cyrilzakka/clinical-trials huggingface dataset:
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection for Rectum Cancer

Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms.

Patients undergoing LAR for rectum cancer is subjected to peritoneal microdialyses during the postoperative period until the 7. postoperative day. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. Before removing the microdialysis catheter a CT whit rectal enema is preformed. Every day the patient will be evaluated whit a standardised clinical scoring system with attention at anastomotic leakage.

A total of 150 patients will be included in this study. The results of the peritoneal microdialyses will be compared with the clinical scorings system in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.

The study is approved by the local scientific ethical committee No. ------

Eligibility Criteria:
Inclusion Criteria:

* Histological verified cancer
* The cancer must be located in rectum maximum of 15 cm.
* Diverting stoma is allowed
* Perioperative radio-chemotherapy is allowed

Exclusion Criteria:

* Disseminated cancer
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis

A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study.

During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist.

Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was \< 0.05. Statistical analyses were performed using R software (version 4.0.5).


Eligibility Criteria:
inclusion criteria :

* patients older than 18 years
* with a performance status ≤ 2,
* who underwent complete (no macroscopic residual disease) CRS-HIPEC.

exclusion criteria :

* the presence of an infectious disease prior to surgery,
* CRS without HIPEC,
* incomplete CRS
* expressed refusal to participate in the study
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients

This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.

The primary objective of this study is to assess the extent to which the Prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. The oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. No genomic tools will be used in the initial assessment. Changes in recommendation after availability of Prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

Eligibility Criteria:
Inclusion Criteria:

* Surgically resected node-negative, estrogen receptor-positive, HER2-negative early-stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

  1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
  2. HER2 status will be evaluated by IHC and/or by in-situ fluorescence hybridization (0 or 1+, or 2+ will be considered negative in the absence of in-situ fluorescence hybridization).
* Postmenopausal females, which is defined as:

  1. Natural Amenorrhea \> 12 months, regardless of age
  2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
  3. Radiological castration with amenorrhea \> 3 months, regardless of age
  4. Hysterectomy and postmenopausal blood levels of FSH/LH
* Able to give informed consent
* Eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by the treating physician
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Tumor specimen from core needle biopsy (CNB)
* Tumor stage T3-T4
* Non-invasive breast cancer (e.g., Paget's disease, DCIS)
* Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
* Tumors that are estrogen receptor (ER) negative or HER2-positive
* Have metastatic disease
* Have received another genomic test for prognosis of early breast cancer (i.e., Oncotype Dx, Mammaprint, or BCI)
* Unable to give informed consent
* Unable to complete patient reported outcome surveys
* Have contraindications for adjuvant chemotherapy, as determined by the treating physician

  o Age, performance status, significant comorbidities, etc.
* ECOG performance status \> 1
Radiotherapy for Malignant Astrocytomas in the Elderly

A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status \> 70.


Eligibility Criteria:
Inclusion Criteria:

* Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed
* Brain CT scan or MRI within 28 days before surgery
* Age: 70 years or older
* Karnofsky performance status, 70 or more.
* Life expectancy over 12 weeks
* Informed consent

Exclusion Criteria:

* Brain radiotherapy
* Chemotherapy
* Severe systemic disease
Rehabilitation with Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

Preoperative rehabilitation before total knee arthroplasty (TKA) has not been proven to be effective. Latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. However, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. Pre-operative muscle atrophy, although not systematic, is often observed. The preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy.

As part of the "FOLLOWKNEE" (RHU) project, which attempts to implement a personalized management of TKA and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before TKA.


Eligibility Criteria:
Inclusion Criteria:

* Terminal stage gonarthrosis with total knee arthroplasty (TKA) indication
* TKA indicated by the surgeon
* Body Mass Index \< 35
* Acceptance to realize a preoperative rehabilitation in outpatient setting
* Adult between 18 and 80 years old
* Patient affiliated to social security
* Patient who signed an informed consent

Exclusion Criteria:

* Functionally uncomfortable osteoarticular illness (disabling pain, functional limitation of joint amplitudes or muscle strength) of controlateral leg.
* Unable or refusal to consent
* Contraindication to electrostimulation (skin lesion, nearby implanted metallic material, implanted cardiac or neurologic electrostimulator, intolerance to muscle electrical stimulation)
* Unstable medical situation preventing the continuous realization of a program of at least 4 weeks
Glaucoma After Congenital Cataract Surgery

To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
* cataract surgery performed in ZOC;
* age at cataract removal younger than 16 years;

Exclusion Criteria:

* the preoperative IOP was above 21 mm Hg;
* family history of glaucoma;
* signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
* ocular trauma history;
* previous surgery intervention and
* they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma

The purpose of this trial is to determine

1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy
2. Progression-free survival (PFS) 3 years after registration


Eligibility Criteria:
Inclusion Criteria (B-CAP):

* classical Hodgkin Lymphoma
* Age 60 years or older
* ECOG performance status ≤ 2 or ≤ 3 if due to HL
* CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)
* Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
* written informed consent

Exclusion Criteria (B-CAP):

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* Prior chemotherapy or radiation for HL except prephase
* Peripheral neuropathy greater than CTC Grade 1

Inclusion Criteria (BV only):

* classical Hodgkin Lymphoma
* Age 60 years or older
* stage IA to IVB
* CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
* Patients not eligible to curative poly-chemotherapy at the investigators judgment
* written informed consent

Exclusion Criteria (BV only):

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
* Peripheral neuropathy greater than CTC Grade 1
Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs

About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.


Eligibility Criteria:
Inclusion Criteria:

* With neoplasms, histologically confirmed
* Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician, the referring physician or the physician investigator
* Covered by a medical insurance
* Written, signed informed consent

Exclusion Criteria:

* Cons-indication to physical activity practice, at discretion of the investigator
Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

A prospective clinical, uncontrolled, open-label, explorative phase 2a trial on patients with histologically-confirmed superficial and nodular basal cell carcinoma (BCC). The study assesses tolerability and tumor clearance after laser-assisted topical delivery of topical ingenol mebutate.

Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. .

local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30.

Primary outcome:

1. severity and duration of clinical local skin reactions including erythema, scaling, edema, blistering, erosion/ulceration and crusting using a 0-4-point scale at all visits from baseline to day 90.
2. To monitor BCC tumor response on clinical assessments supported by non-invasive imaging techniques including optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) at baseline, day 29 and day 90.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria are eligible to participate in this study

* Patients with histologically verified, low-risk, previously untreated superficial or nodular BCCs on the scalp, face, extremities or trunk
* \> 18 years of age at baseline
* Legally competent, able to give verbal and written consent
* Communicate in Danish verbally as well as in writing
* Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
* Fitzpatrick skin phototype I-III
* Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.

Exclusion Criteria:

Subjects meeting any one of the following criteria are not eligible to participate in this study

* Patients with

  o High-risk BCC
* Tumors on the following anatomical locations:

  * Midface region
  * Orbital areas
  * Ears
* ii. Size:
* \> 20 mm in facial/scalp areas
* \> 50 mm in non-facial/non-scalp areas

  * Subtype:
  * Morpheaform
  * Medical history
* Gorlin syndrome

  o Immunosuppressive medication
* Subjects with a known allergy to IM.
* Individuals with other skin diseases in the area of research interest
* Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study
* Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
* Subjects with Fitzpatrick skin phototype IV-VI
* Lactating or pregnant women
Prognostic Influence of Light Rheography Measurement of Patients With Secondary Raynaud Syndrome With Ulcers on Hands

The purpose of this study is to evaluate the prognostic influence of light rheography measurement at the fingertips from subjects with secundary Raynaud syndrome.

Digital Ulcers (DU) belong to one of the most prevalent complications of systemic scleroses, leading in course to considerable impairment in everyday and professional life. The aetiology of the emergence of DU in patients with systemic scleroses (SSc) is complex, whereas the disease itself is primarily characterized by a vasculopathy of the small arterial vessels. In the course of the disease this chronic infection leads to fibrotic intimal hyperplasia, adventitial fibrosis, and thus to a significant lumen narrowing. So far, a number of independent risk factors have been identified, such as male gender, chronic infections of the esophagus, pulmonary-arterial hypertension, evidence of specific antibodies (e.g. anti-Scl70) in the blood, or the a previous manifestation of a Raynoud Syndrom.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Limited or diffuse systemic sclerosis/scleroderma with at least one ulcera at fingertip
* Age \> 18 Years
* Weight \> 40 Kg

Exclusion Criteria:

* Sympathectomy
* Ulcers due to other condition (PVD, DM, Thromboangiitis obliterans etc.)
* Antibiotic concomitant medication
* Therapy with Prostanoids within the last 4 weeks
* Previous Bosentan therapy
* Severe liver and renal insufficiency(creatinin \>2.0 mg/dl;AST/ALT \> 3X UNL)
* severe cardiac- pulmonal diseases
* Untreated or therapy refractory Hypertension
* Noncompliance
* Pregnancy or nursing (Pregnancy test required)
A Study of 14C JNJ-67953964 in Healthy Adult Male Participants

The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose 14C-aticaprant in healthy adult male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history (screening only), vital signs, and electrocardiogram (ECG) performed at screening and admission to the study site on Day -1. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
* Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight \[kg\]/height\^2 \[m\^2\]) within the range of 18.0 to 29.9 kilogram per meter square (kg/m\^2) (inclusive)
* Blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg) and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and Day -1
* A 12-lead ECG consistent with normal cardiac conduction and function, at screening and Day -1, including: sinus rhythm; pulse rate between 40 and 100 beat per minutes (bpm), extremes included; QTc interval less than or equal to (\<=) 450 milliseconds (ms) for men; QRS interval of less than (\<) 120 ms; PR interval \< 210 ms; morphology consistent with healthy cardiac conduction and function
* Non-smokers (not smoked for 3 months prior to screening)

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy, which is considered cured with minimal risk of recurrence)
* Known allergies, hypersensitivity, or intolerance to aticaprant or its excipients
* History of clinically significant (example: in the opinion of the investigator) drug and/or food allergies
* Participant has presence of left bundle branch block, atrioventricular block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator
* Anatomical (nasal) abnormalities which may make the placement of the nasoduodenal tube difficult (only for participants with duodenal sampling)
Internet-based Self-help After Spousal Bereavement or Divorce

The purpose of this study is to evaluate the efficacy of an internet-based self-help intervention for older adults with prolonged grief symptoms after spousal bereavement or separation/divorce. The study design is a randomized trial with a waiting control condition of 12 weeks and a follow-up after 6 months. The investigators will test the following main hypotheses:

1. The intervention group shows a significant decrease in grief symptoms, psychological distress, depression symptoms and embitterment, and a significant increase in life satisfaction, as well as session related outcomes from baseline to 12 weeks post intervention assessment.
2. The effects in the intervention group are larger than the effects in the waiting control group.
3. These effects are stable from the post measure at 12 weeks to the 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Marital bereavement or separation/divorce. Both events should have happened more than 6 months before participating in the study.
* Seeking support for coping with grief symptoms
* Internet access
* Mastery of the German language
* Informed Consent

Exclusion Criteria:

* Acute suicidality (BDI Suicide item \> 1 or suicidal ideation in the telephone interview)
* No emergency plan: In the telephone interview, an emergency plan will be developed which specifies a health care professional, who participants can turn to in an acute crisis. If no such person or health care service can be found, individuals will be excluded from the intervention.
* Severe psychological or somatic disorders which need immediate treatment.
* Concomitant psychotherapy (participants may take part in the self-help intervention, but will not be included in the study.)
* Prescribed drugs against depression or anxiety lead to an exclusion if prescription or dosage has changed in the month prior or during the self-help intervention.
* Inability to follow the procedures of the study, e.g. due to comprehension problems
Objective Measurements of Lens Opacification After Intravitreal Injections

The main hypothesis is the opacification of the lens would be increase by the IVT.

The opacification of the lens can be objectived by :

* the objective scatter index (OSI) on the OQAS device
* the average lens density (ALD) on the IOLMaster device.

Eligible patients will be followed at least 12 months after in intravitreal injection and the opacification of their lens is regularly controlled with OSI and ALD.

The objective is to study the dynamics of lens opacification in IVT-treated eyes evaluated by OSI for at least 1 year.


Eligibility Criteria:
Inclusion criteria:

* An indication of an intravenous injection of a dexamethasone 700 μg (Ozurdex®) or anti-VEGF for at least one of the two eyes for macular edema or neovessels linked to DMLA, retinal venous occlusion, diabetic macular edema or posterior uveitis
* Phake patient, at least of the injected eye

Exclusion criteria:

- Pseudophakia of the injected eye