superior mesenteric artery
* Known delayed gastric emptying
* Known and untreated small intestinal bacterial overgrowth
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database

This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥16 years at index date.
2. Patients with records of receiving high dose ICS or high dose ICS/LABA and diagnosed as asthma (ICD-10 code: J45 or J46 ) during baseline period. High dose ICS and high dose ICS/LABA will be defined in the appendices (Table 6-9).
3. Patients who had visit histories at least one visit during baseline period, at least two visits during outcome period and at least one visit after outcome period.
4. Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date.

Exclusion Criteria:

1. Patients diagnosed with selected autoimmune diseases during the baseline period because OCS is used as a therapeutic agent for these disease. Autoimmune disease will be identified by following ICD-10 code (M30, M05, M06, L93, M32, K50, K51, K52, N04).
Comparison of High Intensity Interval Training Verses Aerobic Exercises on Emotional Intelligence of University Students

High Intensity Interval Training verses Aerobic Exercises on Emotional Intelligence of University Students

Null hypothesis: There is no difference in effects of high intensity interval training verses aerobic exercises on emotional intelligence of university students. Alternative hypothesis: there is difference in high intensity interval training and aerobic exercises on emotional intelligence of university students.

Eligibility Criteria:
Inclusion Criteria:

20-30 years old Both males \& females Previously involved in any physical activity will be included in this study.

Exclusion Criteria:

Insomnia, ADHD, schizophrenia, bipolar disorder\& depression, anxiety etc. Headache, epilepsy and seizures, stroke, Alzheimer disease , dementia \& Parkinson's disease Drugs \& alcohol abuse Any other known medical condition
Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women with Breast Ultrasound BI-RADS 4 Grade

1. Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases.
2. The accuracy of VOCs indicators and ultrasound 4a/4b/4c diagnosis will be compared in determining benign and malignant diseases based on pathological gold standards.

Inclusion Criteria:

Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c Surgical treatment within one week after Exhaled VOC test informed consent form should be signed

Exclusion Criteria:

Male Women who have been diagnosed as breast cancer by puncture Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c Pregnant or lactating women A positive smoking history within one year Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma) The past history of metabolic diseases, including diabetes, gout, etc Respiratory diseases that have been clearly diagnosed in the past, such as asthma and chronic obstructive pulmonary emphysema, are not suitable for participation in the study Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study Combination application of drugs related to the treatment of elderly dementia Possible cases which researchers believe it is not suitable for this clinical research

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c
* Surgical treatment within one week after Exhaled VOC test
* informed consent form should be signed

Exclusion Criteria:

* Male
* Women who have been diagnosed as breast cancer by puncture
* Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c
* Pregnant or lactating women
* A positive smoking history within one year
* Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma)
* The past history of metabolic diseases, including diabetes, gout, etc
* Respiratory diseases that have been clearly diagnosed in the past, such as asthma and chronic obstructive pulmonary emphysema, are not suitable for participation in the study
* Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study
* Combination application of drugs related to the treatment of elderly dementia
* Possible cases which researchers believe it is not suitable for this clinical research
Miglustat on Gaucher Disease Type IIIB

evaluate the combination therapy with Miglustat and enzyme replacement therapy (ERT) on Gaucher disease

understand if Miglustat (glucosylceramide synthase inhibitor) could improve neuropathy in patients with Gaucher disease

Eligibility Criteria:
Case_Miglustat

Inclusion Criteria:

1. Confirmed diagnosis of Gaucher Disease: blood test shown lack of beta- glucocerebrosidase, and found L444P homozygous on GBA gene.
2. Aged 6 years old or above.
3. Already have regular ERT (30-120 IU/kg/ every 2 weeks) at least a year; dosage and frequency of ERT had not been changed in recent 3 months.

Exclusion Criteria:

1. History of tremor and abnormal extremities perception ( pain, numbness, tingle etc.)
2. Abnormal kidney function.
3. Pregnant or plan to have a baby ( potentially pregnant patient need to be transferred to gynecologist for the test and promise to have proper contraception measures).
4. Allergic to Miglustat.

Control_normal Inclusion Criteria

1. Age 6-18 years
2. No significant physical, mental, or psychiatric problems

Exclusion criteria

1. Children with eye disease (not include myopia, hyperopia, Astigmatism)
Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines

This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.

Severe trauma is responsible for more than 5 millions of deaths annually worldwide. Haemorrhagic shock secondary to uncontrolled bleeding is the leading cause of preventable death in this population, making bleeding and coagulopathy treatment a key element of the early phase of trauma management. European trauma guidelines have been developed to help clinicians in severe trauma management and improve bleeding and coagulopathy treatment in this population. Investigating who these guidelines are followed in routine is crucial to identify opportunities to improve early management of bleeding severe trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients with injury severity score equal to or higher than 16 year old admitted to the Brest academic trauma centre within the 24 hours following the trauma

Exclusion Criteria:
REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy

Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.


Eligibility Criteria:
Inclusion Criteria:

1. ≥15 years old
2. anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2

Exclusion Criteria:

1. Cardiopulmonary Resuscitation \> 5 minutes
2. Penetrating cranial injury or exposed brain matter
3. Anticoagulation treatment
4. Transfer patients
5. Known pregnancy
6. Prisoners
Use of In-Line Filtration in Critically Ill Children

The purpose of this study is to determine whether the use of in-line filtration shows any effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis, or organ failure in critically ill children admitted to the pediatric intensive care unit (PICU).

Scientific background:

Particulate contamination of infusion solutions and their systemic administration during infusion therapy has been linked to various clinical problems.

Organ failure and Multi-Organ Failure (MOV):

It is well established that the pathophysiology of MOV involves deteriorations of the microcirculation and integrity of endothelial cells. As a consequence of this an imbalance between pro- and anticoagulatory factors may develop and microthrombi may form. Mediators like tissue factor (TF) and platelet activating factor (PAF) have been linked to the formation of microthrombi.

Particles have been discussed as a causative agent for this syndrome by various authors. Their effect on morbidity and mortality of patients has however not yet been established.

Particles may have additional harmful effects:

* Direct thrombogenesis by the particle material
* Damaging endothelial cells in the capillary network
* Embolisation of the pulmonary vasculature
* Acting as a cristallisation focus for the development of granuloma
* Promoting the formation of Giant Cells

Various authors have shown that the use of end line infusion filters significantly reduces the rate of thrombophlebitis. A recently published study by van Lingen et al. (2004) also showed that the use of end line infusion filters significantly reduced the rate of overall complications in neonates.

Study Hypothesis:

The use of end line positively charged 0.2 µm and uncharged 1.2 µm infusion filters will prevent particles, microorganisms and their endotoxins from the infusate to enter the patient's circulation in the study group and will reduce significantly the complication rate of these patients.

The following clinical diagnoses are defined as "Complications". They are main contributors to morbidity and mortality in intensive care wards:

* catheter related thrombosis of the central veins
* sepsis with proven infectious organisms
* Septic syndrome without proven infectious organisms
* Failure of one of the following organs/systems

  1. Lung
  2. Kidney
  3. Liver
  4. Circulation

Eligibility Criteria:
Inclusion Criteria:

* Children admitted to pediatric intensive care unit (PICU)

Exclusion Criteria:

* Suspected death within 48 hours
* Duration of PICU stay less than 6 hours
* Patients recruited for Simulect or Sintra Study
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban: The Pilot Study

This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.

Recently developed new oral anticoagulants (OAC) overcome some of the limitations of established therapy with vitamin K antagonists (VKA) and low molecular weight heparin (LMWH) for treatment of acute venous thromboembolism (VTE), due to ease of administration and more predictable pharmacokinetic properties. Many clinical questions about the new OAC remain unanswered because there have not been direct head-to-head comparison trials. For example, although studies have shown that rivaroxaban and apixaban are at least as effective and safe as LMWH and VKA, meta-analyses suggest that apixaban may be associated with lower bleeding risk. Concerns about the potential impact of medication non-adherence have been raised. Compliance with twice daily medications (e.g. apixaban) is often worse than once daily medications (e.g. rivaroxaban). Both of these medications are approved by Health Canada for treatment of VTE yet there is genuine uncertainty about which of the two direct OAC confer the best risk-to-benefit ratio.This is a multi-centre, prospective randomized open blinded end-point (PROBE) trial assessing clinical feasibility for a larger multi-centered trial comparing bleeding outcomes using apixaban vs. rivaroxaban for treatment of acute VTE. The primary objective of the study is to determine if it is feasible to conduct a large randomized multicenter trial comparing apixaban vs. rivaroxaban for the treatment of acute VTE. The secondary objectives are to assess safety and superiority of apixaban vs rivaroxaban.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed newly diagnosed acute VTE (proximal lower extremity deep vein thrombosis and segmental or greater pulmonary embolism)
* Age ≥ 18 years old
* Written informed consent

Exclusion Criteria:

* Any contraindication for anticoagulation such as active bleeding
* Clinically significant liver disease or alanine aminotransferase (ALT) levels ≥ 3 times the upper limit of normal range
* Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula (29)
* Known allergies to either apixaban or rivaroxaban
* Pregnancy
* Use of contraindicated medications with apixaban or rivaroxaban
* Active malignancy in the last 6 months (excluding localized skin malignancy)
* No private insurance coverage for the study drug or not willing to pay for study drug