louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03954795: OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
Official title: The Comparison of Analgesic Sparing Effects of Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Transversus Abdominis Plane Block (TAP) in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Postoperative
Keywords: TAP OSTAP Postoperative pain
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and OSTAP in patients undergoing laparoscopic cholecystectomy.

Detailed description: Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1: Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was induced and maintained in all patients. At the end of the operation patient controlled analgesia with morphine was applied to all patients.

Pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption and pain scores were compared.

Eligibility criteria: Inclusion Criteria:

* Scheduled for laparoscopic cholecystectomy
* ASA status I-II

Exclusion Criteria:

* Local anesthetic allergy
* Coagulopathy
* Infection at procedure site

Primary outcomes:
measure: Change in postoperative pain scores throughout time evaluated by VAS
timeFrame: Pain scores will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.
measure: Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
timeFrame: The amount of Morphine demanded by the patient will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.
measure: Amount of total intraoperative remifentanil infusion
timeFrame: At the end of surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04398381: Prognosis of SRD Patients in the ICU
Official title: One-year Outcome of Critically Ill Patients With Systemic Rheumatic Disease: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Rheumatic Diseases
Intensive Care Unit
Corticosteroids
Keywords: outcomes
prognostic factors
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
name: Sorbonne University
name: Hôpital Lariboisière Fernand Widal
name: Université Montpellier
First posted: 2020-05-21
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive SRD patients admitted to ICUs during the study period

Brief summary: Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).


Eligibility criteria: Inclusion criteria:

* All consecutive SRD patients admitted to ICUs during the study period
* at least one urine sample

Exclusion criteria:

* Age \< 18 years
* Persons under protection
* Paritcipation rejections
* Admition to the ICU after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of SRD
* Cancer treated with chemotherapy within a month before ICU admission

Primary outcomes:
measure: Mortality rate in the ICU associated risk factors
timeFrame: 1 day
Secondary outcomes:
measure: Mortality rate in the hospital and one-year after ICU admission and associated risk factors
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Romaric Larcher, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02206581: Using Hydration Monitor to Detect Changes in the Hydration Status Athletes
Official title: The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Keywords: dehydration
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
name: Appalachian State University
First posted: 2014-08-01
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject pool will be comprised of 100 young, healthy, physically active male and female subjects.

Brief summary: The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.


Eligibility criteria: Inclusion Criteria:

* male or female athletes
* ages 18-25 years old

Exclusion Criteria:

* open wounds or rashes on calf testing area
* active skin infection
* pregnant female subjects

Primary outcomes:
measure: To observe statistically significant changes in ultrasound velocity associated with acute dehydration
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boone
country: United States
facility: Appalachian State University
state: North Carolina
Study officials:
References:
Clinical trial NCT00013481: Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation
Official title: Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: stroke, hemiparesis, CNS, motor coordination
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine whether a therapeutic exercise program for improving motor coordination in locomotor tasks in post-stroke, hemiparesis patients will result in CNS recovery. The study will develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables.)

Detailed description: Primary objective of this study is to determine whether a therapeutic exercise program which targets the functional recovery of persons with the post-stroke hemiparesis results in CNS recovery (improved motor coordination). They will determine whether motor coordination during a locomotor task is improved after an exercise program. They will then develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables) Overall goal is to develop a more rational basis for the design of stroke rehabilitation programs which target individuals most likely to recover and which are based on physiological principles. This study will supplement an NIH funded randomized clinical trial to evaluate a post-stroke exercise program designed to increase balance, strength, and endurance. Study will include 60-70 prospective patients enrolled in the randomized clinical trial at Kansas University Center on Aging. between Oct 1999 and Oct 2001.

Eligibility criteria: Inclusion Criteria:

Functionally impaired elderly

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Pamela W. Duncan, PhD MA BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06881381: Swallowing and Oral Sensory Complaints in Preterm Children
Official title: Investigation of Swallowing Complaints and Oral Sensory Problems in Children with a History of Preterm Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Dysphagia
Feeding Disorder of Infancy or Early Childhood
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 158
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were parents of children attending a state hospital's Pediatric Clinic.

Brief summary: Objective Preterm children face an elevated risk of neurodevelopmental delays and feeding difficulties, necessitating early assessment to support their long-term health. This study investigates swallowing disorders and oral sensory problems in children aged 3-10 years born preterm.

Methods Parents of preterm children completed two validated tools: the Pediatric Eating Assessment Tool (PEDI-EAT-10) to assess swallowing difficulties and the Oral Sensory Profile (Oral-SP) to evaluate oral sensory processing. Data collected included age, gender, gestational age, height, weight, neonatal intensive care unit (NICU) stay duration, feeding methods (e.g., tube feeding, pacifier, bottle use), medical history, and prior interventions like speech-language therapy.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria were having a preterm child (born before 37 weeks), aged 3-10 years, being Turkish-speaking, and volunteering.

Exclusion Criteria:

Participants were excluded if they withdrew during data collection.

Primary outcomes:
measure: gestational age
timeFrame: 24-37 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
state: Tarsus
Study officials:
References:
citation: Cerro N, Zeunert S, Simmer KN, Daniels LA. Eating behaviour of children 1.5-3.5 years born preterm: parents' perceptions. J Paediatr Child Health. 2002 Feb;38(1):72-8. doi: 10.1046/j.1440-1754.2002.00728.x.
Clinical trial NCT06766981: Infiltration Anesthesia vs. Block Anesthesia
Official title: Effectiveness of Local Anesthetic Infiltration With Articaine 4% in Comparison to Inferior Alveolar Nerve Block With Lidocaine 2% for Mandibular 1st Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Keywords: Local Anesthesia
Inferior Dental Nerve Block
Infiltration Anesthesia
Lead sponsor: Babylon University
Sponsor class: OTHER
Collaborators: name: Babylon University
First posted: 2025-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional group will undergo tooth extraction under the infiltration anaesthesia technique
Primary purpose: TREATMENT

Brief summary: Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction

Detailed description: Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration. In comparison, the second group will receive a conventional inferior alveolar nerve block technique with 2% lidocaine with epinephrine (1:80,000). Pain will be measured para-operatively using a verbal rating scale.

Eligibility criteria: Inclusion Criteria:

* The systemic condition must be normal.
* Patient has no cardiovascular, metabolic, or transmitted disease.
* The patient has a Mandibular 1st. Molar tooth indicated for extraction.
* The tooth is non-restorable.

Exclusion Criteria:

* Chronic cardiovascular condition, metabolic, or infectious disease.
* Pregnant women.
* The tooth is restorable.

Primary outcomes:
measure: Verbal Pain Rating Scale
timeFrame: during the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: College of Dentistry, University of Babylon
state: Babylon
city: Hilla
country: Iraq
facility: College of Dentistry/University of Babylon
state: Babylon
Study officials:
References:
citation: Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.
citation: Madden VJ, Kamerman P, Leake HB, Catley MJ, Heathcote LC, Moseley GL. The Sensation and Pain Rating Scale: easy to use, clear to interpret, and responsive to clinical change. medRxiv [Preprint]. 2024 Jan 9:2023.09.08.23295128. doi: 10.1101/2023.09.08.23295128.
Clinical trial NCT02405481: SEPA III: The Effectiveness Trial
Official title: SEPA III: The Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.


Eligibility criteria: Inclusion Criteria:

* Hispanic Women,
* 18 to 50 years old,
* Sexually active in the past three months

Exclusion Criteria:

* Non-Hispanic,
* younger than 18,
* older than 50,
* not sexually active

Primary outcomes:
measure: Condom Use
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Nilda Peragallo Montano, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04225481: Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
Official title: Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects undergoing aesthetic plastic surgery or OA patients undergoing prosthetic surgery

Brief summary: Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.


Eligibility criteria: Inclusion Criteria:

OA patients

* Subscription of informed consent
* BMI \< 30
* age between 55-75 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Healthy subjects from aesthetic plastic surgery
* Subscription of informed consent
* BMI \< 30
* age between 18-50 years included
* subjects undergoing liposuction and/or abdominoplasty

Exclusion Criteria:

* HCV, HIV, HBV, TPHA infection
* Pregnancy (auto declaration)

Primary outcomes:
measure: Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL
timeFrame: surgery as scheduled by clinic routine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05121181: Reaching Consensus on the Definition of Difficult Cholecystectomy
Official title: Reaching Consensus on the Definition of Difficult Cholecystectomy Among Spanish Experts. A Delphi Project. Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Getafe
name: Complejo Hospitalario Universitario de Badajoz
name: Hospital Miguel Servet
First posted: 2021-11-16
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish experts in laparoscopic cholecystectomy

Brief summary: Being able to predict the difficulty of a preoperatively can increase safety and improve results. However, a consensus must be reached regarding the definition of a cholecystectomy as "difficult". The aim of this study is to achieve a national expert consensus.

Methods A Delphi study was conducted. Based on the literature, a history of biliary pathology, preoperative clinical, analytical, and radiological data, and intraoperative findings were selected and rated on a Likert scale.

Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

Detailed description: A Delphi study was conducted. Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

Eligibility criteria: Inclusion Criteria:

* Spanish surgeons
* experts in laparoscopic cholecystectomy, with more than 10 years of experience

Exclusion Criteria:

* not Spanish
* not experts in laparoscopic cholecystectomy.

Primary outcomes:
measure: consensus
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Alba Manuel Vázquez
Study officials:
affiliation: Hospital Universitario de Getafe
name: Alba Manuel Vázquez, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680481: Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks
Official title: Traveling Wave Transcranial Alternating Current Stimulation for the Control of Large-Scale Brain Networks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Working Memory
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-12-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.


Eligibility criteria: Inclusion Criteria:

1. the patient can consent for themselves;
2. the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation;
3. age 18+ years old;

Exclusion Criteria:

1. diminished capacity to consent;

Primary outcomes:
measure: Electrophysiological outcomes
timeFrame: Immediate effect during stimulation
measure: Working memory outcomes
timeFrame: Immediate effect during stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alexander Opitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: