cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.

Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients aged 6 to 59 months
* Body weight \>5 kg
* Uncomplicated Plasmodium falciparum malaria
* Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
* Axillary temperature ≥37.5°C
* Ability to tolerate oral therapy
* Informed consent by the legal representative of the subject
* Residence in study area

Exclusion Criteria:

* Previous participation in this clinical trial
* Haemoglobin \<5 mg/dl
* Mixed plasmodial infection
* Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
* Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response
* History of allergy or intolerance against study medications
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV


Eligibility Criteria:
Inclusion Criteria:

Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.

Exclusion Criteria:

* Contra-indication to non-invasive ventilation
* Pregnancy
Cystoscopic Imaging Collection and Enhancement pROject

This study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.

Flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the United Kingdom. While the equipment to record bladder examinations exists, it is not simple or quick to use so examinations are rarely recorded. Methods of enhancing the images obtained during these examinations also exist but these are generally hardware based, requiring specific equipment, or use a fluorescent dye and special endoscope, which is expensive for the clinical service provider, inconvenient for the patient and may cause allergic reactions.

The new proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment to which it can be connected. Additionally, the device incorporates a foot pedal which allows the operator to "bookmark" points of interest during the examination. These points are marked in the recorded video data file and aid later navigation and review of examination session videos.

The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. Once the software has been developed, the enhanced and un-enhanced videos will be reviewed by experts (clinical urology specialists) and non-experts (other healthcare staff and laypeople), who will be asked to report areas of interest in the videos, without knowledge of the diagnosis for each examination. A statistical analysis of reporting of areas of interest by expert and non-expert reviewers will be produced, to assess the usefulness of the software image enhancement in identifying abnormalities in the bladder.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo cystoscopy examination as they are considered to possibly have undiagnosed bladder cancer, or;
* patients scheduled to undergo a post-treatment follow-up or routine surveillance cystoscopy examination, having previously been treated for bladder cancer; and
* Have provided written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out.

Exclusion Criteria:

* patients who are incapable of providing written informed consent agreeing to participation in the study.
Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
* Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \< 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \< 50%, no more than one NCCN intermediate risk factor).
* Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
* Currently receiving any other investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Unable to undergo general, spinal or local anesthesia.
* Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.
PD-Improved Dialysis Efficiency With Adapted APD

The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.

In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.

The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients with indication for renal replacement therapy
* Patient treated or to be treated with aAPD
* Fluid status regularly monitored with BCM

Exclusion Criteria:

* Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
* Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission

The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.

Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.

In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.

Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.

After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.

The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of 5%, 252 patients will have to be randomized.

Secondary endpoints include:

3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia in first remission
* Standard-or high-risk marrow cytogenetics
* HLA-matched related or unrelated donor available (in case of high-risk disease)
* Age 18 to 60
* Informed consent
* Consent of donor to donate peripheral blood stem cells
* sufficient liver function (elevation of transferases \< 2.5 x upper limit)

Exclusion Criteria:

* AML with t(5;17)
* AML with t((8;21)
* clinically relevant heart failure (NYHA II-IV)
* Renal failure (creatinine \> 200 µg/ml)
* Liver function failure (bilirubin \> 3 mg/dl)
* Concomitant Neurological or psychiatric disease
* Contraindications to receive prescribed study medication
* HIV infection
* Pregnancy
Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.


Eligibility Criteria:
Inclusion Criteria:

Adult Patient with:

1. Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and
2. Either:

   * Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or
   * Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma

Exclusion Criteria:

* Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

3+3 step up design method will be used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with operable breast cancer
* Life expectancy of at least 3 months
* Adequate organ function
* No allergy to Vitamin E and TRF
* Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

* Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
* Uncontrolled concurrent illness
* Pregnant / breast feeding women
* Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
Dynamic Imaging of the Hip for Pre-operative Planning

One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. However, if detected early, this deformity can be treated surgically by reshaping the hip joint. If the hip joint could be better visualized before surgery, then surgeons would be able to develop less invasive surgical techniques to correct this deformity.

In this study, we are trying to develop a way to help surgeons visualize the hip joint before surgery in order to assist with pre-operative planning. This will be done by comparing the dynamic hip images in patients with femoroacetabular impingement to the hip images of healthy volunteers with no hip problems.

Eligibility Criteria:
Inclusion Criteria:

* All participants (patients and controls) must be between the ages of 18 and 55, with a BMI less than 35.

The patients must have a probable diagnosis of femoro-acetabular impingement (FAI). Their hip pain must have been ongoing for at least 3 months. The controls must have a normal hip as defined by AP pelvis radiographs.

Exclusion Criteria:

* Participants (patients and controls) will be excluded if they are pregnant, have a knee injury or replacement, or history of childhood hip disease. Patients will be excluded if have they have arthritis, previous fracture or trauma to the hip, previous hip surgery, dysplasia, or avascular necrosis. Controls will be excluded if they have hip pain.
LYell SYndrome MEsenchymal Stromal Cells Treatment

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions (SCARs) to drugs.

To date, no curative drug has demonstrated with a good level of evidence its ability to promote SJS and TEN healing and could contribute to earlier reepithelialisation. Mesenchymal stroma cells (MSCs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome.

Recently, MSCs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation.

Moreover, MSCs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (GVHD) by improving thymic function and induction of Tregs. Indeed, MSCs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. MSCs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as VEGF, basic FGF and various cytokines.

Therefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, MSCs might be valuable as a cell therapy strategy for promoting cutaneous healing in SJS-TEN syndrome and subsequently decrease the morbi-mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 75 years-old
* Admission less than 10 days after onset of the reaction
* Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine
* At least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease)
* Written consent from patient or trustworthy person or legal representant or family member
* Affiliated to a social security scheme

Exclusion Criteria:

* Pregnant or breastfeeding women
* History of malignant disease within the past ten years and or presence of metastasis
* Positive serology for HIV
* Active infection for hepatitis B or C
* Decompensated cardiac failure
* Uncontrolled epilepsia
* Previous history of allogenic bone marrow transplantation
* Participation in other interventional drug research
* Patient deprived of liberty by a judicial or administrative decision or under the protection of justice
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule
* Patient under tutorship or curatorship
* Patient under psychiatric care according to art. L1121-6 CSP
Assessment of Complementary Feeding of Canadian Infants

With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. New recommendations from Health Canada include meat as a potential first food as well as other iron fortified foods. This has lead to uncertainty of both public health officials and parents about the optimal introduction and choice of solids after exclusive breastfeeding.

In addition to meeting iron needs with the first solid food choice, the investigators are concerned about the possible generation of reactive oxygen species (ROS) in the gut of the infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that most of the residual iron enters the colon. Normally excess iron is sequestered by a variety of mechanisms in the body, but there is no such system for the sequestering of iron in the gut lumen. The investigators have shown that providing iron supplements to adults where the majority of the iron is unabsorbed passes through the digestive tract can lead to the generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive the same dose and are likely producing ROS in their digestive tract. This may cause inflammation and make infants more susceptible to disease. The investigators think that meats and infant cereals with phenolic antioxidants available from fruits will likely reduce the generation of ROS in vivo. Therefore the investigators wish to determine if traditional and newly recommended first foods are safe from a free radical and inflammatory perspective.

HYPOTHESES:

1. Consumption of infant cereals with iron will increase ROS generation in the gut
2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut
3. Consumption of meat will not generate ROS
4. Consumption of iron fortified cereals or meat will maintain iron status during infancy


Eligibility Criteria:
Inclusion Criteria:

* Full term infant
* Birth weight more than 2500g
* Absence of any medical conditions

Exclusion Criteria:

* Consumption of more than 200ml formula
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

Study CKJX839B1FR01 in an In silico trial to predict the efficacy of Inclisiran therapy on major adverse cardiovascular events (MACE) and cardiovascular (CV) death in virtual patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.

Purpose of this study is to predict the size of efficacy of inclisiran 300 mg s.c., administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in addition to currently available lipid lowering therapies (LLTs) on a 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke, and on CV death, in a secondary prevention cohort of ASCVD virtual patients with a LDL-C ≥ 70 mg/dL. This will be compared to 1) placebo in adjunct to high-intensity statin therapy with or without ezetimibe, 2) ezetimibe in adjunct to high-intensity statin therapy, 3) Evolocumab in adjunct to high-intensity statin therapy and ezetimibe.

Eligibility Criteria:
Inclusion Criteria :

1. Patients with atherosclerotic CV disease, defined as any of the following

   i. Previous MI

   ii. Previous ischemic stroke

   iii. Previous symptomatic peripheral arterial disease (PAD) as evidenced by either intermittent claudication with ABI \<0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
2. Fasting LDL-C ≥ 70 mg/dL
3. Under stable (≥ 4 weeks) well-tolerated high-intensity statin with or without ezetimibe.

Exclusion Criteria :

Patients with acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \<4 weeks prior to the first study visit
The RECLAIM Study.

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
* Failure of 3 or more preventive pharmacological therapies
* Stable on preventive migraine treatments
* Psychologically stable

Exclusion Criteria:

* Concomitant invasive or non-invasive neuromodulation
* Previous exposure to an implantable neuromodulation device for headache
* Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)
* Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
* Use of steroid infiltrations or IV administration in the past 3 months.
* Not pregnant, nursing or not using contraception