cyrilzakka/clinical-trials huggingface dataset:
Survival Analysis: TACE vs. Combination Therapy in HCC

This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC.

Standard treatments provide limited benefits for patients with intermediate or advanced hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens for patients with locally advanced HCC have attracted much attention. Therefore, this retrospective research was designed to evaluate the clinical outcomes of TACE alone or in combination with immune and targeted therapy in the primary treatment for patients with intermediate to advanced stage HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Both sexes, aged 18-75 years old; (2) HCC was clinically or pathologically diagnosed according to the American Association for Liver Diseases (ASSLD) criteria; (3) One or more tumor lesions could be measured according to modified response evaluation criteria in solid tumors (mRECIST) on enhanced CT or MRI; (4) For patients with Barcelona Clinic Liver Cancer (BCLC) stage B or stage C hepatocellular carcinoma (HCC) in Barcelona, and who are not suitable for surgical resection, it is recommended to undergo transarterial chemoembolization (TACE) or combination therapy involving TACE as the initial treatment; (5)Child-Pugh grade A or B, no hydrothorax, ascites and hepatic encephalopathy requiring treatment; (6) Eastern Cooperative Oncology Group performance status (ECOG-PS) score 0-1; (7) Have enough liver and kidney function in patients with appropriate laboratory indicators: hemoglobin concentration (HGB) hemoglobin, acuity 9.0 g/dl, neutrophils acuity 1500 cells/mm3, PLT 50 \* 109 / L, or serum propagated 28 g/L, or TBIL\< 50umol/L, ALT, AST\< 5 times the upper limit of normal, Bun, Cr\< 1.5 times the upper limit of normal, INR\< 1.7 or PT prolongation \< 4s

Exclusion Criteria:

1. Other malignant tumors outside HCC, such as liver metastasis of colon cancer; (2) Child-Pugh grade C; (3) Contraindications to TACE, lenvatinib or tislelizumab; (4) Any active autoimmune diseases or autoimmune disease, thyroid function hyperfunction or decline, which is to be bronchodilator treatment of asthma; (5) There are serious complications, including serious heart, lung, kidney, blood coagulation dysfunction; Important cardiovascular diseases such as heart disease of the definition of New York heart association level 3 or higher, instability during the treatment of myocardial infarction, arrhythmia, unstable angina, etc; (6) Past history of patients with idiopathic pulmonary fibrosis , Machine pneumonia (e.g., occlusive bronchiolitis), drug pneumonia, idiopathic pneumonia or chest CT screening to find evidence for an active pneumonia; (7) Patients with previous allogeneic stem cell or solid organ transplantation, including patients after liver transplantation; (8) Clinical data absence or incomplete information.
Advance Care Planning Among Older People From Moroccon Origin in Belgium

Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and care, to discuss these goals and preferences with family and health-care providers, and to record and review these preferences if appropriate. Research has shown that most Western patients express the need about what ACP entails. Ethnicity creates an important cultural impact on how people look at life and death, so that there is an influence on making decisions about end-of-life care.

The moroccan ethnic group is one of the largest visible non-Western minority groups in Western countries. Studies on how ACP is perceived among patients from moroccon origin are lacking. The objective of this study is exploring the knowledge, experiences, point of views, preferences, attitudes, facilitators and barriers concerning advance care planning of older people from moroccan origin in Belgium. Semi-structured interviews (in the native moroccan/arabic language) will be used.


Eligibility Criteria:
Inclusion Criteria:

* People with Moroccan origin who live in Belgium and are older than 65 years and who have also given informed consent to participate in this qualitative interview study

Exclusion Criteria:

* Patients who are terminal ill which means having a life-limiting disease with irreversible decline and who are actively dying (actively dying is related to patients with days of survival). (41)
* people who have cognitive impairment
MSCs With or Without Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment

The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC) in treating patients experiencing poor graft function or delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation.

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) is the only cure for many hematologic diseases. However, about 5-27% of patients would suffer from poor graft function (PGF) and more recipients might develop delayed platelet engraftment (DPE) after allo-HSCT. These complications are associated with considerable mortality related to infections or hemorrhagic complications. Treatment of PGF and DPE usually involves hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF) and thrombopoietin (TPO), or second transplantation, but these methods have dismal effect or even a significant risk of graft-versus-host disease (GVHD).

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs include improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. Some studies have shown that MSCs combined with PBSC or cord blood could be useful to improve engraftment after HSCT. Several reports suggested MSCs might be effective in the treatment of PGF.

However, the efficacy of MSCs as single-drug treatment for PGF or DPE is unsatisfactory in our previous study. Therefore, in the present study, G-CSF mobilized PBSC will be used combined with MSCs in the patients with PGF or DPE after allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Age：14-65 years
* PGF or DPE after allo-HSCT
* Subjects (or their legally acceptable representatives) must have signed an informed consent document

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Chemotherapy in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of COL-3 in treating patients who have advanced solid tumors.

OBJECTIVES: I. Define the maximum tolerated dose of COL-3 in patients with advanced solid tumors. II. Identify the dose limiting toxicity and safety profile of COL-3 in these patients. III. Define the pharmacokinetics and pharmacodynamics of COL-3 in these patients. IV. Observe any evidence of antitumor activity through standard response criteria or biologic surrogate markers.

OUTLINE: This is a dose escalation study. Patients receive oral COL-3 once daily. Treatment continues in the absence of disease progression and unacceptable toxic effects. Cohorts of 3-6 patients each receive escalating doses of COL-3. Dose escalation to the next level occurs after 3 patients have completed 28 days of treatment without dose limiting toxicity (DLT). Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience DLT.

PROJECTED ACCRUAL: Up to 30 patients will be accrued within 1 year for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytopathologically proven advanced solid tumors for which no conventional therapy exists or that is refractory to standard therapy No primary brain tumors or active brain metastases, including known evidence of cerebral edema by CT or MRI, known tumor progression from prior imaging studies or clinical symptoms of/from brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin normal PT or PTT normal ALT or AST less than 2.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction, stroke, or congestive heart failure within 3 months Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of gastrointestinal disorders that interfere with absorption of COL-3 No active infections or other medical illnesses No psychological or social problems No emotional disorder or substance abuse No hypersensitivity to tetracycline or its derivative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy At least 6 weeks since nitrosoureas or mitomycin At least 3 months since suramin Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior large field radiation therapy (greater than 20% of total bone marrow) Surgery: At least 14 days since major surgery No major upper gastrointestinal surgery Other: No concurrent anticonvulsant medications
Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.

We will conduct this study (based on principles of motor learning) using novel smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of newly established vocal behaviors into daily life. This first study will determine which of three types of ambulatory feedback results in better learning/retention (100% frequency, 25% frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis: Patients receiving lower frequency or summary feedback will produce lower initial performance but higher short- and long-term retention than patients receiving feedback 100% of the time.

Eligibility Criteria:
Inclusion Criteria:

Patients with vocal fold nodules

Exclusion Criteria:

Non-English speakers are excluded because prompts on the smartphone app are only available in English
Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA
* Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
* Active RA at time of screening and baseline

Exclusion Criteria:

* Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
* Concurrent treatment with a DMARD, other than MTX, at screening
* Receipt of any DMARD, other than MTX, within 3 months before screening
Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients

The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.

Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..

The main question it aims to answer are:

1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
2. Effectiveness of exercises using Swiss ball in lowering BMI.
3. To assess the effectiveness of exercise interventions on fasting blood sugar (FBS) levels and glycosylated hemoglobin (HbA1c) in individuals with Type II diabetes.
4. To evaluate the effectiveness of exercise interventions on autonomic nervous system activity in patients with Type II diabetic peripheral neuropathy.
5. To assess the comparative effectiveness of two therapeutic exercise interventions and a control group in improving the Michigan Neuropathy Screening Instrument (MNSI) score.

By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).

Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type II diabetic neuropathy
* 40-70 year's old patient, will be refer by physicians.

Exclusion Criteria:

* lower extremity complications fracture
* having experience dislocation at least six months prior to the study
* having any history of surgical operations in muscles, bones, and joints of lower extremities,
* suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report)
* knee joint flexion contracture
* interruption of the intervention sessions for more than two days
ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).

This is a 2-part study. Part 1 is a phase I, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective drug intensity (SDI) of single ascending intravenous (IV) doses of ELE-101 in healthy male and female adult participants. Part 2 is a Phase IIa, open-label study to evaluate a range of pharmacodynamic effects of a single intravenous dose of ELE-101 in patients with depression.

Healthy participants will receive either ELE-101 or placebo as an IV infusion in Part 1 and patients with MDD will receive ELE-101 as an IV infusion in Part 2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants aged 18 to 65 years, inclusive.
* Participants have a body mass index (BMI) of 18 to 35 kg/m2, inclusive.
* Participants are able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the study Protocol and clearly and reliably communicate their subjective symptoms to the Investigator.
* Part 2 Only: Patient has a diagnosis of MDD and is not on antidepressant medication.

Exclusion Criteria:

* Current, or history (within the last 6 months) of, alcohol or substance use disorder.
* Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS within 30 days or 5 half-lives (whichever is longer) prior to Screening.
* Current or clinically relevant history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder or panic disorder.
* In first-degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
* History of a diagnosis of Hallucinogen Persistent Perceptual Disorder (HPPD).
* Significant suicide risk.
* Other personal circumstances and behavior that is incompatible with establishment of rapport or safe exposure to psilocin, as judged by the Investigator.
* Part 1 Only: Ongoing current MDD, or history of MDD within the last year.
Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients with Ascending Aortic Aneurysm

The biomechanical properties of the aorta are currently poorly understood. A better understanding would optimize surgical indications and monitoring techniques for patients with thoracic aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given oral consent
* Patient with ascending aortic aneurysm with surgical indication for replacement
* Age \> 18 years old
* Scheduled surgery

Exclusion Criteria:

* Person not affiliated to the national health insurance system
* Protected adult
* Pregnant or breastfeeding woman
* MRI Contraindication
* Emergency surgical procedure
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial

Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)


Eligibility Criteria:
Inclusion Criteria:

adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation

Exclusion Criteria:

liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease
Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®

Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.

A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
* OSDI score between 12 and 45
* Provided informed consent

Exclusion Criteria:

* Patients with one blind eye
* Visual acuity of 20/100 or worst in any eye
* Patients with any active ocular disease that would interfere with study interpretation
* Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
* Patients with history of hypersensitivity or contraindication for any drug used in the study
* Contact lens users
* Pregnant patients, at risk of pregnancy or breastfeeding
* Patients without birth control treatment
* Patients who had participated in any clinical trial in the last 90 days
* Legal or mentally disabled patients who could not give informed consent
* Patients who do not provide informed consent
Noroxin Efficacy and Safety Trial

To determine the efficacy and safety of Norfloxacin (Noroxin)

Urinary tract infections (UTIs) are some of the most common bacterial infections, affecting 150 million people each year worldwide. Clinically, UTIs are categorized as uncomplicated or complicated. Uncomplicated UTIs typically affect individuals who are otherwise healthy and have no structural or neurological urinary tract abnormalities; these infections are differentiated into lower UTIs (cystitis) and upper UTIs (pyelonephritis). Several risk factors are associated with cystitis, including female gender, a prior UTI, sexual activity, vaginal infection, diabetes, obesity and genetic susceptibility.

UTIs are caused by both Gram-negative and Gram-positive bacteria, as well as by certain fungi. The most common causative agent for both uncomplicated and complicated UTIs is uropathogenic Escherichia coli (UPEC). For the agents involved in uncomplicated UTIs, UPEC is followed in prevalence by Klebsiella pneumoniae, Staphylococcus saprophyticus, Enterococcus faecalis, group B Streptococcus (GBS), Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus and Candida spp. Currently, antibiotics - such as trimethoprim sulfamethoxazole, floxacin and ampicillin - are the most commonly recommended therapeutics for UTIs6. UTIs are becoming increasingly difficult to treat owing to the widespread emergence of an array of antibiotic resistance mechanisms. Of particular concern are members of the family Enterobacteriaceae, including E. coli and K. pneumoniae, which have both acquired plasmids encoding extended-spectrum β-lactamases (ESBLs). These plasmids rapidly spread resistance to third-generation cephalosporins as well as other antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis

Exclusion Criteria:

* Duration of UTI symptoms for more than 7 days before physician's visit
* Clinical signs of invasiveness such as fever (axillary body temperature \>38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting
* Known or suspicion of anatomical or functional abnormality of the urinary tract
* Vaginal symptoms: discharge, irritation
* Diabetes mellitus
* Immunosuppression (e.g. prednisone equivalent \>10mg per day for \>14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)
* Any other serious comorbidity as judged by the treating physician
* Bladder catheter in situ or during the past 30 days
* Pregnancy
* Recurrent urinary tract infection (more than 3 infections during the last 12 months)
* Antibiotic treatment during the last 4 weeks