louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06097845: Transcranial Ultrasound Via Sonolucent Cranioplasty
Official title: Transcranial Ultrasound Via Sonolucent Cranioplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cranioplasty
Sonolucent Cranioplasty
Reconstructive Cranioplasty
Keywords: Transcranial Ultrasound
SOC ultrasound
PMMA implant
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.

Detailed description: Standard of care (SOC) imaging techniques routinely used for neurosurgical monitoring, namely computed tomography (CT) and magnetic resonance imaging (MRI), present numerous patient, provider, and institutional burdens associated with transport, invasiveness, contrast administration, radiation exposure, imaging delay, and overall global costs. Ultrasound represents a promising alternative that overcomes many of these disadvantages being noninvasive, low-risk, real-time and portable, but is limited by the acoustic impedance of autologous cranial bone. Recently, material innovations enabling both transparent and sonolucent polymethyl methacrylate (PMMA) - a material commonly used for cranial reconstruction with a longstanding history of safety - have facilitated ultrasound windows within patients already receiving cranioplasty as standard of care. Early results applying transcranioplasty ultrasound (TCUS) through sonolucent cranial plates have been encouraging in regard to agreement with SOC imaging and advanced doppler capabilities. That said, limited published data exists commensurate with the novelty of the technique, therefore investigators herein aim to address this paucity by investigating the feasibility and efficacy of TCUS as compared to standard of care postoperative imaging modalities (i.e. MRI \& CT) in a prospective, quality control study.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.
4. Male or female, aged ≥ 18.

Exclusion Criteria:

1. Patients who are pregnant

Primary outcomes:
measure: Identification of Neuroanatomy accuracy of TCUS
timeFrame: 12 months
measure: Diagnostic accuracy of TCUS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Lenox Hill Hospital
name: Netanel Ben-Shalom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841945: Treatment of Aggressive Localized Lymphoma
Official title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: B Cell Lymphoma
Keywords: Diffuse B larg cell lymphoma
Chemotherapy
Radiotherapy
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

Detailed description: CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 75 years
* Diffuse B large cell lymphoma , CD 20+
* Ann Arbor stage I or II withe a bulk \<7 cm
* stage i ou II confirmed by the PET-scan
* No previously treated
* HIV negative
* Signed Informed consent

Exclusion Criteria:

* Age\< 18 and \> 75 years
* other type of lymphoma
* CD20 negative
* Ann Arbor stage \>II or bulk \> 7 cm
* HIV positive
* Contraindication to Rituximab use according to Sm PC
* Containdication to antracyclin
* cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma
* Refusal of sign the informed consent

Primary outcomes:
measure: Event Free Survival (EFS) and Progression Free Survival (PFS)
timeFrame: EFS PFS one year after treatment
Secondary outcomes:
measure: Pet-scan
timeFrame: pronostic impact of Pet-scan
measure: radiotherapy
timeFrame: Toxicity of the radiotherapy
Other outcomes:
Locations:
city: Rennes
country: France
facility: Regional university hospital
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Thierry LAMY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Bene MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.
citation: Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.
Clinical trial NCT04868747: The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping
Official title: The Effect of Perioperative Lidocaine Intravenous Infusion on Neutrophil Extracellular Trapping After Surgery for Stomach Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

Detailed description: To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase

Eligibility criteria: Inclusion Criteria:

* diagnosis of stomach cancer
* ASA class I-III
* no metastatic disease

Exclusion Criteria:

* hepatic, renal disease
* chronic inflammatory disease, eg. rheumatoid arthritis
* steroid or anti-inflammatory drug medication
* allergies to study drugs
* neuropsychiatric disease
* refusal of participation
* breast feeding or pregnancy
* weight \< 40 kg

Primary outcomes:
measure: serum concentration of NET(neutrophil extracellular trapping)-related biomarker
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: quality of recovery
timeFrame: 24 hours after surgery
measure: postoperative pain
timeFrame: 24 hours after surgery
measure: survival of patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Young Eun Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01272947: Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Blunt Soft Tissue Injuries/Contusions of the Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Blunt Soft Tissue Injuries/Contusions
Keywords: Blunt soft tissue injury/contusion
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years and over.
* Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.

Primary outcomes:
measure: Pain on Movement
timeFrame: VAS Score at 24 hours
Secondary outcomes:
measure: Onset of Pain Relief
timeFrame: From randomization to end of day 1
Other outcomes:
Locations:
city: Brühl
country: Germany
facility: NCH investigative site
city: Butzbach
country: Germany
facility: NCH investigative site
city: Cologne
country: Germany
facility: NCH investigative site
city: Essen
country: Germany
facility: NCH investigative site
city: Gilching
country: Germany
facility: NCH investigative site
city: Munich
country: Germany
facility: NCH investigative site
Study officials:
References:
Clinical trial NCT01483547: Reliability of BIS Monitoring in Neurosurgical Patients
Official title: Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sovra and Intra Tentorial Lesions
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 405
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: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective craniotomy and elective spinal cord and column surgery.

Brief summary: The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.


Eligibility criteria: Inclusion Criteria:

* BIS \> 90 at baseline (awake)
* ASA I or II

Exclusion Criteria:

* GSC \< 15
* anticipated difficult ventilation and/or intubation
* BMI \> 30
* surgical site that does not allow BIS monitoring
* bilateral hearing loss
* not speaking Italian Language

Primary outcomes:
measure: BIS values at LOC, PI and ROC
timeFrame: 8 months
Secondary outcomes:
measure: incidence of intraoperative awareness
timeFrame: 0, 1, 3, 30 days after surgery
measure: incidence of postoperative delirium
timeFrame: 0, 1, 3, 30 days after surgery
measure: predicted site effect drugs concentration at LOC, PI and ROC
timeFrame: 8 months
measure: total amount of anesthetic drugs delivered at the end of surgery
timeFrame: 8 months
measure: recovery time after surgery
timeFrame: 8 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Neurologico Carlo Besta
Study officials:
References:
Clinical trial NCT02169947: Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Official title: Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-06-23
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.


Eligibility criteria: Inclusion Criteria:

* African American
* Aged 18 and older
* Have a BMI ) \> 25 kg/m²
* Associated with a participating church through membership or participation in a church activity
* Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component
* Individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible

Exclusion Criteria

* Not had a heart attack or stroke in the past 6 months
* Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin)
* Not pregnant, not pregnant in the previous six months, or lactating
* Not enrolled in another weight reduction program
* Agree to complete the program assigned to them
* Never had weight loss surgery
* Not have lost more than 10% body weight in the previous 6 months
* Not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months

Primary outcomes:
measure: Change in weight from 6 months to 18 months
timeFrame: Change from 6 months to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Karen Yeary, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02340247: Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official title: Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-01-16
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting plasma glucose \< 7.0mM, HbA1c \< 48mmol/mol 3 months after RYGB.

Exclusion Criteria:

* Fasting plasma glucose \> 7.0mM, HbA1c \> 48mmol/mol 3 months after RYGB.
* Dysregulated hypothyroidism, use of antithyroid treatment.
* Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
* Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).

Primary outcomes:
measure: GLP-1 secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
Secondary outcomes:
measure: C-peptide secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: PYY secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: Glucagon secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: GIP secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: CCK secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: Gherlin secretion (evaluated by iAUC)
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: Changes in bile acids/FGF-19
timeFrame: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
measure: TSH/T3/T4
timeFrame: 0, 60, 120, 180
measure: Appetite measurements (VAS-score)
timeFrame: Baseline, 30, 60, 120, 180
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT02509247: Telemonitoring in CPAP Treatment
Official title: Telemonitoring in CPAP Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea
CPAP
telemonitoring
telecare
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-07-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

Detailed description: Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

This study was part of our regular testing and quality assurance procedure when developing and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable changes in treatment protocol we have to test whether it is feasible and cost-effective to change the protocol. The data was retrospectively collected from hospital records and nurses' notes (nursing time). According to instructions of our hospital, the Ethics Committee approval is not required. The approval of the hospital (Head of the Division of Medicine) for testing the wireless telemonitoring system of CPAP treatment was applied and received (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained from those patients allocated to the telemonitoring group.

Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients commencing CPAP therapy for OSA

Exclusion Criteria:

* Patient not able to co-operate

Primary outcomes:
measure: Nursing time
timeFrame: 3 months
Secondary outcomes:
measure: CPAP adherence measured with in-built clock counter
timeFrame: 1 year
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Hospital District of Southwest Finland
name: Tarja Saaresranta, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546247: A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)
Official title: A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).


Eligibility criteria: Inclusion Criteria:

* Advanced cancer, excluding cancer in the blood
* Availability of 10 tumor tissue slides

Exclusion:

* Known brain metastases
* Severe nerve damage
* Significant cardiovascular disease
* Inadequate blood counts
* Inadequate liver or kidney function
* Inadequate thyroid function or uncontrolled thyroid disease

Primary outcomes:
measure: To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493)
timeFrame: at the end of the study
Secondary outcomes:
measure: To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493)
timeFrame: every 21 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center
state: District of Columbia
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Rotterdam
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: