cyrilzakka/clinical-trials huggingface dataset:
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric

ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.


Eligibility Criteria:
Inclusion Criteria for Cancer Arm Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.
* No prior cancer treatment (local or systematic) with either of the following:

A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.

B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.

Exclusion Criteria for Cancer Arm Participants:

* Insufficient qualified blood samples.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
* With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Disease Arm Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.
* Able to provide sufficient and qualified blood samples for study tests.
* Have either of the following:

A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.

B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

* Insufficient qualified blood sample for study test.
* During pregnancy or lactation.
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
* Recipient of blood transfusion within 7 days prior to study blood draw.
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw.
Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.

Eligibility Criteria:
Inclusion Criteria:

* Patients are more than 18 and less than 65 years old.
* Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).

Exclusion Criteria:

* Patients with renal insufficiency (serum creatinine \> 1.6 mg/dl)
* patients with active urinary tract infection.
* Patients with congenital renal anomalies.
* Morbid obesity (BMI \> 35 kg/m2).
* Pregnancy.
* Bleeding Coagulopathy.
* Skeletal deformity
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

The purposes of this study are to determine:

1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

The primary objective was to demonstrate that drotrecogin alfa (activated) compared with placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete resolution of a composite of cardiovascular, respiratory, and renal organ failure in pediatric patients with severe sepsis.

Secondary objectives included: (1) to assess whether treatment with drotrecogin alfa (activated) reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients, (2) to evaluate the effects of drotrecogin alfa (activated) on individual organ dysfunction (cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, and cutaneous), (3) to demonstrate that drotrecogin alfa (activated) improved patient outcome as assessed by the Pediatric Overall Performance Category (POPC) scale, (4) to demonstrate that drotrecogin alfa (activated) reduced major amputations (at or above the wrist, at or above the ankle, face, and genitals) in pediatric patients with Neisseria meningitidis (proven or suspected) and/or purpura fulminans, (5) to demonstrate that drotrecogin alfa (activated) had antithrombotic and anti-inflammatory properties. The safety objective was to evaluate whether drotrecogin alfa (activated) had an acceptable safety profile when administered to pediatric patients with severe sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or proven acute infection.
* Abnormally high or low core body temperature
* Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
* Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Exclusion Criteria:

* Patients at increased risk of bleeding.
* Patients at high risk for an intracranial bleed.
* Patients who have undergone a bone marrow transplant.
* Patients with end-stage renal disease.
* Patients whose family or primary care physician is unwilling to allow transfusion of blood products.
Factors That Influence Blood Vessel Regulation During Exercise in Humans

This study will examine two separate interventions: 1) the effects of ischemic preconditioning or 2) a high fat meal on the capacity of the brachial artery to overcome sympathetic activation and dilate during exercise (also known as functional sympatholysis). Participants will be asked to complete rhythmic handgrip exercise with and without the application of -20 mmHg lower body negative pressure to increase sympathetic activation. Doppler ultrasound will be used to continuously measure brachial artery blood flow. Participants will complete the handgrip exercise and lower body negative pressure before and after the applications of each interventions. Participants may elect to only complete one intervention rather than complete both protocols. Intervention one is active or control ischemic preconditioning. Intervention two is high or low fat meals.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Healthy

Exclusion Criteria:

* History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months
* Diagnosed cardiovascular or metabolic disease(s)
* Recent musculoskeletal injury handgrip exercise
* Prescription of chronic medications other than oral contraceptives
* History of hypertension or presence of arrhythmia
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \< 22 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)
* Must have at least one confirmed and evaluable tumor site
* Must have a Karnofsky or Lansky performance status ≥60%.
* No chemotherapy for three weeks prior to treatment
* Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3 and platelets ≥100,000/ mm3
* Pre-enrollment chemistry parameters must show: bilirubin\<1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\<2.5x IUNL and creatinine\<1.5x IUNL
* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL
* Growth factor(s): Must not have received within 1 week of entry onto this study
* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study
* Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening
* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks

Exclusion Criteria:

* Females who are pregnant or lactating
* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study
* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
Effect of Audible Manipulation Sound in Non-specific Cervicothoracic Pain

The aim of this study is to investigate the effect of auditory manipulation sound on perceived pain, satisfaction and disability in patients with nonspecific cervicothoracic pain.İndividuals with nonspecific cervicothoracic pain will be included. the first group will be determined as those with an audible sound at the end of manipulation, and the second group will be determined as those without an audible sound at the end of manipulation. all evaluations and the patient's satisfaction level will be made before the application and 48 hours after the application.

Before the application, the pain intensity of the individuals will be assessed with a visual analog scale, and the level of disability will be assessed with the 'neck pain and disability index'. neck mobility will be measured with a cervical inclinometer and spinal region fascia mobility modified schober test, and also the thoracolumbar fascia flexibility will be recorded. .

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-specific spinal pain
* Must be able to do exercise by alone

Exclusion Criteria:

* Clinical diagnosis of neurological problems (Alzheimer's, Demans)
* Clinical diagnosis of deep vein thrombosis
* Clinical diagnosis of systemic and uncontrolled metabolic diseases( Diabetes, Thyroid,hypertension)
* Don't have pain while doing exercise
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
* Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion Criteria:

* Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
* Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
* Subjects with an irregular daily sleep schedule.
* Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
* Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
* Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
* Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
* Subjects who are expected to require treatment with ocular or systemic corticosteroids.
* Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
* Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
* Subjects with a central corneal thickness greater than 600 μm in either eye.
* Subjects with any condition that prevents reliable applanationtonometry in either eye.
* Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
* Subjects with previous or active corneal disease.
* Subjects with a history of severe dry eye.
* Subjects with active optic disc hemorrhage.
* Subjects with a history of central/branch retinal vein or artery occlusion.
* Subjects with a history of macular edema.
* Subjects with very narrow angles and subjects with angle closure, congenital, and secondary glaucoma, and subjects with history of angle closure in either eye.
* Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
* Subjects with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
* Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
* Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)

The purpose of the study is to use different x-ray and magnetic resonance (MR) imaging techniques to take pictures of the knee. There are two specific purposes to the study:

1. whether the different x-ray and MRI techniques will give the same or different information about the knee joint and
2. which part of the knee joint will show the biggest change using the different x-ray and MRI techniques. The study is not designed to test a hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 40 years and older
* Subjects who are willing and able to comply with x-ray and MRI procedures
* Evidence of a personally signed and dated consent document

Additional inclusion for normal controls:

* Infrequent knee pain, aching, or stiffness during the past year or infrequent use of medication for treatment of knee pain during the past year
* No evidence of OA on either knee (i.e. K-L grade = 0 diagnosed by knee radiography)

Additional inclusion for OA patients:

* Pain, aching, or stiffness on most days of a month during the past year; or use of medication for treatment of knee pain on most days of a month during the past year
* Kellgren-Lawrence Grade 2 or 3 of the study knee obtained on a Standard knee radiograph (with either the same or less severe OA, or no OA in the contralateral knee)

Exclusion Criteria:

* Subject is unable to undergo MRI because of contraindication
* Women at risk of pregnancy
* Weight greater than 250 lbs
* History of surgery in the study knee
* History of other diseases involving the study knee joint including inflammatory joint diseases, crystalline disease, and infection of the study knee
The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Read, sign, and date an information consent;
* Willing and able to follow instructions and maintain the appointment schedule;
* Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1;
* Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
* Meet protocol-specified criteria for dry eye at Visit 1;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months;
* Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs);
* History of intolerance or hypersensitivity to any component of the study medications;
* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
* Use of any concomitant topical ocular medications during the study period;
* Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
* Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation;
* Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1.
* Participation in an investigational drug or device study within 30 days of entering this study;
* Other protocol-defined exclusion criteria may apply.
Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel

The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.


Eligibility Criteria:
Inclusion Criteria:

* under age of 3
* has fever with no obvious focal infection
* written informed parental permission

Exclusion Criteria:

* parent/legal guardian unable to provide permission
* participation determined by a physician to be detrimental to patient health
MASCT-I Treatment for Advanced Solid Tumor

Multiple Target Antigen Stimulating Cell Therapy (MASCT-I) is a new immunotherapy that dendritic cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused. The previous research data showed that MASCT had the modest overall response and less adverse effects for Hepatocellular Carcinoma patients.

The study is aimed to evaluate the safety of MASCT-1 in patients with advanced solid tumors.

This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.

40-50 patients with advanced or recurrent solid tumors who had failed after standard treatment will be recruited in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically-confirmed, advanced (unresectable) solid tumors（Lung cancer, colon cancer, prostate cancer, soft tissue sarcoma, other rare tumor） who have progressed on standard therapy.
2. With written informed consent signed voluntarily by patients themselves.
3. The time of between Patients enrollment and the end of other anti-tumors therapies≥1 month.
4. ECOG≤2.
5. At least one measurable lesion as defined by RECIST criteria 1.1 for tumors.
6. Life expectancy ≥6 months.
7. With normal cardiopulmonary function.
8. Patients have adequate organ function as defined by the following criteria:

Hemoglobin (HGB) ≥85g/L Absolute neutrophil count (ANC) ≥1.0×10\^9/L White blood cell (WBC) ≥3.0×10\^9/L Platelet count ≥80×10\^9/L Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) of ≤2.5 upper normal limitation (UNL) or ≤5 UNL in case of liver metastasis Alkaline phosphatase (ALP)≤2.5 UNL Total bilirubin (TBil) of ≤1.5 UNL Blood urea nitrogen (BUN) and Creatinine (Cr) of≤1.5 UNL Albumin (ALB) ≥30g/L

Exclusion Criteria:

1. Pregnant or expecting to pregnant
2. Participated in other clinical trials before screening except of observational study.
3. Refused to provide blood samples.
4. Known allergic history of sodium citrate drugs.
5. Known history of organ transplant, including autologous bone marrow transplantation and peripheral stem cell transplantation.
6. Known active brain metastases
7. The use of immunosuppressive drugs with current or 14 days before enrollment.
8. Active primary immune deficiency.
9. known history of tuberculosis.
10. Active infection, including hepatitis B, hepatitis C virus, or human immunodeficiency virus.
11. Patients with serious infection, hepatopathy, nephropathy, respiratory disease, cardiovascular disease or incontrollable diabetes, etc.
12. Patients have other malignant tumors within 5 years,excluding melanoma and carcinoma in situ of cervix.
13. Clinical signs of heart disease.
14. Treatment with any anti-tumors agent within 28days of first administration of study treatment.
15. The research on the influence of non legal persons, medical or ethical reasons
Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study

SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old have been locked down on March 21 and people younger than 20 years old locked down at April 03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at weekends.

Renal replacement modalities have been affected in different ways during the pandemic. Patients with kidney transplantation and patients performing home hemodialysis or peritoneal dialysis have been advised to perform self-isolation at homes. However, center hemodialysis patients continued to come dialysis centers obligatorily.

Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian people in a position called temporary protection. There are many Syrian center hemodialysis patients both in Turkey and in our unit. The investigators do not know if pandemic affected Syrian patients different than Turkish ones. The aim of this study is to compare beck depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Hemodialysis history of more than three months

Exclusion Criteria:

* Patients who can not speak Turkish or Arabic,
* Not volunteer to fill the form
* History of hospitalization for any reason during the pandemic time,
* History of COVID-19 before the questionnaire (Beck Depression Inventory)