louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06105411: Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
Official title: Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Fungal Infections
Keywords: Invasive Fungal Infections
Siderophore
PET
Siderophore-labelled Position Emission tomography
68Ga-labelled TAFC PET/CT scan
Aspergillus spp.
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older at written informed consent who have proven or probable invasive fungal infection (IFI) diagnosis with imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter. They are also willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up.

Brief summary: This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.

Detailed description: This open label, single centre, proof of concept pilot imaging trial will evaluate technique for the diagnosis of invasive Aspergillus infection. It aims to demonstrate uptake of the gallium-siderophore tracer at sites of known proven/probable invasive aspergillus app infection. It will also assess the safety and tolerability of this technique.

10 patients within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis will be recruited to this study over a period of 12-24 months.

Eligibility criteria: Inclusion Criteria:

1. Patient has provided written informed consent
2. Aged 18 years or older at written informed consent
3. Within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis as per EORTC criteria
4. Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter
5. Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up

Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Iron infusion within one week prior to scan

Primary outcomes:
measure: Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
timeFrame: At 60 minutes
Secondary outcomes:
measure: Physiologic bio distribution
timeFrame: Evaluated up to 3 hours following injection of radiotracer
measure: Safety of 68Ga-TAFC-PET/CT
timeFrame: Evaluated within 24 hours of scan
measure: Findings compared to CT and/or 18F-FDG PET/CT
timeFrame: At 60 minutes
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
References:
Clinical trial NCT03641911: Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients
Official title: Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult ICU Patients
Pain, Acute
Keywords: incidence
surgical ICU
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult surgical ICU patients

Brief summary: In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians.

There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment.

To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years.
* Expected duration of mechanical ventilation of more than 24 hours.

Exclusion Criteria:

* Quadriplegia.
* Receiving neuromuscular blocking medications.
* Coma or severe brain injury
* Neurosurgery/ CVT patients/ trauma patients

Primary outcomes:
measure: overtreatment of pain (Richmond agitation sedation scale)
timeFrame: day0- 2 after admitted to ICU
measure: inadequate treatment of pain (Numeral rating scale)
timeFrame: day 0-2 after admitted to ICU
Secondary outcomes:
measure: Mortality rate
timeFrame: 30 days after admitted to ICU
measure: ICU length of stay
timeFrame: 30 days after admitted to ICU
measure: Duration of mechanical ventilation
timeFrame: 30 days after admitted to ICU
measure: Incidence of acquired complication
timeFrame: 30 days after admitted to ICU
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Karuna Wongtangman
state: Bangkok
Study officials:
References:
Clinical trial NCT00649311: A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension
Official title: Clinical Protocol For A Double-Blind, Randomized, Active- Controlled Comparison Study Of The Antihypertensive Effect Of Eplerenone Versus Losartan In Patients With Mild To Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.

Detailed description: This Phase 2 study EPLA-0501-072 (A6141012) was conducted beginning 02 April 2003 and was prematurely terminated due to poor enrollment on 12 September 2003. There were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. There were no serious adverse events or deaths reported during the study.

Eligibility criteria: Inclusion Criteria:

* History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and \<110 mmHg and seSBP \<180 mmHg
* Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period

Exclusion Criteria:

* Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension
* The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit

Primary outcomes:
measure: Mean change from baseline in seated trough cuff diastolic blood pressure (seDBP) at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean change from baseline in seated cuff systolic blood pressure (seSBP) at Week 8
timeFrame: 8 weeks
measure: Percent of patients meeting the goal BP of DBP <90 mmHg or a reduction of ≥10 mmHg in DBP
timeFrame: 8 weeks
measure: Overall safety and tolerability of all treatments as assessed by change in vital signs, 12-lead electrocardiograms, clinical laboratory tests, and adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00154011: Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.
Official title: Characterization of Vascular Effects of Rosiglitazone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: vascular reactivity, venodilation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

Detailed description: The aim of the study is to investigate the effect of oral rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks 4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with rosiglitazone.

Eligibility criteria: Inclusion Criteria:

* Male
* Healthy
* 18 - 40 years old
* Non-smoker
* No additional medication

Exclusion Criteria:

* Any relevant disease
* Smokers
* Elevated liver enzymes
* Body weight different from Broca norm \> 20%
* Allergies

Primary outcomes:
measure: Vascular reactivity after 8 weeks treatment.
Secondary outcomes:
measure: Changes in angiotensin peptide metabolism.
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Institute of Clinical Pharmacology
Study officials:
affiliation: Institute of Clinical Pharmacology
name: Wilhelm Kirch, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02210611: 36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination
Official title: 36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 71
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.


Eligibility criteria: Inclusion Criteria:

1. Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
2. Patients who have no more than 4 follicles of 14 mm or more
3. Patients who have no more than 6 follicles of 10 mm or more

Exclusion Criteria:

1. Patients who cannot give informed consent to language or comprehension barriers
2. Patients who are deemed to be at high risk for high order multiple gestations
3. Patients who cannot be monitored on the day of hCG administration or one day before

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4 weeks following insemination
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: Haemek Medical Center, Afula, Israel
name: Amir Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546311: Evaluation of a Pro-Active Dynamic Accommodating Socket
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Keywords: prosthetic socket
residual limb volume fluctuation
instantaneous bladder
Lead sponsor: Infoscitex Corporation
Sponsor class: INDUSTRY
Collaborators: name: Liberating Technologies, Inc.
name: Telemedicine & Advanced Technology Research Center
First posted: 2012-03-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study.

Brief summary: The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.

Detailed description: The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls.

Eligibility criteria: Inclusion Criteria:

* transfemoral or transtibial amputation
* unilateral or bilateral amputation
* stable residual limb volume
* read, write, and speak English for proper consent and responding to questionnaire

Exclusion Criteria:

* evidence or history of residual limb skin conditions such as irritation or sores
* presence of phantom limb pain

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holliston
country: United States
facility: Liberating Technologies, Inc
state: Massachusetts
city: Newton
country: United States
facility: Next Step O&P
state: Massachusetts
Study officials:
affiliation: Infoscitex Corporation
name: Kristen J LeRoy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830111: The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women
Official title: The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Stress
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.

Detailed description: In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. The following validated self-report measures were administered before and at five days after the intervention, Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.

Eligibility criteria: Inclusion Criteria:

* woman
* aged 20 years or more
* able to understand and write Chinese
* singleton birth
* having a full-term and healthy newborn

Exclusion Criteria:

* suicidal ideations
* psychosis
* medical or obstetric complications

Primary outcomes:
measure: Stress variable
timeFrame: baseline on childbirth first day (before the intervention) .
measure: Depression variable
timeFrame: baseline on childbirth first day (before the intervention).
measure: Anxiety variable
timeFrame: baseline on childbirth first day (before the intervention).
Secondary outcomes:
measure: Stress variable
timeFrame: on childbirth fifth day (after the intervention)
measure: Depression variable
timeFrame: on childbirth fifth day (after the intervention)
measure: Anxiety variable
timeFrame: on childbirth fifth day (after the intervention)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan-Lin Pan
Study officials:
affiliation: Head nurse of research hospital
name: YUN-FEI PAO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371811: Use of v Care in Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators use v care during abdominal hysterectomy and evaluate its effect on duration of operation time, surgical complications and vaginal length.


Eligibility criteria: Inclusion Criteria:

* benign causes for hysterectomy

Exclusion Criteria:

* malignant causes for hysterectomy

Primary outcomes:
measure: Vaginal length
timeFrame: within 1 week postoperative
Secondary outcomes:
measure: Bladder injury
timeFrame: within 1 week postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: mohammed elsafty, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06202911: Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance
Official title: Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Preterm Neonates and Feeding Intolerance
Necrotizing Enterocolitis
Oral N-acetyl Cysteine
Keywords: preterm neonates
neonates
feeding intolerance
necrotizing enterocolitis
prematurity
n-acetyl cysteine
oral n-acetyl cysteine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications.

N-acetyl cysteine is an FDA- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.


Eligibility criteria: Inclusion Criteria:

* preterm neonates (less than or = 36 weeks gestational age )
* feeding intolerance

Exclusion Criteria:

* active gastro-intestinal tract bleeding
* Gastro- intestinal tract surgical problem
* Congenital gastro-intestinal tract anomalies
* evidence of allergy to NAC
* use of prebiotics or probiotics

Primary outcomes:
measure: incidence of necrotizing enterocolitis
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university hospitals
Study officials:
References:
citation: undefined
Clinical trial NCT01379911: Developing Methods for Completing Future Satiety Studies
Official title: Developing and Validating a Method for Satiety Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Satiety
Keywords: Satiety
Food intake
Yogurt
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Satiety is defined as the inhibition of eating, as a consequence of fullness after consuming food. Being able to effectively measure satiety is an important concept that has implications in the treatment and prevention of overweight and obesity. Increasing post-meal satiety is recognized a useful strategy for weight management. Recently, the category of foods marketed as having satiating effects has seen significant growth and this trend is expected to continue. The purpose of this project is to develop and validate methods for assessing the degree of satiety induced by foods and natural health products using commercially available food products.

This trial will examine the effects of a commercially available yogurt (containing added protein and fibre) on self-reported satiety and hunger, as well as food intake in both controlled and uncontrolled settings.


Eligibility criteria: Inclusion Criteria:

* Healthy women with regular hormonal contraceptive use, aged between 20 and 35 years
* BMI of 20.0-24.9 kg/m2
* Regular yogurt consumers (i.e. \> 3 servings per week)

Exclusion Criteria:

* Taking any regular medications or herbal supplements other than a multivitamin or folic acid supplement.
* History of cardiovascular disease (including hypertension), diabetes, hypoglycemia, gum disease or any other medical condition
* Vegans or vegetarians who exclude dairy products
* Milk allergies or any other food allergies
* Anyone with known anaphylactic allergic reactions, food or otherwise
* Dislike or unwillingness to consume study foods
* Gastrointestinal disease or disorders, including Celiac disease, lactose intolerance, irritable bowel syndrome, etc.
* BMI \<20.0 or \> 25.0 kg/m2
* Current participation in diet/weight-loss programs and/or changes of \> 5 kg body weight within the past 6 months
* Unusual dietary patterns (i.e. routinely skipping breakfast or other meals)
* Unusual sleep patterns (i.e. shift workers)
* High habitual intake of caffeinated beverages or alcohol
* Restrained or disinhibited eaters, defined by the Three Factor Eating Questionnaire
* Smokers

Primary outcomes:
measure: Self-reported ratings of satiety
timeFrame: Outcome measures will be assessed at fasting (0 min) and postprandially (every 30 min) for 3 hours.
Secondary outcomes:
measure: Food intake
timeFrame: One week
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit, University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: Amanda J Wright, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: