louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00827060: Observation of Initial Procalcitonin and the Clinical Course of Patients With Acute Respiratory Tract Infections
Official title: Observation of the Initial Procalcitonin Values and the Clinical Course of Patients With Acute Respiratory Tract Infections at General Medical Practices in Greater Hannover
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Keywords: primary care
procalcitonin
acute respiratory tract infection
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care patients in 45 practices in greater Hannover

Brief summary: Observation of the initial Procalcitonin values and the clinical course of consecutively included patients with Acute Respiratory Tract Infections at general medical practices in greater Hannover.

Detailed description: Primary endpoint:

* initial Procalcitonin values of patients with Acute Respiratory Tract Infections

Secondary endpoints:

* correlation of initial Procalcitonin values to classify Acute Respiratory Tract Infections
* correlation of initial Procalcitonin values to subjective severity of Acute Respiratory Tract Infections
* correlation of initial Procalcitonin values to antibiotic- prescriptions
* correlation of initial Procalcitonin values to frequency of admission to hospital
* correlation of initial Procalcitonin values to frequency of referrals (radiology, pneumology)

Eligibility criteria: Inclusion Criteria:

* written informed consent
* all types of respiratory tract infection according to investigator´s diagnosis

Exclusion Criteria:

* pretreatment with antibiotics in the past 2 weeks
* portal hypertension
* Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
* Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
* Peritoneal dialysis
* Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
* Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover, Department Pneumology
Study officials:
affiliation: Medical School Hannover
name: Olaf Burkhardt, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.
Clinical trial NCT04883060: Pilot Testing for Midline Measuring Device
Official title: Pilot Testing for Midline Measuring Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventriculo-Peritoneal Shunt Infection
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).


Eligibility criteria: Inclusion Criteria:

* Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery

Exclusion Criteria:

* Patients who are not able to consent

Primary outcomes:
measure: Midline Localization
timeFrame: Immediate postop, an average of 4 hours
Secondary outcomes:
measure: Burr Hole Placement
timeFrame: Immediately Post-op, an average of 4 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Univeristy of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT04779060: Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries
Official title: Intrathecal Fentanyle Versus Dexamethasone in Patients Under Going Gynacological Laparoscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperativ Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA


Eligibility criteria: Inclusion Criteria:

* ASA I, II
* elective gynacological laparoscopic surgery

Exclusion Criteria:

* patient refusal
* chronic kidney and hepatic diseases

Primary outcomes:
measure: intraoperative pain
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT06431360: Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
Official title: Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keloid
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .

Detailed description: Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min

Eligibility criteria: Inclusion Criteria:

* The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；
* Body surface keloid thickness: 2\~5mm, diameter ≥10mm.

Exclusion Criteria:

* Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;
* Patients with cicatricial constitution;
* Abnormal coagulation function;
* Patients who have received an adequate dose or course of radiation therapy;
* People with previous immune system diseases, diabetes and other metabolic diseases.

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS) scores
timeFrame: once every 3 months for 1 year after the last treatment
measure: Vancouver Scar Scale (VSS) scores
timeFrame: once every 3 months for 1 year after the last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical Univerity
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Feng Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT04693260: A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Official title: A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
Ortho-k
vision
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
Collaborators: name: Eye Boutique Optometry
First posted: 2021-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Detailed description: A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Ages =\>7 y.o.
3. Subjects that are minors (\<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English
7. Be treated for myopia with Ortho-K, day contacts, or night contacts

Exclusion Criteria:

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
2. Has traveled outside the country within the last 4 weeks
3. Medications:

   a. Taking medications that may affect ability to follow instructions.
4. Eye Disease:

   a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.
5. Subjects that:

   1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
   2. Lack the ability to follow instruction
   3. Lack binocular vision
   4. Lack the ability to maintain both eyes open
   5. Had eye surgery within the last 12 months (including Lasik)

Primary outcomes:
measure: Departure from scheduled follow-up visits with clinical confirmation
timeFrame: Approximately 21 Weeks
Secondary outcomes:
measure: Measure rapidly changing visual acuity
timeFrame: Approximately 21 Weeks
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Eye Boutique Optometry
state: California
Study officials:
References:
Clinical trial NCT03128476: Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
Official title: Effects of the Supplementation of Essence of Chicken on Physical Fatigue and Brain Functions Such as Working Memory and Attention Among Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Fatigue
Lead sponsor: Sprim Advanced Life Sciences
Sponsor class: OTHER
Collaborators: name: Cerebos
First posted: 2017-04-25
Enrollment: 364
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: In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is consumed as a traditional remedy for several ailments, including the use as a nutritional supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue. While the elderly use it as a nutritional supplement, students use it for relief from anxiety during exam times.

The present study is conducted in order to assess the effects of BEC on various physical and mental parameters including physical fatigue, working memory and attention, mood and stress, in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* Normal BMI
* Not continuously taken Essence of Chicken for the last 3 months
* Physical and psychological fatigue inclusion criteria/test/cutoff using CFQ (where individuals' CFQ scores 4 or above)

Exclusion Criteria:

* Suffering from chronic or malignant diseases e.g. cancer, heart, liver, renal or other metabolic diseases.
* Any psychiatric or neurological disease
* Pregnant and lactating women
* Subjects participated in any investigational drug trial within 4 weeks before screening
* Consumption of food supplement in the previous 2 weeks
* Professional athletes
* Subjects with recent lifestyle changes in the past 4 weeks
* History of allergy to chicken meat and seafood

Primary outcomes:
measure: Fatigue-vitality
timeFrame: 4 weeks
measure: Physical fatigue
timeFrame: 4 weeks
measure: Attention
timeFrame: 4 weeks
measure: Sustained attention
timeFrame: 4 weeks
measure: Working memory
timeFrame: 4 weeks
Secondary outcomes:
measure: Mood
timeFrame: 4 weeks
measure: Stress
timeFrame: 4 weeks
measure: Adverse effects
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04798976: Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer
Official title: Personalized Evidence-based Treatment Improves Survival in Patients With Invasive Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer-specific Survival
Lead sponsor: Center of Personalized Medicine, Pirogova
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
name: I.M. Sechenov First Moscow State Medical University
First posted: 2021-03-16
Enrollment: 3000
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All first invasive breast cancer cases from a National Cancer Registry

Brief summary: A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases


Eligibility criteria: Inclusion Criteria:

All women with stage I-III disease who survived at least 12 months post-diagnosis

Exclusion Criteria:

Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)

Primary outcomes:
measure: The percentage of guideline-consistent and personalized EBM recommendations
timeFrame: 3-year
Secondary outcomes:
measure: Breast cancer-specific survival
timeFrame: 3-year
measure: Quantify the performance of the CDSS (MedicBK) algorithm
timeFrame: 3-year
measure: Predictors
timeFrame: 3-year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Evgeny Pokushalov
Study officials:
References:
Clinical trial NCT03141476: Adequacy of Perioperative Cefuroxime Dosage According to the BMI
Official title: Perioperative Cefuroxime in Obese Patients: Dosage According to the BMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity; Drug
Keywords: Surgery
Obesity
Drug
Antibiotics
Cefuroxime
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BMI: \<30kg/m\*m: 1,5g, 31-50kg/m\*m: 3,0g, \>50kg/m\*m: 4,5g
Primary purpose: PREVENTION

Brief summary: This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m\*m and as well over 50kg/m\*m. Drug levels were measured in blood and tissue.

Detailed description: Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI:

less than 30kg/m\*m: 1,5g 31-50kg/m\*m: 3,0g more than 50kg/m\*m: 4,5g

Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) .

The hypothesis of this study is that adequate drug levels are reached in all groups.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic Intervention
* BMI \< 90 kg/m\*m
* age: 18-85 years

Exclusion Criteria:

* known history of allergy to cefuroxime or other cephalosporines
* absent consent skill
* elective open surgery
* preoperative therapy with antibiotics
* patient's denial of the study

Primary outcomes:
measure: Serum level of Cefuroxime
timeFrame: 30-60 minutes after application of cefuroxime
measure: Serum level of Cefuroxime
timeFrame: 75-105 minutes after application of cefuroxime
measure: Serum level of Cefuroxime
timeFrame: up to 150 minutes after application of cefuroxime
measure: Tissue level of Cefuroxime
timeFrame: 30-60 minutes after application of cefuroxime
measure: Tissue level of Cefuroxime
timeFrame: 75-105 minutes after application of cefuroxime
measure: Tissue level of Cefuroxime
timeFrame: up to 150 minutes after application of cefuroxime
Secondary outcomes:
measure: Surgical site infections
timeFrame: Time until hospital discharge, estimated time period: up to two weeks
measure: Hospital Retention period
timeFrame: Time until hospital discharge, estimated time period: 5-7 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT00984776: Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging
Official title: Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Stable Angina
Unstable Angina
Keywords: coronary artery
MRI
vessel wall imaging
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2009-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: MRI has the ability to visualize the arterial vessel wall. Wall thickening and atherosclerotic plaque components can be visualized in the carotid arteries and the aorta. Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall. The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial infarction.

The goal of this study was to validate MRI of the coronary vessel wall by comparing it to intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall and to look at the uptake of the albumin-binding contrast agent gadofosveset in atherosclerotic plaques. The main hypothesis is that due to the albumin binding characteristics, uptake of the contrast agent will take place in the more vulnerable plaques compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and intravascular ultrasound, two techniques currently considered as the standard of reference for imaging of the coronary arteries and vessel wall.


Eligibility criteria: Inclusion Criteria:

* scheduled X-ray angiography for known coronary artery disease, valvular disease or chest pain with unknown origin
* age \> 18 yrs and \< 90 yrs
* Informed consent

Exclusion Criteria:

* arrhythmia
* hemodynamic unstable patients
* contra-indications for (contrast-enhanced) MRI
* age \< 18 yrs or \> 90 yrs

Primary outcomes:
measure: Validation of MRI: comparison with IVUS. Can plaque be detected?
timeFrame: 1 week
Secondary outcomes:
measure: uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?
timeFrame: 1 day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Tim Leiner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerretsen S, Kessels AG, Nelemans PJ, Dijkstra J, Reiber JH, van der Geest RJ, Katoh M, Waltenberger J, van Engelshoven JM, Botnar RM, Kooi ME, Leiner T. Detection of coronary plaques using MR coronary vessel wall imaging: validation of findings with intravascular ultrasound. Eur Radiol. 2013 Jan;23(1):115-24. doi: 10.1007/s00330-012-2576-1. Epub 2012 Jul 11.
Clinical trial NCT04194476: Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood
Official title: Performance Study of Nova StatStrip® Blood Glucose Monitoring Test System on Neonatal Capillary Blood
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Healthy and Unhealthy Neonates
Keywords: neonates
glucose
Lead sponsor: Nova Biomedical
Sponsor class: INDUSTRY
First posted: 2019-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to determine the validity of Nova StatStrip® blood glucose monitoring test system including the Nova StatStrip® glucose hospital meter and test strips in measuring Chinese neonatal capillary blood glucose levels by evaluating how the results compare to those obtained from laboratory hexokinase method. The study results will be the basis for the regulatory submission and registration of the Nova StatStrip® glucose hospital meter and test strips in testing the neonatal capillary whole blood specimens to the China Food and Drug Administration (CFDA).

Good clinical practice indicates that the performance of a point-of-care glucose monitoring test system be validated before clinical use. It is therefore important to perform a method comparison study to determine how the results obtained from a type of glucose monitoring test system compare to those from a laboratory hexokinase method.


Eligibility criteria: Inclusion Criteria:

* Subject is within 28 days after birth.
* The legal representative of the Subject agrees to sign two copies of the Informed Consent Form.
* The Subject's capillary whole blood needs to be drawn via heel stick for routine clinical laboratory testing according to the prescription.
* The legal representative of the Subject agrees that the Subject provides 300 µL capillary whole blood for glucose and haematocrit testing in addition to routine clinical laboratory testing.

Exclusion Criteria:

* Subject/legal representative is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products;
* Subject has already participated in this study.

Primary outcomes:
measure: blood glucose level measured by StatStrip blood glucose meter
timeFrame: 6 months
measure: plasma glucose level measured by a laboratory biochemistry analyzer
timeFrame: 6 months
Secondary outcomes:
measure: hematocrit of the heel-stick blood
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References: