cyrilzakka/clinical-trials huggingface dataset:
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.


Eligibility Criteria:
Inclusion Criteria:

* 7-18 days of age at Visit 1
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500 g (5 lbs 8 oz) or more
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and use of PHI for infant and birth mother
* Receipt of three protocol-compliant Baseline stool samples

Infants receiving formula:

* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

* Mother has intention to exclusively provide mother's-own breast milk for the duration of the study

Exclusion Criteria:

* Caesarean delivery
* Infant consumption of donor milk prior to randomization/registration
* Maternal antibiotic use within 48 hours prior to or at time of delivery
* Maternal antibiotic use while providing mother's-own breast milk to infant
* Infant use of systemic antibiotics prior to randomization/registration
* Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
* Weight at Visit 1 is \<95% of birth weight
* Infant use of probiotics
* Evidence of significant feeding difficulties
* Infant was born large for gestational age
* History of underlying metabolic or chronic disease or congenital malformation
* Infant is immunocompromised

Infants receiving human milk:

* Consumption of infant formula from 1 day of age
Gut Hormone Response After Paleolithic-type Meals

The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along the lines of the world Health Organisation dietary recommendations

In the current study the effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18-27 inclusive
* Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)
* Having general practitioner
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian
* Reported intense sporting activities less than 10h/w
* Reported alcohol consumption less than 21units/w
* non-smoking
* A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick

Exclusion Criteria:

* Use of medication which interferes with the study measurements (as judged by the study physician)
* Being an employee of Unilever or Leatherhead Food Research
* Scoff questionaire score ≥ 2
* Eating habit questionnaire ≥ 14
* Smoking
* Dislike, allergy or intolerance t the test meals or the ad libitum meal
* Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study
* Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM
Lung cAncer Robotic Comparative Study

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection.

The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology.

In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
* Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
* Aged ≥ 18 years
* Must be willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

* Patients with clinical stage IA3, II, III, and IV lung cancer
* Patient receiving a lobectomy/segmentectomy as an emergency procedure
* Patients receiving a lobectomy/segmentectomy for metastatic cancer
* Patients scheduled to receive a bilobectomy or sleeve-lobectomy
* Mental incapacity to understand or consent to study procedures
* Anticipated difficulty for patient to comply with protocol requirements
* Unable to comply with the follow up schedule
* Pregnant or are planning to become pregnant during the study
* Life expectancy \< 12 months
To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia

The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.

Exclusion Criteria:

* Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study

Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis. Although everolimus-eluting stents (EES) \[(Xience, Abbott Vascular) or Promus (Boston Scientific)\] are very promising for the treatment of CTOs due to their low late loss and excellent deliverability, there are currently no published data on EES implantation in CTOs.

The specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of \> 50% of the minimum lumen diameter of the target stent) after implantation of the EES in CTO.

It is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Successful treatment of a native coronary artery CTO (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents
3. Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months
4. Agree to participate and provide informed consent

Exclusion Criteria:

1. Planned non-cardiac surgery within the following 12 months
2. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
3. Coexisting conditions that limit life expectancy to less than 12 months
4. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)
5. History of an allergic reaction or significant sensitivity to everolimus
A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients

The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:

Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?

Participants will:

Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection


Eligibility Criteria:
Inclusion Criteria:

* 1. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.

Exclusion Criteria:

* 1. Patients with Allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects
Whole Grain and Fiber Addition Study

The human gut microbiota is the complex community of bacteria that reside within the human gastrointestinal tract. This community plays an important role in supporting normal immune function and digestion. Disruption of the microbial communities within the gastrointestinal tract, sometimes termed "dysbiosis" is linked to a wide range of human diseases, including obesity, metabolic syndrome, malnutrition, and cancer. Stability of the microbiome is thought to be important for human health, however the factors that drive microbiome community stability are poorly understood.

Within the gastrointestinal tract, the microbiota is constantly exposed to complex mixtures of foods and the products of digestion. Importantly, changes in diet have been shown to rapidly induce shifts in microbial community composition. These compositional shifts can also affect microbial production of bioactive metabolites, which may be one mechanism to explain how the microbiome impacts host physiology and disease.

Fiber is often considered to be one of the largest contributors to microbial compositional shifts that follow dietary interventions. Fiber resists digestion and persists through the gastrointestinal tract to reach the large intestine where it can be metabolized by bacteria. The end products of this metabolism are the short chain fatty acids (SCFAs), acetate and butyrate, which are often associated with beneficial health outcomes. Fibrous foods are also a source of polyphenols and other phenolic compounds that may be used by microbes in the production of secondary metabolites or freed from the food matrix by microbial enzymes.

The purpose of this study is to: 1) to investigate the impact of high fiber, whole grain and bran cereal on microbiome stability, and 2) to explore the microbial contribution to polyphenol metabolism from whole grain in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over 18 years
* BMI between 18 and 30
* English speaker with ability to use a computer/smartphone.

Exclusion Criteria:

* Women who are currently pregnant or breastfeeding
* Current use of antibiotics or use of antibiotics within the last month
* Self-reported, pre-existing history of gastrointestinal disease including IBD, IBS, Crohn's disease, Celiac disease (or self-reported sensitivity to gluten), history of bowel blockage/impacted stool, fecal incontinence, gastroparesis or diverticulosis.
* Type I/II diabetes mellitus
* Participants actively trying to lose weight
* Chronic use of antacids and/or laxatives
* Use of seizure disorder medications or tricyclic antidepressants
* Consumption of drugs or supplements related to energy intake (i.e. diet pills and appetite suppressants)
Desflurane Versus Isoflurane for Speeding Postanesthetic Recovery and Hospital Discharge

The investigators thus propose a comparative effectiveness quality improvement project to evaluate the feasibility of switching from near-exclusive use of isoflurane in adult general surgical patients to Desflurane.

The three available volatile anesthetics appear to be comparably safe. However, higher solubility slows emergence from isoflurane and sevoflurane compared to Desflurane. Even a few minutes delay in emergence from anesthesia has financial implications since institutional costs of operating room time can easily be $30 per minute. Postoperative care is also expensive. Furthermore, in busy hospitals such as the Cleveland Clinic, inadequate recovery throughput frequently delays surgery.

The investigators thus propose a comparative effectiveness quality improvement project to evaluate the feasibility of switching from near-exclusive use of isoflurane in adult general surgical patients to Desflurane. (The investigators will exclude children because there are compelling clinical reasons to use sevoflurane in pediatric patients.) The proposed comparison is between isoflurane (our current routine) and Desflurane which is no longer used at the Clinic because of price concerns - a decision that that did not consider down-stream effects, including prolonged emergence and recovery.

Eligibility Criteria:
Inclusion Criteria:

* Adults having general anesthesia in the G operating room suite at the Cleveland Clinic Main Campus.

Exclusion Criteria:

* Operations lasting \<1.5 hours.
BAR As a Mortality Predictor in Septic AKI

The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

A complete medical history will be obtained from all patients including age, sex, comorbidities, cause of sepsis, and SOFA and APACHE II scores at admission.

Blood samples will be collected within 24 hours of AKI diagnosis for analysis of Blood Urea Nitrogen (BUN) and serum Albumin levels.

Blood Urea Nitrogen to serum Albumin ratio (B/A) will be calculated by dividing the BUN of a patient by their serum Albumin levels.

Laboratory parameters also will include pH, lactate (Lac), base excess (BE), hemoglobin (Hb), platelet (PLT) count, white blood cell (WBC) count, bilirubin, hematocrit (HCT), creatinine (Cr), serum sodium (Na), serum potassium (K), serum calcium (Ca), serum magnesium (Mg), triglyceride (TG), aspartate aminotransferase (ALT), alanine aminotransferase (AST), prothrombin time (PT), and activated partial thromboplastin time (APTT) values.

Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

Study population will be divided into survival and non-survival groups based on their 30-day survival status

Eligibility Criteria:
Inclusion Criteria:

1. 18 - 60 years of age
2. Fulfilled the diagnostic criteria of Sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (SOFA) score of 2 or higher)
3. Developed AKI during hospitalization according to Kidney Disease: Improving Global Outcomes (KDIGO) guideline

Exclusion Criteria:

1. ICU length of stay\<24 h
2. AKI occurred before current hospital admission.
3. AKI is supposed to be secondary to causes other than sepsis.
4. Receiving renal replacement therapy at the time of admission.
5. Diagnosis with chronic kidney disease.
6. Diagnosis with liver failure.
7. Pregnant or lactating.
8. There was insufficient data for analysis.
9. Patients who had received Human serum Albumin infusion 3 days before ICU admission.
Prediction Model of Occult Omental Metastasis in Patients With Gastric Cancer

A complete omentectomy is typically recommended during radical total gastrectomy for gastric cancer, though its impact on survival remains unclear. This study aimed to assess the frequency and risk factors of metastases in the greater omentum in gastric cancer patients undergoing gastrectomy. It will involve a single prospective cohort of consecutive patients who underwent total gastrectomy with complete en bloc omentectomy and modified D2 lymphadenectomy. Post-surgery, the omentum will dissect from the gastrectomy specimen beyond the gastroepiploic vessels and examine separately for pathological assessment. The primary outcome will focus on the detection of omental metastases.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmation of gastric cancer
2. eligibility for surgical intervention
3. undergoing first rectal cancer surgery
4. acquisition of written informed consent from patients and their families
5. no history of hypertrophic scar or allergic predispositions

Exclusion Criteria:

1. absence of postoperative pathology of the omentum
2. diagnosis of multiple primary malignancies
3. intraoperative discovery of widespread implant metastases within the abdominal cavity
4. severe comorbidities
Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy


Eligibility Criteria:
Inclusion Criteria:

* M \& F 18 years and older
* Diagnosed with diabetes mellitus and presenting diabetic retinopathy

Exclusion Criteria:

* Monocular
* History of current ocular hypertension or glaucoma in either eye defined
* Any significant ocular disease (other than diabetic retinopathy)
Epidural Morphine Following Vaginal Delivery

The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.

Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and safe, this route can be associated with significant perineal trauma and subsequent postpartum perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching and distension associated with labor, to episiotomy and significant perineal tears. In spite of the differences in the degree of injury following vaginal delivery, postpartum pain therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory drugs. The purpose of this study is to determine if a single dose of epidural-administered morphine offers additional advantage to an organized program for the management of immediate postpartum perineal pain following vaginal delivery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy parturients (ASA 1 or 2) of \> 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.

Exclusion Criteria:

* Women whose labor is terminated by cesarean delivery
* Parturients with known morphine allergy
* Parturients with narcotic addiction past / present
Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects

The subjects of this study were patients who underwent corneal endothelial transplantation,who were randomly divided into 3 groups, 2 groups (0.002% and 0.004% ZKY001 eye drops) and 1 placebo control group.

This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-80, regardless of gender;
2. patients who have undergone DSAEK or DMEK and need to remove corneal epithelium;
3. Schirmer test I ≥10mm/5min;
4. normal corneal limbus structure under slit lamp during screening period;
5. sign the informed consent.

Exclusion Criteria:

1. intraocular pressure \> 21mmHg or baseline intraocular pressure \> 35mmHg during screening period;
2. fasting blood glucose \> 9.0mmol/L during screening period;
3. postoperative complications occurred, such as dislocation of the implant and high intraocular pressure caused by air bubbles in the anterior chamber;
4. suffered from eye infection, optic neuritis, pigment membrane inflammation, or fundus, macular lesions that affect vision, glaucoma;
5. serious cardiovascular history (congestive heart failure, uncontrolled hypertension, unstable coronary heart disease or myocardial infarction or severe arrhythmia, etc.);
6. severe hepatic and renal insufficiency, alanine aminotransferase (ALT), alanine aminotransferase (AST) ≥ 2 times the normal upper limit, blood creatinine (Cr) ≥ 1.5 times the normal upper limit;
7. those who wear contact lenses within 3 days before screening;
8. screening drugs that have used corneal repair effect within the first 3 days;
9. have received corneal refractive surgery or keratoplasty;
10. have received internal eye surgery within 3 months before screening or need to undergo internal eye surgery during the study period;
11. have participated in other clinical trials or are participating in other clinical trials within 3 months prior to screening;
12. suffering from central nervous system disease and/or mental state inability to cooperate;
13. women in pregnancy, lactation or childbearing age do not take effective contraceptive measures;
14. allergy to the test product and basic drugs;
15. patients who are not considered appropriate to participate in this study, including those who are unable or unwilling to comply with the protocol requirements.