louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01739270: Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia
Official title: Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia After Supraclavicular Brachial Plexus Blockade
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brachial Plexus Anesthesia
Analgesia
Keywords: analgesia
regional anesthesia
surgery
duration of analgesia
dexamethasone added to levobupivacaine compared to levobupivacaine alone
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 55
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: Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.

Detailed description: Operations of upper extremities are often performed in regional anesthesia blocks. Single-injection blocks are effective, but time limited. Adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. This effect will result in less opioid use postoperatively.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 years or older
* ASA (American Society of Anesthesiologists) physical status I, II or III

Exclusion Criteria:

* refusal of the patients to give informed consent
* preexisting coagulation disorders
* local infection at the site of the block
* neuropathy
* drug or alcohol abusers
* known allergy to the drug used in study
* operation time exceeding six hours

Primary outcomes:
measure: duration of analgesia
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: postoperative analgesic consumption
timeFrame: 24 hour
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
Study officials:
affiliation: Clinical Hospital Dubrava, Head of Anesthesiology, Resuscitation and Intensive Care Medicine
name: Ino Husedzinovic, Professor
role: STUDY_CHAIR
References:
citation: Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9.
citation: Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
citation: Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
Clinical trial NCT05471570: Effect of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Right-hemisphere on Picture Naming in Chronic Aphasia
Official title: The Effect of tDCS Stimulation of Right Inferior Frontal Gyrus on Language Recovery in Speakers With Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: tDCS
Aphasia
naming
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There are two opposing hypotheses, namely the interference and laterality-shift hypotheses, regarding the role of the right hemisphere (RH) in language recovery following a left hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing attention as a potential complement to behavioural therapy.

This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA) to examine the compensatory versus interference role of RH in language recovery, and to confirm the application of tDCS does not induce adverse effects on other cognitive and language functions.


Eligibility criteria: Inclusion Criteria:

* People with chronic aphasia following the stroke

Exclusion Criteria:

* history of seizure or epilepsy,
* previous adverse reactions to TMS/tDCS,
* having a pace-maker or a metal implanted in the brain
* being pregnant

Primary outcomes:
measure: Picture naming task
timeFrame: Immediately after the end of each treatment session and block
Secondary outcomes:
measure: language task
timeFrame: Immediately after the end of each treatment block
measure: Cognitive task
timeFrame: Immediately after the end of each treatment block
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04815070: Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty
Official title: Comparison of Fasting Gastric Volume Using Ultrasound in Diabetic and Non-Diabetic Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Arthritis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients will be recruited in total. One cohort consisting 20 patients will be diabetic. The other cohort consisting of 20 patients will be non-diabetic.

Brief summary: Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.

In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
* American Society of Anestheiologist physical status classification 1, 2, and 3
* Body mass index \< 35 kg/cm2

Exclusion Criteria:

* Previous surgery of the upper gastrointestinal tract
* Achalasia

Primary outcomes:
measure: Volume of Gastric Contents
timeFrame: Less than one hour prior to surgery
Secondary outcomes:
measure: Numerical rating pain scale
timeFrame: One hour prior to surgery, Postoperative 24 and 48 hour
measure: Rescue analgesics
timeFrame: Postoperative 24 and 48 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT06683170: Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
Official title: Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Validation
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 35
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women will be recruited from different units participating in pregnancy care: maternity clinics, pregnancy outpatient clinic and pregnancy follow-up ward. The monitoring during the data collection will not affect the normal pregnancy monitoring practices. The recruitment will be conducted via social media.

The healthcare professionals will be recruited also from different units in the area of Wellbeing services county of Southwest Finland: pregnancy follow-up ward, labour ward, maternity outpatient clinic and maternity clinics. The recruitment will be conducted via work email.

Brief summary: The aims of this clinical pilot study are to:

1. to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure
2. to evaluate the feasibility on detecting fetal movements
3. to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
4. to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring

The participating pregnant women will wear the pregnancy monitoring belt for 2 hours during of which, the data will be collected with pregnancy monitoring belt and patient monitor (reference device). The data from the pregnancy monitoring belt will be compared with the patient monitor data referred as golden standard. The acceptability and usability will be assessed by pregnant women and healthcare professionals by fulfilling a questionnaire and participating in interviews. The data collection will be conducted in hospital environment.


Eligibility criteria: Inclusion criteria for pregnant women:

* duration pf pregnancy at least 29+0 weeks
* single pregnancy
* age at least 18 years
* ability to participate in Finnish No exclusion criteria

Inclusion criteria for healthcare professionals:

* being a healthcare professional working with pregnant women
* being able to participate in Finnish No exclusion criteria

Primary outcomes:
measure: fetal heart rate
timeFrame: Two hour data collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00432770: Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
Official title: A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Archemix Corp.
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Detailed description: The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 to ≤ 65 years of age
* Weight ≤ 110 kg
* Negative qualitative urine drug/alcohol test
* Female volunteers must be of non-childbearing potential
* Male volunteers must agree to use a medically acceptable contraceptive
* Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document

Exclusion Criteria:

Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)

* Tendency to bleed easily
* History of recent trauma or surgery
* History of gout or renal stones

Clinically significant abnormal lab parameters for the following:

* PT INR \> 1.4
* aPTT \> reference laboratory values
* Serum creatinine \> 1.3 mg/dL
* Platelet count of ≤ 100,000/mm3
* ALT/AST \> 2 times ULN
* WBC ≤ 3000 x 109/L
* Hemoglobin \< 11 g/dL
* Total bilirubin \> 1.2 mg/dL
* CBT \> 15 min

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Bioanalytical Systems, Inc
state: Maryland
Study officials:
References:
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
citation: Gilbert JC, DeFeo-Fraulini T, Hutabarat RM, Horvath CJ, Merlino PG, Marsh HN, Healy JM, Boufakhreddine S, Holohan TV, Schaub RG. First-in-human evaluation of anti von Willebrand factor therapeutic aptamer ARC1779 in healthy volunteers. Circulation. 2007 Dec 4;116(23):2678-86. doi: 10.1161/CIRCULATIONAHA.107.724864. Epub 2007 Nov 19.
Clinical trial NCT05133570: Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Official title: Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound Heal
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 12
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: Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh with arterial disease

Brief summary: The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

Detailed description: Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

Eligibility criteria: Inclusion Criteria:

* -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days.
* Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh
* Agreement of the study no-objection form
* Age greater than or equal to 18 years
* Patient affiliated to a social security scheme

Exclusion Criteria:

* -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent

Primary outcomes:
measure: Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: BLAISE
Study officials:
References:
Clinical trial NCT01147770: Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes
Official title: The Effect of Progesterone Supplementation During Early Gestations in Patients Treated With Rec FSH/GnRH Antagonist:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Keywords: progesterone
antagonist
rec FSH
IVF
pregnancy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.


Eligibility criteria: Inclusion Criteria:

* Age equal or less than 39
* Body mass index between 18-29 kg/m2
* Presence of both ovaries
* Basal hormonal values on day 2 of the cycle
* Embryotransfer day3 or day5
* 1 to 3 cycles

Exclusion Criteria:

* Endometriosis stage 3
* Polycystic ovarian syndrome
* Frozen or testicular sperm

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06679075: Clinical and Radiographic Evaluation of Propolis As a Hemostatic Agent for Pulpotomy of Mature Permanent Molars with Irreversible Pulpitis Using Two Different Dressing Materials
Official title: Clinical and Radiographic Evaluation of Propolis As a Hemostatic Agent for Pulpotomy of Mature Permanent Molars with Irreversible Pulpitis Using Two Different Dressing Materials; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Irreversible Pulpitis
Pulpitis
Pulpitis - Irreversible
Keywords: Pulpotomy
Vital Pulp Therapy
Adult Pulpotomy
Irreversible Pulpitis
Hemostasis
Hemostatic Agent
Propolis
MTA
Bioceramic
Full Pulpotomy
Mineral Trioxide Aggregate
Moderate Pulpitis
Severe Pulpitis
Mature Permanent Molars
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effectiveness of propolis as a hemostatic agent in pulpotomy for adult permanent molars, compared to sodium hypochlorite (NaOCl). It also examines how bioceramic putty performs against mineral trioxide aggregate (MTA) in vital pulp therapy for cases of irreversible pulpitis.

Participants will be divided into four groups (15 patients each):

* Propolis + bioceramic putty
* Propolis + MTA
* Sodium hypochlorite + bioceramic putty
* Sodium hypochlorite + MTA The Investigator will record the bleeding time and postoperative pain will be recorded. The researcher will assess the clinical and radiographic outcomes for success at 1, 3, and 6 months.


Eligibility criteria: Inclusion Criteria:

* Participants of both genders falling within the age range of 20 to 45 years.
* Presence of vital mature permanent molars diagnosed as mild or severe irreversible pulpitis per Wolter's classification.
* Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.

Exclusion Criteria:

* Non-vital teeth.
* Teeth with Immature roots.
* Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
* Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.

Primary outcomes:
measure: Clinical and radiographic success rate
timeFrame: 1, 3, 6 months
measure: Bleeding time
timeFrame: During hemostasis (0-10 minutes)
Secondary outcomes:
measure: Post-operative pain
timeFrame: 24 hours, 3 days, 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr International University
state: Obour
Study officials:
References:
Clinical trial NCT05288075: Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product
Official title: Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.


Eligibility criteria: Main Inclusion Criteria:

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

Main Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease
2. Any condition requiring regular concomitant treatment
3. Any clinically significant abnormal laboratory value, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
4. Known hypersensitivity to indacaterol or glycopyrronium
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration

Primary outcomes:
measure: Peak indacaterol and glycopyrronium concentration in plasma (Cmax)
timeFrame: between 0-72 hours after dosing
measure: Area under the concentration-time curve from time zero to 72 hours (AUC72)
timeFrame: between 0-72 hours after dosing
Secondary outcomes:
measure: Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)
timeFrame: between 0-72 hours after dosing
measure: Area under the concentration-time curve from time zero to 30 minutes (AUC30)
timeFrame: between 0-30 minutes after dosing
Other outcomes:
measure: Adverse events
timeFrame: Up to 11 weeks
Locations:
city: Helsinki
country: Finland
facility: CRST Helsinki Oy
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Corporation Clinical Study Director
role: STUDY_DIRECTOR
affiliation: Orion Corporation, Orion Pharma
name: Clinical Study Director
role: STUDY_DIRECTOR
References: