cyrilzakka/clinical-trials huggingface dataset:
Pre-eclampsia and Biochemical Markers

In view of both endothelial injury in pre-eclampsia, high blood pressure and kidney impairment characteristics, a recent study demonstrated that the serum levels of NGAL increased at the end of the second trimester in women who subsequently developed pre-eclampsia compared to the control group.

This correlates well with the endothelial damage that occurs during pre-eclampsia and thus NGAL can be considered as a promising marker in predicting both early and late onset pre-eclampsia. It may be required to combine one or more biomarker with NGAL to increase the precision, and sensitivity for detection of risk and reliability of using biomarkers for pre-eclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years.
* Gestational age \>20 weeks.

Exclusion Criteria:

* Patients with preexisting renal disease,hypertension, diabetes mellitus, gestational hypertension.
* Patients Refuse to participate in the study
* Patients already have complicated preeclampsia.
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery

Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* laparotomy

Exclusion Criteria:

* below 18, pregnancy, prisoners
Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.


Eligibility Criteria:
Principal Inclusion Criteria:

Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.

Principal Exclusion Criteria:

History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates

Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants. NEC is the most common life-threatening gastrointestinal emergency encountered in the neonatal intensive care unit, affecting between 3.8% and 13% of very low birthweight (VLBW) infants (1-3). More recently interest has intensified regarding the possible association between "elective" red blood cell (RBC) transfusions in premature infants and the subsequent development of NEC (4-9). On a physiological basis, a few explanations for transfusion-associated NEC have been proposed: 1) the physiological impact of anemia that can initiate a cascade of events leading to ischemic-hypoxemic mucosal gut injury predisposing to NEC \[10\]; and 2) increased splanchnic blood flow following RBC transfusion leading to reperfusion injury of gut mucosa.

Aim 1. This study will quantify inflammatory cytokine profiles in anemic infants cared for in the NICU prior to and after transfusion with packed red blood cells (PRBC), as dictated by current clinical guidelines for treatment of anemia, and prospectively assess for clinical signs and symptoms of NEC following each transfusion event.

Aim 2. Polymorphonuclear leukocytes (PMNs) isolated from the pre- and post-transfusion blood samples will be assessed in vitro for neutrophil extracellular traps (NET) formation.

Aim 3. A) To determine whether significant anemia preceding a RBC transfusion is associated with impaired intestinal oxygenation, and whether a RBC transfusion temporarily increases splanchnic oxygenation. We postulate that the CSOR will be low (\<0.75) at baseline measurement in infants with hemodynamically significant anemia, and that RBC transfusion will temporarily increase intestinal perfusion in that particular group of babies.

B) To determine whether alterations in mesenteric regional oxygenation saturation(rSO2) can predict the development of NEC in VLBW infants. We hypothesize that overall cerebro-splanchnic oxygenation ratio (CSOR) values will be significantly lower among very low birth weight (VLBW) infants that develop NEC, when compared to CSOR values obtained in infants that do not develop NEC following RBC transfusion.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient in NICU at UUMC, PCMC, or IMC
* Gestational age at birth ≤ 32 weeks
* Birth weight ≤ 1500 grams
* Age ≤ 12 weeks of life

Exclusion Criteria:

* Lack of parental consent
* Multiple congenital anomalies
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.

The main aim of the study us to see if the functional decline in this group can be reduced.

This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery for colorectal cancer
* frail
* ability to read and speak danish (informed concent)

Exclusion Criteria:

* any physical condition that hinder physical exercise (eg. no legs)
* not able to concent
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed moderate to severe OSA
* Age \> 17 years
* Written informed consent for study participation.

Exclusion Criteria:

* Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
* Patients with central sleep apnea syndrome
* Patients with other causes of pulmonary hypertension
* Intracardiac shunt other than via PFO
* Severe valvular heart disease
* Abnormal left ventricular (LV) systolic function (ejection fraction \<50%)
* Obesity with BMI \> 40
* Contraindication to TOE
* Severe pulmonary arterial hypertension (mean pulmonary artery pressure \> 45 mmHg)
Long - Term Low Anterior Resection Syndrome

Data assessing the long-term bowel dysfunction following low anterior resection is still lacking. The aim of this study is to evaluate late functional results of patients who underwent rectal resection for rectal cancer. This included calculating LARS and Wexner score and identifying possible risk factors of late postoperative bowel disorders.

For the last almost 30 years, the gold standard treatment for RC is low anterior resection (LAR) with total mesorectal excision (TME). Unfortunately, up to 80 % of patients undergoing LAR will suffer of bowel dysfunction including faecal urgency, frequent bowel movements, tenesmus or so called Low Anterior Resection Syndrome (LARS). Simply it has been defined as "disordered bowel function after rectal resection, leading to a detriment in quality of life". Same year LARS score was developed. This tool is easy to use and has been internationally and in Lithuania validated. Wexner score is another tool for evaluation of faecal continence.

There are only five studies investigating long-term results after rectal surgery and influence it has on patients' daily life. In one study 47 of 51 patients experienced LARS following ultra-low anterior resection after average 6.5 years. Another study recently reported major LARS in 46% of the patients with the mean median follow-up of 14.6 years. Others showed that 47.5% of patients still experience LARS symptoms at a follow-up period of 13.7 years. Just recently published study assessed bowel function 12 years in patients undergoing rectal resection with or without preventing ileostomy. Authors found that 63 (72%) patients of 87 experienced LARS symptoms with more than a half complaining of major LARS. Moreover, just last year a study published showing that 73% of patients had LARS at first follow up 5 years after the surgery. During the second visit (another 5 years later) same numbers were seen.

The aim of this study was to evaluate late functional results of patients who underwent rectal resection for rectal cancer. This included calculating LARS and Wexner score and identifying possible risk factors of late postoperative bowel disorders.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with rectal cancer without metastasis
* signed consent form
* more than 5 years following the surgery

Exclusion Criteria:

* unwilling to participate
* stage IV disease
* change in operative plan - end colostomy formed
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)

Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%
* Insulin use for at least 12 months and initiation immediately after diagnosis of diabetes
* Method of Insulin administration \[multiple daily injections (MDI) or continuous subcutaneous Insulin infusion (CSII)\] stable ≥ 3 months
* Stable basal Insulin dose ≥ 2 weeks
* Ages 18 to 65 years
* Central laboratory C-peptide value of \< 0.7 ng/mL
* Body mass index (BMI) 18.5 to 35.0 kg/m2

Exclusion Criteria:

* History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
* Oral hypoglycemic agents
* History of diabetes ketoacidosis (DKA) within 24 weeks
* History of hospital admission for glycemic control within 6 months
* Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic unawareness
* Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total bilirubin \> 2X Upper limit of normal (ULN)
* Abnormal Free T4 \[if screening Thyroid Stimulating Hormone (TSH) abnormal\]
* Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula ≤ 60 mL/min/1.73m2
* Cardiovascular (CV)/Vascular Diseases within 6 months
X-linked Hypophosphatemia and FGF21

Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.

In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.

To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).


Eligibility Criteria:
Inclusion Criteria:

* Child with X-linked hypophosphatemia with PHEX gene mutation
* Child between 10 and 18 years old
* Child over 10 kg having a blood sample as part of the treatment (due to regulatory constraints for blood volume taken in 30-day period of 40 mL in children over 10 kg)
* Child and parent / holder of parental authority who has been informed of the study and does not object to participate.

Exclusion Criteria:

- Pregnancy in progress
Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)

This is a fully automated randomized trial with two randomization branch-points. The first is inclusion of disease-specific orders in the admission orders based on a predictive model using real-time data. The second is the use of dynamic orders that are end-user tested rather than static orders designed by a committee. The primary hypothesis is that automatic inclusion of disease specific orders with admission orders will improve adherence to guidelines for patients with COPD. The secondary hypothesis is that clinical and operational outcomes will improve, thereby improving value.

This is a single-center, single-blinded, 2x2 factorial randomized controlled trial to test both automated order set inclusion and evidence-based order set design with end user testing on order set use and clinical outcomes for adult patients admitted to the hospital with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

First, the investigators will develop a predictive model to identify patients admitted to the hospital with COPD exacerbations based on retrospective data, but limited to data that is available in real-time at admission.

Second, 1,000 admissions to UCSF Medical Center of adults predicted to have COPD by the predictive algorithm will be prospectively block randomized by encounter to automatic inclusion of a COPD order set in the admission orders or usual care. Providers caring for patients in both arms of the trial can independently search for and use a COPD order set. Any provider using a COPD order set in either arm will also be randomized to see two versions of the order set. The first is a static list of orders, and the second is dynamic, meaning that orders will display only when appropriate. For example, a patient who just had a chest x-ray does not need a routine repeat test. The dynamic order set will show the provider that the x-ray was completed at a specific time and will not display a prompt for a repeat test. Providers can, of course, still order anything they deem clinically appropriate, and may choose to order a repeat x-ray for a patient with a change in clinical status.

The components of the order set are based on international guidelines from the Global Initiative for Chronic Lung Disease (GOLD initiative, a collaboration between the National Heart, Lung, and Blood Institute and the World Health Organization) and a multi-stakeholder working group at UCSF including two hospitalists, two pulmonologists, two transitional care nurse specialists, one advanced practice nurse, one pharmacist, one respiratory therapist, one physical therapist, and one nurse.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or greater admitted to the Hospital Medicine service at UCSF Medical Center who meet criteria as determined by predictive model to be likely admissions for COPD exacerbation.

Exclusion Criteria:

* Patients admitted to other clinical services at UCSF Medical Center.
The Turkish Version of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)

The Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) is an instrument that assesses the quality and quantity of motor development opportunities available in the home for infants aged 3 to 18 months. Since its initial publication, the AHEMD-IS has grown in popularity as a clinical tool and research criterion. Furthermore, the AHEMD-IS supports the claim that environmental factors can have a positive impact on future motor skills and later cognitive behaviors of infants. Also it is stated that environmental factors are associated with infant motor development and motor abilities. As of writing, it has been translated into eight languages from the original English version and has been reported as valid and reliable in countries such as China, Spain, Lebanon, and Persia. The aim of this study was to produce the Turkish version of the AHEMD-IS and to reveal the validity and reliability of this version.

The International Classification of Health, Function, and Disability (ICF), developed by the World Health Organization, provides a standard framework for identifying the body functions and structures, activity restrictions, and difficulties in children's participation. One of the major innovations in the ICF is that it introduces an environmental factor classification that enables the identification of environmental barriers and facilitators for both the capacity and performance of activities and tasks in daily life. The physical, social, and behavioral environments in which humans live are shaped by environmental factors. Environmental factors are external to the individual and can have a positive or negative impact on an individual's participation, performance, and body function/structure.

One of the tools that evaluate the environmental home environment is the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). The AHEMD-IS is a valuable tool for assessing the home environment, one of the environmental factors affecting infant motor development, and is of considerable research and clinical importance. The importance of this questionnaire is based on evidence not just for the impact of the home environment on motor development, but also on future cognitive and social behaviors. Consequently, this study aimed to translate the original English version into Turkish and to test its psychometric properties for use in children aged 3-18 months. It was aimed to determine whether the translated questionnaire meets the appropriate and necessary standards for measuring the quantity and quality of motor competencies in the home environment of children aged 3-18 month.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-18 months

Exclusion Criteria:

* Children younger than 3 months or older than 18 months
* Congenital or systemic disease
Lifestyle Intervention in Morbidly Obese Patients

The long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

Due to limited recruitment from GP, the study design has been changed into an observational long term study following the participants in the intensive lifestyle intervention group

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients not planned for bariatric surgery

Exclusion Criteria:

* Participation in other weight loss programs during the last 12 mths
* Serious psychiatric conditions
Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.

OBJECTIVES

To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

* increase the number of patients successfully collected in one day
* increase the number of patients successfully mobilized on first collection attempt
* is cost neutral within a Canadian setting


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be 18 years of age or older
2. Patients must be able to provide written consent
3. Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
4. Females of child bearing age will be asked to use an approved form of contraception

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding
2. Patients whose creatinine ≥ 250 μM
3. Serum AST, ALT or total bilirubin \>5X upper limit of normal
4. Acute infection
Are You in a Poor Country; HIPEC is Still in Reach

Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.

On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.

A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.

As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines

Eligibility Criteria:
Inclusion Criteria:

* Any patient candidate for HIPEC procedure

Exclusion Criteria:

* Contraindications to HIPEC procedure
Efficacy of Different Medications as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries

This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.

This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) status of I and II
* undergoing forearm surgeries

Exclusion Criteria:

* coagulopathies
* Local skin lesions
* Pregnancy
* Has a history of significant neurological, psychiatric, or neuromuscular disorders
* Patients refusing participation
* BMI \> 40
* Patient with COPD. hypersensitivity or allergies to local anesthesia