cyrilzakka/clinical-trials huggingface dataset:
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.

A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who agree to participate in the trial and sign the informed consents.
2. Male or female, ≥18 years old.
3. Diagnosed of lung carcinoma by histological and cytological examinations.
4. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
5. Recorded history of COVID19 infection.
6. Sufficiently functional organs.
7. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.

Exclusion Criteria:

1. Life expectance less than 3 months.
2. Less than 3 months since last confirmed COVID-19 infection.
3. Patients unable to return the hospital for follow-up.
4. Patients allergic to COVID-19 vaccine.
5. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men with metastatic castration-resistant prostate cancer
* Progressive disease on androgen deprivation therapy
* Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
* ECOG performance score ≤ 1
* Estimated life expectancy of ≥ 12 months

Exclusion Criteria:

* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
* Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
* History of brain metastasis, active leptomeningeal disease or seizure
* Severe cardiovascular or hepatic disease
* Pituitary or adrenal dysfunction
Identification of Microbial DNA in Maternal Plasma After PPROM

This study evaluates the use of metagenomic next generation sequencing in identifying microbial DNA in plasma samples of patients with preterm premature rupture of membranes.

Although preterm premature rupture of membranes (PPROM) occurs in only 3% of pregnancies, it accounts for 30% of preterm births (PTB) and is associated with serious maternal and neonatal morbidity. An important factor in the underlying pathophysiology of PPROM and subsequent PTB is subclinical infection, which promotes a cascade of events that contribute to synthesis of prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and activation of metalloproteases. Over time, enhanced activity of these infectious and inflammatory pathways contributes to the development of spontaneous labor and/or overt intraamniotic infection (IAI). Unfortunately, the majority of patients with PPROM do not manifest signs and symptoms of infection that are detectable by clinical examination, laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict length of latency period and/or timing of delivery remains a clinical challenge. We propose the use of metagenomic next-generation sequencing (mNGS) to identify microbial DNA in maternal plasma following PPROM. We hypothesize that the presence and abundance of microbial DNA is associated with a shorter latency period and that an increase in the abundance of microbial DNA precedes delivery.

Eligibility Criteria:
Inclusion Criteria:

* For PPROM group, preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks of gestation
* For control group, healthy pregnancy with no evidence of preterm premature rupture of membranes or other major complications

Exclusion Criteria:

* Maternal age \< 18 years
* Major fetal congenital malformation
Epidemiology of Thrombotic Thrombocytopenia Syndrome in Integrated Health-care Database in England

Background/Rationale: A rare syndrome of thrombosis associated with low platelets has been reported in a few cases of recent exposure to COVID-19 vaccine. Medicines \& Healthcare products Regulatory Agency (MHRA) had requested for all cases of thrombosis or thrombocytopenia occurring within 28 days of coronavirus vaccine to be reported via the online yellow card system. This syndrome seems to be affecting patients of all ages and both genders; at present there is no clear signal of risk factors. Up to and including 14 April 2021, the MHRA had received 168 United Kingdom (UK) reports of thrombo-embolic events with concurrent low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca. The United Kingdom (UK) is uniquely placed to study this area because of its registration-based primary care system, and a unique identifier number links primary care to secondary care data. Additionally, vaccination is well advanced, maximising population wide vaccine exposure.

Objectives and Hypotheses: Estimate event rates and describe characteristics of patients with a record for thrombotic thrombocytopenia syndrome, thromboembolism or thrombocytopenia, in the general population of England.

Methods:

Study design: Secondary data analysis using a cohort design. Data Source(s): This is a retrospective cohort study using linked secondary databases in England accessed through the NHS Digital Trusted Research Environment (TRE). The primary care data will be linked with vaccination, primary care data, hospitalization, COVID-19 test results, mortality data at the national level for capture of key study variables. This integrated digital health system will also include other linkages such as the Oxford-Royal College of General Practitioners sentinel network; ORCHID.

Study Population: All patients, with our population of interest in England who are present in the integrated health records of NHS Digital TRE and/or the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) database at the start of each study period.

Variables: Demographic, socioeconomic, clinical descriptors and risk factors for thrombosis and/or thrombocytopenia; COVID-19 vaccines.

Statistical Analysis: The event rates with 95% CIs will be calculated by dividing the number of events with person-time at risk per 100,000 person-years. Further, event count and event rates will be evaluated in a relationship with COVID-19 vaccination date.


Eligibility Criteria:
Inclusion Criteria:

* All patients, with a primary focus from age 16 years old and older, in England who are present in the integrated database at the start of each study period.

Exclusion Criteria:

* Less than 12 months of prior history at start of each respective study period.
HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen E will evaluate the safety and efficacy of a single study drug, SLS-005 (Trehalose injection, 90.5 mg/mL for intravenous infusion) in participants with ALS.

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen E SLS-005 - Trehalose, the participant will complete a screening visit to assess additional Regimen E eligibility criteria. Once Regimen E eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active SLS-005 or matching placebo.

Regimen E will enroll by invitation, as participants may not choose to enroll in Regimen E. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen E.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Eligibility Criteria:
Inclusion Criteria:

* No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

Exclusion Criteria:

* The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).

  1. Current diagnosis or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus
  2. Master Protocol screening glucose \>140 mg/dl
  3. Prior treatment with IV trehalose or known hypersensitivity to trehalose
  4. Current use of oral trehalose (see prohibited medication Section 5.9)
  5. Inability for participant to return to site for weekly drug administration, until approved for home infusions
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. As primaquine can not be used in pregnant women, these women remain at risk of relapse. As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options. The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \>16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus
* Normal fetal heart beat detected by Doppler
* Presence of asexual P. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear)
* Willing to sign or thumb print informed consent
* Willing to return for scheduled follow up visits for treatment and observation until delivery
* Willing to deliver in health facility

Exclusion Criteria:

* Pregnancy \< 16 weeks
* Microscopically confirmed P. falciparum or mixed infection/ parasitemia (P. vivax and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)
* History of allergy or hypersensitivity to interventional drugs
* Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)
* Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)
* History or family history of epilepsy or psychiatric disorder
* Presence of signs and symptoms of severe malaria, severe illness, or danger signs
* Hemoglobin \< 7 g/dl
* Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).
* History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV/ AIDS, known hemoglobinopathy
* Participant's inability to return for follow up visits
* Age \<15 years
Vascular Remodeling After Living Kidney Donation Study

Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. The object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. This approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. These results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. Of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.


Eligibility Criteria:
Inclusion Criteria:

* candidate to living kidney donation
* affiliated to national health insurance
* capable of understanding the consequences of participating to the study
* written informed consent

Exclusion Criteria:

* pregnancy
* breastfeeding
* allergy to iodinated contrast agents
* allergy to echographic gel, allergy to cutaneous dressings
* cutaneous lesions preventing the ultrasonography probe to be applied on the skin
* participation to a drug trial
A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

The current study is designed to evaluate the safety and efficacy, including MRI imaging, across a range of VX-509 doses in subjects with active rheumatoid arthritis (RA) who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs).

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA, and a broad range of other autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 65 years of age (inclusive)
* Diagnosis of RA
* Swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
* Seropositivity based on either a positive rheumatoid factor or anti cyclic citrullinated peptide antibody at screening -OR- known erosive disease based on previous X-ray report or erosions detected on screening hand and foot X-ray
* Baseline CRP level or Westergren erythrocyte sedimentation rate ≥1.2 × upper limit of normal
* Receiving stable therapy with 1 of the following DMARDs: methotrexate, sulfasalazine, leflunomide, anti-malarial drug, or penicillamine
* Palpable 2+ synovitis of the wrist or ≥2 MCPs in the MRI-designated hand

Exclusion Criteria:

* History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature
* Planned surgery during the study
* History of alcohol or drug abuse, or excessive alcohol consumption
* History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
* Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
Cognitive Decline Following Deep Brain Stimulation

This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.

Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Eligibility Criteria:
PD Participants

Inclusion Criteria:

* Subjects above 18 years of age
* Subjects who will undergo DBS surgery as part of their clinical care for PD

Exclusion Criteria:

* Uncorrected visual or hearing impairments, as indicated by self-report
* Individuals who are pregnant or expect to become pregnant during the course of the study
* Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
* COPD with oxygen dependence
* Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

Non-PD Control Participants

Inclusion Criteria:

* Subjects above 18 years of age
* Age matched to participants in PD group

Exclusion Criteria:

* Diagnosis of Parkinsons Disease or other movement disorder
* Untreated neuropsychiatric disorders
* Uncorrected visual or hearing impairments, as indicated by self-report
* Individuals who are pregnant or expect to become pregnant during the course of the study
* Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
* COPD with oxygen dependence
* Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Palmitoylethanolamide and Luteolin in Patients with Acute Ischemic Stroke

Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement.

Experimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA).

The aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* both genders
* first acute ischemic stroke in the middle cerebral artery area confirmed by angio-CT and CTP, eligible for mechanical thrombectomy according to national guidelines
* NIHSS \> 6
* compliant patients
* signed informed consent

Exclusion Criteria:

* hemorrhagic stroke
* previous stroke (TIA, ischemic or hemorrhagic stroke)
* presence of clinically evident neurodegenerative diseases (Alzheimer's disease, Parkinson's disease)
* presence of psychiatric comorbidity (schizophrenia, bipolar disorder, depressive syndrome)
* presence of chronic inflammatory diseases (chronic inflammatory bowel disease, vasculitis etc.)
* current or previous neoplasia
* uncontrolled diabetes mellitus (glycemia on admission \>400 mg/dL or \<50 mg/dL)
* dysphagia, with inability to feed orally
* inability to provide informed consent
* pre-existing disability (pre-stroke mRS \>2)
* allergy or hypersensitivity to the study treatment
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain

To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.


Eligibility Criteria:
Inclusion Criteria:

Initial dose:

* 20 to 64 years
* Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting
* Patients with pain that meets both of the following criteria
* Pain intensity (4-categorical): "moderate pain" or "severe pain"
* Pain intensity (VAS): 45.0 mm or more

Additional dose:

* Patients with pain that corresponds to "4. Agree" or "5. Strongly agree" as the answer to the "question about the pain intensity" during the period from 5 hours to 12 hours post-initial dose of the study drug

Exclusion Criteria:

* Patients with acute inflammatory findings in the oral cavity necessitating treatment
* Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction