cyrilzakka/clinical-trials huggingface dataset:
Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.

The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated cyclin dependent kinase (CDK) N2A in the tumor.

The oral drug PD0332991 is a highly selective reversible inhibitor of cyclin-dependent kinases 4 \& 6 that is being studied for use in the treatment of advanced non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven non small cell lung cancer
* Stage IV (M1a or M1b) disease. Patients may also have recurrence of early-stage disease or locally advanced disease with the presence of new distant metastases.
* Cyclin dependent kinase (CDK)N2a (p16) protein absent or expressed at a low level in tumor biopsy specimen
* Failed or intolerant of at least one prior systemic chemotherapy regimen (there is no maximum number of prior chemotherapy regimens)
* Eastern cooperative oncology group (ECOG) performance status 0-2
* Age \>18 years.
* Adequate organ and bone marrow function
* Measurable disease by standard RECIST v1.1 criteria
* Life expectancy of greater than 3 months

Exclusion Criteria:

* Inability to understand or sign the informed consent document
* Inability or unwillingness to take oral medications
* No available tissue specimen for p16 analysis
* Chemotherapy or radiotherapy within 3 weeks prior to beginning the study drug
* Other investigational agents within 4 weeks prior to beginning the study drug
* All side effects from previous chemotherapy, radiotherapy or investigational agents not resolved, returned to baseline or returned to Grade 1 toxicity (exceptions are grade 2 alopecia and grade 2 peripheral neuropathy)
* Major surgery within 4 weeks prior to beginning the study drug
* Surgical scar from previous surgery not healed prior to beginning the study drug
* High-dose or chronic steroid use
* High-dose statins within 7 days
* History of rhabdomyolysis
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, stroke or myocardial infarction within 3 months, or psychiatric illness/social situations that would limit compliance with study requirements.
* Baseline corrected QT interval (QTc) \>470ms
* Pre-existing clinically significant cardiac, hepatic or renal dysfunction at the discretion of the treating physician
* Untreated or uncontrolled (symptomatic or asymptomatic) brain metastases
* Leptomeningeal carcinomatosis
* Inability or unwillingness to use contraception during the treatment period by patients with reproductive potential.
* Pregnant or breastfeeding women
* HIV-positive patients on combination antiretroviral therapy
Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

The investigator will collect perianal swabs from patients receiving induction chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (HCT), and who are receiving fluoroquinolone (FQ) prophylaxis. FQRE colonization will be assessed by culture, and the investigator will correlate FQRE colonization with the risk of Gram-negative bacteremia during neutropenia.

Population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Results of this study will be combined with a portion of subject data from an identically-designed R01-funded study of FQRE colonization. The combined data will be used for study analysis and reporting.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent
2. Male or female ≥18 years of age
3. Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
4. Receive fluoroquinolone prophylaxis during neutropenia

Exclusion Criteria:

1. Expected to have \<7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
2. First swab collected ≥5 days after onset of chemotherapy
3. First swab collected after the day of transplant (HCT cohort only)
4. Acute promyelocytic leukemia
5. Receiving chimeric antigen receptor (CAR)-T-cell therapy
6. Pregnant women as determined by clinician
The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus

Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections.

Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated.

Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM.

Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects.

Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are:

1. The rate of women requiring medications for glycemic control
2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were diagnosed with GDM from 13 to 32.6 gestational weeks
* 18 years old and older
* Singleton pregnancy

Exclusion Criteria:

* Women with pre-gestational diabetes mellitus
* GDM diagnosed ≥ 33 gestational weeks
* Women using prophylactic antimicrobial treatment
* Immunocompromised women
* Multiple pregnancy
* Women taking oral probiotic products who refuse to stop the consumption (food-containing probiotics is not considered an exclusion criterion).
Study of Radiolabeled Revumenib in Adults With Acute Leukemia

This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 (\[14C\])-revumenib in participants with acute leukemia.

Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.

Eligibility Criteria:
Key Inclusion Criteria:

* Males and females (of non-childbearing potential) aged ≥18 years
* Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease.
* Previously received standard of care therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Adequate liver and cardiac function
* Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose

Key Exclusion Criteria:

* Active diagnosis of acute promyelocytic leukemia
* White blood cell (WBC) count \>25,000/microliters at time of enrollment.
* Detectable human immunodeficiency virus viral load within the previous 6 months
* Hepatitis B or Hepatitis C
* Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
* History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate
* Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers
* Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction
* Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib
* Any concurrent systemic treatment to prevent GVHD
Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome

Observational study regarding the use of supplements in chronic fatigue syndrome patients

Detailed questionnaire regarding the diagnosis of an onset of chronic fatigue syndrome and 100 patients. using Karnofsky scale before and after use of supplements patient scores are compared in a double blind trial.

Eligibility Criteria:
Inclusion Criteria:

* Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection

Exclusion Criteria:

* non inclusion in the above criteria
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.

FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.

Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.

In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.

Eligibility Criteria:
Inclusion Criteria:

- sign informed consent form for participation in the study

Exclusion Criteria:

* other diseases,
* bad feeling of the studied individual on the day of the study,
* the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators.
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. This study is being conducted to evaluate the safety and efficacy of a single dose of SYNCAR-001 followed by multiple subcutaneously administered doses of STK-009. No conditioning chemotherapy (lymphodepletion) will be administered. The study will follow a 3+3 design during dose escalation followed by dose expansion at the recommended phase 2 dose (RP2D).

Eligibility Criteria:
General Inclusion Criteria:

Age ≥18 years at screening.

SLE Inclusion Criteria:

1. Clinical diagnosis of SLE according to the 2019 European League Rheumatism EULAR/ACR classification criteria.
2. Subject must be positive for at least one of the following at screening: Anti-dsDNA (above the upper limit of normal \[ULN\]); or anti-Sm (above the ULN); or anti-Chromatin (above the ULN).
3. Subjects with active, severe, non-renal SLE or subjects with active proliferative LN

SSc Inclusion Criteria:

1. Classified as SSc according to the ACR/EULAR classification criteria.
2. Diffuse cutaneous SSc (dcSSc) or SSc-associated ILD (SSc-ILD; significant or progressive).

General Exclusion Criteria:

1. History of or active central nervous system manifestations of autoimmune disease.
2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).

SLE Exclusion Criteria:

1. Rapidly progressive glomerulonephritis.
2. End stage renal failure requiring dialysis or most recent renal biopsy with purely chronic lesions (Class III\[C\], IV-S\[C\], or IV-G\[C\]) if isolated renal disease.

SSc Exclusion Criteria:

1. FVC \<50% of predicted or DLCO \<40% of predicted.
2. Pulmonary arterial hypertension (PAH) requiring PAH-specific treatment.

Other protocol-defined criteria apply.
Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study

The objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(GIST) after failure of imatinib therapy.

This study is a single-arm, multicenter, observational study. A total of approximately 30 subjects were be enrolled. The patient was orally administered with ripretinib150 mg QD. 4 weeks for one cycle. Efficacy was assessed every two cycles. For subjects with PR or SD after ripretinib treatment, resection of gastrointestinal stromal tumor was performed after discussion by MDT and ensure R0 resection as much as possible.Ripretinib 150mg QD was continued 2 weeks after surgery. Thereafter, subjectss entered the follow-up period for at least 1 year. Safety and survival information will be collected

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
2. 18 years ≤ age \< 75 years, male or female;
3. Histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor;
4. According to the modified RECISTv1.1-GIST-specific criteria, the subject has at least one measurable lesion;
5. Subjects must have progressed on imatinib or have documented intolerance to imatinib.
6. ECOG PS of ≤ 2, ASA score ≤ 3 at screening;
7. No other malignant tumors occurred within five years;

Exclusion Criteria:

1. Molecular pathology report PDGFRA Exon 18 mutation(including D842v);
2. Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc;
3. Pregnant or lactating women;
4. Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
5. Subject has known active central nervous system metastases.
6. Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
7. The patient has participated in or is participating in other clinical studies , or is taking other TKI agents;
A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
2. ECOG performance status 0-1.
3. Aged 20-79 years old.
4. Laboratory values as follows 4000/mm3 \< WBC \< 12000/mm3, neutrophil count \> 2000/mm3, platelet count \> 100000/mm3, hemoglobin \> 9.5g/dL, asparate transaminase \< 2.5 X cutoff value, alanine transaminase \< 2.5 X cutoff value, total bilirubin \< 1.5g/dL, Serum creatinine \< cutoff value, PaO2 \> 60 Torr.
5. Able and willing to give valid written informed consent.

Exclusion Criteria:

1. Allergy against polysorbert 80 or platinum-containing drugs.
2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).
3. Active and uncontrolled infectious disease.
4. Massive pleural or pericardial effusion.
5. Other malignancy requiring treatment.
6. Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential)
7. Peripheral nerve disorder.
8. Pregnant or lactating women.
9. Concurrent administration of pimozide.
10. Decision of unsuitableness by principal investigator or physician-in-charge
The Use of Standing Powered Wheelchairs in Spinal Cord Injury

The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.

There is limited research exploring the comfort, satisfaction, adverse effects, need for repair, and benefit in terms of secondary complications in standing powered wheelchair users with spinal cord injury.

The purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70
* Post-spinal cord injury period \> 1 year

Exclusion Criteria:

- Having cognitive impairment
Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup. Specifically the study intends to address the following research topics:

1. The incidence of squeaking after CoC THA using Delta TT cup.
2. The dislocation rate and survival rate of CoC THA using Delta TT cup.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis
* Rheumatoid arthritis
* Post-traumatic arthritis
* Fractures of femoral neck

Exclusion Criteria:

* Local or systemic infection
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Confirmed nerve or muscle lesion compromising hip joint function
* Unstable medical illness
* Rapidly progressive neurological disease
Agreement and Precision Study

To evaluate the performance of pachymetry function


Eligibility Criteria:
Inclusion Criteria:

* Provide voluntary written consent
* Age at least 22 years old
* For glaucoma group only, visual field defect and optic nerve damage consistent with glaucoma
* For cornea group only, cornea abnormality

Exclusion Criteria:

* Ocular condition that may affect ability to perform cornea measurements
* Have or is suspected to have ocular infection
* Unable to tolerate eye testing