cyrilzakka/clinical-trials huggingface dataset:
KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting

A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.

There is increasing evidence that a circadian rhythm of feeding (cyclic feeding) could be beneficial for critical ill patients. Cyclic feeding and fasting are assumed to have positive effects on the gut microbiome resulting in optimization of host responses to gastrointestinal pathogens. Another positive effect of cyclic feeding potentially results from activation of a "fasting response", inducing repair pathways such as ketogenesis, mitochondrial biogenesis, anti-inflammatory pathways, antioxidant defenses and autophagy processes. The activation of these repair pathways could diminish cellular stress and promote cellular recovery in critical ill patients. A randomized controlled trial by van Dyck et al. could show that fasting-mimicking intervals of 12 hours are sufficient to generate a metabolic fasting response without risking a caloric deficit. This fasting response can be enhanced by additional supplementation of exogenous ketones. A cyclic enteral nutrition with 12 hours of daytime feeding and 12 hours of ketogenic nighttime fasting compared to a continuous enteral feeding for 24 hours can potentially improve the reconstitution of critically ill Intensive Care patients. This improved reconstitution can be measured by maintenance of muscle mass (measured by ultrasound of the musculus rectus femoris), urea/creatinine ration, length of ventilation, length of ICU and hospital stay, 30-day mortality, ICU mobility scale.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent to participate in this study
* admission to ICU
* enteral nutrition

Exclusion Criteria:

* Severe liver dysfunction / liver failure (Child Pugh \>7 points / category B)
* Severe kidney dysfunction (KDIGO stage 3)
* Total pancreatectomy / insulin dependent diabetes mellitus (IDDM)
* Pregnancy / lactation
* Hemoglobin concentration \< 80g/l
* Severe metabolic disorders / severe autoimmune diseases
* Refractory metabolic or respiratory acidosis
* Dysfunction of mitochondrial transport of fatty acids
* Dysfunction of oxidation of fatty acids
* Dysfunction of gluconeogenesis, production and reduction of ketones
* Intermittent Porphyria
* Severe cardiac arrhythmias / cardiomyopathy
* Contraindication against enteral nutrition
* Lack of informed consent
CROS Application in CI

Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral Advanced Bionics CI recipient
* ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
* English speaking

Exclusion Criteria:

* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products

The purpose of this study is to compare the absorption of three different inhalation products with the reference products in healthy volunteers.

Healthy subjects will be enrolled and will receive single doses of 3 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.

The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related morbidity, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.

Eligibility Criteria:
Inclusion Criteria: Potential participants will be

* Patients enrolled in the Bluegrass Clinic
* 18-60 years of age
* Male or female gender
* Able to read, understand and communicate in English
* Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic
* Willing and able to abstain from drug use other than Suboxone
* Exhaled breath on day of study carbon monoxide (CO) \< 5 ppm
* Stabilized on maintenance buprenorphine if having comorbid opioid use disorder.

Exclusion Criteria:

* Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.
* Previous adverse effect with TMS.
* Sub-threshold consistency while performing behavioral tasks.
* Failure to show baseline attentional bias to smoking versus neutral cues.
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants

The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.

Eligibility Criteria:
Inclusion Criteria:

1. \< 32 gestational age and/or \< 1500gr.
2. ≥ 28th day preterm infants
3. Instilled mydriatic eye drops for ROP examination

Exclusion Criteria:

1. Sepsis
2. Shock
3. Severe intracranial hemorrhage
4. NEC
5. Abdominal and cranial surgery
The Utility of a Novel Eye Shield With Reusable Adhesive Anchors for Post-operative Care After Ophthalmic Surgery

The purpose of this research study is to evaluate the efficacy, patient preference, and utility of a novel eye shield that utilizes a different adhesive mechanism in comparison to the current standard of care. The aims are to see if this product could be incorporated into postoperative care in the future to improve patient satisfaction and compliance.

The study will involve 20 patients during the postoperative timeframe after cataract extraction and intraocular lens placement (CEIOL). These patients will be chosen from the clinic of Dr. Marc Toeteberg who will plan to have both eye surgeries done within 3 months of each other. These patients will be randomized to either control or intervention group. Intervention group will receive our novel eye shield prototype, while control group will receive an Alcon plastic eye shield. Both groups will receive the eye shields after surgery and will be sent home with these eye shields with normal postoperative care directions. Patient will be directed to wear eye shields for 24 hours then at night for first 2 weeks after surgery, while adhering to postoperative eye drops regimen.

After successfully healing and passing the postoperative timeframe for the first eye we will proceed to the second arm of the study. Approximately 1-2 months after healing from the first surgery, patient will be scheduled for cataract surgery on the other eye, as is standard of care. After surgery on the second eye the patient will be given the other eye shield than what they received after the first surgery (control groups will receive the novel eye shield and experimental groups will receive the control eye shield). They will proceed to follow identical postoperative protocols after the second surgery. A short quantitative and qualitative questionnaire directly comparing the two eye shield experiences will be provided at the 1 month follow-up after the eye surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female cataract surgery patients of 18 years or older, with surgical plans for cataract extraction via phacoemulsification and intraocular lens placement. Patient must be having plans to have both eye cataracts removed surgically in succession within 3 months of each other.

Exclusion Criteria:

* Patients receiving more advanced intraocular surgery, even if that surgery includes cataract removal and intraocular lens placement, including trabeculectomy, microinvasive glaucoma surgery, vitrectomy, or any other ophthalmic procedure. Pregnancy also an exclusion criteria.
Depuy Synthes Lower Extremity Shaft Nail Registry

The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature adults age greater than or equal to (\>=) 22 years (Retrograde Femoral Nail Advanced \[RFNA\], Tibial Nail Advanced \[TNA\]) and adolescents 12-21 years of age in which the growth plates have fused (TNA only)
* Participant receives an RFNA and/or TNA based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (RFNA); unilateral or bilateral tibial fracture (TNA); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (RFNA only) that will be treated operatively as part of standard of care. In addition, the following will be included: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis
* Participant (legally authorized representative if participant is a minor) voluntarily signs the Institutional Review Board (IRB)/ Ethics committee (EC) approved consent form
* Participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROs)

Exclusion Criteria:

* Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
* In the opinion of the Principal Investigator, participant is unable to comply with the requirements of the Registry
* Participant has known allergies to implant components
The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period

Objective: The main target of this study was to research the early changes of retrobulbar and intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR).

Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy people (control group) were recruited to research the early changes of renal function, retrobulbar and intrarenal hemodynamics, and then to research the correlation between them. The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C, and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.


Eligibility Criteria:
Inclusion Criteria:

1. The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ;
2. No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight;
3. Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and
4. Likely to have good compliance and able to visit our hospital for periodic assessments.

Exclusion Criteria:

1. T1DM, gestation and lactation;
2. Renal inadequacy,hypohepatia,and heart failure;
3. Intensive care with insulin treatment;
4. The patients combined with DR and hypertension (antihypertensive drugs were used);
5. Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery;
6. The patients combinated with DKD;
7. Patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter \> 3 cm);
8. Cholesterol-lowering drugs can not control the blood-fat (TC \> 250 mg/dl, HDL-C \< 30 mg/dL, LDL-C \> 170 mg/dl, TG \> 200 mg/dl) adequately.
Late Preterm Corticosteroids and Neonatal Hypoglycemia

This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.

The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. The American College of Obstetrics and Gynecologists (ACOG) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. Since publication of the ALPS trial, the Society of Maternal Fetal Medicine (SMFM) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days.

A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome.

The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age 34 0/7 weeks to 36 5/7 weeks
* Planned delivery in late preterm period

Exclusion Criteria:

* Prior course of betamethasone during pregnancy
* Twin gestation
* Fetal demise
* Major fetal anomaly
* Maternal contraindication to betamethasone
* Pregestational diabetes
* Expected delivery within 12 hours of randomization
Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis

This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.

Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced.

Intervention Type: Behavioral

Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Relapsing-Remitting Multiple Sclerosis
2. 18-70 years old
3. Able to read and write in English
4. Able to attend sessions at the UC San Diego School of Medicine

   * Age group: adult
   * Gender: both
   * Target enrollment: 20

Participant exclusion criteria:

1. Severe depression (score of 31 or higher on the BDI)
2. Very high levels of fatigue (above an average of 6 on the FSS)
3. Low levels of mindfulness (below an average score of 2 on the FMI).
Intensive Cancer Screening After Cryptogenic Stroke

The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.


Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years
* presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital Neurovascular Unit with a first cryptogenic ischemic stroke after advanced evaluation as per American Heart Association guidelines and Saver approach (maximum 3 months after stroke)
* patient or delegate willing and able to provide informed consent.

Exclusion Criteria:

* contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20 minutes)
* active cancer or previous cancer diagnosis (other than basal or squamous cell carcinoma of the skin)