cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors

Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.


Eligibility Criteria:
Inclusion Criteria:

The patients must fulfill all the following criteria:

* Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme, glioma grade 4 at time of first diagnosis).
* Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy.
* Medically capable of undergoing the planned surgical gross total resection and the catheter placement.
* Age ≥ 18.
* Karnofsky Performance Status of ≥ 70%.
* Life expectancy of ≥ 3 months.
* Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement.
* Patients must be capable of taking, or already taking, anticonvulsant medication.
* Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution.

Exclusion Criteria:

Patients fulfilling any of the following criteria should not be enrolled in the study:

* Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
* Any form of brain radiation within 10 weeks of the start of the infusion.
* Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
* Prior intracavitary biologic response modifiers or monoclonal antibodies.
* Uncontrolled seizures.
* Bilateral or multifocal tumors.
* Evidence of cerebral uncal herniation.
* Midline brain shift on MRI scan of \> 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
* Tumors involving the brainstem or cerebellum.
* Diffuse subependymal or CSF disease.
* Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrheic for at least 12 months to be considered non-childbearing.
* Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
* Prior or concurrent investigational treatment within 30 days of study entry.
* Active infection requiring treatment or having an unexplained febrile illness.
* Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
* Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).
Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery

This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are:

1. Do antibiotics reduce pain following third molar surgery?
2. Do antibiotics influence facial swelling and the patient\&#39;s ability to open their mouth?
3. Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?

Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures:

Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care.

Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery.

Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point.

By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy people (ASA I \&amp; II)
* Older than 18 years
* No history of viral or microbial diseases during the last four months
* No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
* No history of anti-inflammatory or contraceptive drugs use during the last month
* Not being in pregnancy or nursing period for women
* Having at least one unerupted mandibular wisdom tooth needs surgical intervention

Exclusion Criteria:

* History of dental pain, inflammation, or abscess during the last month
* thyroid hormone therapy
* unwillingness to participate in the study.
Effects of Supplementation With Linseed Oil on Blood Lipids in Vegetarians

The study was performed to investigate the effects of a daily consumption of linseed oil on fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.

Recent studies suggest that the daily intake of n-3 LC-PUFA (EPA and DHA) can modulate cardiovascular risk factors and prevent lifestyle diseases.

The major dietary source of EPA and DHA is seafood (seaweeds and fatty cold water fishes), but they can also be found in lean red meat, in organ meats such as liver and brain. Vegetarians who do not eat meat or fish, have very low or negligible intakes of EPA (\< 5 mg EPA/d) and DHA.

The purpose of the present study is to explore the tissue distribution and inter-conversion of ALA to n-3 LC-PUFA as consequence of linseed oil supplementation in vegetarians.

Eight vegetarians (3 m; 5 f) who do not eat meat, fish or seaweeds such as algae foods since least two years ago and two subjects (1 m; 1w) who consume the normal western style diet living in Jena (Germany) entered the study. The participants consumed 10 mL linseed oil per day for 10 weeks. The resulting daily dose of ALA was approx. 5.7 g/d.

Eligibility Criteria:
Inclusion Criteria:

* for the vegetarian sub-group : vegetarian diet pattern

Exclusion Criteria:

* high performance sport, daily alcohol intake and the in-take of dietary supplements (e.g., fish oil capsules)
* for the vegetarian sub-group, the consumption of fish and algae products (e.g. seaweeds, sushi)
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial

the main objective of the study is to compare endoscopic transcanal tympanoplasty with attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of limited attic cholesteatoma.


Eligibility Criteria:
Inclusion Criteria:

* Cases of cholesteatoma limited to the middle ear and/or attic but not extending beyond the posterior end of the lateral semicircular canal (LSCC) proved radiologically with computed tomography (CT) scan

Exclusion Criteria:

* Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach
Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~75 years old, both male and female;
2. Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
3. Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
4. At least one measurable lesion based on RECIST v1.1 criteria;
5. Barcelona clinic liver cancer: Stage B or C;
6. ECOG PS score: 0-1 points;
7. Child-Pugh score: ≤ 7;
8. Expected survival period ≥ 3 months;
9. Adequate organ function.

Exclusion Criteria:

1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
2. Patients with any active, known or suspected autoimmune disorder;
3. Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
4. With known severe allergic reactions to any other monoclonal antibodies;
5. Patients with known CNS metastasis or hepatic encephalopathy;
6. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
7. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
8. Patients with other malignancies currently or within the past 5 years;
9. Patients with hypertension which cannot be well controlled by antihypertensives;
10. Uncontrolled cardiac diseases or symptoms;
11. Patients with other potential factors that may affect the study results.
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.

Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.

Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.

This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection

Exclusion Criteria:

* Emergency surgery
* Liver transplantation
* Preoperative hemodialysis
* BMI \> 30
* Renal depth (distance from the capsule of the kidney to the skin surface) \> 4 cm
* Unable or failed to sign the informed consent
Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.


Eligibility Criteria:
Inclusion Criteria

* The subject is at least 18 years of age.
* The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response).
* The subject has not received first line therapy for treatment of NSCLC.
* The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
* The subject is able to self-administer or has a caregiver who can reliably administer SC injections.
* The subject must have adequate bone marrow, renal and hepatic function as follows:

  * Bone marrow: White blood cell count (WBC) \>= 3,000/mm3; Platelets; \>= 100,000/mm3; Hemoglobin \>= 9.0 g/dL;
  * Renal function: Serum creatinine \<= 2.0 mg/dL;
  * Hepatic function: Bilirubin \<= 1.5 mg/dL; AST and ALT \<= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT \<= 5.0 x ULN.
* The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria

* The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
* The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
* The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
* The subject has received investigational therapy within four weeks prior to study drug administration.
* The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
* The subject has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a common problem facing public health and clinical practice.Metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).Researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.Nowadays, there are more and more studies on insulin resistance in the world. We have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance.

The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.


Eligibility Criteria:
Inclusion criteria

1. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):

   1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
   2. Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
   3. Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females.
   4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.
   5. Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
2. Age from 18 to 65 years.
3. Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.
4. If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention.

Exclusion criteria

1. Pregnant or breast-feeding.
2. Night shift workers.
3. History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event.
4. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite.
5. History of weight-loss surgery.
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (\< 2 years) and children, (2 years to \< 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms

Exclusion Criteria:

* Ileus or acute abdomen
* history of fibrosing colonopathy
* history of distal ileal obstruction without surgery
* solid organ transplant or surgery affecting the large bowel, other than appendectomy
Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (Therefore, attenuating the syndrome during anesthesia is of great importance.


Eligibility Criteria:
Inclusion Criteria:

* patients with end-stage liver disease who will undergo living donor transplantation.

Exclusion Criteria:

* Patients with a history of portopulmonary hypertension.
* Hepatopulmonary syndrome.
* Cirrhotic cardiomyopathy.
* Hepatorenal syndrome types 1 and 2.
The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery

The aim of this study is to examine the effects of bilateral sphenopalatine ganglion block on surgical conditions, hemodynamics, intraoperative and postoperative analgesic use, recovery characteristics, and postoperative pain during septorhinoplasty under general anesthesia. The study was planned as double-blind, randomized, controlled. 72 patients who will undergo septorhinoplasty surgery will be collected. (g power analysis was performed.) Evaluation of the effectiveness of bilateral sphenopalatine ganglion block was planned. Patients will be divided into 2 equal groups (36 patients). After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, the other group (group:2) will be administered 4 cc saline. aspects will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

- patients with an ASA score of I-II and between the ages of 17-45 years, who were to undergo general anesthesia with desflurane, were included in the study.

Exclusion Criteria:

* Patients aged \<17 and \>45 years, patients with liver and/or kidney failure, obese patients (BMI \>30), trauma patients, ASA III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.
Impact of Robotic Surgery on Systemic Immune-inflammation Index

Robotic surgery has been gaining attention because of the physical and metabolic morbidity of the conventional open technique.The systemic immune-inflammation index(SII) has emerged as a recent and more reliable biomarker.In our single-center retrospective cohort study, the investigators investigate SII in robotic gastrectomy in order to show the advantageous effect on immune system which the investigators think as the first study in the literature.

Patients who underwent robotic gastrectomy between January 2021 and September 2024 were included in the study. The primary outcome was to ascertain the beneficial effects of robotic surgery in gastric cancer patients in terms of immune response. The secondary outcome was to examine the reliability of SII as a serum biomarker in comparison to previous studies on the diagnosis and postoperative follow-up of gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

gastric cancer patients treated with surgery

Exclusion Criteria:

patients with haematologic malignancy, immune system disorder, antiplatelet drug usage, operations including splenectomy