cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of dMRI as a Tool for Early Evaluation of Tumor Response in Diffuse Large B-cell Lymphoma

This research study is designed to test whether the results of a diffusion MRI scan performed after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment for individual patients.

Different types of functional imaging are under investigation as a tool to predict response to treatment, as imaging soon after starting therapy might be able to better define the likelihood of response. Functional imaging refers to scans that measure characteristics other than size and shape (anatomic imaging), as measured by CT scans. We are interested in evaluating the potential value of diffusion Magnetic Resonance Imaging (dMRI), which in some settings can be used very early in treatment in predicting patients' response to treatment.

Diffusion MRI (dMRI) detects changes in cell structure, and has the potential to detect and measure cell changes that occur in response to treatment. Several groups are investigating the use of dMRI to monitor treatment responses. This strategy has been most frequently explored in humans in patients with brain tumors, where dMRI has been demonstrated to predict response to treatment early after starting treatment. A few studies have looked at response in other cancers. These studies showed early changes in patients who later responded to treatment, with changes seen within one to 2 weeks.

Although diffusion MRI has been shown to be useful in several cancer types, it has not been explored in the evaluation of lymphoma. This pilot study will evaluate the imaging characteristics of Diffuse Large B-Cell Lymphoma (DLBCL) by dMRI prior to treatment and 7 days after initial chemotherapy in order to explore whether dMRI is useful in evaluating the response of lymphoma to chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new diagnosis of CD20 Positive diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma, who will receive standard R/CHOP as first line chemotherapy will be included.
* Patients must be age 18 or older.
* No selection will be made on the basis of gender, race or ethnicity.

Exclusion Criteria:

* Patients will be excluded if the diagnosis of diffuse large B cell lymphoma cannot be confirmed.
* Patients receiving treatment other than R/CHOP or R/CHOP followed by radiotherapy or who have previously been treated for DLBCL will be excluded. - Patients with HIV infection will also be excluded. No selection will be made based on other medical problems or laboratory values, except as they affect the patient's eligibility to receive standard R/CHOP chemotherapy as determined by the treating physician.
* Patients who have magnetic metal implants or fragments in their body that are incompatible with MRI will be excluded.
Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of ZR regimen (rituximab \& Zanubrutinib) combined with intravitreal methotrexate and followed by Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

All the patients will be treated with ZR regimen (Rituximab 375mg/m2 IV d1, Zanubrutinib 160mg Bid, 21 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses. The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete remission (CR) or partial remission (PR) will receive 3 more cycles of ZR regimen. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again, the patients with CR or PR will go to Zanubrutinib maintenance for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. And the patients with SD or PD will receive a salvage regimen. During following-up, surveillance ophthalmologic examination, and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up to the first 2 years, followed by the doctor visit every 6 months up to 5 years or the disease relapses.

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed primary vitreoretinal lymphoma
* ECOG≤2
* creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault
* Total bilirubin # 2 upper limits of normal, alanine aminotransferase#ALT# \< 3 upper limits of normal
* Sign the Informed consent
* Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
* Male subjects must agree to use condoms throughout study drug therapy.

Exclusion Criteria:

* primary central nervous system lymphoma involved eyes and brain
* systemic B cell lymphoma involved eyes
* Pre-existing uncontrolled active infection
* Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
* Pregnancy or active lactation
* Co-existing tumors
* HIV or HBV or HCV
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation.

The study includes Phase Ib (combination therapy with dose escalation stage) and Phase II (expansion stage). The study will includes a total of 4 cohorts:

Phase Ib will enroll subjects in 4 cohorts (cohorts 1-4). Subjects will be allocated to appropriate cohorts by the investigator according to specific indications and treated with the corresponding combination regimen for safety and tolerability assessment. The Bayesian optimal interval (BOIN) design will be used for dose escalation and MTD determination.

In Phase II, according to the results of the Phase Ib and SMC decision, 1-2 appropriate dose groups will be selected. In the dose group(s), the sample size (including subjects in the dose escalation stage) will be increased to 20 for each indication according to the cohort for expansion to further evaluate the efficacy of QLC1101 combination therapy in the treatment of subjects with advanced solid tumors harboring KRAS G12D mutations


Eligibility Criteria:
Inclusion Criteria:

* Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.
* Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy
* The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1
* ECOG PS score: 0 or 1

Exclusion Criteria:

* Subjects who have been previously treated with inhibitors for KRAS G12D mutations
* Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study
* Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening
A Single-center Study of CM313 in Patients With Pemphigus

A prospective, single-center, single-arm clinical study aimed to explore the efficacy and safety of the anti-CD38 monoclonal antibody CM313 combined with low-dose glucocorticoids in patients with pemphigus.


Eligibility Criteria:
Inclusion Criteria:

* Clinical manifestations:① Flaccid blisters and bullae on the skin that are prone to rupture.② Persistent erosions formed after the rupture of blisters and bullae.③ Blisters or erosions on the mucous membranes.④ Positive Nikolsky's sign.
* Adult patients aged between 18 and 80 years old.
* Moderate - to - severe pemphigus vulgaris/foliaceus: According to the Pemphigus Disease Area Index (PDAI) score, a score of 9 - 24 indicates moderate severity, and a score of ≥25 indicates severe severity.

Exclusion Criteria:

* Pregnant or lactating women and women planning to conceive.
* Patients with known positive serology for HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C in the active stage of the disease.
* Patients who have received intravenous cyclophosphamide injection, plasma exchange, or immunoadsorption therapy within 8 weeks before screening and enrollment.
Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)

A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.

Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.

Exclusion Criteria:

* Patients without capacity to give consent at time of recruitment
Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.


Eligibility Criteria:
Inclusion Criteria:

Patients with symptomatic severe aortic valve stenosis (valve area \<0.8 cm2) are considered candidates for TAVI (TAVR) if they have a logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) ≥15% or surgery is deemed to be at excessive risk because of comorbidities and other risk factors not being captured by these scoring systems. Indication for TAVI in the individual patient is discussed in a consensus conference of cardiologists and cardiac surgeons, and patient's or physician's preference alone is not considered adequate for decision making. The performance of TAVI in these patients is approved by the local authorities. All patients have to agree to participate in the study, and written informed consent is obtained.

Exclusion Criteria:

Patients are excluded from TAVI (TAVR) in the presence of any of the following conditions:

* bicuspid aortic valve
* aortic annulus diameter ≤18 or ≥27 mm
* procelain aorta
* unprotected left main disease
* recent myocardial infarction or cerebrovascular event
* sepsis or active endocarditis
* severe aortic atheroma
* left ventricular or atrial thrombus
* active peptic ulcer
* bleeding diathesis
* hypersensitivity to antiplatelet therapy
Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study

A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy (RARC) from for bladder cancer in 32 institutions in China were enrolled in this study. Baseline condition, perioperative, pathological, and survival outcome were collected. The study was aimed to report the real-world condition of RARC in China, and evaluate its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old; Clinical stage Ta-T4a/N0-3/M0.

Exclusion Criteria:

* Severe cardiovascular disease; history of previous major abdominopelvic surgery; patients with distant metastases; medical history of malignancy in other organs.
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg

Respiratory complications range from 8% to 79% of the frequency after open heart surgery where the patient is on-pump operated by cardiopulmonary machine. There were many changes in physiology due to anesthesia and cardiac surgery which cause volume and barotrauma complications with mechanical ventilation. These complications increase cost by prolonging morbidity and morbidity as well as hospital stay. Intraoperative and postoperative mechanical ventilation strategies can prevent these complications. CPB stimulates the systemic inflammatory response to the secretion of neutrophil, endotoxin and proinflammatory cytokines in the complex, increasing the permeability of the capillaries. Although coronary artery bypass graft surgery (CABG) is associated with a 0.4% to 2.0% acute respiratory distress syndrome (ARDS), mortality is quite high. Lung-protective ventilation strategies commonly used for prevention of ARDS. Ferrando et al. have proposed pulmonary ventilation with a tidal volume (TV) of less than 10 mL / kg as a pulmonary intraoperative protective ventilation strategy. Investigators aimed to compare oxygenation and ventilation parameters with respiratory mechanics in patients who underwent open heart surgery and were ventilated with 6 ml / kg tidal volume and 8 ml / kg TV, which were recommended as lung protective ventilation strategies during anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing Cardiopulmonary bypass

Exclusion Criteria:

* Severe COPD
* Chronic Anemia
* Active Smoker
* Chronic kidney Disease
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention.

Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.


Eligibility Criteria:
Inclusion Criteria:

* primary THA

Exclusion Criteria:

* neurologic disease
* painful contralateral THA
* severe back or knee pain
* rheumatology
Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.

this is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism in female patients with peripartum cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy

Exclusion Criteria:

* Age less than 18 or more than 45 year old
* females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy
Telephone Intervention for Caregivers of Persons With Traumatic Brain Injury

This study seeks to determine if problem-based telephone counseling improves quality of life and emotional well-being for caregivers of persons with moderate to severe traumatic brain injury (TBI).

Caregivers and patients with TBI are recruited from the acute medical and inpatient rehabilitation units at Harborview Medical Center and the University of Washington Medical Center in Seattle, WA. After informed consent is obtained, information is gathered from the caregiver about his/her living situation, support systems, and the nature of the caregiving relationship. Additional information is gathered from the person with TBI about how he/she is doing cognitively, socially, and emotionally. Prior to discharge home, caregivers are randomly selected to receive either standard care (typical support and/or resources) or standard care plus problem-based telephone counseling.

The telephone follow-up group receives a telephone call from a caregiver support specialist at 2, 4, 6, 8, 10, 12, 14, and 16 weeks after discharge of the patient with TBI home with the option of two additional calls. During those calls, the caregiver support specialist provides training on problem-solving skills along with education on topics of interest to caregivers of persons with TBI.

An outcome assessment is done at 6 months and 1 year after discharge home.

Eligibility Criteria:
Inclusion Criteria:

* Family member or other person having a long-term relationship (at least one year) with person with TBI admitted to hospital and discharged home from acute care, inpatient rehabilitation, and/or skilled nursing facility within 7 months of date of injury.
* Sufficient English to permit communication without an interpreter.

Exclusion Criteria:

* Lack of a telephone.
* Lack of a permanent home address.
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery

Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. Neuropsychological testing before surgery and on 3 or 4 day after surgery. Investigation of relationship between changes of GFAP and scores of neuropsychological tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients with different diseases, who require prolonged laparoscopy or open surgery
* Age more than 60
* ASA I-III
* Informed consent to participate in the study

Exclusion Criteria:

* ASA IV-V
* Severe neurodegenerative or psychological diseases
Somatosensory Amplification and Psychological and Functional Status In Patients With Knee Osteoarthritis

As modern society enters the age of an aging population, the prevalence of knee OA continues to increase, which necessitates multi-faceted research. Although there are studies on exaggeration of bodily sensations, depression, kinesiophobia and functional status in patients with knee OA, there are deficiencies in correlating these factors with each other and in directing evaluation and treatment programs. Based on this, this study aims to demonstrate the relationship between the level of exaggeration of bodily sensations, psychological-functional status and perceived pain level in patients with knee pain due to knee OA.

This study is a screening study designed to reveal the relationship between the level of somatosensory amplification and the psychological-functional status and the level of pain felt in patients with knee pain due to knee OA. Considering the correlation of the features to be examined in the literature, it was found that the required sample size should be at least 80 with a test power of 95%, a type I error of 0.05 and an effect size of 0.34. 88 patients between the ages of 40-84 who have been diagnosed with knee OA and have complaints for at least 6 months will be included in the study. Patients with knee pain due to any rheumatologic disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma will be excluded from the study. The patients' sociodemographic characteristics such as age, height, weight, body mass index (BMI), gender, education level, marital status will be evaluated using the sociodemographic information form, somatosensory amplification levels will be evaluated with the 'Somatosensory Amplification Scale (SSAS)', the presence of kinesiophobia with the 'Tampa Kinesiophobia Scale (TSK)', pain levels with the Visual Analog Scale (VAS), the presence of depression with the 'Beck Depression Inventory (BDI)', and functional status with the total score of the 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)'. Statistical analysis of the data will be done using IBM SPSS Statistics version 20.0 (SPSS Inc., New York, USA). Kolmogorov-Smirnov test will be used to determine whether the variables are normally distributed, and the socio-demographic information of the participants and the scores they received from the SSAS, TAMPA, VAS, BDI and WOMAC questionnaires will be expressed as percentages, ratios or averages. The linear relationship between quantitative variables will be analyzed with Pearson correlation analysis, and the correlation between qualitative and quantitative variables will be analyzed with variance analysis (ANOVA), and independent samples t-test. In all analyses, p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with knee OA and had complaints for a minimum of 6 months

Exclusion Criteria:

* any rheumatological disease other than OA and individuals with knee pain due to a recent traffic accident or other lower extremity trauma
Systemic Fungal Infections in ICU Patients

This study aims to :

1. Diagnosis of Systemic fungal infections in ICU patients.
2. Detection the most common fungal species in ICU.
3. Detection of in vitro antifungal sensitivity pattern

Systemic fungal infections are a significant and growing public health problem ,Over the past few years, major advances in healthcare have led to an unwelcome increase in the number of life-threatening infections due to true pathogenic and opportunistic fungi ,These have a significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in critically ill patients in intensive care unit ( ICU).

Health care workers encounter at risk patients in ICU in various settings : including diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the presence of central vascular catheters, and therapy with immunosuppressive agents,Prolonged treatment with corticosteroids before ICU admission, liver cirrhosis with prolonged ICU stay (.7 days), solid organ cancer, HIV infection and lung transplantation are also considered as risk factors ,It can also occur following trauma or invasion of wounds covered with contaminated dressings, e.g. in the ICU. One outbreak of gastric mucormycosis in ICU patients reported in Spain arose in association with the use of contaminated wooden tongue depressors in critically ill patients.

Candida and Aspergillus species are the most frequent causes of healthcare-associated fungal infections in these patients, Although Candida infections are the most frequent fungal infections in ICU patients, invasive aspergillosis is associated with higher morbidity and mortality rates even in the absence of traditional risk factors,Invasive candidiasis is a highly lethal infection associated with mortality rates between 40 and 60 %. The five most common Candida species are Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.

Accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal agents can be started rapidly. However, early diagnosis is not always easy. Microscopic examination is rapid and can be helpful but a negative result does not exclude infection. Blood cultures are positive in only 50-70 % of cases of Candida BSI, Furthermore, it can take several days before Candida is identified at the species level and antifungal susceptibility data are available but remain the gold stander in diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids..........etc)
* Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest discomfort.
* Persistent fever resistant to antibiotic therapy.
* Urinary manifestations resistant to antibiotic therapy.

Exclusion Criteria:

* Patients who received antifungal therapy within 3 days prior to sample collection.
* Patients refused to participate in the study.