cyrilzakka/clinical-trials huggingface dataset:
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT

The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma \[NTG\],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes.
* Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day 0\[after washout for the subjects already on treatment\]): mean/median IOP ≥15 mmHg and ≤36 mmHg at 10 AM in at least 1 eye; and IOP ≤36 mmHg in both eyes.
* Subjects with a corrected Decimal visual acuity (VA) or a Best-Corrected Decimal Visual Acuity (BCVA) of 0.5 or better in both eyes.

Exclusion Criteria:

* Subjects who are unable to discontinue contact lens use during and for 15 minutes following instillation of study drug and during study visits.
* Subjects who are unable to discontinue other eye drop medications such as artificial tears for 15 minutes prior to and 15 minutes after instillation of study drug.
* Subjects with a central corneal thickness greater than 600 μm in either eye.
* Subjects with any condition that prevents reliable applanation tonometry in either eye.
* Subjects with advanced glaucoma with a mean deviation (MD) \< -12 dB, a history of split fixation, or a field loss threatening fixation in either eye.
* Subjects with any condition that prevents clear visualization of the fundus.
* Subjects who are monocular (fellow eye is absent).
* Subjects with aphakia in either eye.
* Subjects with an active corneal disease in either eye.
* Subjects with severe dry eye in either eye.
* Subjects with a history/diagnosis of a clinically significant or progressive retinal disease in either eye.
* Subjects with very narrow angles and subjects with angle closure congenital, or secondary glaucoma, and subjects with history of angle closure in either eye.
* Subjects with any intraocular infection or inflammation in either eye within 3 months prior to Visit 1 (Screening).
* Subjects with a history of ocular laser surgery in either eye within the 3 months (90 days) prior to Visit 1 (Screening).
* Subjects with a history of incisional ocular surgery or severe trauma in either eye within 3 months prior to Visit 1 (Screening).
The Dynamic Monitoring of Cerebrospinal Fluid ctDNA

Focusing on advanced EGFR mutation in NSCLC patients with leptomeningeal metastasis, vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was used to dynamically monitor ctDNA in cerebrospinal fluid (CSF), analyze the ctDNA gene mutation profile of CSF in different patients, and explore the relationship between ctDNA and efficacy and prognosis.

This is a single-center prospective cohort study. Patients with advanced EGFR-mutated NSCLC with leptomeningeal metastasis were treated with vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed). Dynamic monitoring of cerebrospinal fluid ctDNA was performed to analyze the ctDNA gene mutation profile of cerebrospinal fluid in different patients, and to explore the relationship between ctDNA and efficacy and prognosis. At the same time, the study of drug vacation in the treatment of leptomeningeal metastasis is to explore the efficacy and safety of brain drug vacation, so as to reduce the patient's tolerance to drugs and the side effects of drugs. The endpoint was progression-free survival (PFS) of intracranial lesions.

Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC patient with EGFR mutation, associated with leptomeningeal metastasis
* Patients who meet the requirements of OMMAYA cystlateral ventricle chemotherapy
* Age \> 18 years
* Complete serologic tumor markers (CEA, SCC) and imaging data (enhanced CT and/or MRI, PET-CT)
* Liver, kidney, and hematologic measures were normal (as measured by laboratory testing within 1 week before enrollment in the absence of ongoing supportive care), with a neutrophil count of more than 1.5×109/L, a platelet count of more than 100×109/L, and a hemoglobin level of more than 9.0g/dl ，Bilirubin normal or \<1.5×ULN; AST(SGOT), ALT(SGPT) \<2.5×ULN; Serum creatinine \<1.5×ULN
* The patients were fully aware of the study, provided voluntary written informed consent, and were able to adhere to the protocol-defined visit and follow-up procedures

Exclusion Criteria:

* Patients who do not meet the requirements of lateral ventricular chemotherapy
* History of allergy to vormetinib and pemetrexed
* Severe complications occurred during the treatment
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Severe infection in active stage or with poor clinical control
* Mentally ill, substance abusers and pregnant or lactating women
* No informed consent was signed
* Eligibility as judged by the other investigators
TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II

The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≤ 365 days of age at the time of diagnosis.
* Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible.
* Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
* Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.

Exclusion Criteria:

* Patients with prior therapy, other than therapy specified in inclusion criteria.
* Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
* Patients with Down syndrome.
* Inability or unwillingness of legal guardian/representative to give written informed consent
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

The goal of this clinical trial is to learn if a brief writing intervention works to improve quality of life outcomes in adult patients newly diagnosed with advanced stage cancer.

A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QoL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 item Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation via writing at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QoL.

Eligibility Criteria:
Inclusion Criteria:

* within 8 weeks of being informed of diagnosis (primary or recurrent)
* cancer stage III or IV of a primary solid tumor, or a high-grade hematological malignancy, and
* age 18 years or older

Exclusion Criteria:

* medical condition precluding participation (e.g., too ill or fatigued, acute mental confusion as determined by the treating physician), or
* enrolled in other psychosocial experiments
Measurements Of Zinc Concentration On Specimens Taken During Trans-Perineal Prostate Biopsy

The purposes of this study are to: i) confirm and improve the accuracy of the correlation between levels of Zinc in prostate tissue and the grade of prostate cancer in that tissue as determined through pathology; and ii) determine the levels of zinc in prostate tissue declared as non-cancerous by pathology and located in the vicinity of tissue declared as cancerous by pathology, and verify that the Zinc levels for the declared non-cancerous tissue are lower (statistically significantly) than the levels for benign tissue not in the vicinity of cancerous tissue.


Eligibility Criteria:
Inclusion Criteria:

* Elevated PSA, \>10ng/mL
* Subject underwent primary and at least one secondary (repeat) prostate biopsy with negative diagnosis
* Subject directed at saturated trans-perineal biopsy

Exclusion Criteria:

* Subject was under Zn supplement nutrition treatment
Long Term Follow up of Failed Back Surgery Syndrome(FBSS)

The purpose of this study is to reveal the effectiveness and satisfaction of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observation patients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with Failed Back Surgery Syndrome(FBSS) and who have been admitted to Gangnam Jaseng Hospital of Korean medicine and Bucheon Jaseng Hospital of Korean medicine for 2011.11-2014.09.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Failed Back Surgery Syndrome and was admitted to Jaseng hospital of Korean medicine.
* Patients have agreed to participate the study.
* Patients who had participated "Long-term course of failed back surgery syndrome (FBSS) patients receiving integrative Korean medicine treatment: a 1 year prospective observational multicenter study"
* Patients aged 19-70 years on the date

Exclusion Criteria:

* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic
A Single-arm Exploratory Study of Neoadjuvant Therapy

Neoadjuvant EGFR TKI therapy targeting EGFR mutation has some problems failure to fulfill clinical requirements such as low MPR rate, tissue fibrosis and other major surgical impacts and unmet clinical needs.This study hypothesized that Tisleizumab combined with chemotherapy in the neoadjuvant treatment of stage II-IIIA non-squamous NSCLC with EGFR-mutant PD-L1 expression ≥1% could significantly improve the pathological response rate after neoadjuvant therapy, improve the surgical complete resection rate, reduce perioperative complications and do not increase the surgical difficulty.In this study, biomarker analysis is going to explore the possible direction of neoadjuvant therapy population screening, and to explore a possible method for the efficacy and safety of neoadjuvant immunotherapy in clinical stage II-IIIA non-squamous non-small cell lung cancer with EGFR mutation and expression of PD-L1.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in clinical research;Fully understand and be Informed of the study and sign the Informed Consent Form (ICF);Willing to follow and able to complete all test procedures;
2. Age 18-75 (boundary value included), no gender limitation;
3. Histologically proven stage II-IIIB Lung Adenocarcinoma (as defined by the American Joint Commission on Cancer, 8th Edition);
4. EGFR gene mutation positive (can be tested by tissue or blood samples);
5. PD-L1 ≥ 1%
6. ECOG PS score 0-1 (including boundary value);
7. Cardiopulmonary function is good, and the requirements for surgical resection for radical treatment are confirmed;
8. Meet the conditions for receiving platinum containing two-drug chemotherapy;
9. The expected survival time is ≥3 months, and feasible surgery is planned;

Exclusion Criteria:

1. Any previous treatment for current lung cancer, including systemic therapy or radiotherapy;
2. there are locally advanced unresectable diseases (regardless of disease stage) and metastatic diseases (stage IV).
3. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Patients with any severe and/or uncontrolled disease or symptom
Central Pain Syndrome in Survivors of Head and Neck Cancer

This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

Primary objectives:

* To correlate structural and functional MRI signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain.
* To correlate the presence of chronic systemic symptoms with pain phenotype

Exploratory objectives:

- DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven head and neck cancer
* Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)

  * We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed.
* Completed multi-modality therapy a minimum of 6 weeks prior to study entry.
* Willing and able to provide informed consent
* All participants must be at least 21 years of age
* Able to speak English

Exclusion Criteria:

* Patients who are pregnant
* Patients who are unable to lie still
* Patients who are unable tolerate pressure stimulator
* Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants
* Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers

This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Subject whose parents/legal guardians had given written informed consent,
* Male or female, aged 3 to 6 years (upper bound excluded),
* Attending day-care centres or preschools 5 days a week in the Moscow area,
* Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
* Subject who appreciated dairy products and multi-fruit flavour.

Exclusion Criteria:

* Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
* Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), or with any known food or respiratory allergy.
* Subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes...) or any past or actual health condition that could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive...).
* Subject having experienced any infectious disease during the last 7 days.
* Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had been using laxatives during the week prior his participation to the study.
* Subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study.
* Subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia...).
* Subject currently receiving, or who had received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics, antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid antiinflammatory substances, immunosuppressant treatment...
* Subject already enrolled in another clinical study, or currently under an exemption period from a previous study.
* Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Local Infiltration Analgesia in Total Knee Arthroplasty

40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* Contraindication for central and/or peripheral nervous blockade
* Reoperation on previous total knee arthroplasty
* History of allergic or other adverse reactions on the agents used in the study
* Chronic opioid or gabapentinoid use
* Serious psychiatric, mental and cognitive disorders
* Language barrier
* Difficulty in understanding or using a patient controlled analgesia device
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.

This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE\[s\]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP-1025 at the RDE(s).

Eligibility Criteria:
Key Inclusion Criteria:

* Patients must be at least 18 years of age at the time of signing the informed consent.
* Patients must be willing and able to provide written informed consent
* Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists
* Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test
* Patients must be HLA-A\*02:01 positive by central assay
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
* Adequate hematological, renal and hepatic function
* Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation

Key Exclusion Criteria:

* Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation
* Patients who have received other p53 R175H-directed therapies
* Patients who have not fully recovered from adverse events due to previous anticancer therapies
* Patients with active infection requiring systemic antimicrobial therapy
* Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.
* Known active central nervous system metastases and/or carcinomatous meningitis
Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction

The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged over 19 years who are scheduled for sleep endoscopy

Exclusion Criteria:

* basal skull fracture
* facial anomaly
* consciousness disorder
* Risk of aspiration
* necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
Wrist-based Blood Pressure Monitoring Study

To observe blood pressure variation in various real-world settings

This is an observational study, which will utilize a wrist-based blood pressure monitor to explore blood pressure variation in up to 75 participants in various real-world settings. There is no intervention in this study. The study will take place over a 4-week period. During this time, participants will be asked to sample their blood pressures 1) at random times, several times per day; 2) during specific periods of either emotional stress or relaxation; 3) during guided orthostatic testing. Study participants will utilize an application on their smartphones to log the device-measured blood pressures and flag selected blood pressure measurements as either being part of the orthostatic testing or during periods of emotional stress/relaxation. At the close of the study a post-study questionnaire will be sent electronically to each participant.

Eligibility Criteria:
Inclusion Criteria:

* Consortium members within the All of Us Research Program
* ≥18 years of age
* Own an iOS or Android device

Exclusion Criteria:

* Inability to give informed consent
* \<18 years of age
* Inability to understand written English language