cyrilzakka/clinical-trials huggingface dataset:
Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission

The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.

Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.

In friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.

Literature about this issue is rare, so the investigators conducted a study to check this possibility.

Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.

The most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.

Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.

The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.

Eligibility Criteria:
Inclusion Criteria:

* all newborn infants

Exclusion Criteria:

* infants born after less than 35 complete gestational weeks
Research on the Brain Death Determination in China

Purpose China has a population of 1.4 billion and an enormous medical expenditure burden, and Chinese traditional culture has a long history. It takes time to recognize and accept the concept of brain death (BD) as death. Promoting brain death determination (BDD) and rationally allocating medical resources have become major national policy issues. To identify the safest and most reliable ancillary tests needed if the clinical examination is incomplete.

Method The technical group of the Brain Injury Evaluation Quality Control Center of the National Health Commission retrieved coma cases registered from 2013 to 2019. According to clinical criteria for Brain Death Determination (BDD), the patients were divided into two groups: a brain-death (BD) group and a non-BD group. The BD group was divided into a complete brain death with no doubt group (BD1 group) and an incomplete brain death with doubt group (BD2 group). Depending on the site of the brain injury, the accuracy of BDD was evaluated using the independent ancillary test or combined ancillary tests. Data from the BQCC/NHC database and yearbook were obtained, and data analysis and status comparison were conducted on six practical activities: organizational system construction, standard and specification formulation, case quality control, professional skills training, scientific research publicity and education, and international communication.


Eligibility Criteria:
Inclusion Criteria:

* All cases met the clinical criteria for BD, involving deep coma (Glasgow Coma Scale (GCS)=2T), the absence of brainstem reflexes (pupillary light reflex, corneal reflex, oculocephalogyric reflex, oculovestibular reflex, and cough reflex), and spontaneous respiration. Ancillary tests were completed for all patients.

Exclusion Criteria:

* Does not meet BD clinical evaluation criteria. Ancillary tests were not implemented.
Prevalence and Associated Factors of Anesthetic Drug Administration Error, a Web Based Crossectional Survey, 2022.

The operating room (OR) is a demanding and time-constrained setting, in comparison to primary care settings, where perioperative medication administration is more complicated and there is a high risk that the patient will experience a medication error.

Without consulting the pharmacist or seeking assistance from other staff members, anesthesia clinicians prepare, deliver, and monitor strong anesthetic drugs.

The operating room (OR) is a demanding and time-constrained setting, in comparison to primary care settings, where perioperative medication administration is more complicated and there is a high risk that the patient will experience a medication error. Anesthesia clinicians prepare, deliver, and monitor strong anesthetic drugs without consulting pharmacists or seeking assistance from other staff members.

The aim of this study was to determine the prevalence of medication administration errors by anesthetists and associated factors in referral and teaching hospitals in the Amhara region of, Ethiopia.

Eligibility Criteria:
Inclusion Criteria:

* all anesthetists with a minimum of six months of working experience, the ability to respond to the questionnaire using the listed online choices, and involvement in direct patient care to be included in the study.

Exclusion Criteria:

* Anesthetists who were not involved in medication administration and those serving in administrative positions were excluded from the study.
Effect of Lactobacillus Reuteri in Cystic Fibrosis

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics.

Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present.

Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.

Eligibility Criteria:
Inclusion Criteria:

* Forced expiratory volume in the 1st second (FEV1) \> 70%.
* No inhaled or systemic steroids.
* No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
* No serious organ involvement.

Exclusion Criteria:

* History of pulmonary exacerbation or upper respiratory infection in the previous two months.
* Changes in medications in the past two months.
* History of hemoptysis in the past two months.
Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes

The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.

Diabetic kidney disease is the leading cause of new cases of kidney failure in the United States. In the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. Because of this many patients eventually require dialysis or kidney transplantation. A new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. It is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.

Eligibility Criteria:
Inclusion

* Type 1 or type 2 diabetes
* Males and females greater than or equal to 18 years.
* Abnormal kidney function determined by glomerular filtration rate
* History of proteinuria
* Blood pressure controlled to \<140/90 on anti-hypertensive medication

Exclusion

* Cancer, liver disease, hepatitis, HIV+
* History of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months
* Pregnant or planning to become pregnant during the study period
* Other known kidney disease besides diabetic nephropathy
* Expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation

The purpose of this study is to assess the impact of different feeding solutions on patients with breathing difficulty being supported by a breathing machine.

The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon dioxide production in patients with respiratory failure.

Patients who agree to participate in the study and fulfil the inclusion criteria, will be randomised to one of two treatment groups.

1. Standard therapy group. Will receive high carbohydrate, low fat enteral feeding, (16.7% protein, 30% fat and 53.3% carbohydrate). The target rate is determined by the treating physician and dietician, for a minimum of 5 days following randomisation.
2. Alternative therapy group will receive high-fat, low carbohydrate enteral feeding, (16.7% protein, 55.2% fat and 28.1% carbohydrates. At a target rate determined by the treating physician and dietician, for a maximum of 5 days following randomisation.

All patients will receive enteral feeding by continuous flow for 24 hours a day. The decision to commence or cease enteral feeding will remain with the treating physician.

The measurement of VO2, VCO2, resting energy expenditure and respiratory quotient wil be made on all participants 12 hourly for a maximum of 5 days using the direct calorimeter. The indirect calorimeter is connected to the expiratory outlet of the ventilator, collecting and analyzing gas that is normally discharged in to the atmosphere.

The hypothesis of the study is that the use of high- fat, low-carbohydrate enteral feed, significantly reduces the carbon dioxide production and the respiratory quotient in critically ill, mechanically ventilated patients with respiratory failure. Compared to standard high-carbohydrate low-fat enteral feed.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient, 18 years or older admitted with acute respiratory failure (PaO2/FiO2 \<300), needing mechanical ventilation. Are expected to be require mechanical ventilation for more than 48 hours.
2. Patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube.
3. Patients or their next-of-kin consent to participate in the study. -

Exclusion Criteria:

1. Patients under the age of 18 years
2. Patients with contra-indications to enteral feeding
3. Patients receiving total parental nutrition
4. Patients who are already enrolled in another study that may influence the outcome of this study.
5. Patients who are not receiving active medical management or are expected to die within 24 hours at the time of study entry.
6. Patients with diabetes mellitus, renal failure or liver failure.
7. Patients or next-of-kin who do not consent to participate in the study. -
The Kickstart Health Program

This study is testing the acceptability and feasibility of an active, experiential group therapy for health behavior change within a medical setting.

The purpose of the current study is to offer a preliminary test of feasibility and acceptability for a group intervention, conducted in a primary care setting, that aims to teach skills that initiate health behavior change. Participants will be recruited from a local family medicine clinic and groups will be held on site at the clinic. Patients will be recruited by their physicians and given a baseline survey of their exercise and nutrition behaviors as well as their overall well being and self efficacy to change their health behaviors. Participants can join the group at any time and attend as many sessions as desired. Groups are held 2 times per month and include worksheets, meditations, and exercise. Patients and their providers will be given 2 follow up surveys after 5 and 13 weeks to assess for acceptability and feasibility of the program, as well as health behavior change. Statistical analyses will include multivariate analyses, descriptive analyses, and frequency data collection.

Eligibility Criteria:
Inclusion Criteria:

* A patient of the Beaumont Family Medicine Center - Troy/Sterling Heights
* Access to a computer or electronic device with an internet browser
* Internet connectivity
* Patient verbally confirms during recruitment phone call that they can independently or with minimal assistance complete online surveys
* English speaking

Exclusion Criteria:

* Individuals who do not have regular access to internet connectivity
* Not approved by their physician to complete the group exercises
* Denies the ability to fill out online surveys with minimal assistance
* Non-English speaking
Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality

The aim of this study is to analyze the effect of a brief psychological intervention supported by Information and Communication Technologies, on the subjective well-being of hospitalized cancer patients. Participants are randomly assigned to one of 2 conditions: Intervention condition (4 Virtual reality sessions) and Control condition (waiting list control group).


Eligibility Criteria:
Inclusion Criteria:

* adults with any cancer diagnosis
* hospitalized for at least 1 week
* Karnofsky functional state ≥50
* life expectancy ≥2 months

Exclusion Criteria:

* serious psychopathology
* cognitive impairment
Rehabilitation Post Lumbar Microdiscectomy

The purpose of this study is to determine whether a rehabilitation program following lumbar microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in quality of life, activity and endurance.

Exercise

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Single level lumbar microdiscectomy

Exclusion Criteria:

* Potential subjects will be excluded is they exhibit symptoms suggestive of facet arthrosis or neurogenic claudication, or if their plain radiographs showed more than 50 percent loss of disc height at the relevant level.
* Patients in whom the protrusion occupied more than 50 percent of the sagittal diameter of the spinal canal or in whom sequestrated fragments were seen on MRI will also be excluded.

Other exclusion criteria will include:

* Previous back surgeries
* Presence of any other concurrent foot pathology besides leg and low back pain and associated single level disc injury
* Nervous system problems (e.g., stroke, dementia, seizures)
* Cognitive dysfunction (e.g. TBI, CVA, Alzheimer's)
* Uncontrolled cardiovascular disease
* Evidence of cord compression
* Uncontrolled hypertension
* Infection
* Severe respiratory disease
* Pregnancy
* Rheumatic joint disease
* Peripheral vascular disease with sensory loss of the foot
* Any condition that the subject identifies that might limit participation in physical activity
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

Eligibility Criteria:
Inclusion Criteria:

* Children suffering from primary nocturnal enuresis with no organic pathology.
* Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France).
* Children with a minimum of 6 wet nights in 2 weeks.

Exclusion Criteria:

* Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms.
* Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine.
* Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency.
* Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 3 to 17 years of age
* Chronic hepatitis C
* Hepatitis C virus genotype 1a or b at the Screening Visit
* Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator.
* Signed informed consent form (ICF), and where appropriate, signed Assent Form

Exclusion Criteria:

* History of or prior evidence of a medical condition associated with chronic liver disease other than HCV
* Body weight \<15 kg or \>90 kg
* Prior evidence of hepatic decompensation
* Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV)
* History or other evidence of severe retinopathy or clinically significant ophthalmological disorder
* History of non-genotype 1 HCV
* Participation in investigational drug study as described in Study Protocol
* Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug
Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients

Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.

Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.

A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Female or male patients aged 70 years and over
* Measurable disease according to RECIST criteria, with at least one measurable lesion
* No prior chemotherapy, biological or immunological therapy
* Adeguate hepatic, renal and bone marrow function
* ECOG Performance Status ≤ 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Newly diagnosed CNS metastases that have not been treated with surgery or radiation
* Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
* Any other experimental or anti-cancer therapy within 30 days before study drug administration
* Concurrent treatment with any other experimental or anti-cancer therapy
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection meeting CDC criteria for AIDS.
* History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).

Required:

- On stable medical regimen.
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.


Eligibility Criteria:
Inclusion criteria:

1. AML (including secondary AML) diagnosed as per WHO criteria
2. For relapsed/refractory subjects only:

   * Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines
   * Medically eligible to receive MEC
   * Absolute blast count (ABC) ≤ 40,000/mm
3. For treatment-naïve subjects only:

   * Subjects ≥ 60 years of age with newly diagnosed AML
   * Medically eligible to receive "7+3" cytarabine/idarubicin
   * ABC count ≤ 40,000/mm
4. ECOG performance status 0-2
5. Hemodynamically stable and adequate organ function

Exclusion criteria:

1. Acute promyelocytic leukemia
2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)
3. Active signs or symptoms of CNS involvement by malignancy
4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
5. Known history or evidence of active hepatitis A, B, or C or HIV
6. Uncontrolled acute life threatening bacterial, viral or fungal infection
7. Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
8. Hematopoietic stem cell transplantation ≤ 4 months of dosing
9. Clinically significant cardiovascular disease