louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05650268: Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
Official title: Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vitamin D Deficiency
Surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether preoperative supplement with high-dose vitamin D3 can reduce the perioperative risk and enhance recovery

Detailed description: Perioperative management for risk reduction in patients undergoing major surgery are taken increasingly important nowadays. The patient factor (age and comorbidities mainly), type of surgery and extent of tissue injury are major contributions to the development perioperative complications. From nutrition support to nutrition therapy, a comprehensive nutrition plays a pivotal role to optimize the above three key factors and hence reduce the perioperative risk. Vitamin D, a pleiotropic hormone with extensive physiological effect, is one of the nutrients critical to perioperative outcomes. It not only meets the essential demand of surgical patients, such as wound care, infection control, metabolic support and organ support, but also attenuates oxidative stress, modulates dys-inflammation and repair the damaged organelles like telomere and mitochondria. This is a double-blind, randomized controlled trial in a single center. Sixty eligible adult patients who will undergo general surgery are to be included.

The experimental group will receive 576000 IU in single oral dose of liquid vitamin D 3\~7 days prior to the surgery. The primary endpoint is rapid recovery index, such as bowel recovery, pain control, sedation and fatigue assessment. The secondary endpoints include perioperative inflammatory indexes, hemodynamic parameters, glycemic control as well as safety evaluation of vitamin D.

Eligibility criteria: Inclusion Criteria:

* 20 years or older
* Adult patients who will receive general surgery

Exclusion Criteria:

* Chronic liver diseases
* Hypercalcemia
* Using estrogen drug, bisphosphonate, other durgs to treat bone diseases
* Sarcoidosis, Multiple myeloma or Primary hyperparathyroidism
* Pregnant women
* Other trial participation

Primary outcomes:
measure: Mortality rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Yi Han, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03212768: Outcome of Low Energy Ankle Fractures
Official title: Outcome of Low Energy Ankle Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Grossly displaced fracture-dislocations

Brief summary: Ankle fractures are among the most common osseous injuries to the lower extremity, and remain a significant source of morbidity for both the young and the elderly. Recent cross-national studies have shown a significant increase in the incidence and severity of ankle fractures among the elderly population.


Eligibility criteria: Inclusion Criteria:

- all types of trumatic ankle fractures due to low energy amenable to surgical open reduction and internal fixation .

Exclusion Criteria:

* previous surgery.
* Disorders of bone metabolism other than osteoprosis (ie, Paget disease , renal osteodystrophy , osteomalacia )
* Patient with moderate or severe congnitive impairment or patients with Parkinson disease or dementia

Primary outcomes:
measure: The rate of recovery from the surgery of fractures
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02973568: Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit
Official title: Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
EMERGENCY MEDICINE
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Canarias
First posted: 2016-11-25
Enrollment: 641
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evety patient admitted in emergency center during 1 month for acute pain and who need treatment for pain

Brief summary: Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.

In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital


Eligibility criteria: Inclusion Criteria:

* Patient admitted in emergency center for acute pain.
* Patient who accept to participate.

Exclusion Criteria:

* Refusal of patient to participate

Primary outcomes:
measure: pain VAS (visual analogic scale)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Groupe Hospitalier Paris Saint-Joseph (FRANCE)
name: Jonay PERERA GIL, PhD student
role: STUDY_DIRECTOR
affiliation: Fondation Hôpital Saint-Joseph
name: Olivier GANANSIA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902472: A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
Official title: A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV-1
Truvada
FTC/TDF
Pre-exposure prophylaxis
PrEP
Resistance
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred fifty (150) HIV-1 negative adults (any sex/gender, including transgender) and ≥ 18 years of age who seroconvert while taking FTC/TDF for PrEP.

Brief summary: This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.


Eligibility criteria: Inclusion Criteria:

* Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study
* HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study.
* Evidence of seroconversion while receiving FTC/TDF for PrEP

Exclusion Criteria:

* This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.

Primary outcomes:
measure: Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication
timeFrame: Baseline to Year 3
measure: Proportion of seroconverters with resistance mutations
timeFrame: Baseline to Year 3
measure: Proportion of seroconverters with signs/symptoms at or before seroconversion
timeFrame: Baseline to Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Foster City
country: United States
facility: Gilead Sciences, Inc.
state: California
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06638372: Caffeinated Chewing Gum on Special Forces Performance
Official title: Caffeinated Chewing Gum on Special Forces Performance: a Cross-over Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caffeine
Placebo
Keywords: exercise performance
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to investigate the effects of caffeine chewing gum on the cognitive functions and special operations capabilities of special forces.

Detailed description: Using a randomisation crossover design, 20-40 active-duty special forces members who had undergone leave and special forces reserve training were divided into a caffeine trial (CAF) and a placebo trail (PL). After chewing caffeine-containing gum containing 5 mg/kg (CAF group) or caffeine-free gum (PL group) for 15 minutes, then performed a simple reaction test, a stroop test, a visual search test, a grip strength test, a vertical jump test, a 20-metre sprint test, and a counter-terrorism simulation test. A heart rate monitor was used to measure the heart rate and heart rate variability of the participants. Saliva samples were collected and analysed for α-Amylase, cortisol and caffeine concentrations before the test, after a 15-minute break from chewing gum and at the end of the test. Completion time of cognitive functions, grip strength, vertical jump height, 20 m sprint time, time to completion of the counterterrorism simulation test, and target score will be analysed using paired-sample t-tests.

Eligibility criteria: Inclusion Criteria:

* Active Special Warfare Unit members who have passed the Grade A Special Forces Reserve Training
* No cardiovascular and joint diseases
* Adult male over 20 years old

Exclusion Criteria:

* Non-active Special Warfare Unit members
* Have cardiovascular and joint diseases
* Under age

Primary outcomes:
measure: Stroop task
timeFrame: 15 minutes after intervention
measure: visual search test
timeFrame: 15 minutes after intervention
Secondary outcomes:
measure: anti-terrorist operations
timeFrame: 15 minutes after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
state: North
Study officials:
affiliation: Professor
name: ChihHui Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344772: Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
Official title: Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fracture
Keywords: femoral neck fracture
total hip arthroplasty
internal fixation
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (\>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.


Eligibility criteria: Inclusion Criteria:

* Acute displaced femoral neck fracture Garden III or IV,
* Age over 65 years,
* Admission from their own home,
* No concurrent joint disease or previous fracture in the lower extremities,
* Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
* Harris hip score of 100
* Acceptance from the patient to participate in the study.

Primary outcomes:
measure: Harris hip score
timeFrame: 17 years
Secondary outcomes:
measure: Reoperations and complications
timeFrame: 17 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital
name: Olof Sköldenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325272: Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions
Official title: Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions: Indication of Cochlear Damage in Newborn.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Function
Keywords: otoacoustic emissions in newborns
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2011-03-29
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born in this institution

Brief summary: To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and preterm infants who had transient otoacoustic emissions and verify if the presence of response is related to gestational age, gender or risk factors for hearing loss.


Eligibility criteria: Inclusion Criteria:

* born in this institution
* have presence of transient otoacoustic emission

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu
state: SP
Study officials:
affiliation: Faculdade de Medicina de Botucatu
name: Daniela Polo Camargo da Silva, Mestre
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01544972: Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
Official title: Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patent Ductus Arteriosus
Keywords: Patent Ductus Arteriosus
Paracetamol
Ibuprofen
Serum levels
Preterm infant
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

Detailed description: To determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.

One of the following echocardiographic criteria of a duct size \> 1.5 mm, a left atrium-to-aorta ratio \> 1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Three consecutive blood sample from infants for 3 days before dose application of drugs(ibuprofen and paracetamol will be obtained.

The relation of pharmacokinetics of drugs to drug response will be evaluated

Eligibility criteria: Inclusion Criteria:

* Birth weight below 1250 gram
* Diagnosed patent ductus arteriosus by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Severe thrombocytopenia \< 60.000
* Severe intracranial bleeding (Grade III - IV)
* Intestinal abnormality and necrotising enterocolitis

Primary outcomes:
measure: To detection of safe and effective serum levels of paracetamol and ibuprofen in preterm infants treated for PDA
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Sadık Yurttutan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05524272: Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Official title: Stress-Relieving Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Chronic Diseases in Children
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study was conducted to find out the effects of colour by number mandala in decreasing the stress of hospitalized children with chronic disease.

Design: A randomized controlled study. Methods: This study was conducted with 120 children between the ages of 8 and 11. 60 children formed the experimental group, while 60 children formed the control group. Descriptive Information Form and Perceived Stress Scale were used in data collection.

Detailed description: Experimental group: The children, along with their parents, were interviewed by one of the researchers on their first day of hospitalisation. The parents were informed about the Descriptive Information Form and the Perceived Stress Scale for Children, which the researcher filled out in the presence of the children and their parents. The children were then given a colour-by-number mandala and colouring pencils. A different colour-by-number mandala was given to each participant every day; the mean length of hospital stay was 3 days. At the end of the third day, the same researcher interviewed the children and filled out again the Perceived Stress Scale for Children.

Eligibility criteria: Inclusion Criteria:

* parents who agreed to participate in the study

Exclusion Criteria:

* visually impaired child
* mentally retarded child
* speech impaired children

Primary outcomes:
measure: this study was measured colour-by-number mandalas do reduce the perceived stress levels in children hospitalised due to a chronic disease.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat University
state: Campus
Study officials:
References:
Clinical trial NCT01444872: Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
Official title: A Randomized, Single-Blind, Placebo-Controlled, Adaptive, Ascending Dose Study to Evaluate the Effects of TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Mild to Moderate Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Kidney Disease
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Heart Failure
* Mild to moderate renal dysfunction
* Age 18- \<75
* Males and females (non-childbearing potential)

Exclusion Criteria:

* Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
* Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
* Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
* Clinical signs or symptoms of acute decompensated heart failure
* Pregnant or lactating

Primary outcomes:
measure: Change from Baseline Glomerular Filtration Rate
timeFrame: Every hour during final 6 hours of study drug infusion
measure: Change from Baseline in Vital Signs (Blood pressure, heart rate)
timeFrame: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
Study officials:
References: