cyrilzakka/clinical-trials huggingface dataset:
The Removing Port of the Laparoscopic Cholecystectomy Material

Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections.

Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about which port place is optimal for the removing of the cholecystectomy material from the abdomen. There are different port site infections rates in the literature. The minimal tissue damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there are series with an infection range of 8 %. The investigators are investigating is there any difference at the port site infection rates when the cholecystectomy material removed from different ports from the abdomen at the laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subject has cholelithiasis

Exclusion Criteria:

* Subject has perforated gallbladder
* Subject has malignancy
* Subject has increasing wall thickness of the gallbladder
* Subject has malignancy in the preoperative ultrasonography in the gallbladder
* Subject has pregnancy
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia

Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
* Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
* Adequate organ function.
* Detectable CD20 positive of the tumor cells.
* Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.

Exclusion Criteria:

* Treatment of WM within the past 28 days.
* Treatment with rituximab or alemtuzamab within the past 3 months.
* Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
* Current participation in another interventional clinical study.
* Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
* Active cerebrovascular disease.
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery

This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.

Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.

Exclusion Criteria:

* Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions

Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain

Postoperative pain is a world wide problem related with surgery. Multimodal analgesia may include ketamine, aimed to decrease opioid adverse effects in postoperative analgesia for major surgery, and risk of chronic postsurgical pain. Ketamine has shown efficacy as adjuvant in multimodal analgesia, however, neuropsychiatric and cardiovascular effects of ketamine at low doses in continue postoperative infusion are less known. This type of adverse effects may compromise appropriated recovery.

Objective

to determine frequency of delirium, agitation, sedation, hallucinations, bad dreams and cardiovascular changes associated with ketamine analgesic infusion treatment for postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

- patient scheduled for abdominal, thoracic or orthopedic surgery

Exclusion Criteria:

cognitive disfunction psychiatric illness cardiovascular disease
Comparison of IgA Levels in the Bronchoalveolar Lavage Fluid of Patients With and Without Antibiotic Therapy

Investigators hypothesize that Immunoglobine (Ig) production is influenced by the microbiota of the gut. Investigators will compare microbiota-dependent Ig production in the bronchoalveolar lavage fluid of patients with and without antibiotic therapy in order to detect significant differences.


Eligibility Criteria:
Inclusion Criteria:

* endotracheal intubation
* antibiotic therapy for 2 weeks OR no antibiotic therapy for at least 3 months

Exclusion Criteria:

* active infection
* pregnancy
* immunodeficiency
Obalon Balloon System Post-Approval Study

The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal

Eligibility Criteria:
Inclusion Criteria:

* At least 22 years old
* BMI of 30-40 kg/m2

Exclusion Criteria:

* Contraindicated for the device
* Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months.
* Known history of endocrine disorders affecting weight.
* Participation in any clinical study which could affect weight loss within the past year
* Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus
* Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
Effects of Maximum Strength and Acceleration Ability on Performance and Training in Wheelchair Sports

The goal of this observational study is to learn about the relation between grip position and maximal strength and power in wheelchair rugby and basketball athletes. The main question is to investigate the relationship between maximal isometric force, acceleration, and sprint time.

Participants will

* pull in their sport wheelchair against a force transducer
* push in their sport wheelchair from a force transducer
* accelerate as fast as possible with one push
* accelerate as fast as possible over a distance of 20m

Researchers will compare the wheelchair basketball against wheelchair rugby players to see if there is a difference in the parameters.

The study duration is approximately 2 hours per participant. First, the screening will be done and the participant does a warmup (\~30 min). After that, the participant gets ready for testing, which will last for approximately 90 minutes. In each test, the participants have trial rounds to familiarize with the test procedure. The testing consist of three different exercises, the isometric strength test (IsoMST), the maximum initial push propulsion (MIPP) and the sprint. In the IsoMST a pull setup which was already used in literature and a push setup which has yet to be validated will be used. For the pull setup, the chair of the athlete is fixated on the wall which results in a static situation and allows for an isometric effort. For the push setup, a bumper is installed on the wall, against which the athletes can push with their chair. Different grip position will be measured. In the MIPP test the participants are instructed to accelerate as quickly as possible from standstill with only one push on the rim. The MIPP will be executed with several different grip positions, equal to the IsoMST. For the sprint, 20m will be marked out on a playing court. The athletes are instructed to complete the distance as quickly as possible. Several split times as well as the total time will be measured.

Eligibility Criteria:
Inclusion Criteria:

* squad members or doing more than 3h per week wheelchair basket/rugby training
* adequately informed and consent confirmed per signature

Exclusion Criteria:

* Pregnancy based on anamnesis
* acute illness, injury, infection, etc., which would impact the measurements.
Surveillance of Association of Immune Status and Prognosis of CNS Germ Cell Tumor Survivors

Platinum-based chemotherapy, alternating at 21-days intervals with cycles of ifosfamide, cisplatin, and etoposide (ICE) and subsequently received radiotherapy were considered as standard treatment for intracranial germ cell tumors. However, whether reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with CNS germ cell tumors before and after chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of therapy.This study is designed to prospectively analyze the dynamic changes of immune status, prognosis and society function after standard treatment in patients with intracranial germ cell tumor.

Immune status influences the reaction of anti-tumor and health condition of intracranial germ cell tumor patients. Peripheral blood and cerebrospinal fluid lymphocytes subsets, cytokines reflects those and be measured. Therefore, we designed the study to estimate patients health condition and survival outcomes in order to provides diversified assessment methods.

Peripheral blood will be collected from patients who will undergo surgery and/or neoadjuvant or adjuvant chemoradiotherapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of an intracranial germ cell tumor (Histologically confirmed intracranial non-germinomatous or germinoma germ cell tumor).
* Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm.
* No history of anti-tumor treatment
* Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
* Be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria:

* Patients with immune function deficiency : immunosuppression status, including autoimmune disease, post-operation of organ transplantation, in-taking immunosuppressive drug, human immunodeficiency virus (HIV) positive patients,
* Known history of active tuberculosis not adequately treated or positive QuantiFERON TB Gold test.
* Hypoproteinemia (eg, in case of severe liver disease or nephrotic syndrome) with serum albumin \<3.0 g/dL.
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer

The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.

The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.

The primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic Adenocarcinoma, histologically and/or cytologically proven
* Locally advanced pancreatic cancer, surgically non resectable
* No distant metastasis
* Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis
* ECOG performance status : ≤ 2
* Primary tumor visible on CT-scan
* Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)
* White blood cell count \> 3000 /uL, Neutrophils \> 1500 /uL, Platelets \> 100 000/uL, Hemoglobin \> 95 mg/L, Total bilirubin \< 1,5 normal limit, AST/ALT \< 2,5 normal limit, normal creatinin
* ≥ 18 years of age
* Signed informed consent

Exclusion Criteria:

* Prior abdominal radiation therapy
* Connective tissue disease (scleroderma, lupus)
* Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.
Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients with diffuse brain lesions and clinical outcomes.

This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the internal carotid artery and intravenously.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females between Age 18 and 80 years.
* Patient with current diagnosis of Diffuse Brain Lesions with cognitive and/or functional impairment
* MRI not showing gross atrophy or any other pathology of brain.
* Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

* Contraindication for MRI
* General medical contraindications for minor surgery or angiography
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. Patients known to have tested positive will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg;
* Resting heart rate \> 100 bpm;
* Active clinical infection within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Renal Manifestations During Idiopathic Inflammatory Myopathies

There are currently no recommendations regarding treatments for Idiopathic Inflammatory Myopathies (IIM) due to the difficulty in conducting high-powered randomized controlled trials.

Generally speaking, corticosteroids constitute one of the cornerstones of treatment and are, with some exceptions, always used at least in the initial phase of the disease. In general, this involves oral corticosteroid therapy initiated between 0.5 and 1.5 mg/kg/day followed by a gradual decrease after 4 to 6 weeks of treatment. It is generally necessary to introduce immunosuppressive treatment early with the aim of avoiding corticosteroids. The most commonly used as first-line treatment and having shown effectiveness in observational studies are methotrexate, azathioprine, mycophenolate mofetil and calcineurin inhibitors. In general, rituximab is reserved for severe forms refractory to several first-line immunosuppressants, and has shown some effectiveness during a randomized study. Likewise, cyclophosphamide is only considered in the most severe forms, generally rapidly progressive interstitial lung damage. More recently, Janus kinase inhibitors have been evaluated in several open-label and small-number studies, showing interesting effectiveness, particularly for refractory forms, as shown in this recent review of the literature. Immunoglobulins are the only treatment that has shown superiority compared to placebo in good quality randomized controlled studies. However, due to their cost and difficulty of access, they should be reserved for the severe form, particularly in cases of dysphagia, or refractory form.

Apart from these medicinal treatments, it is necessary to add all the non-drug measures which are an integral part of the management of IIM. Performing regular physical activity helps prevent muscle loss and also has a beneficial effect on other comorbidities often present in patients and aggravated by corticosteroid therapy, such as cardiovascular risk factors, osteoporosis and resistance to 'insulin.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥ 18 years old)
* Inflammatory myopathy defined by the ACR/EULAR 2017 criteria
* Kidney biopsy performed
* Supported at the Strasbourg University Hospital during the period from January 1, 1990 to May 1, 2023.
* Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

It is the responsibility of the investigator to verify the absence of opposition in the patient's medical file.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Known etiology of renal damage excluding inflammatory myopathy.
Randomized, Multicenter, 2-Dose Level. Open-Label, Phase IIa Study With the Intraperitoneally Infused Trifunctional Bispecific Antibody Removab(TM) (Anti-EpCAM x Anti-CD3) to Select the Better Dose Level in Platinum Refractory Epithelial Ovarian Cancer Patients

Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.EpCAM is expressed in a large number of epithelial ovarian cancer, fallopian tube or peritoneal cancer tissues. Thus targeting these cancers with an anti-EpCAM antibody is a promising innovative therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

women 18 years and older histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum measurable disease signed and dated informed consent one or two prior chemotherapies, the last platinum containing platinum refractory disease ECOG performance status 0-2

Exclusion Criteria:

acute or chronic infections previous treatment with mouse monoclonal antibodies known or suspected hypersensitivity to removab inadequate renal function inadequate hepatic function ileus cachectic patients
Evaluation of Contact Phase Activation During Hemodialysis

Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.

During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with hemodialysis since at least three months.
* Hemodialysis treatment schedule of 3 x 4 hours weekly.
* Arteriovenous fistula (AVF) use for vascular access.
* Treatment with oral acetylsalicylic acid 80 or 100mg q every day.
* ≥ 18 years of age.
* Patients able and agree to provide signed informed consent.

Exclusion Criteria:

* Use of vitamin K antagonists or novel oral anticoagulant therapy.
* Use of chronic heparin treatment, UFH or LMWH.
* Use of clopidogrel.
* Use of ACE-inhibitors.
* Known allergy against one of the dialysis membranes used during this study (PMMA: BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).
* Known heparin-induced trombopenia type 2.
* Active infection and/or ongoing systemic antimicrobial treatment.
* Presence of central venous catheter, tunnelled or non-tunnelled and/or AV graft.
* Hospitalized patients.
* Planned surgery during study period.
* Mean Qb of \<300ml/min during one of the last 3 dialysis sessions before inclusion.
* Vascular access dysfunction defined as (a) known AV access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion.
* Planned conversion of dialysis modality during study period.