cyrilzakka/clinical-trials huggingface dataset:
Analysis of Donor Milk

The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America

Aim 1: To measure the micronutrient, macronutrients, microbial count, and endotoxins present in donated human breastmilk purchased from commercial human milk banks in North America (Table 2).

Aim 2: To compare the results of the nutrient analysis to nutrient recommendations for premature infants. (Table 3).

Aim 3: To use the results of the nutrient analysis to calculate the final nutrient content of donor human milk after the addition of commonly used human milk fortifiers (HMF). We will compare the calculated nutrients with intake recommendations for premature infants.

Background Preterm infants are at risk for nutrition depletion because of inadequate placental transfer, low volume feedings in the first days of life, and increased nutrient needs.1-3 Adequate intake of nutrients during neonatal development is crucial for growth. In addition, preterm infants are vulnerable to feeding-related complications, including necrotizing enterocolitis (NEC) and enteral feeding intolerance.4,5 Human milk feedings reduce the risk of NEC and enteral feeding intolerance and are considered the standard of feeding for this population. When mother's own milk (MOM) is not available or is inadequate to meet the needs of the infant, donor human milk (DHM) is the recommended feeding choice for preterm infants with birth weights ≤1500 grams.5 Several factors influence the nutrient composition of human milk, including lactation stage, gestational age at delivery, maternal age, body mass index (BMI), diet, and race.6-8 Preterm MOM is more nutrient-dense than mature human milk and continues to change as the lactation stage progresses.6,7,9 Donors of human milk are typically mothers of infants born at term and are unlikely to donate milk in the first month after delivery when milk is most nutrient-dense.

In 2011 22% of American neonatal intensive care units (NICU) used DHM to feed preterm infants. By 2017 the number of NICU purchasing DHM increased to 75%.10 To meet the demand for DHM, the number of human milk banks has increased from two in 1985 to more than thirty in 2020. The human milk banking industry is self-regulated with little oversight from governmental agencies. Donor human milk can be purchased from non-for-profit, private, public-benefits companies, or mother's milk co-operatives. Practices for donor selection, milk pooling, pasteurization or sterilization, nutrient analysis, and labeling vary by bank.11 Most DHM banks in North America do not report the nutrient composition of the DHM they sell. Of those that do, only three report nutrients other than protein, energy, and fat. Understanding the nutrient profiles of DHM is essential for creating feeding plans to meet the needs of preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Donor human milk from commercially available milk banks

Exclusion Criteria:

-
Prevalence of Neuropsychiatric Manifestations in IBD Patients in Upper Egypt

Estimation of neuropsychiatric symptoms prevalence in IBD patients and their impact on quality of life.

Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of idiopathic inflammatory bowel disease (IBD), clearly distinct pathophysiological entities. UC, the most common form of IBD worldwide, is a disease of the colonic mucosa only; it is less prone to complications. In contrast, CD is a transmural disease of the gastrointestinal mucosa which can affect the entire gastrointestinal tract . CD and UC should be considered systemic diseases since they are associated with clinical manifestations involving organs outside the alimentary tract. Extraintestinal manifestations involve several organs, and either precede the onset of intestinal manifestations or appear and evolve in parallel with them . Neurologic involvement associated with IBD is frequently underreported. Nevertheless, it is important to quantify the morbidity burden of clinically significant neurologic complications in IBD because early recognition and treatment of neurologic diseases are crucial for preventing major morbidity . Neurologic involvement in IBD as a subgroup of the EIMs may precede the appearance of digestive symptoms or develop after diagnosis of IBD. In addition, neurological symptoms may exacerbate during flare-ups of IBD or evolve independently from intestinal manifestations without responding to treatment provided for the underlying bowel disease.Within (IBD) literature, anxiety and depression symptoms are commonly identified to be associated with increased disease activity and reduced quality of life. Research also indicates that ongoing psychological distress can exacerbate disease activity,\] and increase the risk of flare-ups and health care costs. Given this, screening and targeted treatment of neuropsychological conditions in IBD patients are crucial.

Eligibility Criteria:
Inclusion Criteria:

* patients under the care of the hospital IBD outpatient service and having been diagnosed with IBD, aged over 18 years, and able to complete the examination and questionnaire.

Exclusion Criteria:

* Patients under the age of 18.
Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer

The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
* Metastatic colorectal carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
* Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen
* Unidimensionally measurable disease
* Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
* At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
* Adequate hematologic, renal and hepatic function

Exclusion Criteria:

* Symptomatic brain metastases requiring treatment
* History or evidence of interstitial pneumonitis or pulmonary fibrosis
* Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
* Prior epidermal growth factor receptor (EGFr) targeting therapies
* Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy

This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).

An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.

During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.

Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.


Eligibility Criteria:
Inclusion Criteria:

* Male and female between 18 and 79 years of age
* Patients diagnosed with thyroid disease who will undergo total thyroidectomy
* Naive patients to thyroid surgery
* Given written informed consent
* Childbearing potential female patients who give the consent for contraception during the study

Exclusion Criteria:

* Pregnant or breast-feeding female patients
* Abnormal coagulation panel test
* Clinically abnormal laboratory values
* Inappropriate general health conditions
* Past or current medication history for hyperthyroidism
* Medication with aspirin (or anti-platelet) before surgery
* Current medication with anticoagulants
* Inoperable (thyroidectomy) concurrent diseases
* Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes
* Participating in other interventional clinical trial
Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry on a Cohort of Patients Receiving Plerixafor

In the European Union (EU), plerixafor is indicated in combination with granulocyte colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells (HSCs) to the peripheral blood (PB) for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (MM) whose cells mobilise poorly.

This is a clinical outcome analysis of a prospectively defined cohort of patients with data reported retrospectively to the European Group for Blood and Marrow Transplantation (EBMT) who have lymphoma or multiple myeloma (MM), whose cells mobilize poorly, and who have undergone autologous haematopoietic stem cell (HSC) transplantation during the years 2008 up to and including 2012.

The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database.

The analysis of data from a well established registry like the EBMT registry allows for follow up of a large number of patients who are representative of the patient population receiving plerixafor.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in the cohort analysis, patients must have data in the EBMT registry that meet the following criteria:

* Adults diagnosed with lymphoma or multiple myeloma (MM)
* Received first autologous transplants of peripheral blood (PB) non ex-vivo manipulated stem cells in the time period listed above using cells mobilised with one of the following regimens:

  * plerixafor plus granulocyte colony stimulating factor (G-CSF)
  * plerixafor plus G-CSF plus chemotherapy
  * G-CSF alone or
  * G-CSF plus chemotherapy

Note: Patients included in the plerixafor groups will be those treated according to the label

* Provision of informed consent (i.e., all patients with data in the EBMT registry will have signed consent at the time of transplantation for the potential use of their data for analysis)

Exclusion Criteria:

* Patients treated with plerixafor NOT according to the European Union (EU) label.
* Patients whose graft product underwent ex vivo manipulation will be excluded from analysis
Muscle Ultrasound for Sarcopenia Leading to Early Detection

Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. Despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive, hospital-based, model of healthcare where muscle wasting is only assessed after a loss of functional independence. The investigators propose an affordable, portable screening method with ultrasound imaging to be performed in primary care settings.

The investigators long term goal is to identify individuals at risk, and intervene with treatments that may prevent the onset of debilitating loss of muscle function in the elderly.

Purpose: The overall goal of this pilot project is to validate a rapid, portable, cost-effective, sarcopenia identification method using diagnostic sonography. This method would be used for screening to aid early detection, diagnosis in clinical settings, and monitoring the effects of formal intervention. The investigators central hypothesis is that the sonographic muscle characteristics will be significantly associated with estimates of lean body mass (LBM) and functional status.

Research Setting: George Washington University, Exercise Science Laboratory.

Participants: Subjects will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from George Washington University and the surrounding community.

Implications/Significance: Diagnostic musculoskeletal ultrasound is a portable, inexpensive modality suitable for bedside use or community health initiatives, and features no exposure to low-dose radiation. It is important to note that DXA is considered a relatively low cost procedure, and DXA-based measures may continue to be used as the standard for the sarcopenia syndrome LBM criterion. Consequently, this study will examine if LBM values obtained with ultrasound may serve as a viable proxy of LBM measures obtained with DXA.

The innovation in the investigators study is reflected by a proactive approach to sarcopenia screening that is responsive to the growing shift of healthcare from hospitals to alternative, community-based settings.

Eligibility Criteria:
Inclusion Criteria: You are eligible to participate if:

1. You are between the ages of 18 - 29 years, or 55 - 75 years.
2. You must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable).

Exclusion Criteria: You are not eligible to participate if:

1. You have a medical condition that results in edema.
2. You have had an upper or a lower extremity amputation.
3. You are, or may be, pregnant.
4. You have a body mass index (BMI) \> 30.0.
A Study Exmining the Effect of Multiple Doses of Bitopertin on the Single Dose Pharmacokinetics of Midazolam in Healthy Volunteers.

This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.

A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.

Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 to 65 years of age, inclusive.
* A BMI between 18 to 30 kg/m2, inclusive.
* Healthy as determined by the Investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiogram (ECG)
* Female participants must use effective contraception as defined by the protocol and cannot be pregnant or breastfeeding
* Non-smoker or smoker of fewer than 10 cigarettes per day
* Must be able to refrain from smoking during the in-patient stay

Exclusion Criteria:

* Personal or family history of congenital long QT syndrome or family history of sudden death
* Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days prior to study start
* History of alcoholism, drug abuse or addiction within the last year prior to study start, or suspicion of drug abuse/addiction or alcohol use prior to study start
* Current alcohol consumption averaging more than 24 g of alcohol per day
* Any significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator
CBT4CBT for Office Based Buprenorphine

In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (N=100).

In this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (Central Medical Unit, CMU) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with CBT4CBT-Buprenorphine substituting for on-site counseling. This will be a 12-week trial.

Eligibility Criteria:
Inclusion Criteria:

* Meets current Diagnostic Statistical Manual (DSM-5) criteria for opioid use disorder
* Requesting buprenorphine maintenance treatment at Central Medical Unit of the APT Foundation

Exclusion Criteria:

* Unstabilized psychotic disorder
* Currently suicidal or homicidal
* Current cocaine, benzodiazepine, or alcohol use disorder.
* Any history of PCP (phencyclidine) use.
* Pregnant or lactating
* Any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
* Has read and signed an information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule;
* Is an adapted soft contact lens wearer
* Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
* Has no more than 0.75 diopters of refractive astigmatism
* Willing to wear contact lens in both eyes
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
* To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Exclusion Criteria:

* Is participating in any concurrent clinical or research study
* Has any known active\* ocular disease and/or infection
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
* Is aphakic
* Has undergone refractive error surgery
Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma

The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Several authors reported the use of barbed sutures in myomectomy , hysterectomy and closure of vaginal vault. A recent meta-analysis comparing the efficacy of laparoscopic suturing using barbed suture or conventional sutures in myomectomy or hysterectomy revealed that suturing with barbed sutures was associated with less suturing time and operative time.

Although numerous studies revealed the advantages of using barbed sutures , no studies have yet evaluated the use of barbed sutures in laparoscopic excision of endometrioma.

The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral endometrioma more than 3 cm in mean diameter

Exclusion Criteria:

* Bilateral endometriomata
* Conversion of laparoscopy to laparotomy
* Contraindications for general anesthesia
Bone Age of Chinese Child (BACC)

The bone age of the hand and wrist will be assessed with X-rays in more than 20,000 healthy children age 3-18 years old recruited in 28 sites from 14 province.The bone mineral density (BMD) will be measured as well.

As part of the "National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings "(ChiCTR1900022825), more than 20,000 children age 3-18 years old was recruited from 28 sites of 14 provinces within the framework of the ChiCTR190002282 study protocol. The population of this study was proportional to the ChiCTR190002282 study. The X-ray of no-dominant hand and wrist was taken with a mobile X-ray unit with shielding. A step wedge was imaged along the side of the hand at the same time for bone mineral density measurement. The bone age of the hand and wrist was assessed by trained MSK radiologists according to Chinese standard. The bone mineral density of the wrist was measured with radioabsorptiometry (RA). The demographic parameters were collected by the study of ChiCTR190002282 protocol.

Eligibility Criteria:
Inclusion Criteria:

* participants of ChiCTR1900022825 study
* healthy children age 3 to 18 years old.
* willing to participate this study
* Consent by parents

Exclusion Criteria:

* no consent by parents
* under 3 years old