cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Low Flow and Normal Flow Anesthesia Management in Robotic Assisted Laparoscopic Surgeries

Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In our clinic, we routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.

To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.

Robotic surgery is the performance of laparoscopic surgery using a robotic interface. The robotic surgery system used today is called Da Vinci S. In surgeries performed with the help of a robot, the surgeon can work more precisely and with greater maneuverability. Therefore, an operation can be performed that is less traumatic for the patient than other methods.Robotic-assisted laparoscopic surgery has many advantages compared to conventional open surgery, such as less postoperative pain, shorter hospital stays, and faster recovery times. Robot-assisted surgeries require general anesthesia. In these applications, fresh gas flow in anesthesia systems can be made with traditional high, normal or low flow strategies, depending on the preference of the clinicians.Low-flow anesthesia creates a breathing air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow amounts does not pose a safety risk for patients, and that the use of low-flow anesthesia methods should be more widespread due to the advantages it provides. In our clinic, investigators routinely apply low-flow anesthesia methods in addition to normal flow methods in many surgical applications, according to clinician preferences. The aim of this study is to determine the effects of low flow (0.5 lt/min) and normal flow (\>1 lt/min) anesthesia applications in robotic-assisted laparoscopic surgeries.

To compare perioperative hemodynamic and respiratory parameters in terms of inhalation agent and soda lime consumption.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75
* ASA I,II
* Patients undergoing robotic-assisted laparoscopic surgery

Exclusion Criteria:

* ASA III,IV,V
* Those with serious cardiac, respiratory, hepatic, renal disease
* People with mental status disorders, psychiatric illnesses
* Patients with hearing problems and glaucoma
* Desire to be out of work
Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study

Evaluation of endothelial glycocalyx damage in on-pump conventional coronary artery bypass surgery using a syndecan-1 (CD138) blood test. The study will be carried out in two stages. Pilot study for testing and correcting research methodology and the main study.

Study tasks:

1. To evaluate changes of syndecan-1 concentration during surgery and postoperative period.
2. Determine the effect of aortic clamping and on-pump duration on endothelial glycocalyx damage.
3. Assess the risk of early postoperative complications and syndecan-1 plasma concentrations.
4. To evaluate the correlation of inflammatory status with glycocalyx damage.
5. To evaluate glycocalyx damage to patients with diabetes vs non-diabetes.

Methods:

Patients undergoing cardiopulmonary bypass surgery are being treated at the Heart, Chest and Vascular Surgery Clinic of the Lithuanian University of Health Sciences Hospital in Kaunas Clinics. After receiving patients written consent a syndecan-1 concentration test will be performed upon arrival at the operating room, before cardiopulmonary bypass (CPB), after CPB, upon arrival in the ICU and after 24 hours.

All needed data for evaluating patients outcome will be taken from medical documentation during patients stay in hospital.

Eligibility Criteria:
Inclusion Criteria:

* Elective on-pump coronary artery bypass surgery needed.
* Normal heart function at the time of operation.
* Patients without infections.
* Patients who signed study informed consent form

Exclusion Criteria:

* Life saving operation.
* Renal or hepatic dysfunction.
* Off-pump heart operation.
Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Primary Objective:

* To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral formulation in patients with chronic renal failure undergoing peritoneal dialysis.

Secondary Objectives:

* To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation
* To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special) oral formulation and 250 mg IV formulation

* Screening: 7 to 10 days
* Treatment period: 14 days (Period 1: 7 days; Period 2: 7 days)
* End of study: 7 days after the last dosing,
* Total duration from screening per subject: 22 to 25 days.

Eligibility Criteria:
Inclusion criteria :

* Male or female, 18 years old or older, with chronic renal failure undergoing peritoneal dialysis for at least 3 months.
* Women of childbearing age should have a negative pregnancy test before administration of the study drug

Exclusion criteria:

* Contra-indications to furosemide, including:

  * Hypersensitivity to furosemide or to sulphonamide-derived drugs or to any ingredient in the formulation or component of the container.
  * Glomerular filtration rate below 5 mL/min
  * Glomerular filtration rate above 20 mL/min
  * Severe liver disease
  * Patients with renal failure accompanied by hepatic coma and precoma
  * Renal failure due to poisoning with nephrotoxic or hepatotoxic substances
  * Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension
  * Nursing women
* Pregnancy
* Treatment with any diuretic, which cannot be discontinued with the required washout period before the first drug administration
* Existence of any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with absorption, distribution, metabolism or excretion of drugs.
* Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
* Treatment with the following inhibitors of secretion at the renal level: clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and verapamil, which cannot be discontinued during the course of the study.

Interfering substance:Subjects must abstain from alcohol and beverages containing stimulating xanthine derivates (e.g. coffee and tea) during the entire study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Three Laparoscopic Access Techniques

The study compares the Veress needle technique, the Direct trocar insertion and the Open technique with each other, in terms of minor complications, in elective laparoscopic procedures for benign pathologies.


Eligibility Criteria:
Inclusion Criteria:

* not-obese adult patients referred for scheduled laparoscopic and gynecologic procedures,
* benign pathology
* no previous abdominal surgery
* Age range was 18-70 years

Exclusion Criteria:

* obesity, defined as a body mass index (BMI) \> 30 kg/m2
* previous abdominal surgery by laparoscopy or laparotomy
* history of PID
* irritable Bowel Syndrome
* suspicion of malignancy or malignancy at the histological examination
Music Therapy as Procedural Support for Young Children Undergoing Immunizations

Many young children undergo medical procedures that are painful and distressing. Negative experiences during medical procedures can have serious long-term effects, including fear and avoidance of medical procedures during adulthood. Distraction interventions can help prevent children from forming negative memories of medical procedures. Live music therapy has been shown to alleviate pediatric distress during both invasive and non-invasive procedures. The objective of this study is to examine the effects of music therapy on the child's distress behaviors and time to calm, as well as the length of the procedure and use of restraint, and parents' and healthcare staffs' behaviors during the procedure, for young children undergoing immunizations and influenza vaccinations. It is hypothesized that children receiving music therapy will show fewer distress behaviors, calm more quickly, and have shorter procedures with fewer instances of restraint compared to children who receive standard care. In addition, it is predicted that adults (parents and staff) will show fewer distress-promoting behaviors during, before, and after the procedures.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be pediatric patients (N = 60) from 48 to 72 months of age who are undergoing immunizations, as well as their parents/legal guardians (N = 60) and the healthcare staff who are conducting/assisting with their procedure (N = 60).

Exclusion Criteria:

* Any children whose parents are non-English speakers or staff who are non-English speakers will be excluded.
Chitinases and Transforming Growth Factor Beta (TGFB) in Human Asthma

The purpose of this study is to find out the roles of two specific gene families (the chitinase gene family and the TGFB family). We hypothesize that chitinases and TGFb pathway genes will be differentially expressed in the airways of non-asthmatic subjects and subjects with asthma. We further hypothesize that genetic variants in CHIT1, AMCase, and TGFb pathway genes that show associations with asthma and related phenotypes will change the expression and/or function of the protein of these genes in the airway in several ways, including the transcript numbers for full length genes and splice variants and, for the chitinase genes, the levels of chitinase activity in airway secretions.

This is a cross-sectional study in patients with asthma and healthy controls in which we will analyze how the expression or function of CHIT1, AMCase, and TGFb pathway genes in the asthmatic airway is affected by genetic variation in these genes. We propose detailed phenotyping of the asthmatic subjects and the healthy controls, including collection of induced sputum, exhaled air and detailed physiologic measures including measures of airflow, lung volumes, and methacholine responsiveness as well as collection of airway cells and tissues by bronchoscopy. We will determine the relative expression of CHIT1 and AMCase in specific lung compartments (large airways, small airways, epithelial cells, macrophages) and the effects of genetic variants in CHIT1 and AMCase on expression of splice variants and levels of chitinase activity in the airway. These human samples will also allow us to determine if any of the multiple TGFb pathway genes analyzed show differential expression in the lung in asthma.

Eligibility Criteria:
Inclusion Criteria:

* History of asthma
* No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6 weeks
* Hyperreactivity to methacholine (PC20FEV1 Methacholine ≤ 8.0 mg/mL).
* At least one of the following symptoms, beta agonist use, or FEV1 criteria:

  * Asthma symptoms on at least two days per week, or
  * Beta agonist use on at least two days per week, or
  * FEV1 \< 85% predicted
* Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs).

Exclusion Criteria:

* Cigarette smoking: Subjects must be non-smokers. Non smokers are defined as subjects who have never smoked or who have not smoked for 1 year and have a total pack-year smoking history \< 10 packs.
* Pregnant women
* Subjects with a history of a medical disease which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study.
* Healthy control subjects must have no history of asthma or allergic rhinitis
* Upper respiratory tract infection in the 4 weeks prior to enrollment in the study
Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne

The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.

Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate facial acne vulgaris
* Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions

Exclusion Criteria:

* Nodulocystic acne lesions more than 3 and pure comedonal acne
* Additional truncal acne needs systemic therapy
* Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months
* Application of chemical peels and laser in last 4 weeks
* Usage of hormones in last 3 months
* Clinical signs of hyperandrogenism in females
* Pregrancy and lactation
* Hypersensitivity to interventions
* Additional facial skin diseases (eg. atopic and seborreic dermatitis)
* Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions
MapTrek for Sedentary Workers

The aim of this study is to determine if participants randomized to our mHealth MapTrek game increases daily physical activity (average steps/day, active minutes/day) compared to a control group among sedentary office workers over 10 weeks. The investigators hypothesize the MapTrek intervention group will significantly increase their daily steps and active minutes compared to the control group over 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were 21 to 65 year of age, working full-time (at least 35 hours/week) in a desk-dependent job (self-report sitting \>75% of work day), who owned a smart phone.

Exclusion Criteria:

* Exclusion criteria included ages \<18 years or \>65 years, pregnancy or planned pregnancy, prisoner status, and any contraindications to engaging in regular physical activity as identified by the Physical Activity Readiness Questionnaire (PAR-Q), not owning a smart phone, (Cardinal, Esters, \& Cardinal, 1996).
Nutritional Supplementation With Agmatine Sulfate During Small Fiber Neuropathy

This is a nonblinded Case-only study that evaluates the effects of Agmatine Sulfate on small fiber peripheral neuropathy. Patients will be started on Agmatine sulfate (a metabolite of Arginine) and monitored for two months. Improvement will be noted on their response to the Neuropathic Pain Questionnaire. Additionally the investigators will note improvement by performing autonomic function testing at the beginning and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women Ages 18-75 with symptoms of small Fiber Neuropathy and have been diagnosed via autonomic function testing and or skin biopsy

Exclusion Criteria:

* Women who are pregnant or breast feeding, patients with history of substance abuse, and patients with myelopathy
RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib

To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable).
* The date of progression on sunitinib and/or sorafenib must be within 6 months.
* Patients may have received one or both agents
* Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors (i.e., bevacizumab) are permitted.
* Prior vaccine therapy in the adjuvant setting is permitted.
* Patients with at least one measurable lesion at baseline as per the Response evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
* Patients with a Karnofsky Performance Status ≥70%.
* Adequate bone marrow, liver and renal function.
* Patients with a life expectancy ≥ 3 months.
* Women of childbearing potential must have had a negative serum or urine pregnancy test 48 hours prior to the administration of the first study treatment.
* Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

* Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have received these within 4 weeks of study entry
* Patients who have previously received mTOR inhibitors.
* Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus) or to its excipients.
* Patients with untreated CNS metastases or who are neurologically unstable despite treatment of the CNS metastases. (Patients with treated CNS metastases, who are neurologically stable off of corticosteroids, are eligible to enter study).
* Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
* Patients with a known history of HIV seropositivity.
* Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
* Patients who have any severe and/or uncontrolled medical conditions
* Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
* Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to randomization
* Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply.
Pain Perception After Tubal Ligation

The purpose of this study is to attempt to determine retrospectively whether there was a statistically significant difference in patient need for postoperative narcotics between two different groups of women who received a laparoscopic tubal ligation. One group received a local anesthetic injection or gel at the surgical sites, in addition to general anesthesia. The other group did not receive any local anesthetic but did receive general anesthesia. The investigators hypothesize that the group that received the local anesthetic injection or gel had lower average postoperative narcotic requirements and shorter postoperative dismissal to home times than the group that did not receive the auxiliary local anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 21-52,having a laparoscopic tubal ligation by the fallopia ring method at Oklahoma State University Medical Center between January 1, 2005 and December 31, 2009

Exclusion Criteria:

* We will exclude women with the following comorbid conditions, since they may alter the patient's pain level or her perception of pain after the tubal ligation: history of chronic pelvic pain, history of pelvic inflammatory disease, opiate abuse, conversion to open procedure, unsuccessful tubal ligation, laceration of tube, more than one ring placed on single tube, admittance to the hospital, additional procedures performed, endometriosis, allergy to marcaine, lidocaine, or bupivicaine.
Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid

Tranexamic (TXA)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. Additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. However, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( PPH) and have not focused on assessing the effects of tranexamic acid in high-risk women. The aim of this study is to evaluate the efficacy of IV versus topical application of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is topical application of Tranexamic acid effective in reducing blood loss during and after an elective Caesarean section? The Research Hypothesis the TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will, therefore, state that: There will be no difference between topical and IV TXA and placebo in reducing blood loss during and after elective Caesarean section.

patients were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min. Throughout the operation, irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).At the end of operation, another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women with a single term fetus scheduled for elective cesarean section who will be at risk of postpartum hemorrhage

Exclusion Criteria:

* Patients with a cardiac, hepatic, renal or thromboembolic disease. ,
* patients with the high possibility of the morbid adherent placenta,
* known coagulopathy and
* those presented with severe antepartum hemorrhage
* refuse to participate
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

* Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
* Birth length- and/or birth weight-SDS adjusted to gestational age \< -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
* Current height-SDS \< -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
* Growth velocity SDS \< 0 during the last year before inclusion (Brandt/Reinken 1988).

Exclusion Criteria:

* Severe SGA (birth weight or length \< -4 SD) and clinically relevant dysmorphic features.
* Severe pre-maturity (GA \< 32 weeks of gestation).
* Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
* Inability to perform one- or two leg jumps from a standing position.
* Prior GH treatment.