cyrilzakka/clinical-trials huggingface dataset:
Food Supplement for the Treatment of Patients With Amyotrophic Lateral Sclerosis

The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)

This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 18 to 75 years, Females\>50 years
2. Diagnosis of "probable" or "definite" ALS according to the El Escorial revised criteria
3. A documented history of ALS symptoms for more than 6 month prior to study enrolment, and no more than 40 month.
4. Patients capable of understanding and signing Informed Consent.

Exclusion Criteria:

1. Patients allergic to seafood
2. Patients with forced vital capacity \< 75%
3. Patients who are respiratory dependent, underwent tracheostomy, or cannot swallow.
4. Patients with cardiovascular diseases
5. Patients with diabetes
6. Patients with active peptic ulcers
7. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
8. Patients suffering from other chronic significant disease, malignant diseases or any other disease that may risk the patient or interfere with the ability to interpret the results.
9. Patients that can not sign/understand the Informed Consent Form.
10. Female patients who are pregnant or lactating
11. Patients who have received and experimental drug or have participated in a clinical trial within 1 month prior to screening
'Optiflow + Duet' Interface' vs 'Standard' High Flow Nasal Cannula

High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been largely investigated in chronic obstructive pulmonary disease (COPD) patients but only marginally in patients experiencing acute respiratory failure after extubation. Promising data have been published in vitro about new asymmetrical high flow nasal cannula, named 'Optiflow + DUET'. Positive airway pressure, that dynamically changes with breathing, and clearance of anatomical dead space are the key mechanisms of noninvasive respiratory support with nasal high flow. Pressure mainly depends on flow rate and nare occlusion. The hypothesis is that an increase in asymmetrical occlusion of the nares leads to an improvement in dead-space clearance resulting in a reduction in re-breathing and breathing work.

A prospective cross-over RCT on the effects of 'Optiflow + DUET' as compared to convetional symmetrical high flow cannula and Venturi mask.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old;
* invasive mechanical ventilation \> 24h;
* acute respiratory failure within 120 minutes after extubation (defined during a spontaneous trial using Venturi mask and assessing a PaO2/FiO2 ratio \< 300;
* absence of Sars-Cov-2 positivity;
* absence of cardiological or long-term respiratory disease

Exclusion Criteria:

* pregnancy
* tracheostomy
* non-invasive ventilation after extubation
* second tracheal intubation
* contraindications for EIT belt
* facial or nose abnormalities
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.

Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.

However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.

Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.

Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old scheduled for hip joint surgery

Exclusion Criteria:

* Patients with impaired consciousness or delirium before surgery
* Patients who are hemodynamically unstable before surgery
* Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
* Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
* Patients with known allergy to benzodiazepine, flumazenil
* Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Patients with hypersensitivity to Dextran40
* Patients who have been taking benzodiazepine for long term
* Patients with end stage renal disease requiring hemodialysis
* Patients with history of acute angle glaucoma
* Patients with alcohol or substance dependence
* ASA classification 4 or 5
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study


Eligibility Criteria:
Inclusion Criteria:

1. patients currrently participating in Novartis study CAMN107A2109
2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
3. males or females ≥18 years of age
4. WHO Performance Status of ≤ 2
5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

Exclusion Criteria:

1. Impaired cardiac function; use of therapeutic coumarin derivatives
2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
Factors for the Onset and Course of Axial Spondylitis

In a research project, investigators want to study the course of the disease of axial spondylitis: the causes of disease onset, prognosis, and treatment effects. The goal is to improve treatment and in the long run also prevention of the disease. The project has a focus on the body\&#39;s own substance prostaglandin, and its proinflammatory role in spondylitis, but also other substances may be analyzed in blood and urine samples.

The purpose of the research project is include newly diagnosed treatment-naive patients with axial spondyloarthritis, to follow them after 1 and 2 years after treatment start, to collect clinical data, questionnaires, blood and urinsamples to find blood or urine markers that can be used for precision therapy of axial spondylitis.

The EISPA study is an epidemiological and translational study in axial spondylitis patients who are included in the Swedish Rheumatology Quality Register (SRQ). EISPA aims to include consecutive newly diagnosed axial spondylitis patients.

Despite the fact that the disease is relatively common, it takes on average 10 years after start of symptoms for patients be diagnosed with axial spondylitis.

Axial spondylitis diagnosis is based on clinical findings rather than diagnostic tests, which reflects lack of knowledge about what causes the disease. At present, our possibilities to predict the course of the disease (and thereby individualize the care of the patient) are limited. Current treatment decreases inflammation rather than treating the cause of the disease.

The first treatment step of axial spondylitis is with non-steroidal anti-inflammatory drugs or COX inhibitors, which usually have insufficient effect against inflammatory pain and stiffness. In addition, these drugs are associated with side effects, such as gastrointestinal and cardiovascular side effects. Axial spondylitis is a multifactorial disease where the arachidonic acid cascade, an increased prostaglandin production and release may play a major role. With this there is a clear potential to develop new specific drugs to slow down the prostaglandin cascade in patients with axial spondylitis.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed patients with axial spondyloarthritis
* treatment-naive
* 18 years of age or older
* Swedish-speaking
* Able to give informed consent

Exclusion Criteria:

* DMARD treatment,
* ongoing infection
* ongoing malignancy
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital

Describe demographic and clinical data of infant and pediatric with cardiac catheterization who admitted to cardiology unit of Assiut university children hospital Asses outcome of cardiac catheterization in pediatric and infant at AUCH

Cardiac catheterization and intervention in pediatric cardiac diseases have evolved significantly in the past 30 years. During the last 10 years, there have been major technological achievements in pediatric interventional cardiology There have also been substantial advancements in cardiac imaging modalities, such as intracardiac echocardiography (ICE), real-time 3-dimensional (3D) transesophageal echocardiography (TEE), cardiac computed tomography (CT) and magnetic resonance imaging (MRI), rotational angiography with 3D roadmap, holography, 3D printing, and Echo-Navigator and Vessel-Navigator systems. As a result of such technological advances, more types of congenital heart diseases (CHDs) can be treated in the cardiac catheter laboratory today than ever before. Therefore, the possibility exists that many surgical procedures will be replaced by catheter-based procedures

The pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects (CHDs) to minimize the need for open heart surgery and optimize overall outcomes. Many CHDs are effectively managed with transcatheter techniques. Atrial and ventricular septal defects, valve stenosis, patent ductus arteriosus, aortic coarctation, pulmonary artery and vein stenosis and arteriovenous malformations are some examples, routinely treated with catheterization in the pediatric population For most such interventions, these efforts lead to more highly acceptable outcomes and lower complication rates than the alternatives of surgery or no intervention

Eligibility Criteria:
Inclusion Criteria:

children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.

-

Exclusion Criteria:

1-Neonate aged less than 1 month and adult \>16 years old 2-Patients with chronic renal and hepatic disease could affect results

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Diabetic Macular Edema Severity at Diagnosis

The purpose of this study is to identify the severity level distribution at the moment of diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify the rate with severe macular edema that needed immediate treatment.

The international severity scale grades macular edema as mild, moderate or severe, according to the distance of the thickening from the center of the fovea; However, this scale does not define the distances which fulfill the criteria of "distant from" or "approaching" the center of the macula; a quantitative and reproducible tool, such as optical coherence tomography (OCT), could be more accurate to grade severity, by localizing thickening in a standardized way.

As far as we know, distribution of clinically significant macular edema at the moment of diagnosis, according to the international scale has not been described. A study was conducted to identify the rate of eyes that had severe macular edema at the moment of diagnosis, whose risk of visual loss could be higher and required immediate treatment.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic
* regardless of diabetes duration and retinopathy severity level
* one or both eyes with CSME

Exclusion Criteria:

* media opacities that prevented an adequate fast macular map from being acquired
* a thickened posterior vitreous
* any additional retinal disease
Clinical Application of Autologous Mitochondria Transplantation for Improving Oocyte Quality.

Embryo quality was ranked as one of the most important predictors in determining the success of implantation, while clinically some patients may experience repeated IVF failure due to persistent poor embryo quality.Mitochondria, as the energy factory, is confirmed being a hallmark of quality and developmental potential of human oocytes, and decreased mitochondria copy number was reported to be associated with oocyte aging and dysfunctional mitochondria would be expected to influence the late stages of oocyte maturation and early embryogenesis.The objective of this study is to evaluate the effect of mitochondria transfer from bone marrow mesenchymal stem cell on the quality of oocyte.

This study is a pilot study to investigate the effect of autologous mitochondria transplantation for improving oocyte quality.

Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Sep 2018 to Sep 2021.

Intervention: The comparison was made between mitochondria transfer（MIT) group and the control group, both groups are conducted with the GnRH-a super-long protocol for IVF treatment. MIT group injects autologous mitochondria from bone mesenchymal stem cells into oocyte.

Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.

Eligibility Criteria:
Inclusion Criteria:

1. Women age \>20 years and \<43 years.
2. Anti-müllerian hormone（AMH） level ≥1.1 ng/ml.
3. Previous failed transfer cycle ≥2.
4. BMI\>18kg/m2 and \<25kg/m2.
5. Written informed consent.

Exclusion Criteria:

1. Abnormal uterine development, endometrial adhesion or previous endometrial dysplasia (\<7mm)
2. Other medical diseases that cannot be pregnant.
3. Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
4. Untreated hydrosalpinx.
5. The man has definite factors that affect the quality of the embryo, such as persistent abnormal DNA fragment rate (\>30%) and non-obstructive spermatozoa.
6. Intracytoplasmic sperm injection with donor.

Eliminate or falls off Criteria:

1.The number of retrieved oocytes \<6.
Efficacy of Minoxidil in Children With Williams-Beuren Syndrome

The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus.

Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.

These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications.

Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis.

Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children.

Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome.

Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension.

Total study duration:30 months including a 12 month-recruitment period


Eligibility Criteria:
Inclusion Criteria:

* proven diagnosis of Williams Beuren syndrome (genetic test)
* normotension or hypertension, treated or not
* male or female,
* 6\< age \<18,
* negative pregnancy test for childbearing potential female
* effective birth control for sexually active female
* signed consent form collected from parents or legal guardian

Exclusion Criteria:

* pulmonary hypertension secondary to mitral stenosis
* myocardial infarction within 1 month prior randomization
* known allergies to minoxidil or any of the components of Lonoten.
* asthma
* renal failure (creatinine clearance \<40ml/min)
* no affiliation to a national health insurance program (social security)
* intolerance to lactose
* current vasodilator anti hypertensive treatment
Eptinezumab in Participants With Episodic Cluster Headache

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period and Active Treatment Period of the study.

The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The participant has episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit 1.
* The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated.
* The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine).
* The participant is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit 2.
* The participant has a medical history of first symptoms of cluster headache from ≤60 years of age.

Exclusion Criteria

* The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies \[mAbs\] and gepants).
* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
* The participant has a history or diagnosis of hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
* Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit 2 are also excluded.
* The participant is, at Screening Visit 2, at significant risk of suicide.
* The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.
Emergency Curative Resection of Colorectal Cancer

The feasibility and efficacy of emergency curative resection of complicated colorectal cancer is still controversial. This prospective study aim is to assess surgical and oncologic outcomes after emergency compared to elective curative resection of colorectal cancer

60 consecutive patients presented with complicated colorectal cancer managed by emergency surgery were included and compared to another 155 consecutive patients admitted during the same period with uncomplicated colorectal cancer managed by elective surgery. Both groups were compared regarding curative resection rate, early postoperative mortality and morbidity, 3-years tumor recurrence and survival rates.

Eligibility Criteria:
Inclusion Criteria:

* All patients presented with Potentially operable colorectal cancer
* No clinical or radiological evidence of metastatic disease

Exclusion Criteria:

* Patients received preoperative chemoradiation
* Patients with clinical or radiological evidence of metastatic disease
* Patients with intraoperative evidence of metastatic disease
* Patients with intraoperative evidence of irresectable disease
* Patients with incomplete follow up