cyrilzakka/clinical-trials huggingface dataset:
The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

CTC levels collected pre-surgery will be correlated with pathological samples.

Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore \& describe the pattern of CTC detection in all patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
* Age 18 or older
* Signed informed consent
* Patients who are incapable of providing informed consent are excluded from participating in this study.
Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.

This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant, non-lactating females, age 18 years or older
2. Chronic atopic dermatitis for at least 6 months
3. BSA of AD involvement of at least 10%
4. EASI score of at least 16.

Exclusion Criteria:

1. Significant AD flare with 4 weeks
2. Use of biologic therapy within 12 weeks
3. Regular use of tanning booth within 4 weeks
4. Skin condition that could interfere with study assessments
Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors

The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.

Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.

Eligibility Criteria:
Inclusion Criteria:

Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.

Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.

Exclusion Criteria:

Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.

Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of melanoma
* Progressive disease that is not surgically resectable, or metastatic Stage IV
* Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
* No prior chemotherapy
* Measurable disease
* ECOG performance status ≤ 1
* At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
* Prior immunotherapy allowed
* Adequate organ function

Exclusion Criteria:

* Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
* Primary ocular or mucosal melanoma
* Bone-only metastatic disease
* History or presence of brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Organ allograft
Genetic Variation in Platelet Aggregation

The aim of the study is to test whether genetic variation in the alpha 2A adrenergic receptor affects diurnal variation in platelet aggregation.

There is a marked diurnal fluctuation in the occurrence of acute myocardial infarction and sudden death, with peak incidences occurring in the early morning. Platelet aggregation has also been shown to increase in the early morning. The investigators will test the hypothesis that alpha 2a-adrenergic receptor (ADRA2A) genetic variation, specifically haplotype 4, affects platelet aggregation. The investigators will compare diurnal platelet aggregation in haplotype 4 subjects with subjects in the other haplotype families. In addition, the investigators will compare platelet aggregation after the cold pressor test in haplotype 4 with the other haplotype families. If there are no differences among haplotypes, then the haplotypes will be combined to analyze.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 - 45 years inclusive.
* Women of the above age will be studied between day 1 and day 14 of a normal menstrual cycle.
* Subjects must be willing to give informed consent for the study and able to adhere to the study diet and study procedures.
* Subjects and immediate extended family up till grandparents will be Caucasians or African Americans only.
* Subjects will be free of any clinically significant disease.
* Clinical laboratory test (CBC, blood chemistry) will be within acceptable limits.

Exclusion Criteria:

* Subjects who have taken any antiplatelet, anticoagulant or procoagulant medicines within the last three weeks preceding the study.
* Subjects who have taken medications (including over the counter medications) other than oral contraceptives in the past two weeks.
* Subjects who smoke or have smoked in the past 3 months.
* Subjects who are presently or were formerly a narcotic addict or alcoholic.
* Females with a positive pregnancy test.
* Females who are breast feeding.
Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor

The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.

The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.

During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:

1. Scheduled recording four times a day
2. In case of suspecting arrhythmic event, i.e. feeling symptoms
3. In case the wrist device instructs to perform a recording by vibrating and showing an LED light

The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.

Eligibility Criteria:
Inclusion Criteria for the main study group:

* At least 65 years of age
* Self-assessed ability to use the study devices
* Ability to give informed consent
* Volunteering for the study

Inclusion criteria for the active endurance athlete group:

* Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon...) and currently an average amount of training of at least 10 hours a week.
* Age: ≥ 50 years
* Self-assessed ability to use the study devices
* Ability to give informed consent
* Volunteering for the study

Exclusion Criteria for both groups:

* Cardiac pacemaker
* Earlier diagnosis of atrial fibrillation
* Inability to give informed consent
* Denial
Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease

Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.


Eligibility Criteria:
Inclusion Criteria:

* identified Barlow disease suffering from significant mitral insufficiency with indication to surgery

Exclusion Criteria:

* Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease
* Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)
* Pregnancy
* Inability to give consent
Tele-Rehabilitation Pilot Evaluation Study

A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.

This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.

Eligibility Criteria:
Inclusion Criteria:

* at least 21 years of age
* Admitted into an inpatient or outpatient rehabilitation unit, nursing home or day care centre for an acute or chronic disability
* Deemed by any members of the multi-disciplinary rehabilitation team to potentially able to safely receive and benefit from rehabilitation post-discharge
* Cognitively able to understand and follow instructions (the Abbreviated Mental Test's score of 6 or above (out of 10).

Exclusion Criteria:

* Patients with previous seizure episodes
* Patients with limb musculoskeletal pain of at least moderate intensity (visual analogue Scale \> 6 out of 10)
* Patients with pacemakers.
Kaneka Endovascular Embolization and Protection

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)

Study Duration

Anticipated timeline for study:

Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Eligibility Criteria:
Inclusion Criteria:

* Target aneurysm of 4mm - 14mm in size
* Ruptured or unruptured
* Suitable for embolization with coils
* May be treated with or without assist devices

Exclusion Criteria:

* Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
* Pre-planned staged procedure of target aneurysm
* mRS score 3 or more
* Hunt Hess Score more than 3 for subjects with ruptured aneurysm
* Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis with COPD

Exclusion Criteria:

* allergic to gel
* unable to perform spirometry
* unable to communicate
* no history of infection or exacerbation of respiratory symptoms
Test to Stay in School: COVID-19 Testing Following Exposure in School Communities

Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.

This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).

If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.

Eligibility Criteria:
Inclusion Criteria:

* Consent completed
* Child or adult that is part of a school community
* Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school sporting event, etc.)

Exclusion Criteria:

* None
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).

The study will start with the ADU-1805 monotherapy dose escalation arm following an i3+3 design until the RP2D is defined. The ADU-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the ADU-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the RP2D for the combination is defined.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years
* Signed and dated informed consent form
* Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists
* Measurable disease according to RECIST (Safety Expansion only)
* ECOG Performance status of 0 or 1
* Adequate organ and marrow function

Exclusion Criteria:

* Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
* Pregnancy or breast-feeding
* Prior treatment with or receipt of:

  * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805
  * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.
  * anti-SIRPα or anti-CD47-directed therapy
  * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805
  * other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805
  * vaccine containing live virus within 28 prior to the first dose of ADU-1805
* Active untreated brain metastases
* Active infection requiring systemic therapy
* Impaired cardiac function or clinically significant cardiac disease
* Current Grade \>2 toxicity related to prior anti-cancer therapy
* History of drug-induced severe immune-related adverse reaction
* Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
* Major surgery within defined period
* Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
* Allogenic tissue/solid organ transplant
* Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study
Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination

The study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old.

Background: Allergic rhinitis (AR) is a disorder caused by hypersensitivity of the immune system to harmless allergens in the environment, which represents a global public health problem affecting up to 20-50% of the population. Allergen immunotherapy (AIT) is the only effective treatment that not only has disease-modifying property but also confers long-term clinical benefit after cessation of treatment for AR patients. Vaccination is one of the most powerful interventions for reducing disability and death caused by infectious disease. Immunization with the inactivated SARS-CoV-2 Vaccine remains the most effective strategy to combat COVID-19 infections. Nevertheless, the influences of allergic rhinitis and allergen immunotherapy on SARS-CoV-2 vaccination are still unknown.

Objectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults.

Design and trial size: This is a prospective study. A total of approximately 120 subjects, 18-55 years old, including 40 healthy subjects, 40 patients with AR without AIT, and 40 patients with AR with AIT for more than 1 year, will be enrolled in this study.

Intervention and duration: All of the study participants will be vaccinated with an 2 doses inactivated vaccine against SARS-CoV-2 (COVILO). Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine. One-month additional data analysis leads to the trial duration of 3 months.

Eligibility Criteria:
Inclusion Criteria:

18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year

Exclusion Criteria:

1. who infected with COVID-19 previously
2. Cannot finish the follow up
3. Previous allergic to other vaccines
4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
5. pregnancy or breastfeeding
6. Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.
Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.

This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) early access program (EAP) study. The study will be conducted in 2 phases: a Screening Phase (approximately 30 days prior to administration of first dose) and a Program Drug Phase (Day 1 up to 30 Days after last dose of study drug). Enrolled participants will receive 420 milligram (mg) oral ibrutinib once daily on a 28-day cycle until disease progression, occurrence of unacceptable toxicity, no longer achieving clinical benefit, or the end of program. Treatment will be continuous (without interruption) and self-administered. Disease evaluations will be conducted according to local standard of care as clinically indicated. Participant's safety will be monitored throughout the study. All enrolled and on-going participants in the program will continue to receive ibrutinib by the EAP until marketing approval or 6 months after this date.

Eligibility Criteria:
Inclusion Criteria:

* Has Eastern Cooperative Oncology Group (ECOG) performance status of less than (\<) 2
* Has a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets published diagnostic criteria (Hallek 2008):

  1. Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing at least one B-cell marker (Cluster of Differentiation 19 \[CD19\], CD20, or CD23) and CD5
  2. The diagnosis of CLL requires a history of lymphocytosis with a B-lymphocyte count greater than or equal to (\>=) 5,000/microliter (μl)
* Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria
* Must have received at least one prior therapy for CLL and not be appropriate for treatment or retreatment with purine analog based therapy
* Able to receive all outpatient treatment and all laboratorial monitoring at the institution that administers program drug

Exclusion Criteria:

* Known central nervous system (CNS) lymphoma or leukemia
* Known prolymphocytic leukemia or history of or currently suspected Richter's transformation
* Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
* Prior exposure to ibrutinib or randomization in an ibrutinib study
* Requires treatment with a strong Cytochrome P3A4/5 (that is, CYP3A4/5) Inhibitor