cyrilzakka/clinical-trials huggingface dataset:
RL Versus Glucose Saline in Cancer Patient Undergoing Major Surgeries and Its Impact on Electrolytes, GLC & pH

To compare two electrolytes maintenance in perioperative period in children undergoing major surgeries on perioperative change in pH,lactate,sodium and glucose level

Patients were randomized into 2 groups ringer lactate versus 5%dextrose in 0.9% saline,using a computer generated random list in blocks of 4 after recruitment the enrolling investigators opened sealed opaque envelopes that concealed group allocation participants ,trial investigators,attending anesthetist providing general anesthesia for the cases and the outcomes were blinded to group allocation

Eligibility Criteria:
Inclusion Criteria:

* 1to 10 years Children undergoing major surgeries ie considered major if any invasive procedure in which extensive resection will be preformed e.g body cavity is opened,organs are removed and normal anatomy is altered abd duration not less than 2 hours or more than 5 hours.

Exclusion Criteria:

* patient guardian refusal

  _ Children with documented endocrine distrubances(DM,inborn error of metabolism,hyperthyroidism)
* age less than one year
* preexisting renal disease,hepatic disease and patien suffering from heart failure.
* preexisting electrolyte imbalance (normal sodium level 135-145)
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD

The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.

In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis. Further, non-clinical data show that JSM6427 inhibits scarring and inflammation. Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.

Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity in the study eye between 5 and 7 letters inclusive using and ETDRS chart (Snellen equivalent of appx. 20/800 to 20/40.
* Subfoveal choroidal neovascularization (CNV) due to AMD.
* Total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≤ 12 DA, of which at least 25% must be active CNV.
* For patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks.
* Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening.
* Intraocular pressure of 21 mm Hg or less.
* Retinal thickness ≥ 250 μm by OCT.
* Normal screening ERG
* Normal ECG

Exclusion Criteria:

* PDT within 120 days prior to screening in the study eye.
* Previous therapeutic radiation to the eye.
* Any retinovascular disease or retinal degeneration other than AMD.
* Serous pigment epithelial detachment without the presence of neovascularization.
* Presence of pigment epithelial tears or rips.
* Previous posterior vitrectomy or retinal surgery.
* Any periocular infection in the past 4 weeks.
* Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening in the study eye.
* Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening.
* Cataract surgery in the study eye within three months of screening.
* Intraocular surgery in the study eye within three months of screening.
* Presence of ocular infection in the study eye.
* Presence of severe myopia (-8 diopters or greater) in the study eye.
* Allergy to or prior significant adverse reaction to fluorescein.
* Any major surgical procedure within one month of trial entry.
Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.

The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain, tactile sensation of the sole and PI were evaluated at the start and after each session till the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Type II DM with DPN (grade I-II) in lower limbs
* Duration of DM\>5 years
* Visual Analog Scale (VAS) ≥3 in the feet
* Sensory impairments in the lower extremities

Exclusion Criteria:

* Patient with previous stenting or surgical intervention of lower limb arterial system.
* Patients with previous history of DVT.
* Pregnancy
* Diabetic infectious wound
* Cardiac pacemaker presence
* Severe liver and kidney dysfunction or history of heart and lung disease.
Assessing the Impact of myHealth Rewards New Hire Enrollment Emails

The purpose of the study is to evaluate, prospectively, the potential impact, on myHealth Rewards wellness program enrollment prior to the 2019 November submission deadline, of sending different messages via email to Geisinger Health Plan (GHP) members who have just been hired.

The myHealth Rewards wellness program managed by GHP rewards those GHP members who carry their insurance through employment at Geisinger with reduced health insurance premiums over the course of the following year, if members register for the program and have their health measures on file by the enrollment deadline and are then able to meet their health goals by the respective due date. In spite of the potential savings to health plan members and the wellness program's potential to motivate engagement in healthy activities (with consequent improvement in health outcomes), about 23% of eligible existing GHP members did not enroll during the primary 2019 enrollment period, even after receiving promotional email communications and reminders. Therefore, the current study was developed to test whether a revised version of a standard welcome email is more effective than the standard email in increasing myHealth Rewards login and enrollment rates. The standard welcome email is what would typically be sent by GHP to encourage enrollment among new hires; it mentions the benefits of enrollment (maintaining good health and saving money on insurance premiums), the average premium savings, the ease of the registration process, and the deadline for registering and having health measures on file, plus it provides registration steps and hyperlinks for registering and finding free health screenings where health measures can be collected and registered at one convenient time and location. The loss frame email recommends that GHP members not "throw away" a precise monetary amount in savings by not participating and that they can therefore avoid missing out on substantial gains (i.e., savings) by taking action. It is hypothesized that, on average, the loss frame email will increase enrollment compared with the standard email, among this population of new hires for whom this is only the second time that they have been informed about myHealth Rewards. Findings will help inform how best to increase enrollment in a wellness program among health plan members who are new to the system.

Eligibility Criteria:
Inclusion Criteria:

* Any Geisinger new hire, regardless of benefits status, who started on or after July 1, 2019 and before November 30, 2019

Exclusion Criteria:

* Existing Geisinger employees hired prior to July 1, 2019
* New hires who do not have an email address on file
Long-term Prognosis of Patients With Sepsis After Immunotherapy

Current clinical studies of thymosin α1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy.

Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis patients in the TESTS study Patients who discharged from hospital after recovery

Exclusion Criteria:

* None
Analysis of Neuromuscular Responses and the Balance After the Application of Physiotherapy Resources

The aim of this study was to evaluate the effect of ice and shortwave diathermy in different regions of lower limb neuromuscular response and balance.

Applying ice and shortwave diathermy was performed separately (on different days) in the foot, ankle and calf. To assess the neuromuscular response was evaluated electromyographic activity of the rectus femorals, biceps femorals, gastrocnemius and tibialis anterior. To assess the effect of applications on balance, through a force platform was evaluated oscillation of the center of pressure as well as ground reaction forces.

Eligibility Criteria:
Inclusion Criteria:

* woman
* healthy
* young
* sedentary

Exclusion Criteria:

* sensory changes
* history of fractures in the lower limbs
* being in the menstrual period
* diabetes Mellitus
* Bone, muscle and/or neural diseases
LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension

This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female (post-menopausal or surgically sterile).
2. Age from 18 to 75 years inclusive.
3. Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.

Exclusion Criteria:

1. History or evidence of a secondary form of hypertension,
2. History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
3. Clinically significant valvular heart disease.

Other protocol-defined inclusion/exclusion criteria may apply
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-15
* Presence of growth failure indicated by height standard deviation score less than equal to -2
* Body mass index greater than or equal to 25th percentile for height age
* IGF concentration less than or equal to 33rd percentile
A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

* nocturia

Exclusion Criteria:

* habitual or psychogenic polydipsia,
* known or suspected cardiac insufficiency
* other conditions requiring treatment with diuretics
* moderate and severe renal insufficiency
* known hyponatremia
* syndrome of inappropriate ADH secretion
Comparison of Automated Control Anesthesia and Manual Control Anesthesia in Minimal Flow Anesthesia

With the introduction of technology into our lives, we come across two different anesthesia management modules in anesthesia machines. The first of these is the traditional method, the manual controlled anesthesia technique; the other is the automatic controlled anesthesia technique. In our daily practice, both anesthesia techniques can be used in patients who have undergone general anesthesia. These two techniques can be used in both high-flow anesthesia and low-flow anesthesia applications.

In the manual technique, the inspired and exhaled gas concentrations are regulated by the anesthetists manually by the fresh gas flow during general anaesthesia. When administered manually, low-flow anesthesia requires the attention and time of the anesthesiologist, especially the difference between the gas concentrations set in the anesthesia machine and the respiratory system, and the delay between changes in fresh gas concentrations and the end tidal fraction (EtAA) of the anesthetic agent. The most important risks of manually controlled low-flow anesthesia are hypoxia and awareness that may occur due to low doses of inhaler anesthetic agents.

In the automatic controlled anesthesia technique, it is a method in which the values desired by the anesthetists during general anesthesia are determined at the beginning of anesthesia and automatically adjusted by the anesthesia device without any additional intervention. After intubation, anesthetists set 3 parameters on the anesthesia device: inspiratory or expiratory oxygen fraction (FiO2- End tidal O2 concentration), anesthetic agent concentration (MAC or End-tidal Anesthetic agent concentration) and fresh gas flow amount. With this method, it is aimed to provide safer and more stable anesthesia. In addition, it has been stated in many previous studies that automatic control anesthesia technique reduces anesthetic gas consumption and less anesthesiologist intervention is needed to reach target values.

In our study, we aimed to compare the safety, efficiency and cost aspects of automatic controlled anesthesia and manual control methods in achieving intraoperative target anesthetic and oxygen concentrations. We hypothesized that anesthesia applied with the end-tidal control method would have a lower cost, less workload, and similar anesthetic depth with the manual control method.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-75 year-old
* ASA 1-3
* Will undergo gynecological operation
* Expected surgery time (\>1 hour)

Exclusion Criteria:

* ❖ BMI \>30

  * Chronic opioid use
  * Contraindication to any of the anesthetic agents to be used
  * Neurological disorders
  * Surgery lasting \<1 hour
Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation

Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5\*3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5\*3/\*3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing orthotopic liver transplantation in our center.
2. The postoperative immunosuppression regimen was tacrolimus、methylprednisolone and balipremumab for injection in all cases,and no drugs that interacted with tacrolimus were used.
3. The postoperative follow-up time was greater than 6 months and no serious rejection occurred during the follow-up period.

Exclusion Criteria:

1. Combined organ transplantation.
2. liver transplant patients on other immunosuppressive regimens.
3. Preoperative CKD or need RRT.
4. Preoperative serum creatinine (SCr) \> 133 mol/L.
5. Loss of follow-ups.
Does Manual Therapy Provide Immediate Improvement in Lumbar Range of Motion?

The goal of this clinical study is to determine if manual therapy can improve lumbar mobility in healthy individuals.

The main questions it aims to answer are:

* Is there an immediate local spinal effect?
* Is there an associated distal effect?

Researchers will compare an experimental group and a control group to examine the effects.

Upon consent, participants will be assessed for lumbar spine mobility using inclinometers, hamstring flexibility using the active knee extension test and the modified sit-and-reach test, and ease of lifting a small, weighted object. After baseline measures are recorded, the participants will receive an intervention that will be either therapeutic (myofascial release) or sham (non-therapeutic hand placement). The choice of intervention received will be previously determined through the use of randomization software. The intervention provided will be applied to the low back and last for a total of 10 minutes. Immediately following the intervention, participants will again be assessed for lumbar spine mobility, hamstring flexibility, and ease of lifting a small, weighted object as noted above.

Eligibility Criteria:
Inclusion Criteria:

* New York Institute of Technology students
* At least 18 years old
* Good overall health

Exclusion Criteria:

* Pacemaker
* Any previous history of lumbar or connective tissue pathology
* Down syndrome
* Prolonged steroid use
* Oswestry Low Back Disability score of \>10 (ODI)
* Inability to provide informed consent
Comparison of Different Video Laryngoscopes in Infants Undergoing Neurosurgery: a Prospective Randomized Clinical Trial

difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of \<1 year old children undergoing neurosurgery.

Aim: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

Methods: We enroll 20 patients age under 1 year old undergoing neurosurgery in this prospective randomized study. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of \<1 year old children undergoing neurosurgery regarding intubation times and intubation success rates.

Eligibility Criteria:
Inclusion Criteria:,

* 0-1 age
* undergoing neurosurgery
* ASA 1-2

Exclusion Criteria:

* cardiac problems
* ASA 3-4
* emergency
Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments

Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer after PDS/IDS surgery.

This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the number of cycles of adjuvant treatment after PDS.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old.
2. Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological examination.
3. The participant has read and fully understands the patient information, and has signed the informed consent form.
4. The patient is willing to undergo primary debulking surgery (PDS) or interval debulking surgery（IDS）. -

Exclusion Criteria:

1. Other tumors have been detected within the last 5 years.
2. Organ transplant recipients or those who previously had non-autologous (allogeneic) bone marrow or stem cell transplants.
3. Patients was deemed unsuitable to participate in this study by other researchers.
4. Patients who have previously received neoadjuvant chemotherapy or targeted therapy.
Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected.

The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.


Eligibility Criteria:
Inclusion Criteria:

* premature neonates born at after 26 week of gestational age studied after 32 weeks, mothers living in Picardy and more than 18 years

Exclusion Criteria:

* neonates with neurological, respiratory and cardiac disorders or receiving treatments known to affect cardiorespiratory variables or sleep structure