cyrilzakka/clinical-trials huggingface dataset:
Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer

To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients

To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients undergoing surgery, radiation therapy, and chemotherapy, and to establish a patient blood management program and introduce it as a standard treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-80 years
2. Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
3. Patients with ECOG performance status 0-2
4. Patients with ASA PS 1-2
5. Preoperative Hgb ≥ 7 g/dL
6. Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
7. In case of showing proper organ function WBC ≥ 3,000/mm3 Platelets ≥ 100,000/mm3 Creatinine ≤ 2.0 mg/dL Bilirubin ≤ 1.5 x institutional upper limit normal SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
8. Patient who voluntarily signed the informed consent form

Exclusion Criteria:

1. Patient who unable to determine whether or not to consent on their own
2. Patients with serious underlying diseases or complications
3. Women who are pregnant or lactating
4. Patients with concurrent infection
5. Patients who are allergic to existing iron preparations
6. Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
7. Patients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder
8. Patients with iron overload or iron utilization disorders
9. Patients with serum ferritin \> 800ng/mL or TSAT \> 50% on Iron panel tests
Respiratory Muscle Strength and Function in Healthy Kids

Respiratory muscle strength training (RMST) is a potential treatment option that has been shown to increase strength and ventilatory function in critically ill patients, patients on ventilators and patients with mild neuromuscular weakness. Currently researchers are examining the role of inspiratory muscle strength training (IMST) in pressure performance of ventilator dependent children with Pompe disease. However, normal pressure-flow-timing responses of lung function are not well-characterized in healthy children. The purpose of this study is to measure RMST-induced changes in respiratory function in healthy children. Children will undergo one session of lung function and strength testing. By studying healthy children's respiratory function, this study will also help to develop more efficient respiratory muscle training exercise prescriptions for children with neuromuscular weakness and impaired respiratory function.

The goals of this study are to collect and evaluate respiratory muscle strength training (RMST) induced changes in ventilatory function in healthy children. Children will undergo one session of pulmonary function and strength testing to quantify rate of inspiratory and expiratory pressure development and to determine whether inspiratory and expiratory pressure correlate to maximal respiratory pressures and forced pulmonary function tests. Currently normal pressure-flow-timing responses are not well-characterized in healthy children. The purpose of this study is to help develop more efficient RMST exercise prescriptions for ill children on ventilators and with neuromuscular weakness.

Participants in the study will refrain from caffeine products and exercise on the day of respiratory testing. In conjunction with respiratory testing, baseline and exertional blood pressure, heart and respiratory rate, and pulse oximetry will be monitored. Participants will complete tidal flow-volume assessments and forced expiratory maneuvers according to the AMerican Thoracic Society guidelines. Participants will undergo 5 sets of 10 maximal-effort breaths against standardized resistances (one set each at 0, 5, 10, 15, and 20 cm H20). Following each set, subjects will rate the load magnitude and their feelings of breathing discomfort using a 0-10 visual analog scale. Participants will also perform maximal inspiratory and expiratory pressure maneuvers. All tests will be separated by at least 2-3 minutes of rest.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 4-16 years of age.
* Healthy subjects

Exclusion Criteria:

* Have primary pulmonary disease
* Have primary neuromuscular disease
* Have a connective tissue or autoimmune disease
* Have had a respiratory infection with in 15 days prior to study date
* Have acute aminoglycosides antibiotic therapy with in 15 days prior to study date
* Have acute corticosteroids with in 15 days prior to study date
* Have a need to use an inhaler routinely
* Have hepatic failure
* Have hematologic failure
* Have participated in other studies related to medications or exercise
* Have used tobacco products
* Have other precautions
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia

The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial efficacy of the VOCALE LBD+ intervention in caregivers of persons living with Lewy Body Dementia. The main question\[s\] it aims to answer are:

* What is the extent to which the VOCALE LBD+ intervention affects caregiving mastery scores at the end of the eight-week intervention
* What is the extent to which a change in caregiving mastery scores is retained four weeks after the end of the VOCALE LBD+ intervention

Participants will be asked to participate in a fully online asynchronous VOCALE LBD+ intervention that involves a moderated web-based discussion platform, peer-to-peer support, didactic training, and problem-solving skill enactment.


Eligibility Criteria:
Inclusion Criteria:

* Informal and/or lay caregiver of a patient with LBD
* Can read, write, and speak English
* Has access to a device that can be used for videoconferencing and/or phone calls
* 18 years or older

Exclusion Criteria:

* Not an informal and/or lay caregiver
* Cannot read and write in English
* No access to a device that can be used for videoconferencing and/or phone calls Younger than 18 years old
Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

Surgical patients undergo preoperative counseling which varies in quality and duration. Proper communication during the preoperative consultation can deliver relevant health information and guide improvement of perioperative health status. The methods, however, are non-standardized and the explanation of the postoperative course is generally vague or varies from person to person. We hypothesize that high-risk patients who receive pre-operative counseling with the help of the NSQIP surgical risk calculator compared to the current standard of care will have higher satisfaction concerning information on the perioperative journey.

The control arm will receive standard preoperative counselling and written consent will be taken.

The NSQIP arm will receive standard preoperative counselling along with the details provided by NSQIP Surgical risk calculator and written consent will be taken.

Anxiety among the patients will be accessed with the use of Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepali.

Duration of counselling period will be noted from the start of counselling session till the consent is signed.

Eligibility Criteria:
Inclusion Criteria:

* ASA III or above and/or age above 65 high-risk surgical patients undergoing surgery at Nepal Mediciti Hospital

Exclusion Criteria:

* Adults who cannot consent Pregnant women Non-Nepali speakers Consent by surrogate
Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
* In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

* Target lesion located in the left main trunk.
* Target lesion located in the bypass graft.
* In-stent restenosis.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
* Inability to take clopidogrel for at least 6 months.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School

Aim of present study is to evaluate the efficacy of hospital school experience in the reduction of distress, pain and negative emotion in children from 8 to 12 years old, hospitalized in oncology and pediatric wards. Investigators also want to explore the ideas and opinions of teachers and parents about hospital school service.

Hypothesis: the investigators expect a reduction in pain, distress and negative emotions.

The school service into the hospital was born as an attempt to support emotionally, relationally and cognitively the hospitalized children, who have to spend a lot of time alone, without being educated by teachers with their classmates. There are not many studies in the Italian contest about this issue and with the present study the investigators intended to implement the acknowledgement about this theme.

The principal aim of this study is to explore if the school service reduces negative emotions experienced by oncological children as well as perceived pain and distress. To evaluate this aims, the investigators organized the study in 3 sections: the first is about the emotions experienced by oncological children between 8 and 12 years old, who benefit from the school service into the hospital; the second is about their parents' opinions and believes about the hospital school service; the third is about opinions, training and educational method dedicated by hospital school teachers and not hospital school teachers (who previously thought to our oncology children sample).

Eligibility Criteria:
Inclusion Criteria for children:

* age between 8 and 12 years old
* knowledge of Italian language
* consent for study participation
* recovery
* be/not be in contact with classmates (group A and group B)

Exclusion Criteria for Children:

* patients who have already had hospital school experience in the past
* cognitive disability
* patients that cannot complete the study because of health or mental issues incoming during the period of the research

Inclusion criteria for hospital teachers:

* Italian knowledge
* Being a hospital teacher

Exclusion criteria for hospital teachers:

- Have earlier experience as a hospital children in other hospitals

Inclusion criteria for not hospital teachers:

* Italian knowledge
* Being a teacher of the hospitalized children in the past or present time exclusion criteria for not hospital teachers:
* A past experience as a hospital teacher

Inclusion criteria for parents:

* Italian knowledge
* consent for study participation
* Health or mental issues that can cause problems in completing questionnaires or answering questions

Exclusion criteria for parents:

* Cognitive disability
* Health or mental issues that can cause problems in completing questionnaires or answering questions
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.

This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant.

Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Currently on hemodialysis for ≤12 months
* Successful creation of a single stage radiocephalic end to side fistula

Exclusion Criteria:

* Prior AV access created on the limb where the fistula surgery is planned
* Planned start of peritoneal dialysis within 6 months of randomization
* Known hypersensitivity to the following: sirolimus, beef or bovine collagen
* Known to be HIV positive
* Prisoner, mentally incompetent, and/or current alcohol or drug abuser
Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes

The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.

With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.

Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-18 years
* T1D for greater than one year;
* Willing to perform at least three self-monitoring blood glucose tests per day;
* Has been using continuous subcutaneous insulin infusion for more than one month
* English speaking

Exclusion Criteria:

* Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)
* Use of corticosteroids that have systemic effects and affect glucose levels
* Currently using continuous glucose monitoring
* Cognitively unable to self-manage, based on parent's and/or care provider's opinion
Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?


Eligibility Criteria:
Inclusion Criteria:

* No significant analgesic medication use before surgery as defined in the protocol
* Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladder removal (laparoscopic), and knee scope (arthroscopy).

Exclusion Criteria:

* Anticipated other surgery within 12 months
* Anticipated life expectancy of \<12 months
* Those that have legal guardians (due to special permission to enroll in trials)
* Participants with complex chronic conditions per the Pediatric Medical Complexity Algorithm (e.g., trisomy 21)
* Patients with contraindications to non-steroidal anti-inflammatory drug (NSAID) drugs in the NSAID arm, opioid drugs in the opioid arm, or acetaminophen will be excluded.
* Liver disease
* Acute psychiatric instability (defined as current uncontrolled severe depression, severe post-traumatic stress disorder (PTSD), or suicidal ideation), substance use disorder not in remission or treatment, and history of diversion of controlled substances (opioids)
Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?

The aim of the study is to determine whether spontaneous LH peak is superior to human chorionic gonadotropin before a transfer of a day 3 frozen embryo.

For surplus embryos after fresh IVF-cycles, cryopreservation has become common medical practice. These frozen embryos are mostly replaced in an artificial cycle with exogenous estrogen and progesterone or in a natural cycle. Often, hCG is administered as an ovulation induction agent for scheduling purposes.

Successful implantation requires a co-ordinated series of events allowing a timely dialogue between a receptive endometrium and the intrusive blastocyst . The period of receptivity is thought to be 3 days in human. It is suggested that blastocyst apposition begins about day LH+6 and is completed by day LH+10

In general, the aim is to transfer the embryo during the 'window of implantation', what is defined as the period during which the uterus is receptive for implantation of the free-lying blastocyst. This has been a subject of debate since many years.

A prospective study by Fatemi et al. (2010) revealed a significantly higher ongoing pregnancy rate after transferring frozen-thawed embryos in natural cycles with a spontaneous LH peak compared with natural cycles controlled by hCG for final oocyte maturation and ovulation (31.1% vs. 14.3%, respectively). In this trial, FrET (frozen embryo transfer) was planned 5 days after the LH surge or 5 days after the administration of 5000IU of hCG.

In order to optimize the synchronization in the hCG group, and therefore enhance the pregnancy rates, the aim is to plan a FrET 6 days after hCG administration instead of 5 days. The rationale behind is that day 3 frozen embryos are thawed the day before embryo transfer, which means they are already at day 4 of the embryonic development.

Eligibility Criteria:
Inclusion Criteria:

* Natural cycles, in which a frozen-thawed day 3 embryo is replaced.
* Signed informed consent.
* Regular cycle (i.e. between 26 and 35 days)
* Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa.
* Embryos frozen by vitrification.
* Single or dual embryo transfer.

Exclusion Criteria:

* Known allergic reactions to progesterone products.
* Intake of experimental drug within 30 days prior to study start.
* Contraindication for pregnancy.
* Embryos of women above 39 years of age at the time of embryo freezing.
* Recipients of oocyte donation cycles
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)

In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 65 - 85 years
* 18.5 \< BMI \< 30 kg∙m2

Exclusion Criteria:

* Type II diabetes
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
* Use of anticoagulants, blood diseases, allergy for lidocaine
* Use of NSAIDs and acetylsalicylic acid
* Patients suffering from PKU (Phenylketonuria)
* Presence of implantable cardioverter defibrillator and/or pacemaker
* Performed regular resistance type exercise in the past 6 months
Adaptive Optics ScanningLaser Ophthalmoscope Safety and Efficacy Clinical Trial

This prospective, multicenter, single-group, target-value clinical trial was designed to evaluate the efficacy and safety of an Adaptive Optics ScanningLaser Ophthalmoscope(AOSLO) for ophthalmic examination.

objective: This study aims to collect AOSLO retinal images from human population to assess the imaging quality and quantitative measurement consistency of AOSLO devices manufactured by Robotrak and also monitor any possible side effects.

study population: randomly invited 194 volunteers who meets inclusion criteria

design: the study is an observational protocol that participants will be imaged with Robotrak AOSLO systems to get cellular level images of photoreceptors and blood vessels in foveal area. Automatics analysis of cell/blood vessel morphology parameters will be calculated for consistency evaluation. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, slit lamp examination, ocular biometry, OCT, fundus imaging, multi-focal ERG and OCT scan to assess potential side effects of AOSLO imaging.

outcome measures: the primary efficacy outcome measure of this study are multi expert grading of the image quality collected.

the secondary efficacy outcome measure are quantitative assessment of the morphological parameters generated from the captured images and device operator ratings.

the safety measures are side effect signs from ophthalmic examinations before\&after AOSLO imaging

Eligibility Criteria:
Inclusion criteria：

1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;
2. Can fully cooperate with instructions to complete the inspection
3. The subject (or their designated agent) voluntarily participates and signs an informed consent form. Note: At least 63 subjects with no obvious eye abnormalities were enrolled (determined by the researcher through ophthalmic examination)

exclusion criteria：

1. Patients with high intraocular pressure (\>21mmHg) or other reasons who cannot undergo mydriasis;
2. For those with a spherical lens degree exceeding 5D or a cylindrical lens degree exceeding ± 2D,
3. those with ptosis or other conditions that cannot fully expose the pupil area
4. Aphthalmic or intraocular lens eyes
5. Those who have received photodynamic therapy within 48 hours;
6. Individuals with a history of photosensitivity or taking medication that may cause photosensitive side effects 7）Those who have obvious skin lesions on the lower jaw or forehead and are unable to contact the lower jaw or forehead support

8) Individuals with epidemic keratoconjunctivitis or in the active phase of other infectious diseases 9) Those whose refractive medium is turbid and unable to obtain satisfactory images; 10) Poor fixation or inability to cooperate with the examination due to other reasons; 11) Pregnant or lactating women;