cyrilzakka/clinical-trials huggingface dataset:
Neurologic Manifestations of COVID-19

This study will determine the neurological profile and predictors of outcomes in patients with COVID-19 disease in the Philippines. It will also evaluate if there is significant difference between COVID-19 patients with neurological manifestations compared to those COVID-19 patients without neurological manifestations in terms of various prespecified clinical outcomes. Furthermore, the likelihood of these outcomes in COVID-19 patients with neurological manifestations compared to those without neurological manifestation will be determined in this study.

This quantitative, retrospective, cohort study will determine the following: 1) demographic, clinical and neurological profile of patients with COVID-19 disease in the Philippines; 2) the frequency of neurological symptoms and new-onset neurological disorders/complications in patients with COVID-19 disease; 3) the neurological manifestations that are significant predictors of mortality, respiratory failure, duration of ventilator dependence, intensive care unit (ICU) admission, length of ICU stay, and length of hospital stay; 4) if there is significant difference between COVID-19 patients with neurological manifestations compared to those COVID-19 patients without neurological manifestations in terms of mortality, respiratory failure, duration of ventilator dependence, ICU admission, length of ICU stay and length of hospital stay; and 5) the likelihood of mortality, respiratory failure and ICU admission in COVID-19 patients with neurological manifestations compared to those without neurological manifestations.

Eligibility Criteria:
Inclusion Criteria:

* Cases confirmed by testing approved patient samples (i.e. nasal swabs, sputum, bronchoalveolar lavage fluid) employing the real-time reverse transcriptase polymerase chain reaction (RT-PCR) from COVID-19 testing centers accredited by the DOH;
* adult patients at least 19 years of age;
* male or female;
* cases with clinical symptoms and signs attributable to COVID-19 disease (i.e. respiratory as well as non-respiratory clinical signs and symptoms), with or without the availability of ancillary tests (i.e. complete blood count, chest x-ray); cases with disposition (i.e. discharged or died) at the end of the study period.

Exclusion Criteria:

* Pediatric patients ≤18 years
* Cases with conditions of diseases caused by other organisms (i.e. bacteria, other viruses, fungi, etc.) or caused by other pathologies unrelated to COVID-19 disease (i.e., trauma).
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria

Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.

Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. The primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children in Mozambique and Gabon.

The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin.

The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged three to ten years
* Body weight ≥12kg
* Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
* Asexual parasitaemia between 1,000/µL and 200,000/µL
* Ability to tolerate oral therapy
* Willingness of the parent or guardian to provide informed signed consent

Exclusion Criteria:

* Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
* Body weight \<12kg
* Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
* Severe malnutrition with weight for height \<70% (according to WHO tables) or clinical kwashiorkor
* Gastro-intestinal disturbance with persistent vomiting (\> three episodes within previous 24 hours) and/or diarrhoea (\> 5 loose stools in the preceding 24 hours)
* Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment
* Packed cell volume (PCV) on arrival \<22%
* Adequate anti-malarial treatment within previous 7 days
* Inability to tolerate oral therapy
* Parent or guardian deemed to be unsupportive
* On co-trimoxazole prophylaxis
* Any known allergies to the investigational products
Role of Roflumilast in Ulcerative Colitis

This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .

* Study design and study population This study will be randomized, controlled, parallel study.
* It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups

  1. Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months.
  2. Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
* Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
* A written informed consent will be obtained from all patients
* This study will be approved by the Research Ethics Committee of Tanta University.
* Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form .
* Randomization will be carried out based on days of hospital admission

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to endoscopy units in Tanta University hospitals during the period of the study.

Patient with mild to moderate UC diagnosed as:

1. Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (\>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss.
2. Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion Criteria:

* Other inflammatory bowel disease (crohn's disease) .
* Patients \<15 and \>80 years
* Patients who didn't give consent to participate in the study
* Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded
* History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness .
* Depression , thoughts of suicide , anxiety and emotional instability .
* Excessive weight loss .
* Moderate to severe hepatic impairment (child pugh class B or C) .
* Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction )
* Loxapine ( Risk , X interaction )
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.

The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
* Unsuccessful predilation of one or more of the planned lesion to be treated.
* Planned treatment of in-stent restenosis of a previously placed metallic stent.
* Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.
* Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
* Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
* Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
* Subjects with a limited life expectancy less than one year.
* Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
* Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
* Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
Tick-borne Encephalitis Virus Research in Limousin

Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The main objective is to demonstrate the presence of TBEV in Limousin, in patients with a positive Lyme serology, or a neurological picture compatible with TBEV.

Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The epidemiological situation in France is poorly known with about 20 cases diagnosed per year, mainly in Alsace and Haute-Savoie. The infection can result in fever and an influenza-like picture, which can be complicated by encephalitis-like neurological disorders, or even death. TBEV is transmitted by the tick Ixodes ricinus, which also carries Borrelia burgdorferi, the agent of Lyme disease. Limousin is one of the French regions with the highest prevalence of Lyme disease. These ticks can harbor various pathogens, including TBEV. A case was described in 2007 in Bordeaux. More recently, a case was described in Haute-Loire. The investigators are therefore interested today in the emergence of this virus in Limousin following a possible progression through the Massif Central, potentially favored by numerous anti-Covid-19 control containments. The study begins with a computer extraction of patients with Lyme serology from our GLIMS laboratory software (with positive or negative results), a check for non-oppositions. Then the investigators will measure by ELISA in microplates the anti-TBEV IgG as well as the anti-TBEV IgM on the sera + in TBEV IgG. The investigators will then send a patient questionnaire with an information note to document the context of this TBEV seropositivity and to eliminate false-positivities (vaccination). Finally, the investigators will perform PCR on CSF if serum positive and CSF available, followed by an analysis of results.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Lyme serology. Neurological picture compatible with neuroborreliosis or encephalitis.
* No objection from the patient to the use of biobank samples

Exclusion Criteria:

* Patient's opposition.
Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C.

In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with a positive SARS-CoV-2 PCR test and presenting with one or more clear clinical symptoms of COVID-19 disease
* No contraindication to HEP-1
* Obtained informed consent

Exclusion Criteria:

* Patients who had received any immuno-modulator therapy
* Active or chronic kidney/ liver diseases,
* Oncological diseases
* Other viral infection including HIV and hepatitis.
* Any allergic reaction or sensitivity to HEP-1
* Breast feeding or pregnancy
The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks).

70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.

Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps
2. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity at screening and at baseline.
3. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).
4. Recorded use of intranasal corticosteroids for at least 4 weeks before screening

Exclusion Criteria:

1. Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety。
2. Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.
3. Other.
Myopia Control Spectacle Lens Cessation Study

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.

To quantify axial length progression following cessation of use of specific spectacle lenses.


Eligibility Criteria:
Inclusion Criteria:

* Previously a successfully completed participant in the CYPRESS Extension study;
* Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
* Willingness to participate in the trial for up to 12 months without contact lens wear;
* The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

* Known allergy to proparacaine, tetracaine, or tropicamide.
Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence.

The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

Patients with acute lobar ICH fulfilling the Boston criteria for probable or possible CAA will be enrolled within 30 days after ICH onset. Brain MRI performed at baseline will be analyzed blinded to clinical data. Patients with presence of cSS will be compared with those without cSS.

During a systematic follow-up of 24 months, patients will undergo neurological, neuropsychological and MRI evaluation. The investigators will compare the rate of recurrent symptomatic ICH at 24 months in patients with vs. without cSS.

Eligibility Criteria:
Inclusion Criteria:

* Lobar ICH within 30 days after onset
* Available brain MRI sequences of adequate quality including fluid-attenuated inversion recovery (FLAIR) and T2\*-weighted gradient-recalled echo (T2\*-GRE) sequences.
* Modified Boston criteria for probable or possible CAA
* Age ≥ 55 years
* Written consent

Exclusion Criteria:

* Secondary brain hemorrhage : vascular malformation (arteriovenous malformation, aneurysm, cavernous); cerebral veinous thrombosis; brain tumor; coagulopathy; vasculitis; hemorrhagic infarction,
* Infratentorial siderosis
* Contraindications to MRI
* Neurosurgical intervention before inclusion,
* Progressive neoplasm
* Patient without affiliation to the french social security
* Patient under guardianship
An Observational Study to Assess Change in Disease Activity and Treatment Patterns of Upadacitinib When Given Alone or Co-Administered With Methotrexate in Adult Participants With Active Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis.

Upadacitinib (RINVOQ) is approved drug for the treatment of adult participants with active PsA in Europe. Approximately 450 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in Europe: France, Germany, Greece and Italy.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 24 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of active psoriatic arthritis (PsA) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician.
* Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.
* Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.

Exclusion Criteria:

* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days.
* Prior treatment with upadacitinib.