cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy

The goal in this work is to compare between the effects of intraperitoneal versus intramuscular neostigmine on pattern of postoperative GIT motility in patients undergoing laparoscopic cholecystectomy

Despite numerous advances in surgical technique and perioperative care, postoperative ileus (POI) continues to be one of the most common and expected aspects of abdominal surgery. It prolongs hospital stays, increases medical costs and frustrates patients and surgeons.

Many authors suggest that POI is a mandatory phase of the recovery period for any intra-abdominal procedure, and only an ileus lasting greater than 5 days is abnormal - to be termed a prolonged POI.

Under this definition, fully 40% of patients undergoing laparotomy experience prolonged postoperative ileus.

In 2006, different types of postoperative ileus (primary, secondary, recurrent, prolonged) were defined through consensus, and prolonged postoperative ileus was defined as absence of bowel function after the third postoperative day for laparoscopic surgery and after the fifth postoperative day for open abdominal surgery.

What constitutes prolonged postoperative ileus is debated, with many different definitions reported; consequently reported incidences range from 3% to 32%. Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction, thereby increasing contractions in the normal gut.

Eligibility Criteria:
Inclusion Criteria:

ASA status I and II patients, aged between 20 and 60 years, who are scheduled for laparoscopic cholecystectomy.

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Exclusion Criteria:

Patients with electrolyte imbalance Patients with diabetes mellitus Patients who are addict to opioids Patients with neurological defects or paralysis or preoperative recumbence. Patients with atrial-ventricular conduction disturbances, sinus bradycardia \< 60 BPM or a nodal rhythm.
The COSMOS Trial. A Pilot Study A Pilot Study

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. Data obtained in the proposed pilot cohort will guide design of a future robust randomized trial comparing clinical interventions and serious complications with blinded versus unblinded continuous ward monitoring.

The investigators plan a pilot study to evaluate patient tolerance of the GE Portrait Mobile Monitoring Solution, along with appropriate alert thresholds, and clinical utility. The system is a novel battery-powered untethered monitor for continuous monitoring of oxygen saturation, respiratory rate, and pulse rate that is designed for use by patients on surgical wards. The initial phase will evaluate patient tolerance, with clinicians and patients blinded to monitor data. Results will be used to evaluate the frequency of respiratory events and pulse rate abnormalities. These data will be used to design clinical alert settings, based on various durations at various thresholds (e.g., saturation \<85% for \>1 minute). Our main goal will be to identify clinically meaningful vital sign abnormalities with a minimum of false alerts. Secondarily, the investigators will evaluate the frequency and duration of abnormalities, and the fraction that are detected clinically.

In the second phase of the pilot, clinicians will be unblinded to the GE Portrait monitors, and alerts provided based on the durations and threshold identified in the initial part of the pilot. The primary outcomes will be clinician tolerance and the extent to which clinicians believe that vital sign trending and alerts provided useful information rather than distraction. Specifically, the investigators will assess the fraction of alerts that clinicians deemed meaningful, and the fraction that resulted in clinical interventions. In the third phase of the pilot, the durations and thresholds for saturation, respiratory rate, and pulse rate that trigger alerts will be adjusted based on results from the second phase.

Eligibility Criteria:
Inclusion Criteria:

* Are admitted to one of the wards equipped with the GE Portrait Mobile Solution.
* Are designated American Society of Anesthesiologists physical status 1-4.
* Had major noncardiac surgery lasting at least 1.5 hours.
* Are expected to remain hospitalized at least two postoperative nights.
* Had general anesthesia with or without neuraxial anesthesia.

Exclusion Criteria:

* Have language, vision, or hearing impairments that may compromise continuous monitoring.
* Are designated Do Not Resuscitate, hospice, or receiving end of life care
* Have previously participated in the study.
Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma

Proposed treatment of subjects with newly diagnosed glioblastoma with novel personalized drug regimens identified to be effective in vitro using cancer stem cells derived from their individual tumors, alongside standard of care radiation and TMZ.

A panel of FDA approved drugs will be tested by high throughput screening, which is CLIA certified allowing for clinical decisions based on the results, to identify a combination of up to 3 drug candidates for treating individual patients. Lead candidates will be evaluated by pharmacists and a team of physicians, to confirm that prescribed drugs do not utilize pharmacological/ metabolic pathways that are known to increase the likelihood of toxicity, prior to initiating treatment. Investigational drug therapy, targeting CSCs, will be initiated alongside standard of care chemoradiation with TMZ.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of GBM (WHO grade 4)
* Subjects ≥18 years of age
* Patients must have a life expectancy of \>6 months
* Patients must have a surgically accessible tumor with the intent for a gross or near total resection of the tumor mass (GBM, WHO grade 4)
* Patients must have a KPS rating of ≥70
* Patients should not have received any prior systemic anti-cancer therapy
* Patients must be negative for HIV, Hepatitis B and C
* Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:

  * Hemoglobin (Hgb)\> 8 g/dL
  * Absolute Neutrophil Count (ANC) \> 1,000/mm3
  * Platelet count \> 100,000/mm3
  * Creatinine \< 2 mg/dL
  * Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 3x upper limit of normal (ULN)

Exclusion Criteria:

* Metastatic disease
* Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
* Serious intercurrent medical illness
* Inadequately controlled hypertension
* History of myocardial infarction or unstable angina within 6 months
* History of stroke or transient ischemic attack within 6 months
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion Criteria:

* Current treatment with any chemotherapy other than imatinib.
* Current treatment with any dose of imatinib other than 400 mg
Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve.

The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during DSA in lower extremity diagnostic angiographies with non-inferior image quality.

The aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography.

The project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional DSA using a standard care protocol (Siemens Artis Zee, Extremities Care setting, 1.2 µGy/frame) (Group B) and a study group examined by means of DVA using a low-dose protocol (0.36 µGy/frame corresponding to 70% decrease of radiation dose) (Group A). During each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. Qualitative image review is done to compare conventional DSA and reduced radiation exposure DVA images after image acquisition.

Our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lower limb peripheral arterial disease, admitted for diagnostic angiography
* Fontaine II- IV
* Normal renal function: GFR\> 60ml/min/m2
* Age \> 18

Exclusion Criteria:

* Acute myocardial infarction
* Severe heart/liver/renal failure
* Iodine contrast allergy
* Atrioventricular block
* Coagulopathy and Hematological Bleeding Disorders
Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction

Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth muscles help in the treatment of resistant erectile dysfunction not responding to medical and injection therapy, thus avoiding surgical treatment options.

The treatment group will be injected intracavernously with 50 units of BTX-A. The control group, 12 patients, will be injected with a normal saline injection.

24 males with will be included in the study. All will be subjected for full history taking, general and genital examination. Penile duplex will be performed to assess a vascular etiology before the treatment and 2 weeks later. The patients will be randomized into a treatment group (12 patients) and a control group (12 patients).

All patients will sign an informed consent. The treatment group will be injected IC with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for color Doppler assessment, followed, next day by 50 units of BTX-A. The control group, 12 patients, will be injected with the trimix solution during penile color Doppler assessment followed next day with a normal saline injection. The erection hardness score (EHS) will be assessed during the Doppler exam.

Procedure: At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units of BTX-A. Direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.

Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the the Sexual Encounter Profile questions 1 and 2 (SEP 2 \& SEP 3), and the global assessment question (GAQ) before and 4 weeks after treatment.

The rational for selecting the minimum 2-weeks waiting period is to give a chance for the BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections.

Eligibility Criteria:
Inclusion Criteria:

* 24 males will be included in the study recruited from Andrology, Sexology \& STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular ED proved by penile duplex.
* Unable to develop erections sufficient for intercourse.
* Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
* Age between 40 to 70 years.

Exclusion Criteria:

* Significant cardiovascular disease interfering with sexual activity
Sleep Buddy Application in Hospitalized Children

The study was planned as a randomized controlled experimental study to investigate the effect of sleep companion application on psychosocial symptoms in hospitalized school children aged 6-12 years.

The sample of the study consisted of a total of 97 school-age children hospitalized in the Pediatrics and Pediatric Surgery-Endocrine Service of the Health Services Application and Research Hospital of a university hospital and in the Pediatrics Service of a state hospital. Children who met the inclusion criteria and whose written and verbal consent was obtained from their parents for participation in the study after being informed were included in the study.

The study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.

Data were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.

The toy, which was selected as a sleep companion for the children in the experimental group, was introduced to the children and accompanied them for 3 days during their hospitalization. The experimental and control groups were observed for psychosocial symptoms.

The data will be analyzed with SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized school-age children (6-12 years old),
* No mental disability,
* Volunteer to participate in the research,
* No allergies,
* Children who are hospitalized for at least 3 days

Exclusion Criteria:

* Hospitalized children under 6 years of age and over 12 years of age,
* Predicted discharge in less than 3 days,
* Children with a sleeping companion
Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population.

However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy.

This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Age \>= 18 years.
* Histologically or cytologically documented inoperable, locally advanced (stage IIIb with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.
* Patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment.
* ECOG PS 0-2.
* Adequate hematological function: hemoglobin =\> 9 g/dl; neutrophils count =\> 1.5 x 10(9)/l; platelet count =\> 100 x 10(9)/l.
* Adequate liver function: Bilirubin \<= 1,5 x ULN; AST and ALT \<= x 3 ULN when no hepatic metastases or \<=5 x ULN if hepatic metastases; Alkaline phosphatase \<=5 x UNL except that there is hepatic metastases.
* Adequate renal function: Calculated creatinine clearance =\> 40 mL/min (Cockroft y Gault) or serum creatinine \<= 1.5 x ULN .
* Patient able to meet the requirements of the study and accessible for correct follow-up.
* Oral swallowing capability.

Exclusion Criteria:

* Previous treated with more than one chemotherapeutic treatment for NSCLC
* Concomitant treatment with another drug under investigation.
* Pregnancy or lactation. Fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. In addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study.
* Evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
* Contraindication for the use of erlotinib or docetaxel.
ADenoVirus Initiative Study in Epidemiology in Italy

The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Italy. The planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms.
* Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data.
* No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).

Exclusion Criteria:

* Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result.
* Previous enrolment in the present study.
* Any direct involvement with the study conduct at site or any family link with study site staff.
Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

This study aims at evaluating efficacy and safety of Vonorazon and amoxicillin dual therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Vonorazon and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 18\~70, both gender. 2. Patients who had failed H.pylori eradication therapies . 3. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

* 1. Patients who have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.

  2. Contraindications to study drugs. 3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

  4. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).

  5. Pregnant or lactating women. 6. Underwent upper gastrointestinal Surgery. 7. Dysphagia. 8. Evidence of bleeding or iron efficiency anemia. 9. A history of malignancy. 10. Drug or alcohol abuse history in the past 1 year. 11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

  12. Mental disorder. 13. Enrolled in other clinical trials in the past 3 months. 14. Refuse to sign informed consent.
Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial

The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:

What is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?

Patients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.

Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.

Based on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).

Exclusion Criteria:

* Missing or incomplete informed consent.
* age below 18 years