cyrilzakka/clinical-trials huggingface dataset:
Rett Syndrome Registry

The Rett Syndrome Registry is a longitudinal observational study of individuals with MECP2 mutations and a diagnosis of Rett syndrome. Designed together with the IRSF Rett Syndrome Center of Excellence Network medical directors, this study collects data on the signs and symptoms of Rett syndrome as reported by the Rett syndrome experts and by the caregivers of individuals with Rett syndrome. This study will be used to develop consensus based guidelines for the care of your loved ones with Rett syndrome and to facilitate the development of better clinical trials and other aspects of the drug development path for Rett syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with a pathologic loss of function alteration of MECP2

Exclusion Criteria:

* Male or female with a gain of function alteration of MECP2, including those with MEPC2 duplication or triplication
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.

This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
* Indication for craniotomy for removal of a suspected or recurrent brain tumor
* Karnofsky Performance Scale \>/- 60%

Exclusion Criteria:

* Prophyria, hypersensitivity to porphyrins
* Renal insufficiency as defined per protocol
* Hepatic insufficiency as defined per protocol
* Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
* Nursing women or women using inadequate contraception
ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

To evaluate graft vascularization and compare the vascularization patterns of conjunctival autografts with amniotic membrane grafts to better understand the factors involved in pterygium recurrence.

The vascularization and perfusion of conjunctival autografts and amniotic membrane grafts after surgery may have significance in terms of pterygium recurrence and progression. Fluorescein angiography of the anterior ocular segment has been used to evaluate ocular inflammation in scleral inflammation. However, when fluorescein is used, the quality of the angiograms is limited by rapid extravasation of the dye due to diffusion through the fenestrated capillaries of the conjunctiva and episclera. Because fluorescein has a low molecular weight and is not a protein bound molecule, patchy leakage during the first transit of the dye, which obscures the angiographic details even before the late phases of the angiogram, can be seen.

In contrast, indocyanine green (ICG) is a larger molecule than fluorescein and is more highly found in protein bound form. Therefore, it remains within the fenestrated vessels and shows negligible extravasation, which makes it ideal for use in anterior segment angiography.

Tan and coworkers have shown that the morphology of pterygium recurrence inevitably reflects a high degree of vascularity.

In this prospective study, we evaluated the anterior segment indocyanine green angiography (ICGA) findings for graft vascularization after primary pterygium excision with LCAT or AMT.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had primary pterygium

Exclusion Criteria:

* Patients with major systemic diseases (eg, diabetes), vascular disease (excluding hypertension), serious ocular surface disease (eg, cicatricial pemphigoid), glaucoma and previous history of ocular surgery
* Patients with pterygia of both eyes
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.

Patients : All children treated by ECMO in the 4 PICUs involved in the study

Measurements : A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx \> 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.

Eligibility Criteria:
Inclusion Criteria :

* Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

* Lack of parental consent
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* untreated ITP.

Exclusion Criteria:

* ITP with relapse;
* positive test result for HIV or hepatitis B or C;
* active infection requiring systemic therapy;
* malignancy within 3 years before study.
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.


Eligibility Criteria:
Inclusion Criteria:

* Weight at least 40 kg
* A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
* Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
* During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
* Currently on stable antiepileptic treatment regimen.

Exclusion Criteria:

* A history of nonepileptic or psychogenic seizures
* Presence of only nonmotor simple partial seizures or primary generalized epilepsies
* Presence or previous history of Lennox-Gastaut syndrome
* An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
* Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
* History of alcoholism, drug abuse, or drug addiction within the past 2 years
* History of status epilepticus within 3 months of Visit 1
* A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
* More than 1 lifetime suicide attempt
* Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
* A history of any previous exposure to YKP3089
Forecast Number of Covid-19 Cases Worldwide

Coronavirus disease-19 (Covid-19) had an unprecedented effect on both nations and health systems. Time series modeling using Auto-Regressive Integrated Moving Averages (ARIMA) models have been used to forecast variables extensively mainly in statistics and econometrics. The investigators aimed to predict the total number of cases for Covid-19 using ARIMA models of time-series analysis.

Coronavirus Disease 19 (Covid-19) is an infectious disease initially defined in December 2019 before becoming pandemic. Respiratory disease is the main form of disease causing acute respiratory distress as the main cause of death.

Increased number of cases worldwide had put an enormous load on public health resulting lockdowns, quarantines and curfews. Predicting number of cases is hard as the increment of cases between communities differ.

Time series had been used in different fields of science to predict, such as signal processing, mathematical finance, weather prediction. In medicine, time series analysis were used in number of admitted patients to hospitals. Aim of this study is to predict the total number of Covid-19 cases worldwide using time series anaylsis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed case of Covid-19

Exclusion Criteria:

* Cases not reported
Allopurinol in Chronic Heart Failure

The purpose of this study is to discover whether the inhibition of the xanthine oxidase with allopurinol leads to a reduction of the production of oxygen free radicals in patients with CHF and thereby improves characteristics of oxydative metabolism, peripheral blood flow, immune function and functional status.


Eligibility Criteria:
Inclusion Criteria:

* The patient is a male and at least 21 years of age.
* The patient has clinical evidence of heart failure: a) reduced ejection fraction (≤40%) or cardiomegaly on CXR or left ventricular impairment on echocardiography (LVEDD ≥60mm), b) stable clinical condition and medication for at least 1 month prior to the study.
* No history of unstable angina, myocardial infarction or stroke within 3 months prior to the study.
* The patient is receiving full conventional medical therapy for heart failure (ACE inhibitor or angiotensin II blocker, diuretics etc.).
* The patient is willing and capable of complying with the requirements of this protocol.
* The patient has provided written informed consent .

Exclusion Criteria:

* The patient has any life-threatening disease, other than heart failure (including patients with known, or suspected, myocarditis or with automatic implantable cardioverter/defibrillators).
* The patient has an active malignancy of any type, or history of a malignancy (Patients who have a history of basal cell carcinoma that has been surgically removed are acceptable). Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrolment are also acceptable.
* The patient has had a heart transplant.
* The patient has severe renal disease (S-Creatinine \>300 μmol/l), severe liver disease (ASAT or ALAT \> 3 times of upper limit of normal range), rheumatoid arthritis, or complains of gout.
* The patients has received allopurinol therapy previously or if he is known to suffer from gout (acutely or chronically).
* The patient has an exercise capacity of \> 20 ml/kg/min (treadmill, Bruce protocol) or is in functional NYHA class I.
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
* 6 months history of asthma according to ATS definition
* Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
* Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
* A total ACQ5 score of 1.5 or more

Exclusion Criteria:

* Respiratory infection significantly affecting the asthma
* Any significant disease and disorder that may put the patient at risk or influence study results
* Any clinically relevant abnormal findings
* A smoking history of more than 10 pack years
* Intake of oral, rectal or parenteral glucocorticosteroids
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV positive status
* Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
* Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
* Male or female patients ≥ 18 years
* For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
* Mental status allows comprehension of instructions for troche administration
* Written informed consent

Exclusion Criteria:

* Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
* Presence of perioral lesions only
* Use of other antifungal agents within 5 days of enrollment to the study
* Pregnant or lactating women
* History of hypersensitivity to imidazole or azole compounds
* Patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks)
* Patients has received an investigational drug in the last 30 days
* Treatment with another investigational drug is planned within the next 3 weeks
Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis.

Triple blind placebo-controlled study to determine if administering citrulline in patients with sepsis and severe sepsis slows progression to multiple organ failure and death, measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or citrulline and followed up for 1 month.

Consecutive patients with sepsis are being recited from intensive care unite of IMSS at the CMN Siglo XXI and CMN La Raza over the period of november 2015 through june 2016. After signing an informed consent they will be randomized into 80 for intervention arm and 80 for the placebo arm. All patients will receive usual medical treatment; and during seven days citurlline arm subjects will receive supplementation with oral or nasogastric citrulline (10 g/day), while other group patients will receive during seven days oral or nasogastric placebo (10 g/day) with no visible difference between these. Microalbuminuria and interleukines 1, 6, and 10 will be measured at randomization and at day 7. All subjects will be followed for 28 days, and after the follow-up period results will be analyzed to determine de efficacy and safety of citrulline, primary outcome are the incidence of multiple organic failure and death, also microalbuminuria levels 1,6,10-interleukines. We will use Student-t and Chi2 for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* Severe sepsis
* Diagnosis of sepsis in the first 36 hours of hospitalization.
* Informed Consent
* Intestinal tract intact

Exclusion Criteria:

* Terminal cancer
* Acute and chronic liver diseases
* Chronic renal failure.
* Acute renal failure AKIN III.
* Pregnant and postpartum women
* Dying patients.
* Patients with cardiac arrest.
* Active gastrointestinal bleeding.
* Steroids or immunosuppressants.
* Enrolled in another study intervention.
* Citrulline allergy.
Reduction of Topical Anesthetic Onset Time Using Ultrasound

Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-7, requiring venipuncture

Exclusion Criteria:

* Emergent procedure
* Allergy to lidocaine or sodium lauryl sulfate
Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2

Over the past 20 years, the views and experiences of patients in the field of oncology (through patient-reported outcomes, PROMs) have become increasingly important. When used in clinical trials, PROMs contribute to better detection and are used in clinical trials to improve the detection and management of treatment side effects. The Health-related quality of life assessments are widely used in oncology research, and the development of reliable and valid measurement instruments has become a major challenge.

In this context, health-related quality of life in cancer patients covers various aspects (functional status, physical or psychological symptoms) and several cancer-specific measurement instruments have been developed, including the EORTC QLQ-C30 quality of life questionnaire.

Among the different therapies used to treat cancers, immunotherapy with immune checkpoint inhibitors has been gaining momentum in recent years. Commonly used to treat a wide variety of cancers, it also has a wide range of known side effects.

However, little is known about the health-related quality of life of patients patients who receive this therapy: specific self-questionnaires are almost non-existent or inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity. As for the data currently collected, they suffer from methodological problems.

In view of the increasing use of immune checkpoint inhibitors in cancer treatment, their known side effects and the lack of valid questionnaires specific to these treatments, it appears important to provide a valid questionnaire to take into account these impacts on the quality of life of patients.


Eligibility Criteria:
Patients :

Inclusion Criteria:

* Provision of written informed consent to participate in the study
* Has been diagnosed with cancer
* Either currently receiving, or has received in the previous 12 months, one of the following:

  * an anti-PD-1 or anti-PDL-1 agent as the sole immune checkpoint inhibitor treatment (at least three cycles)
  * an anti-PD-1 or anti-PDL-1 agent in combination with an anti-CTLA-4 agent (at least one cycle)
  * cytotoxic chemotherapy and an anti-PD-1 or anti-PDL-1 agent (at least three cycles)
* Aged ≥18 years

Exclusion Criteria:

* Has an additional primary cancer for which they are receiving systemic therapy
* Cognitive impairment which presents an obstacle to the completion of questionnaires or an interview
* Poor command of the locally dominant language, or an inability to read questions
* \[Phase 1b only\] Was interviewed for Phase 1a

Healthcare professionals :

Inclusion Criteria:

* Holds, or has held, a professional clinical position which involves working directly with cancer patients who are in receipt of immune checkpoint inhibitors
* Is a medical oncologist, nurse specialist (or equivalent), psychologist, or social worker

Exclusion Criteria:

• Has met the inclusion criteria for \<1 years
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).

The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.

The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 80 years.
2. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
3. Acute non-lacunar cerebral infarction.
4. Cerebral infarction with a score on the NIH scale between 5 and 20 points.
5. Patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
7. The patient and/or legal representative or direct family member has signed the informed consent form.

Exclusion Criteria:

1. Advanced disease or terminal with life expectancy \< 6 months.
2. - Over 80 years old
3. Lacunar infarction or small vessel disease.
4. Pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse).
5. Pregnancy or lactation.
6. Acute or chronic renal failure with creatinine clearance \<30 mL/min.
7. Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
8. Treatment with another investigational drug within the past 30 days that may interfere with the study drug.