cyrilzakka/clinical-trials huggingface dataset:
Sulfasalazine in Patients With Metastatic Colorectal Cancer

The aim of this study is to evaluate the potential efficacy and safety of sulfasalazine in patients with metastatic colorectal cancer.

Sulfasalazine is an anti-inflammatory drug that is indicated for treatment of ulcerative colitis and rheumatoid arthritis. Sulfasalazine decreased the risk of ulcerative colitis-related colorectal cancer through its anti-inflammatory effect and induction of oxidative stress in cancer cells. Furthermore, intact sulfasalazine, but not its metabolites, inhibited the growth and metastasis various cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of stage IV (metastatic) colorectal cancer. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic colorectal cancer
2. Male or female patients with age range from 18-65 years old
3. Women of childbearing age will be required to be on acceptable forms of contraception
4. Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
5. No contraindication to chemotherapy (absence of myelosuppression)
6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with concurrent active cancer originating from a primary site other than the colon or rectum
3. Patients who have known allergy to sulfasalazine or its metabolites
4. Patients with nephrolithiasis, severe vomiting or severe diarrhea
5. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants
6. Patients with intestinal or urinary obstruction
7. Patients with known glucose-6-phosphate dehydrogenase deficiency or porphyria
8. Ongoing treatment with sulfasalazine or mesalamine for ulcerative colitis or rheumatoid arthritis
Addiction of Lung Volume Recruitment Technique in Lee Silverman Protocol for Voice Professionals

The goal of this clinical trial in voice professionals with both genders aimed to verify the changes in the vocal range profile and the changes in the glottic and vocal tract configuration for more efficient phonation after applying the adapted Lee Silverman Method and the addiction of lung volume recruitment technique in acoustic and structural analysis.

A cross-over randomized trial with two arms-the Lee Silverman Method and the addiction of lung volume recruitment technique (LVRT)-will be conducted with voice professionals to assess the effects of both interventions on the acoustic, perceptive, and visual aspects of voice and their impact on respiratory muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Voice professionals with no voice disease

Exclusion Criteria:

* smokers
* Glottis paralysis and dysfunction
* dental problems
* Mental and cognitive disorders
Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia

* Up to now, "Hyponatremia" differentially diagnosed by physical examination, plasma and urine osmolalities, Echocardiography and biochemical measurements.
* The purpose of this study is to determine whether bioimpedance spectroscopy can be used for the detection of hypovolemia and hypervolemia for the differential diagnosis of hyponatremia.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study with written informed consent
* Older than 18-years

Exclusion Criteria:

* The presence of pacemaker or defibrillator
* Artificial joints, pin or amputation
* Pregnancy or lactating.
Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor

Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.

In the 7th AJCC/UICC TNM staging system, gastric cancer with positive peritoneal cytology (CY+) is defined as stage IV disease. In NCCN clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as M1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. However, in the Japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the CY+ status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard. Previous studies have also proved that extensive intraperitoneal lavage(EIPL) and Hyperthermic Intraperitoneal Chemotherapy(HIPEC) are effective methods for the treatment of peritoneal metastasis.

In order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy;
* Pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography;
* Clinical stage cT2-4 N0-3 M0;
* Standard gastrectomy with D2 lymphadenectomy is needed according to the clinicians' evaluation;
* ECOG performance score ≤2, with tolerance of standard gastrectomy and D2 lymphadenectomy;
* Positive peritoneal cytology;
* Signed informed consent.

Exclusion Criteria:

* Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers;
* Intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology;
* Postoperative pathologically diagnosed as non adenocarcinoma;
* Pregnant or lactate women;
* Child-bearing period adults who refuse to birth control during the trial;
* Uncontrolled epilepsy, CNS disease or mental disorder that may influence the compliance of the patient;
* Severe/active heart disease, including but not limited to acute coronary syndrome, congestive heart failure with less than NYHA II cardiac function, severe arrhythmia that needs drug control, cardiac infarction within 12 month;
* Organ transplantation patients who needs immune suppression therapy;
* Patients who needs emergency surgery because of bleeding, perforation or obstruction.
Interpretation and Optimization of Nutrition in the Intensive Care Units

Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.

Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.

Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.

The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over.
* French Social Security system registration.
* First stay in ICU
* Admitted to the Lille University Hospital Surgical ICU for at least 3 days.
* Active enteral and/or parenteral nutritional support prescription
* Patient and/or next-of-kin informed about the study and having consented to participation in the study.

Exclusion Criteria:

* Age under 18
* Burn patient
* Admitted to the ICU with a prior active enteral/parenteral nutritional support before day 3, except trophic nutrition
* Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
* Adult under guardianship
* Department of corrections inmate
Fat Reduction Induced by Magnetic Device - Waist Circumference Evaluation

The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.

At the baseline visit photographs of the abdomen will be taken. In addition, patient umbilical circumference will be measured and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. Umbilical circumference and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
* Age ≥ 22 years
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2

Exclusion Criteria:

* Cardiac pacemakers
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Haemorrhagic conditions
* Anticoagulation therapy
* Heart disorders
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over menstruating uterus
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China

To generate real world evidence to compare clinical outcomes and patient health-related quality of life, resulting from catheter ablation therapy with clinical outcome and patient health-related quality of life resulting from drug therapy in China. An economic model will be constructed, and using the clinical events evidence collected in this study, and China long-term disease progression and local disease cost data to perform a cost-effectiveness evaluation of Catheter Ablation versus Drug Therapy in AF (Paroxysmal plus Persistent AF) patients.

The evidence generated by this study is expected to help inform medical decision makers with the clinical and economic data of therapy for AF patients, and also provide policy decision makers with information that can be considered /used to allocate funds for AF ablation and permit patients to have access to appropriate treatment options for AF management.

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent AF eligible for catheter ablation
* Age 18 to 80 years
* Able and willing to comply with all pre,post and follow-up testing and requirements.
* Be able to sign IRB/EC approved informed consent form.

Exclusion Criteria:

* Terminal illness with a life expectancy less than 1 year.
* New York Heart Association (NYHA) Class III or IV
* Previous recipient of catheter ablation therapy for AF
* Bradycardia and previous recipient of pacemaker therapy
* Previous recipient RFCA or ICD therapy
* Uncontrolled hypertension
* Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
* Patients with serious hepatic and renal diseases
* Pregnant or prepare to be pregnant in one year
* For drug therapy arm, if the subject cannot be contacted via phone or the subject shows his/her disagreement to this study at 30 day window, the subject will be withdrawn from this study.
Inhalation of Lidocaine Before Intubation

We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.

Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation

Exclusion Criteria:

* patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.
A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy

An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.

The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or above;
2. Colonoscopy is needed to further characterize gastrointestinal diseases;
3. Ability to read, understand and sign informed consent forms;
4. The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion Criteria:

1. Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
2. Participate in a drug clinical trial and during the elution period of the trial or control drug；
3. Drug or alcohol abuse or mental disorder in the last 5 years;
4. Pregnant or lactating women;
5. Patients with multiple polyp syndrome;
6. Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
7. Patients with known perforation or colonic obstruction;
8. Patients with a contraindication for biopsy;
9. The researchers did not consider the subjects suitable for colonoscopy;
10. The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
Quality of Life With Esophageal Stent Trial

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.

Exclusion Criteria:

* Mentally unable to fill out questionaire
Masitinib Plus Gemcitabine in Pancreatic Cancer

The objective is to compare efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine, in treatment of patients with locally advanced or metastatic pancreatic cancer and who have pain related to the disease.

Masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. The objective of this study is to evaluate the efficacy and safety of masitinib in combination with gemcitabine with respect to placebo in combination with gemcitabine for the treatment of non resectable locally advanced or metastatic pancreatic cancer patients with pain related to the disease. Approximately 330 patients with pain Visual Analogue Scale (VAS) \> 20 and/or treated with 'opioid analgesics' dose ≥ 1 mg/kg/day at baseline will be randomized in a 2:1 ratio to the masitinib and placebo arms, respectively. The primary outcome measure is overall survival (OS).

Eligibility Criteria:
Main inclusion criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas, non resectable locally advanced or metastatic stage
2. Patient with pain related to the disease, as assessed by the investigator and the patient:

   * Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
   * Pain, as assessed by the patient is defined as at least one value out of two values \> 20mm on Visual Analogue Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).

OR

- Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).

3. Chemotherapy naïve patient for the advanced/metastatic disease

Main exclusion criteria:

1. Patient with no pain related to the disease (as defined in the inclusion criterion number 2)
2. Pregnant or nursing female patient
Caspofungin for Pneumocystis Pneumonia in PLWHIV.

Pneumocystis jirovecii pneumonia is a significant concern in peaple with HIV/AIDS, often severe and potentially fatal. While trimethoprim/sulfamethoxazole remains the primary treatment, safety concerns exist with alternative options. Research on Pneumocystis jirovecii's beta-D glucan composition has prompted investigations into echinocandins like caspofungin, showing promise in murine models and some positive results in human studies. Evaluating caspofungin's efficacy through observational studies is crucial due to safety advantages over current treatments and limited documented data.

Pneumocystis jirovecii pneumonia (PCP) is a significant opportunistic disease in immunocompromised patients with HIV/AIDS, becoming increasingly prevalent. This condition can range in severity, at times being fatal and necessitating drastic measures. The standard first-line treatment, trimethoprim/sulfamethoxazole, has been unchanged for over three decades. While other drugs have been approved as second-line treatments, they come with safety concerns such as increased risk of hypersensitivity reactions and adverse effects.

Research on Pneumocystis jirovecii has faced challenges due to difficulties in cultivation, requiring in vivo models for study. Previous studies have found that the wall of Pneumocystis spp. contains beta-D glucans in one phase of its life cycle. This discovery has led to investigations into the effectiveness of echinocandins, specifically caspofungin, on Pneumocystis spp. Promising results have been observed in murine models; however, these studies were conducted on species that do not affect humans. Clinical observational studies in humans have shown positive response and safety, albeit using caspofungin in combination with other drugs rather than as monotherapy.

Considering the superior safety profile of echinocandins compared to first-line treatments for P. jirovecii, and the limited documented data in case reports or series, it is important to assess the efficacy of caspofungin in observational studies to address this gap.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable or proven PCP, according to its diagnostic classification (refer to classification at the end of this section).
* Have clinical laboratory and virological diagnostic laboratory studies at the time of admission.

  * Classification criteria for Pneumonia by P. jirovecii according to Robert-Gangneux et al.:

Proven: Confirmation by pathology or microbiology. Possible: Presence of three out of four clinical or radiological criteria. Probable: Presence of one clinical or radiological criterion without another identified microorganism.

Exclusion Criteria:

* With a treatment switch to caspofungin after day 7 of treatment initiation (applies only to group B).
* Patients who have developed an additional opportunistic lung infection during their hospitalization, other than cytomegalovirus pneumonitis or SARS-CoV-2 pneumonia.