cyrilzakka/clinical-trials huggingface dataset:
Pronostic Value of Gap CO2 During Cardiac Pulmonary Bypass in Cardiac Surgery: a Multicenter Retrospective Study

Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In this study, the investigators aim to explore the use of gap CO2 during cardiac surgery and its relation with CSA-AKI. In order to explore this association, the invetigators built a retrospective, multicentric study. All patient who underwent cardiac surgery with cardiopulmonary bypass in two French ICU between 03/2019 and 04/2023 and for which information about gap CO2 during CPB is available will be included. After inclusion, patient will be divided in two groups according to the presence or absence of an elevated gap CO2. Occurence of CSA-AKI and other outcomes will be compared between groups, using multivariate analysis.

Cardiac surgery associated acute kidney injury (CSA-AKI) is one of the most frequent and severe complications after cardiac surgery. The association between acute kidney injury and the mismatch between oxygen consumption and delivery has been well established during cardiopulmonary bypass (CPB) and contributes to the development of CSA-AKI. In order to explore this association, investigators build a retrospective study including all patients who underwent cardiac surgery requiring CPB in two French hospitals and for which data about gap CO2 during CPB is available. Patients will be divided into two groups according to the presence or absence of an elevated gap CO2 during CPB, defined as \> 6 mmHg. The primary outcome is the occurrence of CSA-AKI, defined by KDIGO recommendations, according gap CO2. Secondary outcomes include others post-operative complications as defined by international guidelines. Performance of gap CO2 to predict CSA-AKI will be evaluated by calculating the Area Under the Curve (AUC) of the associated ROC curve. We'll also assess the correlation between gap CO2 and other perfusion parameters (lactate, svO2) and with mean DO2 during CPB.

Eligibility Criteria:
Inclusion criteria:

1. Informed patients who did not object to the use of their data in the study.
2. Patients undergoing cardiac surgery with extracorporeal circulation.
3. Patients for whom a pCO2 gap measurement is available during ECG.

Non-inclusion criteria :

1. Heart transplant patients
2. Patients who have received long-term cardiac assistance
3. Minor patients
Data Bank for Eosinophilic Disorders

The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders \[EGID\] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis \[EE\], eosinophilic colitis, and eosinophilic gastroenteritis \[EGE\]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.


Eligibility Criteria:
Patients with an eosinophil associated gastrointestinal disorder (EGID), family members of patients with EGID, or normal controls.
Effect of Intraoperative Infiltration With Bupivacain on the Development of Chronic Pain After Inguinal Hernia Repair

The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.

264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).

In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) with primary or recurrent single or double sided symptomatic but not incarcerated inguinal hernias with an elective hernia repair are included.
* No other interventions (i.e. umbilical hernia) are allowed.
* Written informed consent needs to be obtained.

Exclusion Criteria:

* Patients with legal incompetence,
* Pregnant and nursing women,
* Patients with presence or history of active malignancy or systemic diseases,
* Under immunosuppressive treatment,
* With systemic or severe local inflammation or infection,
* With wound healing disorders and with physical or mental incapacity, which makes it impossible to obtain informed consent are excluded.
* As pacemakers interfere with the electrical stimulation of the Pain Matcher® and vice versa patients with pacemakers or other implanted electrical devices were also excluded.
Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery

Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre.

Interviewing senior surgeons trained for doing robot-assisted surgery, this qualitative study is expected to provide new insights to understand the surgeons' behavioral changes when using a robot.

This study will contribute to improving training programs in robot-assisted surgery.


Eligibility Criteria:
Inclusion Criteria:

* Senior abdominal and pelvic cavity surgeons (i.e., visceral surgeons, gynecologist surgeons, or urologists).
* Having completed a robot-assisted training
* Commonly doing laparoscopic surgery

Exclusion Criteria:

* Those who refuse to participate in the study
Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology

Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates.

Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.


Eligibility Criteria:
COHORT 1

Inclusion Criteria:

* Histologically confirmed cutaneous or mucosal melanoma (per American joint committee on cancer (AJCC) staging system) that is unresectable or metastatic
* No prior systemic anticancer therapy for unresectable/metastatic melanoma or clinical/radiological disease progression (RECIST1.1) if previously treated and before new treatment
* No prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as cutaneous carcinoma or cervix)
* followed in Saint Louis Hospital
* Tumor tissue available in Saint Louis Hospital
* Subjects must have signed and approved written informed consent form
* No pregnancy
* Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus

Exclusion Criteria:

* None

COHORT 2 :

Inclusion Criteria :

* Histologically confirmed cutaneous or mucosal melanoma
* Candidates for sentinel lymph node analysis and surgical recovery (this examination is in practice reserved for melanomas \>1mm thick or ulcerated)
* No prior adjuvant anticancer therapy
* followed in Saint Louis Hospital
* Tumor tissue available in Saint Louis Hospital
* Subjects must have signed and approved written informed consent form
* No pregnancy
* Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus

Exclusion Criteria:

* None
SPSIP Block in Breast Surgeries for Postoperative Analgesia

The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.

Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.

Eligibility Criteria:
Inclusion Criteria:

* Female patients who will undergo breast surgery

Exclusion Criteria:

* unstable patients
* patients with bleeding disorders
* Patients allergic to local anesthetic drugs
* Patients who did not agree to participate in the study
* Patients with infection at the application site
Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anasthesia Depth on Quality of Convulsion

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. The goal is to find an anaesthesia-depth that is needed for the well-being of the patient and allows a good ECT.

In daily routine the dose of anesthetic agents and the assesment of anesthesia-depth is based on the subjective estimation of the anesthetist and also on ealier interventions.

The aim of the study is to assess any correlation between measured anesthesia-depth using the Narcotrend TM and the Quality of the ECT.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) Physical Satus I-3
* \>18 years \< 90 years
* Signed informed consent

Exclusion Criteria:

* Refusal of the patient
Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-301.
2. Study Pelle-926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.
3. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.
4. Female subjects must have a negative pregnancy test. For Study 301 subjects a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.
5. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective. Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of investigational product (IP).
6. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.
7. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.
8. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.

Exclusion Criteria:

1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
2. The subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned (while enrolled in this study) participation in an experimental drug study (excluding Study 301).
3. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
4. The subject is pregnant or breastfeeding.
Risk Factors of Primary Fibromyalgia

Fibromyalgia (FM) is a condition with a different non-specific symptoms which lead to a difficult diagnosis. Study suggests that osteopathy can help in improving FM symptoms, nevertheless, it can be difficult to identify which patients may benefit. The knowledge of FM risk factor can be useful tool for osteopaths and other clinician to implement a targeted, fast and multidisciplinary treatment protocol for those kind of patient.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* Patient from Piedmont
* age between 20 and 65 years old
* inform consent
* for case group primary or secondary fibromyalgia

Exclusion Criteria:

* systemic or rheumatic or neoplastic diseases
* for control group the presence of primary or secondary fibromyalgia
Use of Specifically Designed Drills for Internal Sinus Lifting

This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.

This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.

All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).

Eligibility Criteria:
Inclusion Criteria:

* Unilaterally or bilaterally missing teeth in the posterior maxilla,
* Residual bone height (4 mm to 6 mm),
* Completed periodontal and oral hygiene treatment,
* American Society of Anesthesiologists (ASA) score of I or II,
* \> 18 years old,
* Willingness to participate

Exclusion Criteria:

* Infection or pathology related to maxillary sinus and surgical site,
* Tooth extraction within six months in the surgical site,
* Previous maxillary sinus surgery,
* Parafunction,
* Medical conditions associated with impaired or delayed wound healing,
* Smoking habit and alcohol or drug abuse,
* Pregnancy or nursing
Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC

Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -

Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.

-
Trial of Gemcitabine and Cisplatin in Patients With Inoperable Biliary Tract Carcinomas

The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean patients with biliary tract (bile tracts of the gallbladder or liver) cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder, intra/extrahepatic bile ducts or papilla of Vater with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy.
* Disease status must be measurable disease defined as: Bi-dimensionally measurable lesions with clearly defined margins and two perpendicular diameters that are clearly measurable by following:

  * Computerized tomography (CT) or magnetic resonance imaging (MRI), with one diameter 2.0 cm or greater and the other diameter 1.0 cm or greater.
  * Palpable Lesion, with both diameters 2 cm or greater. Disease progressing in areas of prior radiation therapy may be included.
* Patients must have received no prior chemotherapy for advanced disease.
* Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment
* Severe neurological or mental disorder.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Poorly controlled diabetes mellitus.
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System

Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis.

Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Meets one of the following criteria:

  1. detectable HIV RNA and detectable HCV RNA
  2. undetectable HIV RNA (treated) and detectable HCV RNA
  3. undetectable HIV RNA (treated) and undetectable HCV RNA
  4. undetectable HCV RNA (mono-infected)
  5. detectable HCV RNA (mono-infected)
  6. detectable HIV RNA (mono-infected)

Participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria.

Exclusion Criteria:

* None