cyrilzakka/clinical-trials huggingface dataset:
Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum

The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.

In front of a shortage of Caelyx, the implementation of an alternative treatment must be considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin (Myocet®).

Eligibility Criteria:
Inclusion Criteria:

* First or second relapse of a carcinoma of the ovary, the fallopian tubes or the peritoneal tissue histological proved.
* Interval without progress \> 6 months after the last administration of a salt of platinum(deck).
* Measurable Disease (according to the criteria RECIST 1.1) or an assessable disease according to CA-125 (according to the criteria of the GCIG).
* Satisfactory biological Balance sheet(Assessment), according to the following criteria:

  * Neutrophiles \> 1,5x 109/L, Plaques \> 100 x 109/L, Haemoglobin \> 9,0 g/dL.
  * Bilirubine \< 1.5 x LSN (Normal Superior Limit), transaminases and alkaline phosphatase \< 2. 5 x LSN.
  * Creatinin clearance \> 50 mL/min calculated according to the formula of Cockroft-Gault or MDRD.
* Performance status \< 2.
* Life expectancy of at least 12 weeks.
* Age \> 18 years.
* Capacity to follow the protocol.
* Consent signed before any procedure of inclusion.
* Membership in a national insurance scheme.

Exclusion Criteria:

* Tumor of mild histology or borderline, or malignant not epithelial tumor of the ovary, the fallopian tubes or the peritoneal tissue(eg. tumor of germ cells, tumor of the sexual cords and the stroma).
* History of abdominal or pelvic radiotherapy.
* Patient having received more than 2 lines of chemotherapy.
* Patient in 3rd relapse or more.
* History of another malignant tumor during the last 5 years, with the exception of a carcinoma in situ by the neck of the womb or by a squamous-cell carcinoma of the skin treated in a adequate way or any solid tumor considered in forgiveness completes without relapse for at least 5 years.
* Patients having a stubborn illness in the platinum, (eg. progress during the last chemotherapy or in 6 months following the last administration of platinum).
* Occlusive or sub-occlusive disease or presence of symptomatic intellectual metastases.
* Heart disorder dissuading the use of an anthracycline.
* Left venticular ejection fraction (LVEF) defined by MUGA/ECHO \< 50%.
* Wait presenting a severe infection.
* Woman old enough to procreate not using adequate contraceptive method.
* Concomitant disease not allowing a surgery and/or a chemotherapy.
* Pathology severe or concomitant not compatible with the taking of the study treatment or the participation of the patient in the study.
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight

The purpose of this study is to teach primary care physicians effective ways to counsel overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics will take part in this study.

Patients will be identified by research study staff and asked if they would be willing to have their clinic visit audio recorded for research purposes. There are three phases of data collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then, half of the physicians will be randomized to receive a tailored web-based intervention containing information about evidence-based techniques to help adolescents attain a healthy weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all physicians will receive a Summary Report that outlines the adolescent's high risk behaviors that contribute to weight (sweetened beverages, fast food, breakfast, physical activity, screen time, and sleep) and a new set of 200 encounters will be audio recorded.

Data will be collected by trained data technicians, in-person and over the phone. Data is collected on laptop computers and then downloaded into password protected electronic files on a secure network server. All participants (adolescent patients and physicians) will be assigned a code number that is the sole identifier on all study data forms. Prior to and after coding, digital files will be stored in password protected directories to which only the data technicians and project manager have access. The web-based intervention will be password protected.


Eligibility Criteria:
Inclusion Criteria for MDs:

* Specialty is Family Practice or Pediatrics
* Located in participating clinic
* Not planning to leave clinic in the next two years

Inclusion Criteria for teen patients:

* English-speaking
* BMI z-score \>85th percentile
* age 12-18
* not pregnant
* have parental consent to participate if over 18
* have visit at least 7 days in the future
* have access to a telephone

Exclusion Criteria for teen patients:

* BMI z-score \<85th percentile
* not English speaking
* pregnant
* \<12 or older than 18
* incompetent for interview
* seen primarily by non-physician provider
Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients with permanent ostomy and 1 years of life expectancy
* Signed informed consent

Exclusion Criteria:

* Allergy to the compounds of the mesh
* Rejection of the patient
* Rejection of the surgeon
* Field of emergency
* Life expectancy \< 1 year
* Prior meshes in the surgical site
Prevention of Corticosteroid-induced Glucose Intolerance

Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* corticosteroid treatment

Exclusion Criteria:

* congestive heart failure pedal edema
Impact of Transition Programs on Readiness and Quality of Life in IBD

This study is a randomized controlled trial comparing two transition models for adolescents with inflammatory bowel disease (IBD) moving from pediatric to adult care. Patients aged 16-19 years with IBD will be randomized to either a letter-based transition approach (involving a referral supported by a pediatrician's clinical report) or a combined visits-based approach (including joint consultations with both pediatric and adult gastroenterologists).

The primary outcome will be transition readiness assessed using the Transition Readiness Assessment Questionnaire (TRAQ). Secondary outcomes include quality of life (measured by the Pediatric Quality of Life Inventory™), disease activity, and healthcare utilization. Participants will be evaluated at baseline, six months, and one year. The study aims to establish an evidence-based transition model by determining which approach better facilitates a successful transition from pediatric to adult gastroenterology care for young patients with IBD.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* IBD diagnosis according to current guidelines
* Age between 16 and 19 years
* Disease in clinical remission or with mild activity

Exclusion Criteria:

- Subjects unable to provide a free and valid consent to study participation
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims:

1. To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic Leukaemia within the ALLTogether-1 Trial.
2. To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.

This is a multi-centre randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion criteria include: patients with Down syndrome (who already receive ciprofloxacin prophylaxis), contraindication to fluoroquinolones, non-consent to ALLTogether-1 or CiproPAL. AMR of colonising organisms will be assessed with stool or peri-rectal swab cultures performed at five timepoints within the first year. Longer term invasive infection AMR monitoring will include sensitivity testing of all organisms isolated in confirmed infection for the duration of ALLTogether-1.

The primary outcome is the rate of sterile site bacterial infections during induction, evaluated by intention to treat analysis. Secondary outcomes include rates of febrile episodes, febrile neutropenia, severe infection and infection-related death; rates of AMR; antibiotic exposure; secondary infections; and quinolone side effects. A model-based health economic analysis will be undertaken. Using a conservative effect estimate of 40% reduction in bacteraemia (i.e. a reduction from 15% to 9%) 1052 patients randomised 1:1 gives 85% power with a 5% 2-sided alpha.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on ALLTogether-1 in the UK in the first 5 days of therapy, up to 14 days is acceptable.
* Written informed consent

Exclusion Criteria:

* Non-participants of the ALLTogether-1 trial
* Patients with Down syndrome who already receive ciprofloxacin prophylaxis
* Chronic active arthritis
* Other contraindication to fluoroquinolones
Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)

All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center

Exclusion Criteria:

* Missing Informed Consent Form
* Missing Contact Informations for Follow up
Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis

To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

The investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed of Knee Ostoeaarthritis
* without changes in treatment in the last 3 months

Exclusion Criteria:

* food allergies
* pregnancy
Pleural Irrigation with a Novel Devise.

Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion
* Patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion

Exclusion Criteria:

* Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
* Post-procedural empyema or complicated parapneumonic effusion
Comparison of Prostate Fusion Biopsies With Software and Cognitive

This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.

Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.

Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years.
* mpMRI carried out in our center.
* Presence of lesions with PIRADSv.2 ≥ 3.
* Acceptance to participate in the study.

Exclusion Criteria:

* PSA\> 30 ng / ml
* Treatment with 5-ARIs (5-alpha-reductase inhibitors).
* Previous diagnosis of PCa.
* TR\> T3.
Correlation Between Genetic Variants and Long-term Cardiac Effects Induced by Doxorubicin in Breast Cancer Patients

The purpose of this study is to identify the genetic variants that are associated with higher risk of doxorubicin-induced cardiotoxicity can contribute towards developing a predictive algorithm comprising both clinical and genetic factors to select patients who should avoid treatment with anthracyclines.

Hypothesis of this study is certain functional variants in genes that encode for metabolizing enzymes and/or targets in the doxorubicin pharmacology pathway may increase the risk of doxorubicin-induced cardiomyopathy

Doxorubicin is one of the cornerstone therapies in adjuvant chemotherapy in early stage breast cancer. Cumulative doses of 240mg/m2 (4 cycles of doxorubicin/cyclophosphamide) and 300mg/m2 (6 cycles of doxorubicin/cyclophosphamide) are typically administered in the adjuvant setting, which is associated with \<1% chance of severe cardiotoxicity, and are thus considered 'safe dose ranges'. However, Blanco et al recently reported childhood cancer survivors with the CBR3 (a metabolizing enzyme of doxorubicin) V244M homozygous G genotypes to be at increased risk of cardiomyopathy following exposure to anthracyclines doses as low as 101-150mg/m2, suggesting that there is no safe dose threshold for individuals with certain genotypes. We have previously studied several genes in the doxorubicin pharmacology pathway, including CBR1, CBR3, and AKR1C3, and found correlation between functional variants in CBR3 and AKR1C3 with doxorubicin-induced myelosuppression. The CBR3 G allele is present in about 50-60% of the Singapore population, and we postulate that these common variants may similarly modify the risk of anthracyclines-induced cardiomyopathy in adult breast cancer patients. Post-treatment echocardiography is not routinely performed in patients who complete adjuvant anthracyclines-containing chemotherapy. We believe that some of these high-risk individuals may have subclinical reduced left ventricular ejection fraction that may in the future increase the risk of congestive cardiac failure in the presence of other risk factors (eg hypertension, anemia, serious infection, etc). Identifying these individuals could therefore be important as early treatment with ACE inhibitors may improve cardiac function. Confirming the correlation between genetic variants including the CBR3 V244M can also help to develop a predictive algorithm in the future to identify patients in whom anthracyclines should be avoided.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 21 years
* Signed informed consent from patient or legal representative.

Exclusion Criteria:

* Pregnancy
* Breast feeding.
A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany (DELPHIN)

The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period


Eligibility Criteria:
Inclusion Criteria:

* Patients with a physician-reported diagnosis of moderate-to-severe plaque psoriasis initiating deucravacitinib according to approved label in the European Union
* The decision upon treatment with deucravacitinib must have been made before enrollment and independently of this non-interventional observational study
* Patient is at least 18 years of age at the time of treatment decision
* Patient provided written informed consent to participate in the study

Exclusion Criteria:

* Any contraindications according to the approved deucravacitinib Summary of Product Characteristics
* Prior treatment with deucravacitinib
* Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis
ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)

Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions.

The primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. We have an evidence-based electronic health intervention (Elder Tree, ET) that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.


Eligibility Criteria:
Inclusion Criteria:

* Be ≥60 years old;
* Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression;
* Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits);
* Allow researchers to share information with the patient's primary care provider

Exclusion Criteria:

* Require an interpreter
* Report no current psychotic disorder that would prevent participation
* Have no acute medical problem requiring immediate hospitalization
* Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study

The overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning.

Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method.

Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy
* Age \>18 years
* Ability to understand and the willingness to sign a written informed consent document
* Creatinine or creatinine clearance of \<1.5 times the upper limit of normal or \>45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level

Exclusion Criteria:

* Patients who are currently receiving any investigational agents
* Unable to undergo MRIs
* Patients with late stage kidney disease or who have had a liver transplant
* Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.