cyrilzakka/clinical-trials huggingface dataset:
Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

This study is a prospective observational study of a single cohort of the patients who will undergo a scheduled living donor liver transplantation.

The investigators attempt to evaluate the association of intraoperative renal regional oxygen saturation and acute kidney injury in patients undergoing living donor liver transplantation. Near-infrared spectroscopy sensor will be attached to the skin near bilateral kidney areas in all patients and renal regional oxygen saturation will be monitored during the operation. Renal regional oxygen saturation (rSO2) of the patients who developed acute kidney injury postoperatively will be compared with rSO2 of the patients who did not.

Acute kidney injury is a frequent complication after liver transplantation, which is related to poor prognosis and longer hospital stay. There is no sensitive or specific marker for predicting postoperative acute kidney injury, although studies of the biomarkers have shown promising results.

Near-infrared spectroscopy is a non-invasive and real-time monitoring device for regional oxygen saturation measurement. Previous studies revealed that it could be applied to the skin near the kidney and be used to monitor renal regional oxygen saturation.

Therefore, in this study, the investigators will apply near-infrared spectroscopy around kidney area to measure real-time renal regional oxygen saturation during liver transplantation surgery and investigate the association between the intraoperative renal regional oxygen saturation and the development of post-transplant acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to undergo elective living donor liver transplantation
* Patients who provided written informed consent

Exclusion Criteria:

* Missing preoperative serum creatinine value
* Underlying kidney disease, such as hepatorenal syndrome, chronic kidney disease
* History of unilateral or bilateral nephrectomy
* Patients who died within 48 hours immediately after surgery
* Any skin problem at the attachment site of regional oxygen saturation probe
Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure

Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most commonly performed operation to slow-down the disease progression. In this study, we compare the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course and surgical success of trabeculectomy.

Trabeculectomy is still the most popular filtering surgery for glaucomatous patients. In this type of surgery, postoperative care and management is highly important for surgical success. A principle component of postoperative regimen is anti-inflammatory medications. However, corticosteroid eye drops, the most frequently used agents, have some side effects, including raising intraocular pressure.

Cyclosporine A could be an interesting alternative, because not only it has acceptable anti-inflammatory effect and could reduce some ocular surface problems, but also it has minimal direct effect on intraocular pressure. In this study, we will compare the effect of topical cyclosporine A and betamethasone on surgical outcome and postoperative course of trabeculectomy patients.

The study is a prospective study to compare the effect of topical betamethasone and cyclosporine A on postoperative findings of glaucoma patients, undergoing trabeculectomy surgery.

In this study, trabeculectomy patients, who fulfill the study criteria, will be randomized to either study group and follow-up visits will be done in a masked fashion. In each visit, a detailed history taking and eye examination will be done by an examiner unaware of study group. A third party would do data control for patient safety. At the conclusion of the study, the data of the two groups would be compared. All human research ethical codes are strictly respected and the Ethical Committee of the University has an ongoing inspection on all study steps.

We hypothesize that cyclosporine A could provide better inflammation and intraocular pressure control and may enhance surgical success rate. However, our null hypothesis is that the result in study groups will not differ statistically significantly.

Eligibility Criteria:
Inclusion Criteria:

* POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.

Exclusion Criteria:

* Age \<20 years
* History of previous ocular surgery in the same eye;
* Candidate for combined surgery;
* Pregnancy;
* Breast feeding;
* Monocular subject;
* Allergy to any topical antiglaucoma medication or cyclosporine
Relationship Between Homocysteine and BMD

The association between Homocysteine (Hcy) levels and bone mineral density (BMD) has been debated. Some studies have found a relationship between increased Hcy plasma levels and BMD in contrast; other studies have not found a relationship. The purpose of our study was to investigate whether or not Hcy plasma levels are related to BMD in a group of postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* BMD measured by dual-energy X-ray absorptiometry (DXA)

Exclusion Criteria:

* Primary ovarian failure
* Early menopause
* Cardiovascular, liver, or renal diseases
* Surgical menopause
* History of cancer
* Receiving treatment known to influence levels of Hcy or bone mineralization (folates or vitamin B12 supplements, menopausal hormonal treatment, corticosteroids, anticonvulsants, heparin, thiazide diuretics, and antiresorptive agents).
Inverse Ratio Ventilation on Bariatric Operation

for evaluating inverse ratio ventilation of laparoscopic bariatric surgery

inverse ratio ventilation had been improve the oxygenation and respiratory mechanics during care of ARDS patients or during general anesthesia. We hypothized inverse ratio ventilatio could improve the oxygenation and respiratory mechanics on the obese patient also.

Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-2 obese patients(BMI\>30)

Exclusion Criteria:

* underlying cardiopulmonary diasease
Proton Radiation Therapy for Pituitary Adenoma

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on pituitary tumors and analyze possible side effects.

Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven pituitary adenoma.
* Age 18 years or older.
* Status post biopsy, gross total resection (from initial surgery for recurrent disease) or subtotal resection.
* Good to moderate neurological function status

Exclusion Criteria:

\*Previous radiation that would compromise the ability to deliver the prescribed treatment.
The Effect of Live Subject on the Anxiety Level and Perceived Competence Level

This study was carried out to examine the effect of training on the proficiency and anxiety levels of Paramedic students in a realistic, simulated environment of the pre-hospital scene. A total of 72 second-year students in the Paramedic program participated in this study with an interventional approach. The data collection form used in the study consisted of sociodemographic characteristics, a self-efficacy form for approaching trauma patients, and the worry and anxiety scale. Within the framework of the research, a competition named "trauma rally" was organized for university Paramedic students, which consisted of the pre-hospital approach of injured live subjects. Through face-to-face interviews, the data collection form was filled out with the participants before, immediately after and one month after the competition.

Teaching-learning strategies are methods to make it easier for the student to achieve professional goals in personal development. In the context of the academic education of healthcare professionals, ethical issues, patient safety, technological developments, health science, complexity of care measurements and current business world necessities should be taken into account by considering these strategies. In this context, simulation-based learning is one of the most effective and interesting teaching strategies and has been shown to reduce gaps between education and practice and adapt nursing students to clinical environments. Simulation is a set of structured activities that represent actual or potential situations in training and practice. These activities allow participants to develop or increase their knowledge, skills and attitudes, or to analyze and respond to realistic situations in a simulated environment. Simulations are especially important in clinical environments because they imitate various aspects of the real world and provide safe learning environments where students can practice until they reach skill competence through self-correction. As a matter of fact, the European heart association (ERC) points out that simulation programs increase the quality of trauma and advanced life support training and increase resuscitation rates after cardiac arrest. High fidelity simulation-based training can be an important component in preparing students for a successful transition into clinical practice. Additionally, it contributes to student satisfaction, confidence, competence and reduced anxiety levels. For these reasons, simulated experiences may be an option to complement traditional healthcare professional education methods.

Eligibility Criteria:
Inclusion Criteria:

* volunteering

Exclusion Criteria:

* non volunteering
Music During ESWL for Half Treatment

The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).

Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the first part of the treatment (first 1800 SW), patients in group B during the second part.

At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing ESWL from February 2011 to October 2012 and interested in music listening

Exclusion Criteria:

* Contraindication to ESWL
* No interest in music listening
* \< 18 years and \> 80 years
Clinical Study on Chinese Children's Asthma Action Plan

This study is a multi-center randomized controlled trial of children with asthma. The objective of the study is to assess the efficacy of China Children Asthma Action Plan (CCAAP), which is the first asthma action plan for children with asthma in China, in asthma management.

Asthma is the most common chronic illness of childhood. Asthma action plans have been recommended internationally for more than 20 years by the Global Initiative for Asthma and have been shown to improve asthma-related outcomes. The first asthma action plan for children with asthma in China, which is termed China Children Asthma Action Plan（CCAAP）, as well as a mobile phone-based asthma self management application(APP), were developed recently.

The objective of the study is to assess the efficacy of CCAAP in asthma management.

The study is a multi-center prospective case-controlled study.The enrollment period is 3 months. Patients who is in 6-14 years of age will be randomized recruited into two groups: the asthma action plan group and the conventional group. Patients in asthma action plan group will receive written CCAAP and mobile phone-based asthma self-management APP (Youran Respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and Peak Expiratory Flow Meter. Patients in conventional management group will write down the symptoms and PEF in asthma diary. The data of the number of asthma episodes, the improvement of FEV1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, ACT / C-ACT score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of CCAAP in asthma management. The study will recruit 200 cases for each group from ten children's hospitals. The study will be completed in a year.

Eligibility Criteria:
Inclusion Criteria:

* did not receive control treatment or did not reach well-control;
* can perform spirometry pulmonary function tests;
* parents are skilled in using smartphones and APP apps (Android or IOS).

Exclusion Criteria:

* reach the level of asthma control;
* can not use the smartphone APP software;
* can not cooperate the test of peak expiratory flow;
* did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.);
* combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.).
* receiving allergen-specific immunotherapy.
* undergoing trial for other medications or instruments.
Early Hospital Discharge Program in Neonatology

Early discharge of premature infants from the Neonatal Intensive Care Unit will have substantial benefits:

(i) diminish parental stress;

(ii) increase parental - child bonding;

(iii) diminish medical complications derived from prolonged hospitalization;

(iv) reduce cost;

(v) increase number of point of attendance disponible for future patients.

Extremely premature infants have to remain for very prolonged time in the hospital. As a consequence, difficulties for establishing an adequate parental-infant bonding arise causing a substantial parental stress manifested as anxiety and depression, and increasing the risk of short and longterm consequences (neglect, abuse, maltreatment, abandonment). In addition, prolonged hospital stay will increase the probability of having medical complications (infections, excessive blood tests or image studies) and the cost of staying. Once the baby has improved sufficiently early discharge may be given independently of the baby's weight. In order to be successful, caregivers, psychologist and parents have to put forward an established protocol to be able to face satisfactorily this situation. We hypothesize that, with an adequate Early Discharge Program, we could substantially reduce length of hospitalization, cost, and reduce parental stress.

Eligibility Criteria:
Inclusion Criteria:

* Prematurity
* No need for hospital support
* Parents fulfill sociological score
* Cooperation of primary care pediatrician

Exclusion Criteria:

* Active disease
* Need for hospital intervention
* Major congenital malformations
* Chromosomopathies
Oral OKT3 in Combination With Beta-D-Glucosylceramide

This clinical study is designed to evaluate the safety of oral administration of the study drug anti CD3 (OKT3) in combination with β-D glucosylceramide \[GC\] .

Anti CD3 (OKT3): Is an approved drug for intravenous use in the treatment of solid organ transplantation. Preliminary data suggest that the oral administration of OKT3 in low dosages can exert an immune modulatory effect via activation of regulatory T lymphocytes.

β-D glucosylceramide \[GC\]: Is approved for oral administration and is currently being tested in three clinical trials. Recent data suggested that it can serve as an immunological adjuvant in various clinical settings and to augment the immune response via activation of regulatory T cells.

This clinical trial has been designed to assess the safety of oral administration of OKT3 with and without co-administration of GC in healthy subjects. The use of two potential activators of regulatory T cells, may exert an additive effect, augmenting the systemic immune modulatory effect.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the informed consent process culminating with written informed consent by the subject.
* Men and women \> 18 years of age.

Exclusion Criteria:

* Subjects who have undergone surgery within the last 3 months.
* Subjects who have had a prior colostomy, ileostomy, or colectomy with ileorectal anastamosis.
* Subjects presenting with, or who have a history of, persistent intestinal obstruction, bowel perforation, uncontrolled bleeding or abdominal abscess or infection, toxic megacolon.
* Subjects with a clinically significant infectious, immune mediated or malignant disease
* Subjects who are receiving an elemental diet or parenteral nutrition.
* Subjects who have been treated with any time of immune modulatory drug including steroids or NSAID within the last 4 weeks.
* Subjects who have received either methotrexate or cyclosporine or anti TNF alpha (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
* Subjects with a history of coagulopathy.
* Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo -provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
* Subjects who will be unavailable for the duration of the trial, are likely to be non¬compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
* Subjects who are HIV positive
* Subjects who are HBsAg positive
* Subjects who are HCV positive
* Subjects with active CMV
* Subjects who demonstrate a positive PPD
* Subjects with anemia (Hb \<10.5 gm/dl)
* Subjects with thrombocytopenia (platelets \<100K/microliter)
* Subjects with lymphopenia (absolute lymphocyte count \<0.7)
* Subjects with IgG anti-cardiolipin antibody \>16 IU
* Prior exposure to OKT3
* Known sensitivity to any ingredients in the study drug
BOLT Lithotripsy RESTORE ATK Trial

The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.

The RESTORE (ATK) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System that was designed to enhance percutaneous transluminal angioplasty by utilizing delivery of intravascular lithotripsy (IVL) to disrupt calcium prior to full balloon dilatation at low pressures.

Eligibility Criteria:
Inclusion Criteria:

* Age of subject is ≥18.
* Rutherford Clinical Category 2, 3, or 4.
* Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery)
* Calcification is at least moderate. (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm.

Exclusion Criteria:

* Planned major amputation of the target leg (above the ankle)
* The use of chronic total occlusion (CTO) re-entry devices
* CTOs greater than 80 mm in length
* Lesions within 10 mm of ostium of the SFA
* Significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (PTA) or stent and without complications
Telegenetics or In-Person Genetic Counselling

This study aims to compare clinical outcomes (informed choice and genetic counselling outcomes) and cost (provider and patient time, travel, and telehealth platform) between telegenetics and in-person genetic counselling.

This study will compare the patient-reported outcomes of telegenetics with in-person consultations for participants considering germline testing for HBOC or Lynch syndrome. It will clarify if telegenetics is a feasible and non-inferior alternative to in-person cancer genetic counselling. Participant responses are important stakeholder views to guide the design of telegenetics to become a mainstream service delivery model welcomed by patients.

It aims to recruit 150 prospective consecutive patients attending genetic counselling for Hereditary Breast and Ovarian Cancer (HBOC) and Lynch Syndrome in Clinical Genetic Services (CGS) at National Cancer Centre Singapore (NCCS).

Upon completion of the genetic consultation appointments, patients will be completing a series of questions evaluating cognitive and psychosocial outcomes either via hardcopy in-person or online internet-facing questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years old.
* Patients referred to CGS at NCCS for HBOC or Lynch syndrome pre-test genetic counselling.
* Able to read and understand the English Language.
* Able to consent and agree to be randomized to either telegenetics or in-person genetic counselling.

Exclusion Criteria:

* Under the age of 21 years old.
* Patients who require genetic results urgently.
* Cognitive difficulty/ impairment or current psychiatric or physical illness (visual/ hearing/ neurological) which impairs sound judgement and accurate reporting of medical history over video consultation.
Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers 18- 80 years of age and in general good health.
2. Willing and able to understand and sign the informed consent form.
3. Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
4. Be willing to conform to the study protocol and procedures.
5. Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
6. Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
7. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
8. Minimum of 10 teeth

Exclusion Criteria:

1. Subjects unable to understand or unwilling to sign the informed consent form.
2. Medical condition which requires premedication prior to dental visits/procedure.
3. Active disease of the hard or soft oral tissues.
4. History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy.
5. Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
6. Participation in any other clinical study within 1 week prior to enrollment into this study.
7. Subjects who must receive dental treatment during the study dates.
8. Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
9. Presence of orthodontic bands.
10. Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
11. Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months).
12. People on hormone therapy
13. Pregnant or lactating subjects.
14. Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
15. Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).