cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms

To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors

The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Body Mass Index\<30
* Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
* Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
* largest diameter \< 4cm
* Preoperative CT showed no evidence that tumor was connected with main pancreatic duct

Exclusion Criteria:

* Severe cardio/pulmonary complications
* Other pancreatic diseases, including pancreatitis and pancreatic cancer
* Multiple pancreatic neuroendocrine tumors
* Distant metastasis
Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis

The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* Normal menstruation for 3 months before enrollment (25-35 days）
* Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia
* Agreement on the strict follow-up plan
* Without previous hormonal treatment
* Using nonhormonal method of contraception during this study

Exclusion Criteria:

* Serious heart diseases/pulmonary/liver/kidney diseases
* Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain
* Suspected malignancy in endometriosis
* Coagulation disorders with hemorrhagic tendency
* Pregnancy or lactation
* Allergy to GnRHa
* Previous ineffective treatment with GnRHa
End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum

Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.

During the past two decades, remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal surgery for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual-urinary function.The introduction of circular stapling devices is largely responsible for their increasing popularity and utilization. Sphincter-saving procedures associated to partial or total mesorectal excision (TME) for the treatment of mid and distal rectal cancer have become increasingly prevalent as their safety and efficacy have been proved. Total mesorectal excision (TME) is the best available treatment for rectal cancer. With the advancement of surgical techniques, the majority of patients with mid and upper rectal cancer can undergo a sphincter-saving TME procedure. After TME, the most widely used reconstructive technique is straight coloanal anastomosis. With the advancement of surgical technique, the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to 3-8%. Naturally, it is time to focus on how to improve bowel functional outcomes and quality of life (QoL) for rectal cancer patients. However, because the sigmoid colon is usually excised during surgery which decreases the storage volume of stool, there is a common problem seriously influencing the life quality of patients, including increased tool frequency, urgency and incontinence, which is termed as anterior resection syndrome (ARS). About 19-56% of patients would suffer from ARS. Thus, the demand for a technique with better functional outcomes made surgeons modify the straight anastomotic technique. Thus, another modified anastomotic technique, side-to-end anastomosis, which has been used since 1966, has gained attention. Side-to-end anastomosis usually needs a 3-5 cm-long colonic segment. Multiple studies on the literature have shown that compared with straight anastomosis, side-to-end anastomosis has advantages in bowel functional and operative outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age to 80 years.
* Laparoscopic or open anterior resection of cancer rectum.

Exclusion Criteria:

* synchronous colorectal carcinoma
* emergency surgery
* history of colon or rectal segmental resections
* fixed rectal carcinoma who received preoperative radiotherapy
Analyze Changes in Respiratory Rate When Using the Scare Respirator

Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"

With this pilot study the investigator's want to see if the "scare respirator" can modify the vital signs of the newborn (NB) and if there is a relationship according to the frequency per minute given by the scare respirator and the patient's respiratory rate.

The "scare respirator" has been used many times to prevent central apnea in the newborn. This involves using a mechanical ventilator, but instead of connecting it to the patient's trachea to inflate his lungs, the air flow is connected to a surgical glove that inflates and deflates, with the optimal respiratory rate that the patient should have. This will be placed on the back to stimulate it tactically giving the necessary impulse of inspiration so that the patient alone can acquire the movement.

The importance of the development of this study is that it has been seen that the "scare respirator" could avoid central apneas, but no studies have been done on the change in respiratory rate that occurs with the device or if it bothers the NB or alters its wakefulness sleep pattern.

It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20 cycles per minute and finally at 40 cycles per minute. The differences of qualitative and quantitative variables will be assessed with ad-hoc statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized healthy preterm babies,
* weighing more than 1500g at the time of the study

Exclusion Criteria:

* babies receiving any respiratory support
* carrier of any mayor malformation or genetic condition
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
* Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Exclusion Criteria:

* Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
* Untreated brain metastases, spinal cord compression or primary brain tumours;
* Pregnant or lactating women;
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
* Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum toxin type A can be useful for treat these patients.

Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus Botulinum toxin type A in the treatment of patients with knee osteoarthritis.

Methods: A prospective controlled randomized double blind studied with three groups (n = 35 each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular medication in a single moment will be undertaken. The three groups will be: Botulinum toxin type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators " blind " in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain, quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures . Will be considered as statistical significance the difference of 5 %.


Eligibility Criteria:
Inclusion Criteria:

* age above 50 years
* diagnose of knee osteoarthritis using clinics and radiographic criteria
* pain for more than 6 months
* analogic visual scale among 4 to 8
* patients who agree to sign informed consent

Exclusion Criteria:

* secondary osteoarthritis
* skin lesion
* use of intraarticular corticosteroid in the last 3 months
* use of oral corticosteroid in the last 30 days
* Kellgren Lawrence I or IV
* inflammatory arthritis
* neuromuscular disease
* use of aminoglycoside antibiotics
* metalic prosthesis in knee
* peripheric neuropathy
* serious cardiovascular or pulmonary disease
* serious disorder of coagulation
* pregnancy or breastfeeding
* infections
* use of wheelchair
Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function

50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated patients with xerophthalmia
* Undergoing cataract hyperemulsification surgery

Exclusion Criteria:

* No history of ocular surgery and trauma
* Any eye diseases except xerophthalmia
* No treated for xerophthalmia before
* Successful completion of follow-ups
Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study

Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.

16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.

Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.

The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.


Eligibility Criteria:
Inclusion Criteria:

Male subjects

* non-smoking
* apparently healthy
* BMI \>18 and ≤28 kg/m2 or BMI \>30 and ≤35 kg/m2
* Age 20-65 years
* Subject is usually eating breakfast and lunch
* Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD) and sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner).
* Owner of a smartphone so they will be able to download and use the sleeping APP, Sleep cycle, prior to the study days.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

* Night shift workers
* Subjects suffering from sleep disturbances
* Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP \>5mg/l)
* Impaired fasting glucose (fasting plasma glucose \>5.5mmol/l)
* Hematologic disease (leukocyte count \< 1.5x109/l, hemoglobin \<11 g/dl, platelets \<100 x 103/ul)
* Kidney disease (creatinine \> 1.5 mg/dl))
* Liver disease (transaminases \>2x upper normal range)
* Heart disease
* Pulmonary disease
* Inflammatory disease
* History of carcinoma
* History of tuberculosis
* Alcohol consumption \>40g/d
* Smoking
* Known allergy towards Kineret
* Known allergy to ingredients of the test meal
* Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
* Use of any investigational drug within 30 days prior to enrolment or within 5 half-lives of the investigational drug, whichever is longer
* Subject refusing or unable to give written informed consent
Endothelial Cell Gene Networks of CVD

The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

The investigators propose to enroll CVD and healthy subjects between 30 and 60 years of age, matched for age, gender, body mass index, and medication (statin and anti-hypertensive) use. Circulating endothelial progenitor cells will be isolated from blood and cultured in vitro to differentiate into endothelial cells.

Eligibility Criteria:
Inclusion Criteria for CVD subjects::

• \>50% stenosis of one or more coronary arteries

Inclusion Criteria for Healthy subjects:

• absence of coronary artery stenosis

Exclusion Criteria for all subjects:

* type 2 diabetes mellitus
* chronic kidney disease,
* other chronic diseases
* dyslipidemia (fasting plasma LDL-C \>160 mg/dL and triglyceride levels \>150 mg/dL)
Antenatal Micronutrient Supplementation and Birth Weight

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination.

Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

Eligibility Criteria:
Inclusion Criteria:

* Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

* Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age
Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.

This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.

Covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. The introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. Channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. The efficacy of vaccination for the pregnant lady has been established. However, fetus protection via transmission of the antibody during pregnancy is still uncertain. Therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.

Eligibility Criteria:
Inclusion Criteria:

* term pregnancies at 37 weeks or more
* vaccinated 2 doses
* in labour

Exclusion Criteria:

* unvaccinated
* preterm labour less than 37 weeks
* multiple pregnancies
Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 Trial

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-3 Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on length of index hospital stay and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication error correction; 5) surgical site infection; and 6) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers whether patients are taking classes of efficacious medications at 30 days.


Eligibility Criteria:
Inclusion Criteria:

1. are ≥18 years of age;
2. are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and
3. provide informed consent to participate.

Exclusion Criteria:

1. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or
2. reside in an area without cellular network coverage.
Thyroid Hormone for Thyroid Cancer

This study will be a multicentre prospective cohort study on TH-substitution with liothyronine (L-T3) and levothyroxine (L-T4) in DTC patients after TH-withdrawal. The first cohort is patients treated in the University Medical Centre Groningen (UMCG) with L-T3 according to standard local protocol. The second cohort is patients treated in the Radboud University Medical Centre (Radboud UMC) with L-T4, also according to standard local protocol. We will compare effects of L-T3 or L-T4 on TSH, Thyroglobulin (Tg), quality of life (QoL), weight and cardiovascular parameters.

While treatment with L-T4 after TH-withdrawal is widely used in DTC patients to suppress TSH and improve hypothyroid symptoms, the value of L-T3 has not been evaluated in this context. Lifelong monotherapy with L-T3 should not be preferred over L-T4 yet, short-term use of L-T3 to initiate TH-supplementation can be safely implemented. We hypothesize that initial treatment with L-T3 can have a more rapid effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL. To evaluate TH-supplementation with L-T3, we will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients: patients treated in the University Medical Centre Groningen (UMCG) receiving L-T3 and patients treated in the Radboud University Medical Centre (Radboud UMC) receiving L-T4. We will compare potency to suppress TSH, effect on QoL and effects on thyroid- and cardiovascular parameters. Patients (18-75 years) diagnosed with high-risk DTC treated in the UMCG or Radboud UMC and receiving THST with L-T3 or L-T4 after TH-withdrawal will be eligible for inclusion. The primary objective is to compare the proportion of patients reaching target TSH-levels after two weeks of substitution with L-T3 or L-T4.

Secondary objectives are to compare the effects of L-T3 and L-T4 in the first 6 months of treatment on serum thyroid parameters TSH and Tg, quality of life, weight, and cardiovascular parameters

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed DTC (papillary thyroid carcinoma, follicular thyroid carcinoma, oncocytic thyroid carcinoma)
* Classified as high-risk DTC according to the ATA guidelines (1) or, patients for whom the risk of a recurrence is estimated to be higher based on clinical features (assessed by their treating physician).
* Prepared for RAI-therapy with TH-withdrawal
* Patients have to be fit to adhere to the study protocol
* Patients have to be able to read and understand the Dutch language

Exclusion Criteria:

* Pregnancy
* Patients with a psychiatric history or history of depression
* Patients with comorbidities, such as severe heart failure, (poorly controlled) atrial fibrillation, of which the treating physician decides that L-T3 is unsuitable.

Conditions or drugs interfering with thyroid hormone uptake:

- Patients with a history of atrophic gastriti