cyrilzakka/clinical-trials huggingface dataset:
Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients

The purpose of this study is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy (UGE) in cirrhotic patients.

UGE is often performed in cirrhotic patients for the diagnosis and treatment of portal hypertension complications. Current data suggests that propofol sedation may have advantages over benzodiazepines. However, there are few reports comparing propofol versus midazolam in patients with liver cirrhosis. The study's objective is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic UGE in cirrhotic patients. A prospective randomized study will include cirrhotic patients (Child A, B or C and ASA 2 or 3), referred for diagnostic or therapeutic UGE, randomized for group I: propofol (0,5 mg/kg up to 400 mg) and fentanyl (0,05 mg); or group II: midazolam (0,1 mg/kg) and fentanyl. Sedation was performed by an exclusively dedicated gastroenterologist. Efficacy (completion of procedures), complications (hypoxemia, hypotension, arrhythmias) and recovery time (elapsed from the end of the procedure and discharge) will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis, any etiology
* ASA II or III
* Child A, B or C
* Age between 18 years and 75 years
* Patients that agree in participate of study and signed the contentment term

Exclusion Criteria:

* Schistosomiasis
* Recuse
* Hepatocellular carcinoma
* Contraindications to drugs
* ASA IV or V
* Hepatic encephalopathy, neurologic diseases
* Opioids, narcotics, MAO inhibitors or benzodiazepines use
* Alcohol abuse
Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients

The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of DentalVibe in pediatric patients.

This study is a crossover randomized controlled clinical trial where (N=60 ) children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. These children will be selected based on a need for local anesthesia for pulpotomy treatment on both sides of the mandible. All selected children will be randomly allocated into 2 groups. Group I (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional injection). Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment . Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).

Eligibility Criteria:
Inclusion Criteria:

* Age range from 5-7 years.
* Patients who are in need of pulpotomy dental treatment requiring bilateral local anesthesia in the mandible.
* Children free of any systemic disease or special health care needs.
* Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.

Exclusion Criteria:

* Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
* Signs of irreversible pulpitis or pulp necrosis.
* Radiographs show periapical or bifurcation radiolucency.
* Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
* Patients with acute oral or facial infection (swelling and/or cellulitis).
* Patients refusing to participate.
Adoptive Treatment of Advanced Hepatocellular Carcinoma With Allogeneic γδ-T Cells

Brief Summary: In this study, effects of γδ T cells on Advanced hepatocyte carcinoma The goal of this clinical trial is to learn about effects of allogeneic γδ T therapy in advanced hepatocyte carcinoma patients.

The main question it aims to answer is:Will advanced hepatocyte carcinoma patients be benefit from allogeneic γδ T therapy? Participants will received GDKM-100injection (allo-γδ T Cells) Infusion every two weeks.


Eligibility Criteria:
Inclusion criteria

1. Age is 18-75 years old, and gender is unlimited;
2. HCC was confirmed by pathological or clinical examination;
3. Patients with stage CNLCIII, IV primary HCC who are receiving second-line treatment / unable to receive existing treatments, or CNLCI and II of primary HCC patients who are unable to receive existing treatments;
4. Male subjects with partner women of childbearing age must have reliable, effective methods of contraception starting from the signing of the informed consent form until 120 days after the last dose of the study drug. Male subjects with a pregnant spouse must use condoms without other contraceptive methods;
5. Participants volunteered to join the study, signed an informed consent, had good compliance, and cooperated with the follow-up.

Exclusion criteria

1. Gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome;
2. Accept other cellular or immune clinical experiments within 8 weeks before enrollment;
3. Immunological deficiency, a known immunosuppressive disease or HIV;
4. Active infection, unexplained fever;
5. Serious or unstable heart, lung, kidney and hematopoietic system diseases;
6. Autoimmune diseases, such as rheumatoid arthritis;
7. Neurological diseases, diffuse leptomeningeal diseases; combined with neurodegenerative diseases;
8. Hormone use during cell therapy: dexamethasone dose exceeds 2mg / day during immunotherapy;
9. Pregnant or lactating women;
10. The subject had a known history of psychotropic substance abuse or drug use; he had stopped drinking Patients can be enrolled; 11 In the judgment of the investigator, the subject has other factors that may cause the forced termination of the study, such as other serious diseases or serious abnormal laboratory examination or other family or social factors that will affect the subject's safety of the subject, or the collection of trial data and samples.
Comparison Volume-controlled Ventilation, Pressure-controlled Volume-guaranteed Ventilation, and Pressure-controlled Ventilation During Gynecologic Laparoscopic Surgery in the Steep Trendelenburg Position

Objective:

This study aimed to compare the effects of three different mechanical ventilation modes-Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), and Pressure-Controlled Volume-Guaranteed Ventilation (PCV-VG)-on pulmonary and hemodynamic variables during laparoscopic gynecologic surgery in the steep Trendelenburg position. The hypothesis was that PCV and PCV-VG would be superior to VCV in optimizing respiratory mechanics and improving oxygenation, particularly by reducing peak inspiratory pressure (Ppeak).

Methods:

Prospective, randomized, controlled clinical trial. Sixty ASA I-III patients aged 20-65 years undergoing elective laparoscopic gynecologic surgery in the steep Trendelenburg position were included (20 patients per ventilation group).

Patients were randomized into VCV, PCV, and PCV-VG groups. Intraoperative ventilation was performed with a tidal volume of 8 mL/kg, PEEP of 5 cmH2O, and intra-abdominal pressure maintained at 12-14 mmHg.

Data were collected at four time points: T1 (after induction, supine), T2 (30 min after CO2 insufflation, Trendelenburg), T3 (60 min after pneumoperitoneum), and T4 (after CO2 deflation, supine).

Primary outcome: Ppeak comparison between groups. Secondary outcomes: Dynamic lung compliance (Cdyn), mean inspiratory pressure (Pmean), gas exchange, and hemodynamic parameters.


Eligibility Criteria:
Inclusion Criteria:

* The study included patients aged 20-65 years
* Classified as American Society of Anesthesiologists (ASA) physical status I or III
* who were scheduled to undergo an elective laparoscopic gynecologic surgery with pneumoperitoneum lasting at least one hour in the steep Trendelenburg position.

Exclusion Criteria:

* morbid obesity (BMI \> 40 kg/m²)
* pulmonary or cardiac diseases (e.g., chronic obstructive pulmonary disease, heart failure)
* a history of difficult intubation
* Patients requiring conversion to laparotomy or experiencing hemodynamic instability during surgery
Autologous Fecal Therapy

Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.


Eligibility Criteria:
Inclusion Criteria:

Healthy Adults 18-70 years of age-

Exclusion Criteria:

history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -
Behavioral and Neuronal Correlates of Human Mood States

Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 65
* Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
* No medical or surgical contraindication to electrode implantation
* Patient capable of understanding the scope of our project or signing informed consent independently.

Exclusion Criteria:

* Diffuse epilepsy involving several lobes of the brain
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.


Eligibility Criteria:
Inclusion Criteria:

* HCV chronic infection
* Treatment naive and treatment experienced (previous interferon treatment)
* No cirrhosis or compensated cirrhosis

Exclusion Criteria:

* Co-infection with Hepatitis B (HBV)
* Other associated chronic liver illness
* Patients with history of hematemesis (non-cirrhotic portal hypertension)
* Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
* Patients on drugs known to interact unfavorably (Amioidarone, ..)
Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Compatibility of the topotecan therapy in combination with carboplatin.

The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* patient with ovarian cancer after primary therapy
* bone marrow function leukocytes \>= 4,0 x 109/ l, platelets \>= 100 109/l, hemoglobin \>= 9 g/dl
* renal function creatinin \<= 1,5 mg% or creatinin clearance \>= 60 ml/min
* liver function bilirubin \<= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
* ECOG \<= 2
* Intention of regular follow-up visits for the duration of the study
* written informed consent

Exclusion Criteria:

* any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
* ECOG \> 2
* patients with radiotherapy within the last 4 weeks
The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block

It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used
PM8002 in the Treatment of Patients With Advanced Solid Tumors

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
2. Male or female aged 18 to 75 years;
3. Patients with malignant tumor confirmed by histology or cytology;
4. The toxicity of previous anti-tumor therapy has not been alleviated；
5. Adequate organ function；
6. ECOG score was 0-1;
7. Expected survival \>=12 weeks;
8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

Exclusion Criteria:

1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
2. Evidence of major coagulopathy or other obvious risk of bleeding;
3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
4. Patients with uncontrolled brain metastases should be excluded from this clinical trial;
5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
8. Syphilis antibody positive;
9. Patients with active tuberculosis (TB) are excluded;
10. Pregnant or lactating women;
11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.
Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea

in a population of general inpatients who are receiving antibiotics.

General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.

Eligibility Criteria:
Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics.

-

Exclusion Criteria:

* Feeding tube in place
* Pregnancy
* Milk or soy allergy
* Sensitivity to lactose
* Immunocompromised defined as:

  1. Absolute neutrophil count (ANC) ≤ 500 cells/mm3
  2. HIV
  3. Cancer patient receiving chemotherapy or radiation therapy
  4. Immune deficiency
  5. Post organ transplant

Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

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Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock

Octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. When patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. Microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. The aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years old
* patient with liver cirrhosis
* patient with haemorrhagic shock due to variceal bleeding
* patient with an arterial blood pressure less than 65 mmHg despite
* patient able to express consent
* signed written informed consent form
* patient covered by national health insurance

Exclusion Criteria:

* patient less than 18 years old
* patient non covered by national health insurance
* pregnant or breast feeding patent
* known octreotide allergy
* cardiac arrest because of shock
* refused consent
Food Addiction and Hormone Study

The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and compare the gastric myoelectrical activity between persons with food addiction (FA) and a control group. Additionally, this study will explore if differences exist between perceived hunger and satiety and hormone levels related to hunger and satiety in both groups. The comparison of the EGG readings and hormone levels is the next step in furthering our understanding of food addiction and how the physiology - not simply the symptomatology - of FA does or does not relate to weight management.

The study will be conducted over 2 days and will consist of psychological assessments as well as EGG measurement (similar to EGG) and blood draws to examine hunger and satiety hormones.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include men and women who identify with weight struggles related to disordered eating and a control sample of people who do not identify with weight issues or disordered eating. Must be able to read and write English

Exclusion Criteria:

* Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
* Anyone who is currently pregnant, or lactating
* Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications
* Report of medical condition or surgical intervention that affects swallowing ability
* Allergy, aversion, or dislike to any of the meal replacements or snacks offered
* Previous or current diagnosis of a psychiatric illness such as schizophrenia or any other psychotic disorder listed in the DSM-IV or DSM-5
* Report of medical conditions that prohibits overnight fasting
MIST3: Active Patient Safety Reporting

This study will seek to describe and understand adverse events (AE) severity ratings.

Using an explanatory mixed methods design, three different quantitative methods 1. severity ratings based on a series of questions, 2. severity rating based on severity terms, and 3. severity based on definitions will be used to conduct a feasibility study on understanding adverse event reporting system.

Eligibility Criteria:
Inclusion Criteria:

* Health patients

Exclusion Criteria:

* None
Validity and Reliability of the Turkish Version of the Head and Neck Cancer Inventory

The primary treatment option of many patients with head and neck cancer is surgery, radiotherapy and chemotherapy. In the literature, functional problems that occur after surgical interventions applied to head and neck cancer patients are frequently mentioned. Morbidities resulting from the combined application of radiotherapy and chemotherapy are based on more anecdotal information and critical data on long-term functional outcomes in this patient group are scarce. The aim of this study is to make the validity, reliability and cultural adaptation of the Head and Neck Cancer Inventory in Turkish.

In the literature, there are general cancer scales developed to evaluate the quality of life of head and neck cancer patients and sub scales associated with head and neck cancers developed in addition to these scales. In addition, scales specific to head and neck cancers have also been developed. However, previous research shows that even general health status scales or cancer-specific scales cannot determine outcomes related to many head and neck cancer patients. In addition, items containing multiple functions and patients' attitudes (behaviors) cannot be analyzed separately in any of the scales specific to head and neck cancer. Very few surveys contain items related to patients' attitudes (behaviors), or the number of items related to this topic is small because most of these scales are functional items. Unlike its counterparts in the literature, Head and Neck Cancer Inventory evaluates the attitudes (behaviors) of patients associated with various functions in daily life. Head and Neck Cancer Inventory is the only scale in the literature that contains the basic features of the health conditions declared by the patient and has been developed specifically for head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily accepting to participate in the study
* Patients whose native language is Turkish
* Patients diagnosed with head and neck cancer

Exclusion Criteria:

* Patients whose health conditions are too bad to fill the scale
* Having a serious mental disorder or dementia