louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04979091: Sex Hormone Dysregulations Are Associated With Critical Illness in COVID-19 Patients
Official title: Low Testosterone and High Estradiol Are Associated With Disease Severity in Critically Ill COVID-19 Patients - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Critical Illness
Keywords: ICU, COVID-19, testosteron, estradiol, sex-hormone
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2021-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill Covid-19 patients and Critically ill Non-Covid-19 patients

Brief summary: Males develop more severe SARS-CoV-2 infection related disease outcome than females. Herein, sex hormones were repeatedly proposed to play an important role in Covid-19 pathophysiology and immunity. However, it is yet unclear whether sex hormones are associated with Covid-19 outcome in males and females. In this study, we analyzed sex hormones, cytokine and chemokine responses as well as performed a large profile analysis of 600 metabolites in critically-ill male and female Covid-19 patients in comparison to healthy controls and patients with coronary heart diseases as a prime Covid-19 comorbidity. We here show that dysregulated sex hormones, IFN-γ levels and unique metabolic signatures are associated with critical illness in Covid-19 patients. Both, male and female Covid-19 patients, present elevated estradiol levels which positively correlates with IFN-γ levels.

Male Covid-19 patients additionally display severe testosterone and triglyceride deficiencies as compared to female patients and healthy controls. Our results suggest that male Covid-19 patients suffer from multiple metabolic disorders, which may lead to higher risk for fatal outcome. These findings will help to understand molecular pathways involved in Covid-19 pathophysiology.


Eligibility criteria: Inclusion Criteria:

* Admission on ICU
* Covid-19

Exclusion Criteria:

- none

Primary outcomes:
measure: Sex hormone in critical ill COVID-19 patients
timeFrame: Day at admission
measure: Sex hormone in critical ill COVID-19 patients
timeFrame: Day at admission
measure: Sex hormone in critical ill COVID-19 patients
timeFrame: Day at admission
measure: Sex hormone in critical ill patients
timeFrame: Day at admission
measure: Sex hormone in critical ill patients
timeFrame: Day at admission
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Germany
name: Stefan Kluge, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06575491: Ultrasound Guided Supraclavicular and Infraclavicular Subclavian vs Catheterization in Pediatric
Official title: Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterization in Pediatric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Guided
Supraclavicular
Infraclavicular
Subclavian
Venous Catheterization
Pediatric
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications.

Detailed description: Vascular access in children can be challenging. There is a considerable body of evidence supporting the use of ultrasound to aid central venous access in adults, but less so in children. Benefits for experienced operators may be small, but there is evidence of benefit for those acquiring skills and for less frequent operators.

Central venous catheter (CVC) placement is one of the most important invasive procedures in the intensive care for children of all ages. And health care outcomes largely depend on the success of its implementation. There are a large number of historically and clinically significant methods of central venous catheterization, and the advantages and disadvantages of each of them have been discussed for many years.

Ultrasonography is becoming an increasingly useful adjunct in the placement of Percutaneous central lines.

Eligibility criteria: Inclusion Criteria:

* Aged from 4 to 12 years.
* Both sexes.
* All children who need central venous line insertion.
* Intra-operative Hemodynamic monitoring.
* Volume and Inotrope Resuscitation.
* Difficult Peripheral IV Access.
* Intravenous Nutrition and Medications.

Exclusion Criteria:

* Coagulopathy.
* Distorted anatomy.
* Infection systemic or cutaneous near the proposed Point of insertion.
* Skeletal deformity.
* History of previous neck surgery.
* Head and neck mass.
* Guardian Refusal.
* Pneumothorax Or Hemothorax.

Primary outcomes:
measure: Puncture time
timeFrame: Interoperatively
Secondary outcomes:
measure: Total access time
timeFrame: Interoperatively
measure: First attempt success rate
timeFrame: Interoperatively
measure: Quality of needle visualization
timeFrame: Interoperatively
measure: Incidence of complication
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT06913491: Efficacy of PEEK Acuity Versus ETDRS Chart for Assessment of Visual Acuity and Refractive Error
Official title: Efficacy of PEEK Acuity Versus ETDRS Chart for Assessment of Visual Acuity and Refractive Error
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Refractive Errors
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas,

Brief summary: Visual acuity is a key indicator of visual function, often measured using the ETDRS chart, the gold standard in clinical settings. However, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the Peek Acuity application.

Detailed description: This study aims to compare the diagnostic accuracy and efficiency of the Peek acuity application (Portable Eye Examination Kit) with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart in assessing visual acuity and refractive errors. The study will involve 58 participants, selected using a non-probability convenience sampling technique. A comparative cross-sectional design will be used.

Eligibility criteria: Inclusion Criteria:

* Males and females.
* 18 years of age or older.
* Individuals with normal vision or those with refractive error who had their corrected glasses.
* Individuals who are willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Individuals with anterior segment abnormalities such as conjunctivitis, Iritis, uveitis, keratitis, or corneal ulcers.
* Individuals with vision deprivation due to corneal opacities, cataracts, glaucoma, retinal, and optic nerve pathologies.
* Postoperative/intraoperative complications.
* Have received mydriatic drops.
* Individuals who cannot achieve normal visual acuity with corrective lenses (glasses or contact lenses).
* Individuals with neurological conditions affecting vision
* Individuals unable to cooperate with visual acuity testing due to cognitive impairments or language barriers.
* Individuals who have had refractive surgery or other eye treatments within the past 6 months.

Primary outcomes:
measure: Peek Acuity
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Eagle Eyes Relief Trust FF120, Divine mega 2, new airport road
state: Punjab
Study officials:
References:
Clinical trial NCT01133691: Examination of Gastric Emptying in Children
Official title: Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Emptying
Keywords: gastric emptying
children
gastric fluid volume
preoperative fasting
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy children aged 6 - 12 years old

Brief summary: * Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
* Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
* Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.


Eligibility criteria: Inclusion Criteria:

* age 6 - 12 years
* ASA I or II

Exclusion Criteria:

* gastrointestinal pathology
* claustrophobia
* implants like pacemaker, ventriculoperitoneal shunt etc
* symptomatic or relevant cardiac, renal or metabolic disease

Primary outcomes:
measure: Gastric emptying time
timeFrame: 6 hours
Secondary outcomes:
measure: gastric volume after fasting
timeFrame: 6 hours
measure: gastric antral area
timeFrame: 6 hours
measure: visual analog scale of thirst/hunger
timeFrame: 6 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital, Anesthesiology
Study officials:
affiliation: Children's University Hospital Zurich, Anesthesiology
name: Achim J Schmitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06145191: Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy
Official title: Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bleeding
Hemoptysis
Keywords: Bronchoscopy
Tranexamic acid
Adrenaline
Prophylaxis
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple arm randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
* Signed informed consent

Exclusion Criteria:

* Any existing contraindication for diagnostic bronchoscopy
* Coagulopathy (PV INR \> 1.3)
* Thrombocytopenia (\<50x10\*9 or anemia (Hgb \<80 g/L)
* DOAC, LMWH or antiplatelet drug therapy
* Thrombophilia, history of pulmonary embolism or deep vein thrombosis
* Contraindication for endobronchial application of adrenaline
* Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
* Uncontrolled pulmonary hypertension
* Cardiovascular decompensation
* Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)

Primary outcomes:
measure: Number (N) of bleeding episodes / bleeding rate (%) in each group
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
measure: Severity of bleeding after prophylaxis
timeFrame: through study completion, an average of 1.5 years
measure: Number (N) of drug applications needed for bleeding control
timeFrame: through study completion, an average of 1.5 years
measure: Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication
timeFrame: through study completion, an average of 1.5 years
measure: Number (N) of samples taken in each group
timeFrame: through study completion, an average of 1.5 years
measure: Adverse events
timeFrame: through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
Study officials:
References:
Clinical trial NCT06722391: Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
Official title: Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Keywords: Neuromuscular Electrical Stimulation
Glucose Continuous Monitor
Blood Glucose
Obesity
Resting Metabolic rate
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. Subjects will be provided with a standardized diet (55/15/30% CHO/PRO/FAT) prior to collection of pre-intervention data of insulin sensitivity. Individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, NMES, resistance training combined with NMES (RT +NMES), or resistance training (RT) group (n=20 per group), followed by collection of post-intervention data. The control group will receive electrical stimulation up to sensory level, the NMES group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the RT+ NMES will receive stimulation up to tolerable intensity during resistance training, and the RT group will only receive exercise training. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.


Eligibility criteria: Inclusion Criteria:

* Overweight/Obese (BMI ≥25)
* Sedentary Lifestyle: Physical Activity Level\&lt;1.4
* Less than 150min/week of structured Exercise

Exclusion Criteria:

* Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
* Excessive alcohol, drug abuse, smoking
* Pregnant Women
* Unwilling to adhere to the study Intervention

Primary outcomes:
measure: Glycemic Control
timeFrame: 8 weeks
Secondary outcomes:
measure: Respiratory Exchange Ratio
timeFrame: 8 Weeks
measure: Amount of lean mass
timeFrame: 8 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
Study officials:
References:
Clinical trial NCT00656591: Community-Based Interventions for Infant Health in Nepal
Official title: An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal and Infant Mortality, and to Improve Fetal Growth and Cognitive Development in Infancy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Mortality
Keywords: Child mortality, Nepal, Community, care practices
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 192000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 48 village development committee areas

Brief summary: An Evaluation of the Cost-Effectiveness of Community-Based Participatory Interventions for Pregnant Women in Nepal to Reduce Fetal \& Infant Mortality and to Improve Fetal Growth \& Cognitive Development in Infancy


Eligibility criteria: Inclusion Criteria:

* mothers, community health volunteers

Exclusion Criteria:

* none

Primary outcomes:
measure: neonatal mortality rates
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: International Child Health, ICH
Study officials:
affiliation: Institute of Child Health
name: Anthony Costello, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06779994: The Safety and Efficacy of Probiotic for Improving Intestinal and Immune Function
Official title: Safety and Efficacy of Streptococcus Salivarius Subsp. Thermophilus ST36 on Intestinal and Immune Function Improvement.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adults Aged 18-45 Years
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Streptococcus salivarius subsp. thermophilus ST36 in healthy adults on immune function and intestinal health.


Eligibility criteria: Inclusion Criteria:

* 1) Age 18-45 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Streptococcus salivarius subsp. thermophilus ST36/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention;

Exclusion Criteria:

* 1) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

Primary outcomes:
measure: Antimicrobial peptide levels in stool samples
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05932394: Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Official title: Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Postoperative Delirium
Cardiac Surgery
Keywords: cardiac surgery
delirium
intensive care
visual material
mental health
Lead sponsor: University of Huelva
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim is to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium.

A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. CONSORT guidelines were followed.

A control group and an intervention group were established. In the intervention group, the patients underwent a visual projection, while the usual unit treatment was carried out with the control group. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the "Confusion Assessment Method for the Intensive Care Unit scale" (CAM-ICU).

The projection of visual material could reduce the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established.

The results obtained suggest that the visual projection of images is an effective and economical tool to address an increasingly incidental problem due to the aging of the population.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing heart surgery (aortic valve replacement, mitral valve replacement and/or coronary bypass) in the immediate postoperative period during their stay in the cardiac resuscitation unit.
* Over 18 years of age

Exclusion Criteria:

* Not being sedated for at least 24 hours.
* Leven of consciousness.
* Spanish speaker.

Primary outcomes:
measure: Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale
timeFrame: 2 times, previous and post intervention, in the first 24 hours after cardiac surgery. This method is applied individually, through study completion, in an average of 1 year.
measure: Mini-Mental State Examination (MMSE) scale
timeFrame: Baseline (Beginning of the experiment)
Secondary outcomes:
Other outcomes:
Locations:
city: Leon
country: Spain
facility: University Hospital of Leon
state: Castilla-Leon
Study officials:
References: