cyrilzakka/clinical-trials huggingface dataset:
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants

An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until 15th day of hospitalization or until discharge.

Considering the lack of evidence related to breast milk nutritional composition from Brazilian lactating mothers of preterm infants; and also the utilization of human milk analyzer as a tool to optimize nutritional therapy and reach proper growth and development of preterm babies, this study aim to evaluate the nutritional composition of human milk from lactating mothers of preterm infant during the hospitalization, the infant grow and also the applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.

This is an observational and prospective study involving approximately 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit from the Hospital Santa Casa de Misericordia after childbirth. Lactating mothers should have enough milk to provide enough maternal milk their infant(s) require plus additional collection of samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants in the local ICU will be analyzed daily from the moment they express sufficient milk volume beyond their child's requirement until discharge (from 4th day of admission until 15th day of hospitalization ). Three mL of sample milk will be collected every morning and analyzed, according to hospital routine. Characteristics of subjects and details of their premature children, such as gestational age, birth weight (BMI) and birth details (causes of preterm birth, delivery, complications, etc) will be collected by applying a questionnaire on the first day of analysis. The nutritional composition of the last meal before the milk sample collection and also a three no consecutive nutrition questionnaire daily intake will be evaluated.

The determination of the macronutrient content will be made from the use of Human Milk Analyzer MIRIS (MIRIS HMA), Uppsala, Switzerland, properly calibrated. The analyzer is based on the adopted infrared (IR) technology in combination with a patented technology. Sample collection, storage and analysis, as well as equipment conservation, will be carefully followed according to MIRIS protocol. Information about effectiveness, feasibility and equipment costs will also be evaluated. The data obtained by the HMA will be compared to the nutritional composition of human milk and nutritional needs of preterm found in the literature and included in the main guidelines

Eligibility Criteria:
Inclusion Criteria:

* Healthy mothers with hospitalized preterm newborns
* Enough milk to breastfeed their child and donate 3 ml / day for the study
* Being the first sample of milk collected from the 4th day of hospitalization.

Exclusion Criteria:

* Mothers who are not breastfeeding
* Do not have enough milk for collection.
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain

To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.


Eligibility Criteria:
Inclusion Criteria:

* According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.

  1. Repeated knee pain in the past month
  2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.
  3. Joint fluid (\> 2 times) is cool and sticky, WBC \< 2000/ml
  4. Age over 40
  5. Morning stiffness less than 30 minutes
  6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.
  7. The informed consent has been signed

Exclusion Criteria:

* (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study
EndoMAXX Endoluminal Valve Technology (EVT) Compared to EndoMAXX

This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or older
2. Patient (or legal representative) is able to understand and provide signed informed consent
3. Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.

Exclusion Criteria:

1. Patient is unwilling or unable to comply with the follow-up schedule
2. Patient is contraindicated for endoscopic procedure for any reason
3. Patient presents with esophagorespiratory fistula
4. Patient has previously undergone esophageal stenting or esophagectomy
5. Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
6. Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
7. Removal of stent is scheduled to occur within six months
8. Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
9. Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.
Urinary Disorders in Subacute Patients After Stroke

This observational study will address urinary disorders in subacute stroke patients. Patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.

This prospective observational study will include 100 patients after first ischaemic or hemorrhagic stroke directly transferred from an acute hospital to our Institute for inpatient rehabilitation. Within admission assessment, patients will be classified according to stroke type, stroke localisation and time since stroke. Comorbidities will be recorded and associated neurological deficits will be assessed. Post mictional residue will be determined in all patients one day after admission. The patients with urinary disorders will be treated according to the published official protocol, either using the immediate urination approach or the bladder diary approach. Continence will be regularly assessed by the nursing staff. Urination-disorder-related complications (pressure ulcers, falls and urinary infections), drug therapy and the use of continence aids will also be followed.

Eligibility Criteria:
Inclusion Criteria:

* subacute patients after ischaemic or hemorrhagic stroke;
* direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.

Exclusion Criteria:

* incontinence before stroke;
* previous brain injury or other brain disease;
* previous bladder or prostate surgery;
* inability to ambulate before stroke;
* terminal disease with expected survival less than three months.
PMCF Neo Pedicle Screw and Cage Systems

The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.


Eligibility Criteria:
Inclusion criteria:

* Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
* Patient has participated in or is willing to participate in the routine postoperative follow-up program
* Patient is willing to provide written informed consent

Exclusion criteria:

* Patient is under the age of 18 or skeletally immature
* Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
Effect of Allopurinol Treatment on Insulin Resistance

Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30
* Serum uric acid level ≥7mg/dL
* Glomerular filtration rate ≥60 ml/min

Exclusion Criteria:

* presence of Diabetes Mellitus
* history of gout
* history of allopurinol use
* body mass index ≥35 kg/m2
* proteinuria ≥ 1gr/ day
* presence of autoimmune disease
* rheumatology associated disease
* presence of hypothyroidism or hyperthyroidism
* presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)
Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy

This is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
* Prior exposure to at least 1 line of therapy
* Exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial
* ECOG PS 0-2

Exclusion Criteria:

* Presence of a driver mutation that is susceptible to targeted therapy
* No greater than CTCAE v5 grade 3 toxicity attributed to prior immunotherapy
* Other active invasive malignancy requiring ongoing therapy
* Evidence of progressing or untreated brain metastases
* Evidence or history of leptomeningeal disease
* Uncontrolled tumor related pain
* History of an autoimmune disease or IPF
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to galcanezumab or another Calcitonin Gene-Related Peptide (CGRP) antibody.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Comparison of Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx in Radical Cystectomy

The aim of this study is to compare the effect of the liberal and restrictive fluid treatments which are routinely performed in major urological surgeries in the perioperative period on ANP release and the endothelial glycocalyx layer.

In the study, the investigators aimed to compare changes in the glycocalyx structure by measuring the blood levels of ANP and heparan sulfate, hyaluronan and syndecan 1, which form the glycocalyx structure on the patients who received the liberal and restrictive fluid treatments during major urological surgeries.

There is no strong evidence about the optimal fluid resuscitation for the patients undergoing major surgeries. Avoiding excess fluid resuscitation in the perioperative period is essential for reducing postoperative complications, morbidity and long-term mortality. In the perioperative period, ANP is released with increased wall stress in the cardiac atrium due to excess fluid loading. With the release of ANP, damage occurs in the glycocalyx layer, which is the structure primarily responsible for the permeability in the vascular endothelium.

Thus, the amount of ANP released from atrium and heparan sulfate, syndecan 1, hyaluronan in the glycocalyx layer structure increases in the blood.

The aim of this study is to compare changes in the glycocalyx structure by measuring the blood levels of ANP and heparan sulfate, hyaluronan and syndecan 1, which form the glycocalyx structure on the patients who received the liberal and restrictive fluid treatments during major urological surgeries. The blood samples will be taken at the beginning and at the end of the surgery.

The primary outcome of this study is the increase in ANP levels and heparan sulfate , hyaluronic acid, syndecan 1 levels which are the glycocalyx damage products in blood.

Secondary outcomes are intraoperative advanced hemodynamic cardiac measurement values, the amount of blood and blood products replaced to patients, duration of intensive care stay, duration of hospital stay, cardiac and respiratory complications, gastrointestinal complications, urinary complications, surgical complications such as anastomotic leaks, wound infection and fistula.

Eligibility Criteria:
Inclusion Criteria:

* ASA (The American Society of Anesthesiologists) status I-II-III patients
* Cases undergoing major urological surgery
* Cases for invasive artery monitoring and central venous catheterization
* Patients receiving general anesthesia
* Volunteering to participate in the study

Exclusion Criteria:

* Coagulopathy
* Patients with severe heart, kidney and liver dysfunction (EF \<35% and / or GFR \<30, Cre:\> 2.5 and / or impaired liver function tests)
Prediction of Fetal Lung Maturity

Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.

Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant diabetic women
* 37 weeks gestational age .

Exclusion Criteria:

* Women before 37 and after 39 weeks gestational age
* Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
* Multiple pregnancies.
* Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
* Women with premature rupture of membranes (prom)
* Pregnancies complicated by medical disorders other than diabetes mellitus .
* Failure to obtain an informed consent .
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).


Eligibility Criteria:
Key Inclusion Criteria:

* All individuals:

  * Screening laboratory values within defined thresholds for group
  * Use of two effective contraception methods if female of childbearing potential or sexually active male
* For individuals with moderate hepatic impairment:

  * Diagnosis of chronic (\> 6 months) hepatic impairment
  * Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh Class B).
* For individuals with severe hepatic impairment:

  * Diagnosis of chronic (\> 6 months) hepatic impairment
  * Score on the CPT scale of 10-15 at screening (Child Pugh Class C)
* For individuals with normal hepatic function:

  * Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Key Exclusion Criteria:

* All individuals:

  * Pregnant or nursing female or male with pregnant female partner
  * HIV infection
  * History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
* For individuals with moderate or severe hepatic impairment:

  * Active HCV infection
  * Current hepatic encephalopathy
  * Variceal bleeding in the last 6 months unless banded
  * Prior placement of a portosystemic shunt
  * History of hepatorenal or hepatopulmonary syndrome
  * Spontaneous bacterial peritonitis currently or within the last 6 months
  * Hospitalization within the last 2 months related to cirrhosis
  * Confirmed hypotension
  * Suspicion of hepatocellular carcinoma

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Olfactory Training in COVID-19 Associated Loss of Smell

Olfactory dysfunction (OD) like hyposmia or anosmia has been realized as a common symptom or even cardinal sign of the disease and can be persisting after recovering.

There are two different hypotheses on the pathogenesis of OD in past COVID-19: The central hypothesis, which speculates on neurotrophic abilities on olfactory receptors in the neuroepithelium, and the peripheral hypothesis, which speculates on damage of the sensory olfactory epithelium.

Potential treatment strategies aim for the unique neural plasticity of the olfactory system and its potential for recovery.

Clinical studies and case reports have shown a promising effect of olfactory training (OT) by frequent sniffing and/or exposure to odors 2-4 times a day for several weeks.

The main objective of the study is to assess the effects of olfactory training in patients with COVID-19 related OD on:

1. objective olfactory testing with the Sniffin' sticks test (identification and discrimination),
2. subjective OD and its impact on the daily life,
3. other clinical scales and questionnaires referring to OD-related mood and quality of life,
4. gender differences in COVID-19 related OD. Approach / methods OT will be performed twice a day with a 4-odor training set for 12 weeks. Effects of OT on COVID-19 related OD will be measured with objective and subjective efficacy variables.

The sense of smell is an important function for social relationships and is therefore a challenging clinical problem with few proven therapeutic options.

With this new approach, we want to investigate a possible simple treatment for an impedimental symptom of COVID-19, but also learn more about the pathomechanism of post-infectious OD.

To our knowledge, this will be the first study comparing patients with COVID-19 associated OD with and without OT in clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The subject is aged over 18 years;
* confirmed diagnosis of COVID-19 at least three months ago (history of positive PCR-testing required) or positive serum nucleocapsid antibody titer against SARS-CoV2;
* post-infectious COVID-19 related olfactory dysfunction persisting for at least three months with abnormal Sniffin' sticks test (\<13/16 items correct in the identification part);
* the patient is willing to undergo odor training over 12 weeks;
* written ICF is obtained.

Exclusion Criteria:

* History of olfactory dysfunction prior to COVID-19 infection due to other conditions e.g. status post traumatic brain injury, Parkinson's disease, allergic rhinitis, etc.;
* Nasal pathology not related to COVID-19 in the systematic otorhinolaryngological examination including endoscopy.
* the participant is pregnant
Molecular Quantification of Insulin mRNA

The objectives of this study are to:

1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects,
2. determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects,
3. determine the identity of the white cell responsible for expression of insulin mRNA and
4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available.

Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including:

1. normal animals
2. after islet cell transplantation
3. hyperglycemic induced expression and
4. during induction of diabetes with streptozotocin

The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ages 1 to 17 years of age
2. Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
3. Subjects with new onset type 1 diabetes
4. Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
5. Unrelated nondiabetic controls with no family history of type 1 diabetes
6. Of sufficient size to donate 10ml of blood

Exclusion Criteria:

None if subjects meet above inclusion criteria