cyrilzakka/clinical-trials huggingface dataset:
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
* The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
* Age\>18 years
* ECOG status 0 to 2
* Biological criteria prior to any chemotherapy:

Neutrophils\>1.5 109 g/l, platelets\>100 109/l, haemoglobin\>10 g/dl, Creatininaemia\<150 mol/l, bilirubinaemia\<2x normal level

* Signed informed consent
* Life expectancy \> 3 months

Exclusion Criteria:

* Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
* Tumour progression after first line chemotherapy or before randomization
* Other tumour pathology
* Symptomatic cerebral metastases
* Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF\<50%) or coronary insufficiency)
* Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
* Severe renal impairment (creatinine clearance \< 30 ml/min)
* Severe psychiatric disorder (other than controlled depressive syndrome)
* Patient participating in another experiment
* Pregnant women
Phase 4 Study in the Elderly Patients With T2DM

The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
* HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.

Exclusion Criteria:

* Age \> 80 yrs
* BMI \< 22 and ≥ 45 kg/m2
* Secondary T2 DM
* Hepatic failure, moderate/severe renal failure (Cl \< 50 ml/min) and CHF III \& IV
* ASAT / ALAT \> 3 ULN, creatinine clearance \< 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants


Eligibility Criteria:
Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
* Major known congenital malformation or serious chronic disorder.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity

The overarching objective of this study is to make it easier for parents of children with medical complexity (CMC) to take care of their children after discharge home from the hospital and reduce the chance of post-hospitalization morbidity (meaning bad outcomes such as readmissions) after discharge. CMC, or those with multiple chronic conditions, progressive conditions, or technology dependence, are at high risk for post-hospitalization morbidity.

This study will take place in 3 phases at 2 sites: Bellevue Hospital Center (BHC) and Hassenfeld Children's Hospital (HCH). Parents of CMC with a prior or current admission will be recruited at these two sites, as well as pediatricians who care for these children in the inpatient setting for the following 3 aims:

* In Aim 1, parents of CMC and pediatricians will be interviewed to understand their views on what makes it challenging, and what can make it easier, for parents to understand and follow the instructions they get from the hospital about how to take care of their CMC after leaving the hospital. The study team will also ask pediatricians what may make it difficult to provide relevant education to families.
* In Aim 2, a tool will be designed to make it easier for parents to understand and follow the discharge instructions for their CMC. The study team will use structure of existing tool, findings from Aim 1, and extensive interviews and testing of the tool with parents and pediatricians as the new tool is designed.
* In Aim 3, a randomized controlled trial (RCT) will be conducted to study the impact of the tool on parent comprehension and adherence (or how well they can follow) their child's discharge instructions, as well as its impact on post-discharge morbidity (such as readmissions and emergency department visits). Parents will be randomized to either receive usual hospital care and instructions or the intervention/tool (in addition to the usual care and instructions). The study team will also ask parents who receive the intervention about its usability.

Eligibility Criteria:
Inclusion Criteria:

Parents

* English or Spanish-speaking
* Parent or legal guardian and primary caregiver of child who has medical complexity (defined by significant chronic conditions in ≥2 body systems, progressive conditions associated with decreased life expectancy, dependence on technology for \>6 months \[e.g., respiratory equipment, central lines, feeding tubes\], or progressive/metastatic malignancies) who was admitted to the acute or intensive care units
* The individual's child is ≤18 years old
* The individual's child was discharged home or is expected be discharged home on ≥1 daily medication.
* Willingness to be randomized to intervention group
* Willingness and ability to participate in study procedures

Exclusion Criteria:

Parents

* Caregiver \<18 years old
* Poor visual acuity (\<20/50 corrected on Rosenbaum screener for in-person recruitment; by subject report for phone recruitment)
* Self-reported hearing difficulty
* Previously enrolled.
Biomarkers in Tissue Samples From Patients With Hodgkin Lymphoma Enrolled on ECOG-2496 Clinical Trial

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.

OBJECTIVES:

* To explore the predictive power of a gene expression-based multi-gene predictor in classical Hodgkin lymphoma (cHL) with the potential to change clinical practice by basing treatment decisions on biological markers.

OUTLINE: Archived tissue samples are analyzed for gene expression profile using NanoString technology. Results are then compared with patients' treatment outcomes, including failure-free survival and overall survival.

PROJECTED ACCRUAL: A total of 306 patients from ECOG-2496 (training cohort) and 87 patients treated with ABVD in other trials (validation cohort) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Training cohort: Patients diagnosed with locally extensive and advanced stage classical Hodgkin lymphoma (cHL) and treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) or mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone (Stanford V)

  * Pretreatment formalin-fixed, paraffin-embedded tissue (FFPET) from patients enrolled on the randomized phase III ECOG-2496 clinical trial
* Validation cohort: Patients with advanced-stage cHL treated with ABVD at the British Columbia Cancer Agency (BCCA)

  * Pretreatment FFPET available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia

The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. The main questions it aim to answer are: • How many is the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok? • Can the health promotion program improve muscle mass and muscle strength in older people with post-COVID-19 Sarcopenia ? Participants will be asked eating protein supplement one scoop /day and exercising 2 times/week for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Older people with post-COVID-19 sarcopenia aged more than and equal 60 years
* No disabilities
* Able to read, write and communicate Thai langue
* Live in Bangkok
* Moderate post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale
* No soy protein allergy
* Sign inform consent

Exclusion Criteria:

* Severe post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale and complicated health problems
* Disabilities
* Unable to read, write and communicate Thai langue
* Soy protein allergy
* CKD 4 and CKD 5
* Deny or withdraw from project
Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial

The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.

Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle \* 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion.

During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven anaplastic oligodendroglioma or oligoastrocytoma
* Progressed or relapsed after surgery or radiation therapy
* Female or male aged 20 years or over
* At least 1 measurable mass lesion
* ECOG performance status 0-3
* Adequate organ function
* absolute neutrophil count \> 1,500/μL
* platelet count \> 75,000/μL
* hemoglobin greater than 9 g/dL or 900g/L
* serum creatinine less than 1.5 times the upper limit of laboratory normal
* total serum bilirubin less than 1.5 times the upper limit of laboratory normal
* AST or ALT less than three times the upper limit of laboratory normal

Exclusion Criteria:

* Prior course of temozolomide
* Combined glioblastoma
* Pregnant woman
Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19

Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* COVID 19 pneumonias with Hypoxemia
* for whom prone positioning has been decided by the attending physician.

Exclusion Criteria:

* Mechanical ventilation
* ECLS
A Study of Abatacept in Patients With Active Crohn's Disease

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* have had Crohn's Disease for at least 3 months
* moderate to severely active Crohn's Disease
* have had an inadequate response or intolerance to other Crohn's Disease treatments
Crizotinib Continuation Clinical Study

The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.

Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.

Eligibility Criteria:
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
2. Participants must agree to follow the reproductive criteria as outlined in protocol.
3. No ongoing Grade ≥3 or intolerable Grade 2 AEs considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4.
4. Adult Participants (≥18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Pediatric Participants (\<18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Exclusion Criteria

Participants with any of the following characteristics/conditions will be excluded:

1. Female participants who are pregnant or breastfeeding.
2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.

Eligibility Criteria:
Inclusion Criteria:

* Ventricular Tachycardia
* Ventricular Premature Complexes

Exclusion Criteria:

* Organic ventricular tachycardia or ventricular premature complexes
* Drug-induced ventricular tachycardia or ventricular premature complexes
Clinical Trial of Use of Autologous Bone Marrow Stem Cells Seeded on Porous Tricalcium Phosphate Matrix and Demineralized Bone Matrix in Patients With Osteonecrosis

The purpose of this study is to evaluate the safety of use of autologous bone marrow stem cells seeded on porous tricalcium phosphate matrix and demineralized bone matrix in patients with osteonecrosis of the jaw by a prospective, single-center, open, nonrandomized and unblinded clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mandibular osteonecrosis of any etiology defined by clinical and radiological examination.
* Bone defect anteroposterior dimension less than or equal to 4 cm in the mandible or the maxilla 2.5, and / or bone bed sufficient to ensure the integrity of the construct during surgery.
* No response to conservative treatment.
* Provide sufficient assurance of adherence to protocol.
* Provide written consent
* Meet all the inclusion criteria

Exclusion Criteria:

* Concomitant psychiatric illness.
* Uncontrolled concomitant systemic disease.
* Active infectious disease in the focus of mandibular osteonecrosis.
* Neoplastic disease in complete remission less than 2 years.
* Pregnant patients.
* Patients with active feeding.
* Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.
* Patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test.
* Inclusion in other clinical trials in active treatment.
* Inability to understand the informed consent.
* You need not meet any exclusion criteria
Egg Intake and Risk of Type 2 Diabetes

This is a longitudinal study that will collect demographic, anthropometric and dietary data to determine the relationships between meat and egg intake and the incidence of Type 2 Diabetes.

Subjects of the Adventist Health Study who are non-diabetic will provide demographic, anthropometric and dietary data at baseline. Meat and egg intake will be assessed with a validated quantitative food frequency intake questionnaire. The relationship between meat and egg intake and the incidence of Type 2 Diabetes will be determined using multivariate-adjusted logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age \> 30 years

Exclusion Criteria:

* Subjects with missing values in dietary variables were excluded from the analytic sample,
* missing gender
* age \< 30 years
* improbable questionnaire response patterns
* extremes of BMI (less than 16 or greater than 60)
* estimated energy intake (less than 500 or greater than 4,500 kcal/d)
* existing cases of type 1 or type 2 diabetes at baseline
* inconsistent reports of T2D between HHQ version 3 and 5
Retrospective Natural History Study of Retinitis Pigmentosa

This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6A or PDE6B gene mutations.

This is a retrospective, longitudinal, observational case history study to determine the natural history of rods and cones degeneration in patients diagnosed with RP caused by pathogenic mutations in genes with selective expression in rods: rhodopsin (RHO), phosphodiesterase 6A (PDE6A) or phosphodiesterase 6B (PDE6B).

113 participants will be enrolled in this study at the single center: CHNO-CIC Quinze-Vingt Paris in France.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RP caused by pathogenic mutations in RHO, PDE6A or PDE6B genes.

Exclusion Criteria:

* Patients with a pathogenic mutation in any other gene known to be involved in RP.
* Patients with any ocular disorder other than RP, likely to impact the retinal function.
Fludrocortisone in Healthy Volunteers (AFLUCO4)

Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in survival in septic shock patients with relative adrenal insufficiency. However, the utility of low doses of steroids and in particular of mineralocorticoids in septic shock is still discussed.

The purpose of the investigators study is to investigate the effects of 3 increasing doses of fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best pressor response to phenylephrine in healthy volunteers, and simultaneously assess their respective hemodynamic and biological effects.

In a previous study (AFLUCO2) in healthy volunteers with saline-induced hypoaldosteronism, the investigators found that single doses of both hydrocortisone and fludrocortisone induced a significant decrease in the pressor response to phenylephrine, probably due to a rapid non-genomic vasodilatory mechanism, and that these effects were additive.

The investigators also showed that, at the doses used in septic shock, hydrocortisone induced more pronounced mineralocorticoid effects than fludrocortisone and also induced systemic hemodynamic effects whereas fludrocortisone did not.

The investigators now want to perform a dose-response study under normal conditions (ie without saline-induced hypoaldosteronism) and after repeated administrations, to determine the optimal dose of fludrocortisone that allows an increase in the pressor response to phenylephrine and to characterize its concomitant hemodynamic and biological effects.

This placebo-controlled, randomized, double-blind, cross-over, 4-periods (fludrocortisone 100 μg/day, 200 μg/day, 400 μg/day, or placebo) study aims to investigate hemodynamic and biological effects of fludrocortisone administered orally during 5 days, in healthy volunteers.

Each period will be separated from the next one by a washout interval of at least 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 to 25 years
* Body Mass Index between 20 kg/m² and 25 kg/m²
* Nonsmoker since at least 6 months
* Normal clinical examination, electrocardiogram and transthoracic echocardiography
* Normal routine biological parameters
* Written informed consent

Exclusion Criteria:

* History of significant allergy
* Resting heart rate \< 50 bpm
* Subjects with abnormal hepatic or renal function, or cardiovascular, pulmonary, endocrine or psychiatric disease
* Ongoing medication during the study
* Alcohol consumption more than 30g/day or drug addiction
* Exclusion period mentioned on the national registry for clinical trials volunteers.
* Subject under legal protection
Master Allergen Child Nutrition. Reintroduction of Small Doses

Reintroduction of small doses of food in allergic children to lightening the elimination diet.

In four groups of allergic children (peanuts, wheat , milk and egg), a reintroduction of 4 small increasing doses of allergen is carried out progressively double-blind placebo- cons , randomized, during a hospitalization.

The procedure for reintroduction of small doses (MPD) is stopped at the appearance of intolerance (in taking a dose of allergen or placebo) defined by the onset of allergic symptoms or objective severe abdominal pain within 45 minutes of taking.

Eligibility Criteria:
Inclusion Criteria:

* Allergic children 1 and 16 years for peanut, egg and wheat. So, for milk between 9 months and 16 years.
* Accurate diagnostic
* Allergic react rapidly and acute

Exclusion Criteria:

* severe disease