cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules

The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤80 years old, regardless of gender;
2. Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
3. Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
4. Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
5. For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
6. Eastern Cooperative Oncology Group (ECOG) score 1 \~ 2;
7. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;
8. Surgical specimens or puncture specimens containing tumor tissue are available;
9. 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);
10. Agreed to follow up for at least 2 years.

Exclusion Criteria:

1. The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
2. Patients with stage I-III colorectal cancer;
3. Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
4. Presence of metastasis other than lung;
5. Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
6. Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;
7. History of alcoholism or drug abuse;
8. Pregnant or lactating patients.
Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.

This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units \[AFUs\] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants.

Eligibility Criteria:
Inclusion Criteria:

* Nonsmoker
* ≥60 years old
* residing in Carpenter Place Apartments

Exclusion Criteria:

* Active cigarette smoker
* daily secondhand smoke exposure (self-report)
* any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months
* unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators)
* expected overnight travel outside their apartment during the 14-week study period
* unable to provide informed consent
* lung disease requiring oxygen
* renal dialysis
* cancer receiving active treatment or chemotherapy
* severe uncontrolled high BP ≥160/100 mm Hg or SBP\<115 mm Hg.
* CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.
Pain Control After Total Knee Arthroplasty

Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.


Eligibility Criteria:
Inclusion Criteria:

* Indication to Total Knee Arthroplasty
* Signed informed consent

Exclusion Criteria:

* Chronic pain
* Allergy against local anaesthetics
* Not understanding study or questionnaires
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as determined by medical history and physical examination.
* Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
* For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
* For the Control group, no previous history of any meningococcal vaccination.
* Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
* Able to provide a vaccination log or has available vaccination record in the Health Center
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

* Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 37.5°C at the time of inclusion.
* Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment.
* Oral or injected antibiotic therapy within the 72 hours prior to vaccination
* Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
* Previous history of documented invasive meningococcal disease.
* Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine.
* Personal or family history of Guillain Barré syndrome.
* For female, known or suspected to be pregnant at the time of inclusion
Future Leaders Program: Testing a Youth Civic Leadership, Engagement, and Mindfulness Program

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Activism Program with Mindfulness.

The goal of this project is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness (LEAP) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. The investigators seek to understand whether LEAP can support wellbeing for youth of color as a strategy to increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.

The LEAP study will determine whether a 14-session program designed to provide leadership and mindfulness skills to youth of color is an effective and feasible intervention. The curriculum consists of 14 two-hour sessions delivered after school. The comparison group will take part in EnvisionIT, a college and career readiness program designed for students in grades 6 through 12. EnvisionIT aims to prepare students with essential transition skills, digital literacy, and college and career readiness. The comparison group will also have 14 two-hour group sessions. Both LEAP and EnvisionIT will be delivered by trained facilitators. All participants in LEAP and EnvisionIT will be assessed at four time points assessing program outcomes; facilitators will also complete interviews post-intervention and provide feedback on data fidelity and acceptability following each session. This record reports on the UH3 phase of the grant.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents ages 14 and older in grades 9-12 during the Fall/Winter or in grades 9-11 during the Spring
* Enrolled in a partner site in MA or Chicago, Il
* Adolescents are only included with parent consent and youth assent if they are under the age of 18. Adolescents at least 18 years old can provide consent.

Exclusion Criteria:

* They participated in the pilot phase (UG3)
* They cannot commit to participation in the full study (e.g., attendance at all intervention sessions)
* They are not in grades 9-12 at a partner site
* Parent/guardian has a preferred consent language other than English or Spanish.
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients

The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected:

1. Preoperative patient assessment
2. All monitored perioperative biosignal data
3. Intraoperative and immediate postoperative hemodynamic information, input/output balance, and medication usage
4. Short- and long-term prognosis from electronic medical records This database will be used to develop a vigilant monitoring system that integrates multiple biosignal data simultaneously, contributing to the improvement of anesthesia care.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 19 and older
2. Patients scheduled for anesthesia at a cardiovascular hospital for cardiovascular surgery or procedures

Exclusion Criteria:

1) Emergency (surgery/procedure room transfer within 1 hour of visit) where there is insufficient time for the subject (adult 19 years of age or older) or his/her representative (adult incapable of consent) to decide whether to participate in the study
Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)

The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States \[US\], United Kingdom \[UK\], France, Germany, Italy and Spain).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients and their adult care-partners: At least 18 years old; Either have a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis) or being a care-partner for someone with a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis);
* Able to provide informed consent;
* Located in the United States (US), United Kingdom (UK), Germany, France, Spain or Italy.

  \*Care-partners (paired with adult patients) (defined as the individual \[e.g., spouse, parent, sibling, relative, or friend\] providing direct disease-related support to the adult patient.

  \*\*All patient groups including chronic kidney disease (CKD) stage 1-5, with or without dialysis, and with or without kidney transplant will be included.
* Care-partners/parents of children/adolescents: At least 18 years old;
* Being a care-partner of children/adolescents with physician-provided diagnosis of FSGS or IgAN (with renal biopsy or genetic confirmation of the diagnosis);
* Able to provide informed consent; Located in the US, UK, Germany, France, Spain or Italy.

  * Care-partners will be defined as family members who provide disease-related support and unpaid care to child/adolescent patients

Exclusion Criteria:

* Patient has FSGS or IgAN secondary to another condition;
* Patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer;
* Patient has a co-existing glomerular disease (e.g., membranous nephropathy, lupus nephritis);
* Patient is currently participating in a kidney disease clinical trial, and potentially receiving active treatment as part of the trial.
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study

Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia.

The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria.
* Moderate or severe pain from fibromyalgia despite current treatment regimen.
* Will not become pregnant during study.

Exclusion Criteria:

* Seizure disorder.
* Metal implants on or in brain, spinal cord, ear, eye or heart.
* Current use of proconvulsant medications (e.g., bupropion).
* Taking oral amitriptyline \> 100 mg once daily at bedtime.
* Nonscheduled analgesic, anticonvulsant or antidepressant medications.
* Severe depression or suicidality.
* Other significant psychiatric disorder.
* Previous use of TMS.
Topical vs Oral Metronidazole After Benign Anorectal Surgery

While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.

No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex aged below 70 years
* Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.

Exclusion Criteria:

* Grade I-II hemorrhoids.
* acute anal fissure.
* complex anal fistula
* perianal abscess
* perianal Crohn's disease
* malignancy.
Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength

Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr Kenso Kase for prevention and treatment of sports injuries. Research shows that through activation of skin receptors KT improves blood and lymph flow, increases proprioception, helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function. Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its effectiveness in improving strength.

Purpose: The purpose of the current study was to investigate the short-term effects of KT on muscle strength when applied to the quadriceps muscles of healthy subjects.

Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four different sessions. The parameters of interest were: quadriceps and hamstrings maximal strength and power using vertical jump tests (squat jump and countermovement jump), and peak concentric and eccentric knee torque (using isokinetic test protocol).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* allowed to perform jumps

Exclusion Criteria:

* pregnancy
* history of cardio-vascular disease
* antecedents of lower extremity injuries
* use of any doping substances listed by the World Anti-doping Agency
* any contraindication to exercise
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.

Eligibility Criteria:
Key Inclusion Criteria:

1. Patient completed the ECU-NMO-301 trial
2. Patient has given written informed consent

Key Exclusion Criteria:

1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
2. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
Psychiatric Disorders Related to Diabetes Mellitus Type 1

The most common endocrine illness in children and adolescents is type 1 diabetes. It is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control. As a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life. Type 1 diabetes complications and poor quality of life are widespread. Diabetes therapy is difficult during puberty and adolescence. Adolescents with T1D have poor metabolic control and a higher rate of acute complications. Because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.


Eligibility Criteria:
Inclusion Criteria:

1. Both males and females were included.
2. Age ranges from 10 to 19 years.
3. Willing of the parents or the caregivers to participate in the study.
4. Duration of T1DM of at least 1 year.

Exclusion Criteria

1. Adolescents with an intelligence quotient below 70.
2. Adolescents with a history of substance use or psychiatric disorders.
3. Adolescents with medical or other neurological conditions.
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS.

This study will be conducted only at sites in Japan.

Eligible participants will be randomized to receive intravenous (IV) infusion of eculizumab or placebo at a 2:1 ratio. All participants will be on concomitant IV immunoglobulin G (Ig) therapy as per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Participants who meet the GBS criteria.
* Participants who were able to run prior to onset of GBS symptoms.
* Participants with onset of weakness due to GBS \< 2 weeks before screening.
* Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or FG4 to FG5).
* Participants who are already on IVIg or deemed eligible for and who will start IVIg.
* Participants who can start their first dose of study drug before the end of the IVIg treatment period.

Exclusion Criteria:

* Participants who have previously received or are currently receiving treatment with complement modulators.
* Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study.
* Participants who have received rituximab within 12 weeks prior to screening.
* Participants who are being considered for or are already on plasmapheresis.
* Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and \<110 mmHg, mean seated systolic blood pressure \< 180 mmHg)
* able to give written informed consent

Exclusion Criteria:

* known or suspected secondary hypertension
* history of chronic hepatic diseases
* obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
* cardiac arrhythmia
* unstable angina pectoris
* congestive heart insufficiency (New York Heart Association classification III-IV)
* bilateral renal artery stenosis
* isolated renal artery stenosis
* post renal transplantation
* history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
* retina bleeding/effusion
* insulin dependent diabetes mellitus
* uncontrolled non-insulin dependent diabetes mellitus
Insulin Resistance and Severity of Coronary Artery Disease

this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic \& Non Obese Patients.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period.

Exclusion Criteria:

* age \< 18 years,
* pregnancy or breastfeeding,
* BMI \>30 Kg/m2 and
* presence of pre-diabetes or overt diabetes.