cyrilzakka/clinical-trials huggingface dataset:
The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study

A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* All patients with an unruptured intracranial aneurysm undergoing treatment

Exclusion Criteria:

* Arteriovenous malformation related intracranial aneurysm
* Moyamoya-disease related intracranial aneurysm
* Ruptured intracranial aneurysm
Second Toe Length and Hallux Valgus: Greek vs. Egyptian Foot

A total of 150 patients aged 60-80 years with existing foot radiographs will be included in the study. Radiographic evaluations will include measurements of the hallux valgus angle, first intermetatarsal angle, and the metatarsal and phalanx lengths of the first and second toes. The ratio of the second toe phalanx length to the first toe phalanx length will be calculated and recorded. The relationship between the hallux valgus angle, toe lengths, and their ratios will be analyzed using statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Age between 60-80 years
* Presence of foot radiographs suitable for measurement
* No history of prior foot surgery

Exclusion Criteria:

* History of foot trauma or fractures
* Previous foot or toe surgery
* Presence of congenital foot deformities
* Neurological or rheumatologic conditions affecting foot structure
* Severe osteoarthritis or other degenerative foot diseases visible on radiographs
Speed of Processing (SoP) Training Plus α-tACS

The current proposal aims to assess if the combination of Speed of Processing (SoP) training with alpha tACS (α-tACS) is able to increase brain speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training plus sham α-tACS. Moreover, a second aim is to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning. Furthermore, the mechanisms underlying these interventions will be tested, namely to assess brain connectivity and coherence as assessed by EEG. To that purpose, the aim of the current proposal is to conduct a double-blind, parallel randomized trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in participants with Mild Cognitive impairment (MCI).

Dementia is thought to affect 6.3 million people across Europe and is especially prevalent in people over 85 years old (23.7%). In this sense, several cognitive training programs, alone or in combination with non-invasive brain stimulation have been used in order to ameliorate age-related cognitive impairments, and even to act in a prophylactic manner in order to prevent more extreme deficits, such as the ones presented in mild cognitive impairment, or even dementia.

Despite all these efforts, the effects of CT - combined or not - with several forms of non-invasive brain stimulation have been modest at most.

The current proposal aims to assess if Speed of Processing (SoP) training combined with alpha tACS (α-tACS) increases speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training and sham α-tACS. Furthermore, association betweens changes in speed of processing and changes in other cognitive domains, such as memory, language and executive functioning will be assessed. Finnaly, the current proposal aims at probing the mechanisms underlying these interventions, namely to test brain connectivity and coherence as assessed by EEG.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time

Exclusion Criteria:

* Score in the mini mental examination less than 23 (or over 28);
* Diagnosis of Alzheimer´s Disease, any other medical condition that may predispose participants for a forthcoming decline in function, or that may increase their risk of mortality during the duration of the study.
* Any contra-indication to tACS, severe sensory losses or communication difficulties that will prevent them from successfully complete the training.
* Had any cognitive training in the past.
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

1) Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

3. An informed consent document signed and dated by the subject or a legally acceptable representative.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) disease or clinical findings at Screening.
2. History of febrile illness within 5 days prior to the first dose.
3. A positive urine drug screen.
A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients

To evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with Wilson's disease.

An open, single-dose study to determine the pharmacokinetics, and safety of oral administration of trientine dihydrochloride in both children and adult patients with Wilson's Disease. Blood samples will be taken pre-dose and at 10 time-points post-dose to investigate the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study medication in 20 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Children ≥ 6 years and adult patients
2. Confirmed diagnosis of Wilson's disease by Leipzig-Score \>3 (Ferenci et al 2003)
3. Current treatment with trientine dihydrochloride
4. Signed informed consent including parental consent in patients ≤ 18 years
5. Agree to remain in the study site1 for the PK measurements period.

Exclusion Criteria:

1. Known clinically significant allergy or hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient's safety
2. Have any clinically significant conditions that would interfere with the collection or interpretation of the study results or would compromise the patient's health
3. Women of child bearing potential who do not use contraceptives, breastfeeding, or pregnant women
4. Severe anaemia (haemoglobin \<9 mg/dL)
5. In the judgment of the Investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development
6. Participation in any interventional clinical study at the same time or within the 4 weeks prior his study.
IMATINIB IN COVID-19 DISEASE IN AGED PATIENTS.

High-throughput screening studies identified Abl kinase inhibitors (including imatinib) as inhibitors of coronaviruses SARS and MERS. The SARS-CoV-2 coronavirus depend on Abl2 kinase activity to fuse and enter into the cells. Pharmacokinetic studies demonstrated that IC50 of imatinib for ABL1, BCR-ABL1 and ABL2 kinase inhibition is less than 1 microM (around 0.3 microM) below the expected trough plasmatic concentrations of imatinib 400 mg/day (1.7 microM). The EC50 of imatinib for the inhibition of the virus is under investigation but we now have a first estimates with EC50 close to 2.5 microM. This plasmatic concentration is achievable with imatinib 800 mg/d. We hypothesize that clinically achievable imatinib concentration will block the first round of cell to cell virus infection and therefore stop or prevent from SARS-CoV-2 infection in human. Based on our 20 years' experience of prescribing imatinib in patients, we expect that most of the adverse events and pharmacological interactions of imatinib can be anticipated and corrected. The eligible population will be aged (\>70y) patients hospitalized for a non-severe COVID-19 disease for less than 7 days. Patients will be randomized 1/1 between standard of care and imatinib 800 mg per day during 14 days. The primary endpoint will be the death rate by 30 days. Secondary endpoint will include progression to severe CIVID-19 disease, safety, outcome at 3 months. We plan to randomize 90 patients in order to show a 10% benefit in term of death rate reduction from 16% to 6%.


Eligibility Criteria:
Inclusion Criteria:. Patient aged \> 70y 2. Patient with a documented COVID-19 disease by SARS-CoV-2 RT-PCR (if no test is available, suspected COVID-19 disease on CT SCAN).

3. Initial phase (≤ 7 days) of COVID-19 disease 4. Non severe COVID-19 disease 5. Signed informe consent

Exclusion Criteria:

1. Patient in palliative care
2. Severe COVID-19 disease (SpO2 ≤ 94% with O2 ≥ 5 l/min)
3. Contra-indication to imatinib
4. Therapy with Warfarin (Heparin allowed)
5. Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA)
6. Peripheral edema grade \> 2
7. Known HBV, HBC or HIV infection
8. Known hepatic failure
9. Patient under legal protection
Furosemide and Coarctation Surgery Lung Complications

in our study the investigators give furosemide during surgery for repair of aortic coarctation via lateral thoracotomy and evaluated lung complications in comparison to control group


Eligibility Criteria:
Inclusion Criteria:

* coarctation of aorta

Exclusion Criteria:

* heart failure, bleeding diathesis, associated cardiac congenital anomalies
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy

This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the Monarch® Endoscopy Platform in patients with peripheral pulmonary nodules (PPN).

Robotic-assisted navigational bronchoscopy (RANB) improves accuracy of lesion localization and diagnostic yield of the peripheral pulmonary nodule (PPN) biopsy compared to conventional flexible bronchoscopy. Needle based confocal laser endomicroscopy (nCLE) allows real-time microstructural imaging of lung nodule tissues at the needle tip. The study is designed to evaluate the safety and feasibility of utilizing nCLE during RANB biopsy procedure to optimize needle position and diagnostic accuracy, as well as reduce or replace the need for additional imaging tools such as radial endobronchial ultrasound (r-EBUS), cone beam computed tomography (CBCT), and/or fluoroscopy during RANB biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 22 years at signing of informed consent form (ICF).
* Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care.
* ICF signed before any study procedures are initiated.

Exclusion Criteria:

* Medical contraindication to bronchoscopy under general anesthesia, or lack of physical fitness to undergo bronchoscopy under general anesthesia or to follow the study processes, as assessed by the investigator.
* Presence of uncorrectable bleeding disorders, or anticoagulation/anti-platelet aggregation therapy that cannot be withheld for an appropriate interval prior to the procedure, as defined per the institution's standard of care.
* Medical devices interfering with electro-magnetic navigation, including but not limited to pacemakers.
* Subjects who have a target lesion that shows endobronchial involvement on chest CT.
* Participation in any other clinical trial within 30 days of enrollment, that would interfere with this study.
* Known hypersensitivity to fluorescein sodium or any other ingredients in the fluorescein product.
* Planned surgical resection at the time of bronchoscopy
* Female subjects who are pregnant or nursing at the time of the procedure.
Plaque Psoriasis Efficacy and Safety With Secukinumab

To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.


Eligibility Criteria:
Main Inclusion Criteria:

1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and candidate for systemic therapy.
2. Moderate to severe psoriasis at Baseline as evidenced by:

   * PASI ≥ 10 and
   * IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
   * BSA affected by plaque-type psoriasis of ≥ 10%.

Main Exclusion Criteria:

1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor (IL 17AR) antibody.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and guttate psoriasis).
4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study drug.
7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study drug and for 16 weeks after stopping study drug.
9. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)

Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques

The study is being done to test the performance of a Novii Wireless Patch System for following the baby's and mother's heart rates and uterine contractions during labor. We want to find out if the new monitor works as well as other types of monitors that are usually used: Doppler Fetal Heart Rate (FHR), Scalp FHR, Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC).

80 patients will be monitored during the study.

Eligibility Criteria:
Inclusion Criteria:

A woman will be considered for inclusion in the study if she fulfills all of the following criteria:

* She has a term or near term (≥36 completed weeks) singleton gestation in a cephalic presentation and has been admitted to the Labor and Delivery Unit .
* She is in the latent phase of spontaneous labor, or has been admitted for induction of labor.
* She has given her informed consent to participate as a subject.
* She has none of the exclusion criteria.

Exclusion Criteria:

* Known major fetal malformation or chromosome abnormality.
* Multiple gestation
* A condition for which cesarean will likely be carried out shortly.
* Subject plans not to have electronic fetal monitoring.
* Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
* Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to adhesives).
* Parturient is under age 18.
* Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
* Inability to understand the consent information due to medical illness or diminished intellectual capacity, or insurmountable language barrier.
* Potential for coercion, e.g. Medical Center employees, prisoners.
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight must be ≥ 50 kg and \< 130 kg with a BMI ≤ 38.0 (kg/m2).
* Must use acceptable form of birth control during the course of the study and for 3 months following the single dose of study drug.
* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
* Negative test for HIV; hepatitis A, B, and C.
* Must have adequate vital sign reads at screening and check-in.
* Must be able to comply with dietary and fluid restrictions required for the study.

Exclusion Criteria:

* History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug.
* Recent clinical evidence of pancreatic injury.
* Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes.
* Previous diagnosis of malignancy.
* Unwilling to forgo use of any over-the-counter or non-prescription preparations.
Smoking Dependence and Periodontitis

The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis

The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis.

The research question was " How the Fagerström for nicotine dependence (FTND) and the number of cigarette cunsuption (NNC) are correlated to the severity of chronic periodontitis"? Thirty-four consecutive smoker patients presenting a chronic periodontitis were included in the study, and the smoking status was defined both by NCC and FTND.

Periodontal clinical parameters were correlated with NCC and FTND.

All the clinical periodontal parameters were recorded by a single periodontist (L.S). Periodontal assessments included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility and the percentage of sites of PD ≥ 6mm. A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%).

All the participants of the study respected the following inclusion criteria: 1/ smoker patients aged of minimum 18 years old, 2/ chronic periodontitis, 3/ presence of a minimum of 6 teeth at each arch, 4/ a minimum of 6 teeth with pocket depth of 5 mm, 5/ signed the informed consent. The exclusion criteria were: 1/ aggressive periodontitis, 2/ diabetes, 3/ connective tissue disease, 4/ pregnancy, 5/ radio-therapy, 6/ chemotherapy, 7/ psychological disease, 8/ previous periodontal therapy.

The patient smoking status was defined by FTND and NCC FTND scores were categorized in 3 groups

* scores \< 4 for low nicotine dependence,
* scores = 4-5 for moderate nicotine dependence
* scores \> 5 for high nicotine dependence.

The NCC s was classified in three levels of smokers as described in most of the periodontal studies:

* Number of cigarette smoking ≤ 10 per day for low consumption
* Number of cigarette smoking from 10 to 20 per day for moderate consumption
* Number of cigarette smoking \> 20 per day for high cigarette consumption

Eligibility Criteria:
Inclusion Criteria:

* smoker patients aged of minimum 18 years old
* chronic periodontitis
* presence of a minimum of 6 teeth at each arch
* a minimum of 6 teeth with pocket depth of 5 mm
* signed the informed consent

Exclusion Criteria:

* aggressive periodontitis
* diabetes
* connective tissue disease
* pregnancy
* radio-therapy
* chemotherapy
* psychological disease
* previous periodontal therapy.