cyrilzakka/clinical-trials huggingface dataset:
Sunitinib + Docetaxel as Second-line Treatment in Gastric Cancer

The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.

This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.

Eligibility Criteria:
Inclusion Criteria:

1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. prior chemotherapy wit fluoropyrimidine and platinum
4. measurable or evaluable disease according to RECIST
5. age, 18 years or older
6. ECOG performance status 0 - 2
7. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
8. life expectancy of ≥ 3 months
9. signed written informed consent

Exclusion Criteria:

1. more than one prior chemotherapy for metastatic disease
2. severe co-morbid illness and/or active infections
3. NCI CTCAE Grade 3 hemorrhage from any cause \< 4 weeks before enrollment
4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
5. pregnant or lactating women
6. active CNS metastases not controllable with radiotherapy or corticosteroids
7. active and uncontrollable bleeding from gastrointestinal tract
8. known history of hypersensitivity to study drugs
9. prior treatment with sunitinib
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP

To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.


Eligibility Criteria:
Inclusion Criteria:

1. Male, age older than 22 and younger than 75 years of age
2. The patient should be a candidate for surgical treatment of bladder outlet obstruction.
3. Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
4. Prostate volume ˃30 and ≤80 ml
5. PSA \<4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
6. IPSS ≥8 (moderate to severe)
7. Indications for TURIS
8. maximum urinary flow (Qmax) \<10ml/second
9. A written informed consent signed by the patient (including patient's agreement to randomization and treatment).

Exclusion Criteria:

1. Patients under anti-inflammatory or steroid therapy
2. Patients under anti-coagulation at a level that could be exposed to a very high risk of complications based on a comprehensive pre-operatory evaluation.
3. Renal insufficiency Serum creatinine (Scr) \>1.5 x upper limit of normal (ULN); AST and ALT\>2.5 x ULN;Total bilirubin \>1.5 x ULN
4. Previous neurogenic lower urinary tract dysfunction.
5. Patients with urethral strictures
6. Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery.
7. Concurrent participation in any other clinical study
8. Any of the following within the 12 months prior to study: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
9. Previous bladder outlet surgery.
10. A clinically significant acute illness.
11. Intake of medication in which the principle investigator considers to preclude enrollment into the trial.
12. Known disease of the central or peripheral nervous system.
13. Any clinical evidence of carcinoma of the prostate.
14. HIV positive or any other immunosuppressive disorder.
15. Psychological/psychiatric disease /Known cognitive disorder.
Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma

ABSTRACT Objective: To detect presence of a residual tumor in patients of hepatocellular carcinoma (HCC) treated with Lipiodol based conventional trans arterial chemoembolization (cTACE) using density measurements on follow-up computed tomography (CT) scans Study Design: Prospective observational interventional study Place and Duration of Study: Interventional Radiology department of Armed Forces Institute of Radiology and Imaging (AFIRI) from April 2023-March 2024 Methodology: 96 patients undergoing conventional TACE were included in the study and followed up for residual tumor or tumor free status assessment using density measurement for iodine depositions using CT scan analysis and compared with gold standard digital subtraction angiography (DSA). Primary variables measured were comparison of enhancement scores between those with a residual tumor versus tumor free as well as the volume of iodine depositions in the arterial and venous phase between both groups. Sensitivity and specificity of the CT scan in assessing tumor diagnosis was compared with the gold standard digital subtraction angiography.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HCC disease
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses

The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.

Acute lymphoblastic leukaemia (ALL) is the most common form of childhood cancers. Cure rates are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of treatment related complications, mostly related to therapy-induced toxicity and immune suppression. The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. The study is based on patients treated according to the current NOPHO protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol

Exclusion Criteria:

* Milk Allergy
* Lactose intolerance
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open partial nephrectomy
* Patients must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

* Patients with a tumor diameter greater than 4 cm
* Any additional surgical intervention other than partial nephrectomy
* Patients with only one functional kidney
* Patients with known intolerance to blood products or other components of the product
Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts

Aim(s) of the Research:

1. Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts.
2. Explore possible relation between therapeutic response with demographic/clinical data.
3. Identify patients satisfaction with each agent.

Cutaneous warts or verruca are common, benign skin growths caused by human papilloma virus (HPV).

There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) Unfortunately, no single treatment is satisfactory for all patients. Chlorhexidine gluconate(CHX) is a gluconate salt with a broad-spectrum antiseptic action against Gram-Positive, Gram-negative bacteria, aerobes, facultative anaerobes, and fungi such action is mediated through increasing the permeability of the cell walls of microbes, causing their lysis.

Additionally, evidence indicates an in vitro effect against many viruses such as influenza A, parainfluenza, herpes virus 1, cytomegalovirus, hepatitis B, HIV and SARS-CoV-2.

It was hypothesized that the biophysiological mechanisms for the virucidal effect of CHX may be exerted through lysis of viral envelope, deterioration of nucleotide carbon chains, and inactivation and/or blocking of viral proteins.

Garlic (Allium sativum) is one of the most widely used medicinal plants with high therapeutic effects.

Clinical effectiveness of oral and topical garlic extract may be attributed to its antimicrobial, antioxidant, anti-inflammatory, anticancer and aging prevention effects.

However, the mechanisms of these actions are not clearly known. In vitro studies on garlic showed that garlic may enhance natural killer (NK) cells, which are an important part of the immune system in fighting cancers, viruses and certain bacteria.

Previous studies showed garlic extract was effective on complete resolution of cutaneous wart.

Chlorhexidine has not been used for treatment of warts in previous studies so we decided to explore its efficacy in treatment of warts.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the clinical diagnosis of common or plantar warts.

Exclusion Criteria:

* Pregnancy and lactation.
* Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
* Patients with inflamed lesions
* Use of systemic or topical treatments during the last month before enrollment.
* Individuals with history of allergic reactions to garlic or chlorhexidine
* Patient with generalized dermatitis or allergic skin disorders
Effects of an Educational Intervention Program on Marble Factory Workers

Marble cutting exposes workers to dust, increasing risk of lung diseases like asthma, COPD, silicosis, and asbestosis. Many marble cutters in rural areas lack awareness of these risks and work without proper protection. Khyber Pakhtunkhwa has over 4000 marble factories employing over a million laborers, mostly unskilled and vulnerable. Workers face health risks from heavy lifting, poor posture, and respirable dust. Ergonomic disorders are also common due to poorly designed workstations, repetitive motions, and straining postures. Musculoskeletal Symptoms (MSS) can progress into Musculoskeletal Disorders (MSDs), affecting worker well-being and productivity. Findings can inform targeted educational programs and interventions to improve respiratory health and reduce ergonomic risks in the marble industry.

Occupational hazards, such as dust exposure during marble cutting, can significantly increase the risk of lung diseases in workers. This includes common ailments such as asthma and Chronic Obstructive Pulmonary Disease (COPD), as well as more serious conditions such as silicosis and asbestosis. Unfortunately, many marble cutters from rural areas may not be aware of these health risks, which can lead to them working without proper protection. Heavy load lifting, poor work posture, and the production of respirable dust in marble factories contribute to the health risks faced by these workers. Just like dust exposure during marble cutting can harm a worker's lungs, similarly, working in this industry carries a high risk of ergonomic disorders. According to the Bureau of Labor Statistics, ergonomic risk factors are responsible for 35% of workplace injuries in 2021, resulting in MSDs. An extensive amount of research has been conducted globally; however, limited literature exists on this particular topic in Khyber Pakhtunkhwa, specifically in Peshawar. The findings of the study can help inform the development and implementation of targeted educational programs and interventions aimed at improving respiratory health and reducing ergonomic risks in the marble industry.

Eligibility Criteria:
Inclusion Criteria:

* Adult male marble factory workers,
* Age 20-55years
* Working for more than 1year
* Working time(hours): minimum 06 hours daily

Exclusion Criteria:

* Workers with pre-existing lung diseases
* Workers with any other occupational hazard
* Workers who are not willing to participate in the study
Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques Effect on Swimming Performance on Swimmers With Scapular Dyskinesis

Swimming can cause shoulder pain due to scapular dyskinesis. Proper scapula movement is necessary for efficient swimming strokes and to avoid injury. Studying the effects of autogenic and reciprocal inhibition muscle energy techniques on swimmers with scapular dyskinesis can lead to effective interventions and reduce shoulder injuries

Efficient swimming strokes require proper positioning of the scapula. Scapular dyskinesis (SD) is a condition where normal scapular kinematics are altered due to injury or changes in muscle activation. Swimmers, who are considered overhead athletes, have risk of developing SD. Even individuals who do not experience symptoms can have SD, and it may lead to future shoulder injuries. Early diagnosis and treatment of this condition can prevent it from progressing and minimize the risk of injury. Additionally, using autogenic and reciprocal inhibition muscle energy techniques can enhance the activation of the appropriate muscles responsible for scapular movement, which can lead to more effective interventions, improved swimming performance, and reduced injury risk. he intervention protocol (Muscle energy techniques to the upper fibers of the Trapezius, Levator Scapulae, Pectoralis Major, Latissimus Dorsi) will be conducted for 8-14 minutes over 3 weeks with 12 sessions/4 times a week. Outcomes measure will be assessed after the intervention period and data will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Swimmers with at least four times training per week
* Does not have any shoulder pain or injury or operation to the shoulders
* Positive Scapular Dyskinesis diagnosis test
* Freestyle (also known as a front crawl) swimming stroke

Exclusion criteria:

* Shoulder pain in the last six months
* History of shoulder surgery or fracture within the last six months
* Frequent practice of physical activity in any other sport
* Negative result of the Scapular Dyskinesis test
* Other swimming strokes
A Clinical Study on the Efficacy and Mechanism of Tumor Treatment Vaccine (TTV) for Recurrent and Refractory Advanced Solid Tumors

This is a study of the clinical efficacy and mechanism study of tumor treatment vaccine (TTV, also known as Neo-BCV) in patients with recurrent and refractory advanced solid tumors.

The study aims to explore the safety and effectiveness of Neo-BCV in the treatment of advanced solid tumors.The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-75 years;
2. ASubjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug administration;
10. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
11. Subjects in other conditions that are considered unsuitable for this study by the investigator.
Measurement of Diaphragmatic Dysfunction After Thoracic Surgery

This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection

Exclusion Criteria:

* Known Diaphragmatic Dysfunction
* Neuromuscular Disease
* Pleural Effusion \> 1cm
* Pneumothorax
* Known Phrenic Nerve Palsy
Biliary Obstruction of Neoplastic Origin Treated With Drainage. A Prognostic Study.

Inclusion of patients with biliary drainage for inoperable malignant biliary obstruction and analysis of clinico-biological parameters

All patients who had biliary drainage between April 1, 2014 and August 31, 2018 for inoperable malignant biliary obstruction will be included.

Clinical and biological baseline data will be recorded retrospectively. From the electronic medical records (M-Eva software), the following clinical data will be retrieved on the day of procedure: age, gender, body mass index (BMI), percentage of weight loss in the last three months, American Society of Anesthesiologists score (ASA) , Charlson score, Eastern Cooperative Oncology Group Performans Status (ECOG PS), comorbidities, cancer type, liver metastases, obstruction level, pre-procedural sepsis, type of procedure and type of stent.

Serum biological parameters will be recorded: hemoglobin, platelets, leukocytes, urea, creatinine, albumin, total bilirubin and prothrombin time, within 48 hours prior to the procedure.

The continuous variables of biological tests will be analyzed by ROC curves. The survival curves will be estimated using the Kaplan-Meier method and compared using the log-rank test. A prognostic index will be established from the variables independently associated with poor prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Malignant Biliary obstruction : cholestasis (elevated bilirubin \> 40 µmol/L or alkaline phosphatase \> 1.5 time than the normal value) and dilation of biliary tract

Exclusion Criteria:

* Benign obstruction
* Post stent surgery
* First stent placed outside Brest University Hospital
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
* Patient is at least 21 years of age
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Neuromuscular disorders that do not allow control of the joint
* SIgnigicant injury to the brachial plexus
* Non-functional deltoid muscles
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversely affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient has a physical or mental condition that would invalidate the results
Clinical Long Term Evaluation of Glutamine Supplement in MELAS Syndrome

The purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.

Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a genetically heterogeneous disorder. The most common mutation is in the mtDNA gene MT-TL1 encoding the mitochondrial tRNALeu (UUR). For understanding the development of seizures in patients with mitochondrial disease, a study has recently emphasized the deficiency of astrocytic glutamine synthetase, creating a disinhibited neuronal network for seizure generation. The investigators propose to evaluate nine patients with mitochondrial DNA mutation and MELAS. Patients will receive oral supplementation with 12-18 g/day of glutamine (adjusted for weight and plasma concentrations). The primary outcome measures modification in clinical scales.

Eligibility Criteria:
Inclusion Criteria:

* MELAS syndrome Clinically and genetically confirmed.
* Patients have already participated in GLN-9-MIT study

Exclusion Criteria:

* subjects harboring a MELAS-related pathogenic mtDNA mutation no fulfilling the complete diagnostic criteria for the MELAS phenotype