cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.


Eligibility Criteria:
Inclusion Criteria:

* 2 years old and above healthy people.
* Subject or legal representative who consent and has signed written informed consent.
* Subject or legal representative who is able to comply with all study procedures.
* Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Allergic history after vaccination.
* Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
* Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
* Known immunological impairment or dysfunction.
* Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
* Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
* Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
* In pregnancy or lactation or pregnant women.
* Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
* Any contraindications that investigators consider related to vaccination.
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
2. The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
3. The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
4. Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
5. Patient has received paricalcitol or calcitriol for a minimum of 10 days.

Exclusion Criteria:

1. Patient is scheduled for a kidney transplant within 3 months.
2. Patient is expected to stop peritoneal dialysis within 3 months.
3. Patient is expected to transfer to hemodialysis within 3 months.
4. Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.
Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

Objective

The aims of this study are to:

* determine the incidence of PPCs in pediatric patients;
* describe the practice of ventilatory support in children undergoing general anesthesia;
* describe geo-economic differences/variations in ventilatory support and development of PPCs in children undergoing general anesthesia;
* identify potentially modifiable factors that have independent associations with development of PPCs, hospital length of stay and pediatric intensive care unit (PICU) admittance; and
* develop a risk score for the development of PPCs comparable to the ARISCAT score.

Study design Multicenter international observational cohort study. Study population Patients ≤16 years of age undergoing invasive ventilation for general anesthesia in the operating room.

Main study endpoints The primary endpoint is the incidence of PPCs. Secondary outcomes are the ventilator settings, ventilation parameters, length of hospital stay and PICU admittance.

Eligibility Criteria:
Inclusion Criteria:

* aged ≤ 16 years;
* undergoing general anesthesia
* airway management with tube or LMA; and
* connected to mechanical ventilator . minimum duration of procedure: 15 minutes

Exclusion Criteria:

* patients undergoing surgical procedures involving extra-corporal circulation;
* patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation;
* sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and
* (rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain

The purpose of the study is to examine if the hyposthesis of the preventive analgestic characteristic of diclofenac given preoperatively has any effect on postoperative thoracic wall and shoulder pain sensation. We also want to examine the rescue analgetic consumption and the postoperative lung function test values.

Introduction Thoracotomies are thought to be one of the most difficult surgical incisions to deal with post-operatively, because they are extremely painful and the pain can prevent the patient from breathing effectively. Currently in our institute the surgical and post-operative anelgesia are managed by the combination of local anesthetics and opioid pain killers through an epidural cannula. In addition the investigators give diclofenac intravenously (from the 2nd day after the operation per os) as well as nalbuphin is given intravenously to the patients if it is necesserary.

By definition pre-emptive analgesia means that the treatment of pain is initiated before the surgical procedure by analgetics or nerve blockade techniques. The purpose of this method is to inhibit the production of inflammatory mediators and the prevention of the pain stimulus entering the central nervous system. As a result of the pre-emptive antinociceptive treatment, the quantity of post-operative medications can be decreased, the analgesia has less complications and the patients are more satisfied.

In the study the researchers would like to examine the pre-emptive analgetic effect of diclofenac.

Patients and methods:

Patients undergoing thoracotomy are divided into two groups.:

* Study Group: 100mg diclofenac per os (n=50)
* Control Group: patients do not get diclofenac premedication (n=50) The investigators examine every patient for five days: they record the patients' pain with the help of the Visual Analogue Scale (VAS). We measure the analgetic consumption in intramuscular morphin equivalent dose and the local anesthetic consumption via epidural cannula seperately. The lung function testing was carried out two times postoperatively with the help of the MIR Spirolab II mobil spirometer.

Eligibility Criteria:
Inclusion Criteria:

* 100 thoracotomy patients who agreed to take part in our study and signed a consent
* age 18-80 years
* ASA I-III
* men/women equally
* thoracotomies are managed with using intratracheal double lumen tube
* insertion of thoracic epidural cannula and during the operation administration of 1mg/ml bucain, 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed

Exclusion Criteria:

* acute operation
* diclofenac allergy in the anamnesis
* the lack of thoracic epidural cannula
Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation

The primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. If successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.

Physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. Cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. Clinician-rated performance status (cPS; e.g., ECOG or Karnofsky PS) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cPS is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. Objective evaluations of physical function have the potential to augment or even replace cPS in the cancer treatment setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative)
* Age ≥ 18, prioritizing patients ≥ 60 years
* At least 6 weeks out from surgical resection
* Presence of working email address
* Access to internet at home and either access to wireless internet or cellular data reception
* Ability to read and understand English
* Ability to understand and comply with study procedures

Exclusion Criteria:

* Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent
* Contraindication to CPET per standard American Thoracic Society (ATS) guidelines
PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.

This project will measure the impact of a recently validated patient-reported outcome measure for acute pancreatitis, PAN-PROMISE, to detect post-ERCP pancreatitis symptoms and capture its morbidity. The study will compare the change of PAN-PROMISE before and after ERCP to the current standard diagnostic criteria for post-ERCP pancreatitis, the Cotton Consensus Criteria. The main limitations of the Cotton-Consensus Criteria are that it fails to capture outpatient or ambulatory morbidity, uses length of stay to define the severity of pancreatitis without accounting for local or systemic complications for pancreatitis, and it has limited sensitivity in patients with chronic symptoms such as patients with chronic pancreatitis or pancreatic adenocarcinoma. These limitations have impeded the evaluation of potential therapies to prevent post-ERCP pancreatitis. PAN-PROMISE will help capture and quantitate the morbidity related to post-ERCP pancreatitis and thus will enhance our ability to optimize outcomes following ERCP.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing ERCP
2. Age \>= 18 years old
3. Intact major papilla

Exclusion Criteria:

1. Unwillingness or inability to consent for the study
2. Age \< 18 years
3. Standard contraindications to ERCP
4. Intrauterine pregnancy
5. Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication
6. Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication
7. Low probability of completing the follow-up
8. Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.
9. Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.
10. Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.
11. Patients who speak a language other than English, Spanish, Bulgarian, Mandarin, English, French, German, Greek, Hungarian, Italian, Korean, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian, or Hindi (as the PAN-PROMISE has only been translated and validated in these languages.
Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications

Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands....... etc.

Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands.

Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Eligibility Criteria:
Inclusion Criteria:

* All patient who recieve abdominal enterostomies either elective or emergencies in surgery department of assuit university hospital

Exclusion Criteria:

1. Patient underwent repair of previous abdominal surgery
2. Patient known to have incisional or ventral abdominal hernia
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

This study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive Multiple Sclerosis (MS). Participants will also be assessed for an impact of the bile acid on their immune system and gut microbiome. Half of the participants will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo. The investigators believe participants who take TUDCA will have normalization of blood bile acid levels, a normalization of abnormal immune response and a normalization of the gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Progressive MS based on Lublin Criteria
* Low bile acid levels identified using targeted metabolomics analysis
* On the same therapy for the past 6 months and not expected to switch therapy in the next 6 months
* No relapse in the past 3 months

Exclusion Criteria:

* No previous history of liver disease or cholecystectomy
* No stage IV/V chronic kidney disease or other severe metabolic derangements (e.g. poorly controlled thyroid disease or diabetes)
* BMI \< 15 kg/m2 and BMI \> 40 kg/m2
* Female patients who are pregnant or nursing, or not willing to use contraception
* Chronic antibiotic use
* Corticosteroid treatment within the past 30 days
* Known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease
Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Aim of the work:

The study will be conducted to investigate the efficacy of microfat graftinig in cleft lip nasal deformities especially in young patients and those adults who don't need major correction after rhinoplasty.

Microfat grafting was used for the first time in 1880, in reconstructive surgery to correct facial deformities, to reconstruct defects post oncological surgery, to treat complex wounds, and to manage scars. Therefore its usage is increasing widely and particularly in maxillofacial and plastic surgeries.

As lipofilling is a potential filler of reference for rhinoplasty and it can be performed on the dorsum, radix, glabella, pre-maxilla, and nasal pyramid. The investigators are suggesting it's use in cleft lip nasal deformities in some special situations.

Imperfections post rhinoplasty are common and there is an increased risk of patient dissatisfaction in revision surgeries. This may be due to a change in the nasal anatomy, the development of scar tissue, the loss of cartilaginous support, the altered blood supply, and the compromised soft tissue envelope. Here comes the role of fat grafting which is a relatively simple and safe procedure to camouflage nose imperfections in filling the subcutaneous tissue, and in improving the skin quality post rhinoplasty.

Microfat grafting appears to be effective for correcting minor irregularities of nasal skin and may be appropriate for patients who cannot undergo revision rhinoplasty. It is also an effective salvage procedure for severely damaged skin of the nose. Injection of cryopreserved fat over several sessions is well accepted by patients because cryopreservation of excess harvested fat grafts for subsequent use makes repeated fat graft harvesting unnecessary. Microfat grafting is not a replacement for, but may be a complement to, modern rhinoplasty techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Gender : Both sex will be included in the study.
2. Postcleft lip nose deformities.

Exclusion Criteria:

1. Refusing enrollment into the study.
2. Refusing the surgery.
3. Contraindication to anaesthesia.
Thromboelastography Normal Reference Values in China Hunan Province

The purpose of this study was to establish the normal reference range of Thrombelastogram parameters in Hunan by a multicenter study, and to analyze the specificity of Thrombelastogram detection and the influence of gender, age and blood type on Thrombelastogram. The study will provide basic data and statistical basis for the establishment of normal reference range of Thrombelastogram in Hunan.

Thrombelastograghy (TEG) is an important test to assess the blood coagulation function to monitor the whole process of perioperative coagulation. TEG can evaluate the coagulation cascade, from platelet aggregation, clot strengthening and fibrin cross-linking to eventually clot lysis in small volume of whole blood. The reference range is one important element to influence the TEG results. At present, a number of studies have shown that reference range of TEG exists significant differences between different racial and geographic. At the same time, reagent manufacturers also suggested that each TEG laboratory should establish its own reference range. So it is important to establish our own reference range of TEG to guide the clinical blood transfusion and treatment.

Eligibility Criteria:
Inclusion Criteria:

(1) 18\< Age \<65, and Han Chinese residents living in Hunan more than 3 years. (2) Health examination population who physical examination, assistant examination and serological examination were normal; Not suffer from other diseases last 3 months; Not take any medication last 7 days.

Exclusion Criteria:

1. Informed refusal. 2. Pregnancy, woman with menstrual period; volunteers who suffer from hematological system diseases such as hemorrhagic or thrombotic disease and take medicines that affect the function of blood coagulation (clopidogrel and aspirin, warfarin, rivaroxaban, dipyridamole, oral contraceptives, estrogen, antibiotics and traditional Chinese medicine related with blood coagulation, etc.) 3. Volunteers who have a history of liver disease, immune system disease, allergy and other disease within the last 3 months were excluded.
Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy

Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial

Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide.Some studies noticed about overused of opioids in postoperative care , leaded to more adverse effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.

ERAS guidelines has considered to use preoperative analgesics for reducing post-operative opioids consumption, including Gabapentin and Celecoxib.

Gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated the preoperative efficacy and safety of Gabapentin and Celecoxib in variety procedures involving hysterectomy.However, no definite conclusion of optimal dose and timing for preopearive uptake ,apart from no good evidences based supported preoperative Gabapentin or Celecoxib in hysterectomy in Thailand . In addition, the protocol for preoperative analgesics in hysterectomy, has not been performed in the investigator's center.

Therefore the aim of this study is to assess and compare the efficacy and safety of preoperative Gabapentin and Celecoxib to reduce acute postoperative pain in non-gynecological cancerous woman undergoing total abdominal hysterectomy

Eligibility Criteria:
Inclusion Criteria:

* Women ranging age between 18-65 years and having non-gynecological cancerous women who undergoing elective total abdominal hysterectomy
* Women who has ASA physical status I-II
* Women who agrees to participate in this study

Exclusion Criteria:

* Women who pregnancy
* Women who have abnormal kidney function test (Cr \> 1.5 )
* Women who have abnormal liver function test
* Women with history or present of thrombosis such as myocardial infarction, ischemic stroke, deep venous thrombosis or pulmonic embolism
* Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding
* Women who take the antiplatelet or anticoagulant medications
* Women with history of allergy to Gabapentin ,Celecoxib and Sulfa
* Women who have used or known Gabapentin or Celecoxib before
* Women who have chronic alcoholism
* Women who underwent previous surgery
* Women who undergo extended low midline incision
* Women who undergo lysis adhesion
* Women who undergo further operations except salpingo-oophorectomy
* Women who cannot evaluated pain score