cyrilzakka/clinical-trials huggingface dataset:
A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form(s)
* At least 18 years of age
* Advanced histologically or cytologically confirmed predominant squamous NSCLC
* Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases
* Prior treatment for CNS disease as deemed appropriate by the treating physician
* ECOG performance status 0, 1, or 2
* Measurable or evaluable disease
* Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men)

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if \< 6 months has elapsed from completion of treatment to Day 1, Cycle 1
* Extrathoracic metastases as the only sites of disease
* Active malignancy other than lung cancer
* Current, recent, or planned participation in another experimental drug study
* Untreated brain metastases
* Presence of intrathoracic lesion(s) with any cavitation
* Gross hemoptysis within 3 months prior to Day 1
* In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel
* Inadequately controlled hypertension
* Unstable angina or NYHA Grade II or greater CHF
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
* Myocardial infarction within 6 months prior to Day 1, Cycle 1
* Stroke within 6 months prior to Day 1, Cycle 1
* Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1
* History of significant vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Current, ongoing treatment with full-dose warfarin or its equivalent
* Current or recent use of aspirin (\>325 mg/day)
* Known hypersensitivity to any components of bevacizumab
* Serious, non-healing wound, ulcer, or bone fracture
* UPC ratio ≥ 1.0
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study
* Pregnancy or lactation
* Inadequate organ function
* Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C \<200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing endourological procedures for renal stones
* Recurrent stone disease
* Calcium oxalate stones (\>50% of the stone made of calcium oxalate)

Exclusion Criteria:

* Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis)
* Non-calcium oxalate stones
Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children

Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population


Eligibility Criteria:
Inclusion criteria:

1. Age: 6 months - 36 months,
2. Duration of diarrhea ≤48 hours,
3. Some dehydration (judged clinically according to the "Dhaka method"),
4. Written informed consent by either parent/guardian.

Exclusion criteria:

1. Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ \<-3 or presence of nutritional edema)
2. Patients with diarrhea due to cholera.
3. Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
4. Bloody diarrhea
5. Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
6. Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
7. Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages \>18
* Fasting triglyceride ≥200 mg/dL and \<500 mg/dL
* LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and \<100 mg/dL
* High risk for coronary heart disease
* On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant
* Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects
* History of bariatric surgery or currently on weight loss drugs
* Uncontrolled hypertension (BP \> 160/100)
* HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin
* Consumption of more than 2 alcoholic beverages per day
* History of cancers (except if been disease free for \>5 years OR history was basal or squamous cell skin cancer)
* Participation in another clinical trial involving an investigational agent in the last 30 days
* Other parameters will be assessed at the study center to ensure eligibility for this study.
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.

Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.

* Trial with medicinal product

Eligibility Criteria:
Inclusion criteria: - Age \> 18 years

* Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
* WHO-performance status 0-2
* Written informed consent
* Discussion in an intrdisciplinary conference

Exclusion criteria: - Insufficient renal function (calculated creatinin clearance \< 60ml(min)

* Insufficient hematologic function (neutrophil count \<1'000/ul, platelets \< 100'000/ul)
* Uncorrectable coagulopathy
* Severe cholestasis (bilirubin \>100mmol/l)
* Distant metastases in liver, lungs or other organs
* Peritoneal carcinomatosis
* Unresectable tumor (s. 4.2.)
* Contraindication for Whipple procedure
* Uncontrolled infection
* Neurotphil count \> Â°2
* Estimated life experience \< 6 months
* HIV Infection
* Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
* Female patients in child-bearing age without adequate contraception
Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG

This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation with expected duration of \>24 hours
* Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg \<PaO2/FiO2 \<300 mmHg, with PEEP \> 5 cmH2O

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Severe hypoxemia with PaO2/FiO2 \<100 mmHg
* Body mass index \> 40 kg/m2
* Decompensated heart insufficiency or acute coronary syndrome
* Severe Chronic obstructive pulmonary disease (COPD)
* Major respiratory acidosis with PaCO2 \>60 mmHg
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Patient moribund, decision to limit therapeutic interventions
* Catheter access to femoral vein or jugular vein impossible
* Pneumothorax
* Platelet \<50 G/L
* Lacking consent
A Study on BReast Cancer Patient Care Using chAtbot and Video Education for Radiation Therapy (BRAVE)

This randomized trial explored whether digital media (videos and chatbots) used for patient education could more effectively reduce anxiety in breast cancer patients during radiation therapy, compared to traditional paper-based methods. Post-surgery breast cancer patients scheduled for radiation therapy were assigned to groups receiving treatment information through different media combinations. The study aimed to assess whether these modern tools more effectively ease anxiety, thus potentially improving patient compliance and treatment experience.

This study evaluates the impact of patient management and information provision using educational videos and chatbots on patient experience, satisfaction, and patient psychology in the breast cancer radiation treatment process.

The experiment is designed as (2 (with or without using chatbot) X 2 (with or without using video) to distinguish groups.

There is no separate treatment intervention in addition to use chatbot and video utilization.

Eligibility Criteria:
Inclusion Criteria:

1. A breast cancer patient scheduled for radiation therapy after radical surgery.
2. Subjects must have the cognitive ability to use smartphone.
3. Age ≥ 20 year old

Exclusion Criteria:

1. Patients with visual or auditory impairment.
2. Subjects do not consent to participate in this study.
3. Pregnancy, fetus, newborn, underage
4. Age ≥ 75 year old
Improving Dosing of Vancomycin in Young Infants With Infections

Current dosing regimens for vancomycin result in many young infants not reaching the target level of vancomycin in the blood at steady state (when the blood is in equilibrium at 24-48 hours).The purpose of this study is to assess an improved method of calculating the dose of vancomycin ('model-based dosing') in young infants with infections in order for them to achieve the target vancomycin level at steady state. A dosing calculator (which will be available through a web application) will be used for the dose calculation.

Standard of care dosing of vancomycin in young infants is based on weight (eg. 15 mg/kg/dose). There is evidence that many young infants who are prescribed vancomycin using this calculation will not have enough vancomycin in the blood at steady state to treat an infection effectively. In this study a dosing calculator will be used to generate each participant's dose with the aim to improve the number of participant's who achieve the target vancomycin level (10 - 20 mg/L) at steady state. The dosing calculator is based on a pharmacokinetic/pharmacodynamic model of vancomycin which was built from prospective data. The participant's weight, post-menstrual age, creatinine and target vancomycin level will be entered into the dosing calculator (available on a web application), and the calculator will provide the dosing regimen for that participant. The participant will have the vancomycin level checked at 24-48 hours to assess if the target level has been achieved.

This study is 'part 1' of the study protocol (version 4.0) as approved under HREC reference number HREC/51942/RCHM-2019. This protocol also includes a second study, 'part 2', which will be registered with clinicaltrials.gov separately. Part 2 will assess the use of early drug monitoring and early dose adjustment to achieve the target vancomycin level in the blood at steady state. Part 1 of this protocol will be completed before part 2 begins recruitment. Part 1 and part 2 are two separate studies and the results of each part will not be compared to one another. However, each part will be compared to a retrospective control arm - infants from the VANC randomized controlled trial (NCT02210169) who received standard intermittent infusion of vancomycin dosing (as per British National Formulary for children. 15mg/kg/dose) and standard therapeutic drug monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0 - 90 days old
* Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)
* Post-Menstrual age (PMA) matched to PMA-group from retrospective control group

Exclusion Criteria:

* Infants with corrected gestational age of less than 25 weeks
* Infants weighing less than 500g
* Known allergy to any glycopeptide antibiotic
* Vancomycin administered within the previous 72 hours
* Infants receiving any form of extracorporeal life support
* Renal impairment
* Previously enrolled in the study
Establishment of a Tissue Bank (Blood, CSF) for the Understanding of Motor Neuron Disease (MND)

Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.

Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and to better understand the progression of this disease.

Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* less than 18 years old
Prospective Liver Study

This study is designed for patients diagnosed with Liver cancer to collect information about the relationship between types of liver cancer, methods of treatment and outcomes over time.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Hepatocellular carcinoma and referred for percutaneous liver treatment.

Exclusion Criteria:

* Severe liver disfunction
* Active uncontrolled infection
* Significant underlying medical of physical illness
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at 3 s.c. dose levels in Healthy Subjects.


Eligibility Criteria:
Inclusion Criteria:

* For all subjects the following applies:
* Male subjects, if not sterilized, must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the trial corresponding to up to three months following trial drug administration. Male subjects must also agree to refrain from sperm donation from screening (trial start) until 120 days beyond trial drug administration
* For healthy subjects (HS) the following additional criteria applies:
* Male subjects, aged between 18 and 60 years (both inclusive) and in good health, as determined by past medical history, physical examination, vital signs, (electrocardiogram) ECG, and laboratory tests at screening (trial start)
* For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
* Diagnosed with RA at least 3 months prior to trial drug administration
* Active RA, characterised by a Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) greater than 3.2
* Effective methods of contraception
* Male and female subjects aged greater and equal to 18 and greater and equal to 75 years
* Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year). If female of child-bearing potential must be willing to use highly effective method of birth control during the trial until their final visit
* Methotrexate treatment (MTX) treatment for at least 12 weeks at a stable dose (dose at least 7.5 mg/week and maximum 25 mg/week inclusive) for at least 4 weeks prior to trial product administration
* Concomitant medication according to specific list

Exclusion Criteria:

* For all subjects the following applies:
* Body mass index (BMI) between 20.0-38.0 kg/m2 (both inclusive)
* Females with a positive pregnancy test
* History of regular alcohol consumption exceeding 14 drinks per week for females or 21 drinks per week for men
* Donation or loss of at least 400 mL of blood within 8 weeks prior to trial product administration
* For healthy subjects (HS) the following additional criteria applies:
* Body weight greater than 110.0 kg
* For subjects with rheumatoid arthritis (RA) the following additional criteria applies:
* Chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
* History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor

TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy.

In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent,
* Age ≥ 18 years,
* Patients with well differenciated digestive neuroendocrine tumors and liver metastases, for whom a complete surgical resection of liver metastases and of the primary tumor was performed, in 1 or 2 times,
* Immunohistochemical confirmation of neuroendocrine tumors with WHO 2010 grading specification and Ki67 determined of the surgical specimen,
* ECOG Performance Status (PS) 0-1,
* Adequate hematological status: Platelets \>100000/mm3, Hemoglobin \>10g/dL,
* Adequate Clearance Creatinine \>60 mL/min,
* Adequate liver function: Total Serum Bilirubin \<1.5x upper limit of normal (ULN), transaminases \<3 x ULN,
* Grade of In111-Pentetreotide uptake ≥ 2 (scored according to the Krenning et al scale.: more intense than physiological liver uptake),
* Treatment started within 14 weeks after surgical resection,
* Men and women are required to use adequate birth control measures during the course of the study and for a period of 12 months after the last administration of study drug. Female patients with childbearing potential must have a negative serum pregnant test (β-HCG) within 7 days before starting study treatment,
* Life expectancy \>6 months
* Registration with the National Health Care System (CMU included for France)

Exclusion Criteria:

* History of previous or second cancer or progressive cancer occurring within 5 years prior to inclusion, except for basal cell or squamous cell carcinoma,
* Patients with known sensibility or hypersensibility to In111- Pentetreotide or any component of the treatment drug,
* Pregnant or breast-feeding women without adequate birth control measures,
* Patient with known medical history of psychological or psychiatric disorders that may affect patient participation in study due to lack of cooperation or loss of autonomy preventing hospitalization and initiation of study treatment (in good radiation protection conditions),
* Treatment with any investigational drug within 28 days prior to study entry,
* Patient protected by law (tutelage or guardianship).