louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02037802: Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery
Official title: Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: caudal
epidural
pediatric
renal
transplant
hemodynamics
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.


Eligibility criteria: Inclusion Criteria:

* 3-12 years
* end stage renal disease
* no known allergy to bupivacaine
* both sexes

Exclusion Criteria:

* known allergy to bupivacaine
* inflammation at caudal area
* spinal cord deformity

Primary outcomes:
measure: Intraoperative blood pressure
timeFrame: from the induction of anesthesia till end of surgery at half an hour intervals
Secondary outcomes:
measure: postoperative blood pressure
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
measure: intraoperative central venous pressure
timeFrame: fromom the induction of anesthesia till end of surgery at half an hour intervals
measure: postoperative heart rate
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
measure: postoperative central venous pressure
timeFrame: from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours
measure: intraoperative heart rate
timeFrame: from the induction of anesthesia till end of surgery at half an hour intervals
Other outcomes:
measure: pain scoring system (objective behavioural pain score)
timeFrame: from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Sherif M Soaida, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soaida SM, ElSheemy MS, Shouman AM, Shoukry AI, Morsi HA, Salah DM, Fadel FI, Bazaraa HM. Caudal extradural catheterization in pediatric renal transplant and its effect on perioperative hemodynamics and pain scoring: a prospective randomized study. J Anesth. 2016 Feb;30(1):47-54. doi: 10.1007/s00540-015-2087-8. Epub 2015 Oct 22.
Clinical trial NCT01226602: Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
Official title: A Randomized, Double-blind, Placebo Controlled, Crossover, Single Centre Phase I Study to Assess the Effect of Ticagrelor on Adenosine-induced Coronary Blood Flow Velocity in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Flow Speed
Coronary Flow Velocity
Keywords: Ticagrelor
Healthy
Coronary flow velocity
Adenosine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 39
Sex: MALE
Minimum age (years): 18
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 study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.


Eligibility criteria: Inclusion Criteria:

* Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge
* Have a body mass index between 18 and 30 kg/m2

Exclusion Criteria:

* History of clinically significant disease or disorder.
* Abnormal vital signs

Primary outcomes:
measure: Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.
timeFrame: During 6 h at visit 2
measure: Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.
timeFrame: During 6 h at visit 3
Secondary outcomes:
measure: Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline.
timeFrame: During 6 h at visit 2
measure: Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.
timeFrame: During 6h at visit 2
measure: Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.
timeFrame: During 6 h at visit 3
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jay Horrow, MD
role: STUDY_DIRECTOR
affiliation: CTC, Göteborg
name: Marianne Hartford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Mölndal Sweden
name: Mirjana Kujacic, MD PhD
role: STUDY_CHAIR
References:
citation: Wittfeldt A, Emanuelsson H, Brandrup-Wognsen G, van Giezen JJ, Jonasson J, Nylander S, Gan LM. Ticagrelor enhances adenosine-induced coronary vasodilatory responses in humans. J Am Coll Cardiol. 2013 Feb 19;61(7):723-7. doi: 10.1016/j.jacc.2012.11.032. Epub 2013 Jan 9.
Clinical trial NCT06798402: Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate
Official title: Effectiveness of Ciprofloxacin Intralesional Injection in the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate: a Parallel Groups Comparative Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Al-Mustafa University College
Sponsor class: OTHER
Collaborators: name: Al-Mustansiriyah University
First posted: 2025-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection.

In a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.


Eligibility criteria: Inclusion Criteria:

* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion Criteria:

* Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study
* patients on prolonged corticosteroid therapy.

Primary outcomes:
measure: Cure rate
timeFrame: From enrollment to the end of treatment up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Mustansiriyah University
Study officials:
References:
Clinical trial NCT03504202: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
Official title: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.


Eligibility criteria: Inclusion Criteria:

* age≥18 years
* Typical angina symptoms
* Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (\<20%)
* Never used trimetazidine
* The CFR measured by the pressure guide wire is less than 2.0
* agree to participant the study and sign informed written consent
* available for six months follow up

Exclusion Criteria:

* Severe liver and kidney disease
* Contraindications of Trimetazidine
* Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements
* QT interval extension
* Atrial fibrillation or left bundle branch block
* Left ventricular systolic dysfunction (EF \<55%)
* Coronary artery fistula
* Myocardial bridge
* Non-cardiogenic chest pain and other heart diseases
* Severe heart valve disease
* Diabetes
* Recent ACS( Acute coronary syndrome)
* Pregnancy
* Failed to complete inspection

Primary outcomes:
measure: Coronary flow reserve (CFR) improves
timeFrame: six months
Secondary outcomes:
measure: Seattle angina score or Canadian angina grade drops
timeFrame: six months
measure: Six-minute walking experiment improves
timeFrame: six months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06849102: NeuroReAlign Therapy for Balance and Gait Rehabilitation in Stroke Survivors
Official title: Effects of NeuroReAlign Therapy on Balance and Gait in Stroke Survivors: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Middle East University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to investigate the effects of NeuroReAlign Therapy on balance and gait in stroke survivors in the chronic stage (\>6 months). The study will include male and female participants aged 18-70 years.

The main questions it aims to answer are:

Does NeuroReAlign Therapy improve balance in stroke survivors compared to conventional physiotherapy? Does NeuroReAlign Therapy enhance gait performance more effectively than conventional physiotherapy? Researchers will compare NeuroReAlign Therapy to conventional physiotherapy to determine its effects on balance and gait.

Participants will:

Undergo NeuroReAlign Therapy or conventional physiotherapy for 4 weeks. Have their balance assessed using the Berg Balance Scale (BBS), Activities-Specific Balance Confidence Scale (ABC Scale), and Fear of Falling Questionnaire (FoFQ).

Have their gait evaluated using the Dynamic Gait Index (DGI), Rivermead Mobility Index (RMI), Timed Up and Go (TUG), 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT).

Complete outcome assessments at baseline and after the intervention (week 4).


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic or hemorrhagic stroke
* Have a stroke more than 6 months
* Age between 18 and 70

Exclusion Criteria:

* Patients with severe cognitive impairments
* Patients cannot walk independently

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: At baseline (week 0) and after the intervention (week 4)
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Activities-Specific Balance Confidence Scale (ABC Scale)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Fear of Falling Questionnaire (FoFQ)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Rivermead Mobility Index (RMI)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: Timed Up and Go (TUG)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: 10-Meter Walk Test (10MWT)
timeFrame: At baseline (week 0) and post-intervention (week 4)
measure: 6-Minute Walk Test (6MWT)
timeFrame: At baseline (week 0) and post-intervention (week 4)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01773902: Protein for Premies
Official title: High Versus Standard Dose Protein for Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extreme Prematurity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 60
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.

This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.


Eligibility criteria: Inclusion Criteria:

* very preterm infants \<32 weeks gestation and \<1500g birth weight
* \> 100ml/kg/d of enteral feeding

Exclusion Criteria:

* missing informed consent
* decision not to feed breast milk
* congenital malformations
* age \> 7 days at study entry

Primary outcomes:
measure: Weight gain
timeFrame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
Secondary outcomes:
measure: Head circumference growth
timeFrame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
Other outcomes:
measure: Plasma amino acid profile
timeFrame: at 2 and 4 weeks after start of intervention
Locations:
city: Tuebingen
country: Germany
facility: University Children's Hospital Tuebingen
Study officials:
affiliation: Universität Tübingen
name: Axel Franz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maas C, Mathes M, Bleeker C, Vek J, Bernhard W, Wiechers C, Peter A, Poets CF, Franz AR. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jan 1;171(1):16-22. doi: 10.1001/jamapediatrics.2016.2681.
citation: Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR. Effect of increased enteral protein intake on plasma and urinary urea concentrations in preterm infants born at < 32 weeks gestation and < 1500 g birth weight enrolled in a randomized controlled trial - a secondary analysis. BMC Pediatr. 2018 May 8;18(1):154. doi: 10.1186/s12887-018-1136-5.
citation: Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W. Choline and polyunsaturated fatty acids in preterm infants' maternal milk. Eur J Nutr. 2017 Jun;56(4):1733-1742. doi: 10.1007/s00394-016-1220-2. Epub 2016 May 10.
Clinical trial NCT05055102: Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.
Official title: Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysms or Occlusive Disease of the Abdominal Aorta
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society

Brief summary: The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.

We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).

The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.


Eligibility criteria: Inclusion Criteria:

* Subject is volontarily agree to participation
* Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society

Exclusion Criteria:

- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data

Primary outcomes:
measure: Safety and security
timeFrame: 5 years
Secondary outcomes:
measure: Major surgical reintervention
timeFrame: 5 years
measure: Primary permeability
timeFrame: 5 years
measure: Secondary permeability
timeFrame: 5 years
measure: Dilatation of the prothesis
timeFrame: 5 years
measure: Occurence of MAVE and MACE
timeFrame: 5 years
measure: Occurence of adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT01173302: Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Official title: Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rabies
Keywords: Rabies
Anti-rabies antibody
Persistence
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.


Eligibility criteria: Inclusion Criteria:

* 20 to 60 years old
* Healthy
* Given ChengDa rabies vaccine
* Good compliance
* Obtained informed consent

Exclusion Criteria:

* Other than inclusion criteria

Primary outcomes:
measure: Rabies antibody titer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
citation: Zhang X, Zhu Z, Wang C. Persistence of rabies antibody 5 years after postexposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. Clin Vaccine Immunol. 2011 Sep;18(9):1477-9. doi: 10.1128/CVI.05090-11. Epub 2011 Jul 13.