louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05485116: The Influence of Therapeutic Tactics of Analgesia on the Long-term Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds
Official title: The Influence of Therapeutic Tactics of Analgesia on the Long-term Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: pain treatment, therapeutic tactics of analgesia, gunshot wounds, mine-explosive wounds, stages of treatment
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 2215
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: all patients were injured during hostilities

Brief summary: Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Detailed description: The influence of pain management tactics on the long-term results of pain treatment in patients with gunshot and mine-explosive wounds needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Eligibility criteria: Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: Didier Bouhassiraa DN4
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
measure: Mississippi PTSD scale (military version)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT00786916: Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
Official title: Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
propofol
lidocaine
sedation
pediatric
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 109
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.


Eligibility criteria: Inclusion Criteria:

* scheduled for painless diagnostic procedures
* are ASA I or ASA II

Exclusion Criteria:

* have an indwelling central venous catheter
* have received an analgesic or sedative medication in the previous four hours prior to enrollment
* have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
* known hypersensitivity to lidocaine or any component of the formulation
* hypersensitivity to another local anesthetic of the amide type
* Adam-Stokes syndrome
* severe degrees of SA, AV, or intraventricular heart block
* allergy to corn-related products
* contraindication to propofol

Primary outcomes:
measure: Maximal Pain/Discomfort
timeFrame: during initial 3 minute propofol infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Norman C Christopher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237716: Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craniotomy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: scheduled for elective craniotomy

Brief summary: The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P \< 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P \< 0.001) and between -20 min and 10 min (P \< 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P \< 0.001), which returned to the baseline after 20 min.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were: being aged between 16 and 70 years;
* with a body mass index of 18-25 kg/m2;
* with a physical status classified as ASA class I or II;
* and scheduled for elective craniotomy

Exclusion Criteria:

* Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;
* had a previous history of intra-aortic balloon counterpulsation;
* exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission;
* or rejected to participate in this study.

Primary outcomes:
measure: cardiac index
timeFrame: during the procedure
measure: stroke volume index
timeFrame: during the procedure
measure: stroke volume variation
timeFrame: during the procedure
measure: systolic pressure
timeFrame: during the procedure
measure: central venous pressure
timeFrame: during the procedure
measure: heart rate
timeFrame: during the procedure
measure: peripheral vascular resistance
timeFrame: during the procedure
Secondary outcomes:
measure: base excess
timeFrame: during the procedure
measure: lactic acid
timeFrame: during the procedure
measure: DO2I
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00445016: Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol
Official title: Neurologic Complications in Peripheral Regional Anesthesia - A Clinical Follow Up Study to Evaluate the Incidence of Neurologic Complications Defined According to a Standardized Protocol Considering Motoric and Sensory Function and Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia, Conduction
Nerve Block
Adverse Effects
Keywords: peripheral regional anesthesia
nerve damage
adverse effects
neurologic complication
neuropathy
Lead sponsor: BG Unfallklinik Murnau
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving peripheral regional anesthesia (routine)

Brief summary: To evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

Detailed description: Neurologic complications as an adverse effect occur in all types of regional anesthesia. Reviewing the literature, the incidence spreads from 0.02 up to 3 percent. The incidence remains unclear because of different types of definitions, too. In this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. In case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. Further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. This study includes the definition for nerve damage concerning motoric and sensory neural function and pain.

The patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Eligibility criteria: Inclusion Criteria:

* All patients receiving peripheral regional anesthesia

Exclusion Criteria:

* Missing agreement

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Murnau
country: Germany
facility: BG Unfallklinik
state: Bayern
Study officials:
affiliation: BG Unfallklinik Murnau
name: Johannes Buettner, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05712616: Role of Strontium Ranelate in Proximal Femur Fragility Fractures.
Official title: Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fragility Fracture
Femur; Fracture, Pertrochanteric
Clinical Trial
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
Collaborators: name: AO Trauma Middle East and North Africa
First posted: 2023-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.


Eligibility criteria: Inclusion Criteria:

* All patients with age =/\> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
* ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.

Exclusion Criteria:

* Patients with metabolic bone diseases.
* Patients with pathological fractures like tumor, osteopetrosis etc.
* Patients with prior Ischemic heart diseases and underwent PCI or CABG

Primary outcomes:
measure: change in Radiological healing on radiographs
timeFrame: 12 weeks and 24 weeks
Secondary outcomes:
measure: change Bone mineral density through DEXA scan
timeFrame: pre-operatively or peri-admission and at 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
Clinical trial NCT05751616: A Clinical Trial of the Impact of Speed and Conventional Sintering on Ultra-thin, Highly Translucent, Multilayered Zirconia Laminate Restorations
Official title: Effect of Speed Sintering on Translucency and Microstructure of High Versus Low Translucent Zirconia Veneers: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Veneers
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 30
Sex: ALL
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: A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations.

The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.


Eligibility criteria: Inclusion Criteria:

* patients able to understand and sign the informed consent form.
* physically and psychologically able to undergo conventional restorative procedures.
* Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
* Slight malposition.
* Teeth with spacing.
* Teeth with discoloration.
* Patient having natural teeth as opposing dentition

Exclusion Criteria:

* Insufficient surface enamel (60%).
* Abutments with subgingival restorations or root caries.
* Parafunctional habits.
* Lack of opposite occluding dentition in the area intended for restoration.
* mandibular prognathism and maxillary retrognathism

Primary outcomes:
measure: Change in clinical performance
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT03312816: Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Official title: The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2017-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy men and women as judged by study physician.
* BMI \> 18 and \< 35 kg/m2.
* Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.

Exclusion Criteria:

* Recently (\<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.
* Pregnant or lactating women.
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male).
* Reported intense sporting activities \> 10 hours/week.
* Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
* Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Primary outcomes:
measure: POP (plant sterol oxidation products) value
timeFrame: 0 to 42 days
Secondary outcomes:
measure: COP (cholesterol oxidation products) value
timeFrame: 0 to 42 days
measure: Ratio of serum POP concentration
timeFrame: 0 to 42 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Charité Research Organisation GmbH
name: Christian Keicher, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05976516: CXCL2/CXCL8 Promote Intervertebral Disc Degeneration
Official title: Study on the Correlation Between CXCL2/CXCL8 and the Degree of Intervertebral Disc Degeneration and Radiological Progress
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytokine
Intervertebral Disc, Degenerative
Keywords: cytokine
chemokine
Intervertebral Disc Degeneration
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lumbar disc herniation who went to the spinal surgery department of Zhongda Hospital

Brief summary: Low back pain (LBP) is the largest cause of morbidity in the world, and about 80% of Chinese people are affected in their lifetime. Although the prevalence of IDD gradually increases with age, IDD is very common among subjects under 30 years old. In addition to age, there are other factors, such as excessive or uneven mechanical load, obesity, genetics, nutrition, trauma and gender. In addition, it is not clear whether the heavy physical load associated with occupation is an important risk factor for IDD. Some studies have found that IDD is more common among athletes than the general population. Due to the complexity and multifactorial nature of IDD, its pathogenesis and risk factors are still unclear, which seriously hinders the rational stratification of LBP patients and limits the development of personalized treatment.


Eligibility criteria: Inclusion Criteria:

* It meets the diagnostic criteria of lumbar disc degeneration; No previous history of spinal surgery; Good ability of independent behavior and cooperation in completing research; The patient is aware of this study and has signed the consent form.

Exclusion Criteria:

* Patients with spinal tumor, infection, tuberculosis and other diseases; Patients with claustrophobia; Parkinson's syndrome patients; Poor cooperation, Poor image quality; Patients with osteoporosis.

Primary outcomes:
measure: CXCL2/8 content
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00018616: Improving Compliance With Metformin
Official title: Improving Compliance With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: compliance
MEMS
metformin
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized controlled trial of adherence. The study involves monitoring and managing focused intervention in patients prescribed metformin.

Detailed description: The active intervention, MEMS Feedback, involves review of patients' medication-taking over the preceding weeks

Eligibility criteria: Inclusion Criteria:

* Metformin has been prescribed
* Willing to use medication containers with MEMS caps
* Capable of giving informed consent

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
Study officials:
affiliation: VA Connecticut Health Care System (West Haven)
name: Marc I. Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: