cyrilzakka/clinical-trials huggingface dataset:
RIGHTWHEY - Responders In Gut HealTh Markers Using Fermented WHEY

This 8-week intervention will investigate the effect of daily consumption of a fermented whey concentrate on the short-chain fatty acid profile of faeces in healthy individuals.

This study will help us understand if consumption of fermented foods rich in lactic acid have a beneficial effect on gut health.

The 8-week dietary supplementation trial will investigate the action of exogenous lactic acid consumption on the activity (using short-chain fatty acid) and composition of the gut microbiota.

Participants will be stratified according to their baseline faecal butyrate levels. Therefore volunteers will be asked to provide two faecal samples one week apart. Based on the average absolute level of butyrate in the faecal samples, volunteers will be stratified into either low, moderate or high baseline butyrate levels (detailed in table 1 below). The levels for faecal butyrate for each group are set based on a meta-analysis of 9 human studies of healthy volunteers carried out at the Rowett Institute (n=116; LaBouyer et al, 2016, unpublished). Thresholds were derived from the boundaries of tertiles. Therefore, the moderate butyrate producers represent the middle 33% (see table). Each stratification arm will have a minimum of 17 study volunteers bringing the total to n=51. This has been set to ensure the completion of at least 45 volunteers. To optimise equal gender distribution amongst all study arms a minimum of 5 females and 5 males will be recruited for each arm.

Stratification Butyrate range Low ≤13 mM Moderate butyrate 13 - 20mM High butyrate ≥20mM

Primary and secondary outcomes will be analysed between the low and high butyrate producing groups as well as the overall group effect on everyone.

Eligibility Criteria:
Inclusion Criteria:

* i. Men and women aged 18-68 years; BMI ranging from 18-35 kg/m2; measured at the screening visit

Exclusion Criteria:

* i. smokers
* ii. subjects with: diagnosis of diabetes, pregnant, hypertension, renal, hepatic, haematological disease, coronary heart disease or any gastrointestinal disorder
* ii. unsuitable veins for blood sampling;
* iii. inability to speak, read and understand English.
* iv. Use of antibiotics within the last 3 months will automatically exclude volunteers.
* v. Vegans. Fermented whey concentrate, (FWC), is derived from milk (animal product) which excludes potential participants adhering to a vegan diet.
* vi. allergy to any of the following: cow milk, lactose, casein, whey, sucralose, acesulfame K, citric acid, potassium benzoate, fruit flavourings.
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until 36 weeks gestational age or hospital discharge whichever occurs first. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.


Eligibility Criteria:
Inclusion Criteria:

* ≤1250 g birth weight.
* Parental/guardian consent to participate.
* Consent for the use of pasteurized donor milk if mother's milk is not available.

Exclusion Criteria:

* Infant received fortifier or formula before Study Day 1.
* Study Day 1 to occur after day 21 of life.
* Infants with congenital or chromosomal anomalies that may affect growth outcome.
* Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
* Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued.
Effect of Selenium on Serum Adiponectin, Homocystein and Malnutrition-inflammation Complex Syndrome in Hemodialysis Patients

The aim of this study is to determine the effect of selenium supplementation as an antioxidant on serum adiponectin, HSCRP , ferritin , transferrin, albumin and homocysteine level.

After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and give their informed consent to participate in this trial.The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients are randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and followed for 12 weeks.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient. The blood was taken from the patient's arm used for hemodialysis cannulae just before the beginning of the HD session. The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C. Serum levels of adiponectin,high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium, phosphate, albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels (g/dL) were measured in all patients at the baseline and at the end of treatment phase of study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were dialysed three times a week for at least 3 months or more

Exclusion Criteria:

* Patients who took multivitamins or immunosuppressive medications
* Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations
* Patients who had active infection
* Patients who were hospitalized in the previous month.
* Being Pregnant
Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department

The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

A prospective randomized open clinical trial conducted in two high volume emergency departments in France.

Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method.

126 patients are expected to enrol in the study.

Eligibility Criteria:
Inclusion Criteria:

* Superficial skin laceration requiring a suture

Exclusion Criteria:

* Known allergy to lidocaine
* Mucous membrane or eye wound
* Nose, ear or perineal wound
* Active hemorrhage in the wound
* Dirty or infected wound
* Wound requiring operation room management
* Distracting pain in an other location
* Intoxicated or comatose patient
* Patient Under guardianship
* Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia
* Neurologic disorder affecting pain sensitivity
* Dementia
* Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age
* Absence of signed informed consent
* Inclusion in an other interventional clinical protocol
General Anesthesia vs Paravertebral Block With General Anesthesia For Laparoscopic Sleeve Gastrectomy

The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity.

We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.

This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.

Eligibility Criteria:
Inclusion Criteria:

* Patients with body mass index (BMI) greater than or equal to 30
* American Society of Anesthesiologist (ASA) score greater than or equal to 2
* Undergoing laparoscopic gastric sleeve surgeries

Exclusion Criteria:

* Patients with ASA score less than 2 and greater than 4
* Patients with any type of allergy to local anesthesia
* Patients refusing to be part of the study (refusal to sign consent)
* Any complication during surgery or anesthesia
Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures

The purpose of this research is to study the efficacy and cost effectiveness of the VAC device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip fractures, specifically to see if there is a reduction in the incidence of post operative surgical wound drainage, infections, and hospital stay.

Soft tissue injuries are commonly associated with pelvic and acetabular injuries and additional tissue injury occurs during surgery. Post operative wound drainage, infections and prolonged hospital stay are a common problem during postoperative care. Traditional treatment is dressing of the surgical wound with different conventional dressings.

Use of negative pressure wound therapy has been shown to be beneficial in significantly decreasing wound drainage. Stannard et al. reported the results of randomizing 44 patients with lower extremity fractures (including 4 pilon fractures) into either receiving standard post operative dressing versus NPWT (negative pressure wound therapy). His results showed no difference in infection rate or wound breakdown, but did show a significant difference in the drainage time. The NPWT group stopped draining 3 days earlier than the standard dressing group. The use of NPWT has greatly increased over the years and has been an important adjunct to wound management. These results and anecdotal clinical experience with the use of NPWT (wound VAC) has led us to develop our research question; Does the use of incisional VAC following pelvic \&/or acetabular surgery decrease wound complications.

The VAC (KCI USA) device is relatively new device that utilizes negative pressure as a treatment modality for soft tissue injuries following high velocity injuries. VAC device exerts intermittent or constant negative pressure and removes excess fluid from the interstitial space and increases perfusion through vessels. Previous VAC studies showed decreased bacterial load after applying VAC device to the infected wounds.

There have been no randomized studies to prove the cost effectiveness and efficacy of VAC device in reducing wound drainage, infections, and prolonged hospital stays in comparison to traditional gauze dressing wound management during post operative management of pelvic and acetabular fractures.

In examining the incidence of wound complications/infections, we can determine if the incisional VAC decreases the need for additional intervention and if there are any patient related factors (i.e. obesity) related to increased risk of wound complications.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Scheduled for surgical repair of pelvic and/or acetabular fracture
* Subject/guardian able to provide informed consent

Exclusion Criteria:

* Less than 18 years of age
* Subject/guardian unable to provide informed consent
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of kidney.

Study design:

This is a prospective, randomized, single center trial. This clinical trial was approved by the Institutional Review Boards.

Study process:

All patients gave informed written consent after being informed of the details of the study. Subjects were randomized into either the experimental group (specimen removal through posterior vagina fornix incision) or control groups (specimen removal through extended abdominal incision). All participants underwent demographic and history taking, laboratory tests, a gynecologic examination to determine whether specimen removal through vagina is possible.

To evaluate cosmesis, patient satisfaction and quality of life VAS (Visual Analogue Scale), SF-12 (Short Form-12) health survey, BIQ (Body Image Questionnaire) and POSAS (the Patient and Observer Scar Assessment Scale) will be sent to the patients 6 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are accessible with vaginal approach
* Patients scheduled for laparoscopic resection of kidney for benign or malignant diseases
* Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings

Exclusion Criteria:

* Patients without sexual intercourse
* Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination
* Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history
* Patients with abnormal cervical cancer screening tests
* Patients scheduled to perform concomitant hysterectomy
Promoting Math in Young Children: Leveraging Pediatric Clinics to Reach Underrepresented Children in Rural Communities

The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts to the parents of their patients affects the early math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children? Participants will be randomized to receive the early math text intervention or standard of care. Researchers will compare pre-and-post math performance between the intervention and control group.

The goals of this clinical trial to examine how pediatricians prescribing early math enriching texts (TipsbyText) to parents of 3-4 year olds affects the math skills of under-resourced pre-kindergarten-aged children in rural Oregon. The main question it aims to answer is: What is the impact of the text intervention on early math skills in preschool-aged children using the Research-based Early Math Assessment (REMA-Brief)? Two secondary questions of the study are: What is the impact on child literacy using the Phonological Awareness Literacy Screening Tool (PALS-PreK) and parent confidence using the Development and Research in Early Math Education (DREME)? Participants will be randomized to receive intervention (the early math text intervention) or control (no texts). Researchers will compare pre-and-post math performance on the REMA-Brief (primary outcome), PALS-PreK (secondary child outcome) and DREME (secondary parent outcome) between the intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

* Parents of participants must be at least 18 years of age
* Child must be 3 or 4 years old at the time of screening
* Child receives care at a participating Oregon Rural Practice-based Research Network (ORPRN) clinic
* Parent and child can communicate in English or Spanish
* Parent is able to give informed consent
* Child is eligible for Medicaid services

Exclusion Criteria:

* Parent is not able to receive text messages
* Parent is not able to read text messages
* Child is too ill to participate
* Parents who are unable to complete study activities
* Child has a sibling currently enrolled in the study
* Child has a developmental delay including neurodevelopmental disorders such as autism or syndromes associated with developmental delay (e.g. cerebral palsy, seizure disorders, attention deficit / hyperactivity disorder). Isolated expressive speech delay is not a developmental exclusion criteria.
Low-dose Protocol for Computed Tomography-guided Lung Biopsy

The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

With the comprehensive usage of computed tomography examination, patients are more and more aware of the radiation dose of computed tomography. Concerns over the potential for radiation induced malignancies have increasingly been published in the scientific literature and reported in the popular press. The risk is highest for younger patients, who have more radiation-sensitive tissues and longer life expectancies than adults. Recently, the United States Food and Drug Administration announced an initiative to reduce unnecessary radiation exposure from medical imaging. At present, low-dose computed tomography protocol is widely used for the diagnosis of cardiovascular and cerebrovascular diseases.

Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and masses. However, it requires repeating scanning to guide the needles, which inevitably increases the radiation dose. Therefore, low-dose protocol was also used in the computed tomography-guided lung biopsy procedure.

The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.

Exclusion Criteria:

* The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
* Be female, between 18 and 65 years of age at the time of enrollment

Exclusion Criteria:

* Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
* Have undergone a skin reducing mastectomy
* Have a BMI that is \<17 or ≥ 30
* Predicted implant weight more than 500 grams
* Have a known allergy to silk
* Have an abscess or active infection at any location within one month prior to surgery
* Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study
Discontinuation Rate Among Copper IUD Users

The intrauterine device (IUD) is one of the most widely used reversible, long-term contraceptive methods in the world. But despite all its advantages; discontinuation rate of IUD ranged from 9.6% to 37.3 % (according to Demographic and Health Surveys data). In Egypt, in 2014, the discontinuation rate of IUD (within 12 months of use) was 14.3%.This study explores the differences around this rate in Egyptian university clinic and primary healthcare clinic with detailed percentages of possible causes.

The aim of the study is to compare between primary health care unit and university family planning clinic in discontinuation rate among copper IUD users.

1. The Research Hypothesis: (Null hypothesis)

   • In women using copper IUD, discontinuation rate in primary health care unit and university clinic may be similar.
2. The Research Question:

   • In women using copper IUD, Does discontinuation rate in primary health care unit and university clinic differ?
3. METHODOLOGY:

Patients and Methods

• Study setting:

* Family planning Outpatient clinic of Ain Shams Maternity Hospital, (ASUMH)
* primary health care unit in ain shams area

  • Study population:
* Study period: 1 year
* Sample size: was calculated using Sample size computer program 11. After review of literature, no previous similar study was done before, so assume a discontinuation rate of 50% among Cu-IUD users in primary healthcare unit and 25% among Cu-IUD users in university clinic. Based on these values; the study will include 170 Cu-IUD users; equally selected as 85 subjects from each clinic. But due to the expected drop outs, recruitment will start by 200 women from each clinic.

  * Statistics:

    * Descriptive statistics for measured variables will be expressed as range, mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportions (for categorical data). Cu-IUD discontinuation findings in each clinic will be compared using the t-test or the Mann-whitney U test depending on whether the measured parameters are guassian variables. A P-value of 0.05 or less will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age from 18-49 years. 2. Women planning for Cu-IUD insertion as a contraceptive method.

Exclusion Criteria:

* 1. Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use (MEC) -World Health Organization-2015.