cyrilzakka/clinical-trials huggingface dataset:
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.

This prospective study, coupled with the results of the recent POET study evaluating the role of antibiotics in postoperative outcomes for pituitary surgery, will guide physicians in the optimal management of patients following endoscopic pituitary surgery.

The investigator group has an established record of completing multicenter studies (e.g., POET, TRANSPHER) that have influenced clinical practice guidelines, raised the profile of Barrow in the pituitary and skull base community, and resulted in numerous peer-reviewed publications and awards.

Eligibility Criteria:
Inclusion criteria

1. Adult patient undergoing endoscopic surgery for resection of pituitary tumors

   * nonfunctioning adenoma
   * acromegaly
   * prolactinoma
   * Rathke's cleft cyst
2. Adults \>18 and \<85 years of age
3. English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
4. Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable
5. Planned binostril surgical approach
6. Either with or without septal flap reconstruction
7. Either with or without septoplasty

Exclusion criteria

1. Active sinus infection
2. Allergic rhinitis
3. Asthma
4. Vascular or inflammatory disease
5. History of previous sinonasal surgery
6. Any subject who is unwilling or unable to sign informed consent for the study
7. Pregnancy
8. Incarcerated patients
9. Cushing's disease
10. History of chronic sinusitis
11. Extended approaches to the skull base
12. Active sinusitis
13. Nasal polyps
14. Concurrent antibiotics for another indication (i.e., urinary tract infection)
15. Immunodeficiency
16. History of radiation to the skull base
Propofol for Treatment on Emergence Agitation

This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.

Sevoflurane with rapid anesthetic induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. In severe case, it cause injury to the child or to the surgical site and lead to the accidental removal of surgical dressings and intravenous catheters. In case of intense agitation with high risk of self-injury, pharmacologic intervention seems reasonable. Pharmacologic treatment of emergence agitation relies on the administration of IV sedative agents (IV midazolam 0.1 mg/kg12 or propofol 0.5 or 1 mg/kg) or opioid agents (IV fentanyl 1 or 2 mcg/kg). However, these treatments are empirical and were extrapolated from pharmacologic preventive studies performed at the end of surgery or from personal experience. To the investigators knowledge, there is no risk of recurrence of EA after a first episode. Consequently, EA is not per se a factor of increased duration of PACU (post-anaesthesia care unit ) stay, but sedative or opioid agents administered postoperatively to alleviate it might prolong this stay.

Therefore, the investigators design a study to confirm statistically effect of propofol for treatment on emergence agitation after sevoflurane anesthesia in pediatric strabismus surgery through PAED scale. Furthermore duration of PACU stay is checked after propofol administration.

Eligibility Criteria:
Inclusion Criteria:

* ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.

Exclusion Criteria:

* Refusal by parents, neurologic disease, developmental delay, history of any previous surgery, American society of Anesthesiologists physical status score of III or IV, and airway disease
EEG Alterations in Preterm Infants With Thyroid Dysfunction

The aim of this study is to investigate differences in electroencephalography (EEG) evolution between preterm infants with and without transient hypothyroxinemia of prematurity (THOP) in order to find differences in the interburst interval and the background pattern and in the maturation of the sleep-wake cycle.

1. Definition of THOP The determination of thyroid hormones (TH) are assay-specific and related to the infants' gestational age (GA) and moment of determination. Immediately after birth, there will be a surge of TH, subsequently followed by a decrease to basal levels. Therefore, it is difficult to obtain reference values.

   The investigators plan to set out specific reference values for the preterm patient population, based on the TH laboratory results of cord blood, performed in the clinical laboratory of UZ Leuven and available over the last 4 years. The results will be linked to the gestational age. Dependent whether the data distribution is normal or not, the investigators are planning to use standard deviations or percentiles to classify patients.
2. EEG findings In this retrospective study, quantitative EEG- sleep behavior at (near) term age (GA 36-44 weeks) in preterm infants born \<28 weeks GA, will be analyzed (n = 87).

EEGs were taken in the framework of the Resilience study and hereby, parental informed consent was already obtained.

TH function is assessed in preterm infants ≤ 34 weeks as part of the clinical care protocol. No additional blood samples were taken.

Quantitative EEG measures will be compared between the preterm infants with THOP (circulating thyroxine levels\< P10) and without THOP. Logisitic regression will be performed to determine the effect of thyroid function as well as other clinical and demographic variables, on functional brain development at term equivalent age. These results will also be linked to long-term neurodevelopment outcome.

In a subgroup of these preterm patients (n=42) sequential EEGs, recorded during their stay at the neonatal intensive care unit, are available. These EEGs will be analyzed in a fully automatic way to assess functional EEG- brain maturation.

In this way, the investigators want to investigate whether deviations of normal preterm EEG-brain maturation can be discerned in preterm neonates with THOP and without THOP.

In preterm infants with GA \< 32 weeks, developmental follow up data are available at the corrected age of 9 months and 2 years (Follow up Convention). The investigators will use these results and link them to the EEG findings and THOP data.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \< 28 weeks
* serial EEG recordings available
* thyroid function test on the first day of life and at the end of the first week of life available

Exclusion Criteria:

* Presence of congenital abnormalities
A Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.

This study is being done to determine how the body fights off a common virus known as Cytomegalovirus (CMV). CMV is a virus that commonly infects humans and causes disease in patients with compromised immune function such as those who receive organ and tissue transplant. By knowing how the human body responds to the infection, researchers will be able to develop better methods on how to prevent this infection.

This study is looking at the CMV virus in Hematopoietic stem cell donors and recipients. In the donor population, the study is looking at the participants blood to see if they contain cells that are active against the virus. Information about the donor will be obtained through an interview and through review of medical records. A blood sample will be drawn at the time of the donor's evaluation, which will take place in conjunction with the regular blood tests that are ordered. Participants of the study who are donors will only be involved in the study at the time of blood collection.

Participants who will be receiving hematopoietic stem cell transplantation will have data collected through an interview and review of medical records. Participants will have blood drawn prior to transplant, weekly for 12 weeks and then monthly for three months following transplant. In addition, if CMV disease develops during this period of time, blood will be drawn till the participant is cured for the disease. All blood draws for thes study will take place in conjunction with the regular routine blood work. Participants will be in the study for one year after transplant.

Eligibility Criteria:
Participants who will be undergoing blood marrow or stem cell transplant and donors that are 18 years of age or older, may be eligible to participate in this study.
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.

Eligibility Criteria:
Inclusion Criteria:

1. Women, 50 to 80 years of age, both inclusive.
2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3. Postmenopausal
4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

Exclusion Criteria:

1. Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
2. Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
3. Patient with history and/or presence of one severe or \> 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
4. Patient with history and/or presence of hip fracture
5. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
6. Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
7. Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
8. Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results
Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia

The purpose of the clinical trial is to study the therapeutic efficacy and safety of Stemchymal® infusions for polyglutamine spinocerebellar ataxia treatment by a randomized, double-blind, placebo-controlled study design. Eligible subjects will receive Stemchymal® through intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are with genotypically confirmed spinocerebellar ataxia type 2 or spinocerebellar ataxia type 3.
2. Subjects' baseline SARA score are in the range of 8 to15.
3. Subjects are between 20 and 70 years of age.
4. Subjects who had signed informed consent.

Exclusion Criteria:

1. Subjects had been enrolled in any kind of cell therapy within six months prior to screening visit.
2. Females with a positive pregnancy test result.
3. Subjects who had had severe vital organ disease as diagnosed, including but not limited to cardiac (ex. heart failure), liver (ex. acute hepatic failure or chronic liver cirrhosis), lung (ex. respiratory failure) and renal (ex. hemodialysis or peritoneal dialysis) insufficiency, within six months prior to screening visit.
4. Subjects with immunological disorders (ex. Systemic lupus erythematosus), within six months prior to screening visit.
5. Subjects with other neurological disorders (ex. Alzheimer's disease), within six months prior to screening visit.
6. Subjects who had received chemotherapy/radiotherapy within five years prior to screening visit.
7. Subjects with any history of malignancy tumors.
8. Subjects with a history of hypersensitivity/allergy to penicillin.
9. Subjects with dementia or other psychiatric illnesses, including but not limited to disabling depression, bipolar disorder, and schizophrenia.
10. Subjects with Beck Depression Inventory Second Edition (BDI-II) score over 20 points.
11. Subjects with unstable illnesses or contraindication for this clinical trial according to PI's judgment.
Telesonography for Visually Estimating Ejection Fraction

Background: Given that an experienced physician is not always available 24 hours a day, immediately and always available echocardiography is usually impossible in the emergency department (ED) and intensive care unit (ICU). To compensate this limitation, the investigators have investigated that offsite expert guided, inexperienced practitioner-performed ultrasonography could be effectively performed. In this study, the investigators aimed to investigate whether the offsite expert can effectively evaluate the visually estimated ejection fraction (EF) while watching and guiding the echocardiographic procedure of onsite novice examiner using the social network video calling chat.

Methods: sixty patients presenting to the ICU and requiring echocardiography will be included. Sixty novice practitioners without any previous experience of echocardiography will participate. Prior to their procedure, the onsite expert complete the echocardiography in advance and determine the EF using the modified Simpson's method (MSM, Reference value). Then, the novice physicians perform the echocardiography again with the offsite expert's guidance via video call. They obtain parasternal long and short axis view and EF is visually estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the ultrasound video on the smartphone display. The subjects requiring immediate management due to severe symptoms were excluded in this study. Interobserver variability between the calculated by onsite expert and visually estimated by offsite expert was assessed. The agreement of the visual estimated EF obtained by onsite expert and offsite expert via smartphone was evaluated by linear regression and Bland-Altman plots.


Eligibility Criteria:
Inclusion Criteria:

* The patients admit to intensive care unit

Exclusion Criteria:

* Hemodynamic unstable patients
* Patients requiring immediate management
The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota

The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.

Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.

Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.

The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.

PRE-STUDY EVALUATION AND TESTING

1. Complete pre-study questionnaire
2. Complete orientation to the study and provide voluntary consent to join the study
3. Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT

1. Record food intake and gastrointestinal symptoms for 3 days
2. Collect health data and provide a 3-day food frequency questionnaire
3. Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES

1. Provide the blood sample at the laboratory in the morning in an overnight fasted state.

DIETARY INTERVENTION

1. Daily intake of a test or control product for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-55
* Normal bowel function
* Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
* Ability to provide a signed written informed consent
* Willing to provide stool and blood specimens 2 times over the 2-week study period

Exclusion Criteria:

* Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
* Medication: statins, blood pressure medications, antidepressants, other prescription medications
* History of bariatric operation, removal of the gallbladder.
* Food allergies, lactose intolerance
* Recent (previous 3 months) use of antibiotics
* Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
* Current pregnancy or breastfeeding
* Volunteers showing previously unrecognized illness will also be excluded
* Individual unable to give informed consent
Investigation of Cancer Cell Extravasation Through mRNA Analysis of Organ-specific Endothelial Cells and Microfluidics

The project aims at unraveling the role of organ-specific endothelia mediating the preferential metastasisation of breast cancer cells to bone by using a multi-faceted approach, integrating microfluidics and transcriptomic profiling. Based on a recently study published by the investigators \[Jeon et al., PNAS 2015\], it can be hypothesized that phenotypic differences at the level of organ-specific endothelial cells are able to drive the preferential extravasation of breast cancer cells to specific sites. Hence, the transcriptional profile of primary organ-specific endothelial cells derived from healthy patients (i.e. non-affected by breast cancer) will be analyzed to identify phenotypic differences between organ-specific populations of endothelial cells. These analyses will allow to identify potential target genes involved in the organ-specific extravasation of cancer cells (i.e. genes differentially expressed by endothelia of preferential and non-preferential metastasisation sites). The selected genes will be silenced and the effect of gene silencing will be evaluated through microfluidic in vitro organ-specific 3D models designed to study cancer cell extravasation.

In particular, the main aim of the study will be to highlight differences between bone and skeletal muscle microenvironments, which are respectively preferential and non-preferential metastasisation sites for breast cancer cells, in order to identify specific pathways driving breast cancer cells extravasation. To this purpose, differences in the transcriptional profile of ECs derived from bone and muscle endothelium will be investigated. These analyses will be used to select target genes differentially expressed by bone- and muscle-specific ECs. Then, ECs obtained from bone and muscle endothelium will be respectively used to mimic bone and muscle microvessel environments in microfluidic in vitro 3D models allowing for the study of breast cancer cell extravasation. The genes selected according to the results of the transcriptomic analysis (e.g. genes expressed in ECs derived from bone endothelium, but not expressed in ECs derived from muscle endothelium) will be silenced and the effect of gene silencing will be evaluated monitoring breast cancer cell extravasation in order to verify the involvement of the selected genes in this process.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years
* patients undergoing cruciate ligament surgery or hip arthroplasty
* subscription of informed consent

Exclusion Criteria:

- HIV, HCV, HBV, TPHA viral
Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse

This study is aimed to compare the efficiency of two uterus-preserving laparoscopic methods to treat uterine prolapse in a randomized controlled trial. Laparoscopic lateral suspension with mesh (LLSM) will be compared with laparoscopic sacrohysteropexy (LS). Both procedures are known as sufficient uterus preserving methods. LLSM was introduced to be an alternative to others with avoiding dissection of promontory and therefore being safer, faster and feasible technique.

Patient with uterine prolapse can participate in this study. A total of 44 women will be included. At random 22 patients undergo laparoscopic lateral suspension with mesh operation and 22 patients undergo laparoscopic sacrohysteropexy operation. Evaluation will take place during the surgery, at the postoperative visit after 4 weeks, 6th months and 12th months. Quality of life, degree of vaginal prolapse, safety, operation time and complications will be evaluated.

Subjective assessments will include Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS).

Objective assessments will include routine gynecologic sonography, Pelvic Organ Prolapse Quantification System (POP-Q) and pelvic floor biometry measured by transperineal sonography.

Transperineal sonography will include those measurements:

Urethral rotation, Pelvic organ descent, Hiatal Diameter and the Anatomical localization of apex.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* \> Symptomatic prolapse of central compartment with a Pelvic Organ Prolapse Quantitative (POP-Q) stage 2 associated or not with anterior or posterior compartment prolapse.
* Patients who are not comfortable with using or refusing pessary
* Wish to preserve the uterus

Exclusion Criteria:

* Any cue for gynecologic oncological condition
* Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse