louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06302777: MAIN-IMAGE Registry
Official title: Multifactorial Analysis of Coronary Artery Plaques Using INtracoronary IMAGing for Exploration of Atherosclerotic Determinants and Progression - the MAIN-IMAGE Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACS or SAP patients

Brief summary: All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.


Eligibility criteria: Inclusion Criteria:

patients undergoing pre-intervention optical coherence tomography imaging

Exclusion Criteria:

-

Primary outcomes:
measure: Major adverse cardiovascular Events (MACE)
timeFrame: after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Frankfurt University Hospital
state: Hesse
city: Frankfurt
country: Germany
facility: Frankfurt University Hospital
Study officials:
References:
Clinical trial NCT06384677: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery
Official title: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Cancer
Abdomen Disease
Keywords: major abdominal surgery
M-TAPA
opioid consumption
postoperative analgesia
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

Detailed description: The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

Eligibility criteria: Inclusion Criteria:

* patient \> 17 years old
* ASA score 1-3
* undergoing major intra-abdominal surgery

Exclusion Criteria:

* ASA IV patients
* patients with known neurological or psychiatric disorders
* patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
* patients with long-term drug (opioid) or alcohol dependence
* patients with BMI\>30
* patients with intellectual disability
* patients who developed massive bleeding and coagulopathy

Primary outcomes:
measure: Opioid Consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: NRS Scores
timeFrame: postoperative 24 hours
measure: the need for rescue analgesia
timeFrame: postoperative 24 hours
measure: side effects
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
Study officials:
affiliation: Marmara Univercity
name: GAMZE ÇABAKLI
role: STUDY_CHAIR
References:
citation: Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8.
Clinical trial NCT04383977: Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer
Official title: A Phase 2 Randomized, Open-label, Multicenter Trial of Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant or Refractory Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).


Eligibility criteria: Inclusion Criteria:

1. Female patients, ≥18 Years.
2. Epithelial ovarian, fallopian tube or primary peritoneal cancer
3. Platinum refractory and resistant disease (disease progression during platinum therapy or within \<6 months of platinum therapy)
4. EOCG performance status of 0-2

Exclusion Criteria:

1. Non-epithelial tumours
2. Ovarian tumours with low malignant potential
3. Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment
4. Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.

Primary outcomes:
measure: Objective response rate (ORR) by investigator
timeFrame: up to 2 years
Secondary outcomes:
measure: AEs+SAEs
timeFrame: 30 days after the last dose
measure: PFS by investigator
timeFrame: up to 2 years
measure: Overall Survival (OS)
timeFrame: up to 3 years
measure: Pharmacokinetic characteristic
timeFrame: up to 2 years
measure: Pharmacokinetic characteristic
timeFrame: up to 2 years
measure: Pharmacokinetic characteristic
timeFrame: up to 2 years
measure: Pharmacokinetic characteristic
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03906877: Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)
Official title: Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Vocal Cord Paralysis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 6
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 aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (\< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.


Eligibility criteria: Inclusion Criteria:

- Unilateral paralysis in abduction of the vocal cords may be included in the study.

Exclusion Criteria:

* Wear a pacemaker or other implanted devices (prostheses ...).
* Wear metal clips, metal in the head, or an adjustable brain drain.
* Wear non-removable dental appliances (except fillings).
* Wear cardiac valve prostheses.
* Have worked the metals.
* Have a tattoo containing metal particles.
* Have implanted jewelry (e.g., piercing).
* Being prone to epileptic seizures.
* Take medications that alter cortical excitability.
* Have had a brain surgery.
* Suffer from intracranial hypertension.
* Be pregnant or breastfeeding recently.
* Present allergies that are incompatible with the experimental protocol.
* Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.

Primary outcomes:
measure: Laryngeal recurrent nerve reinnervation
timeFrame: 9 to 12 months after paralysis
measure: Recovery of the vocal fold mobility
timeFrame: 9 to 12 months after paralysis
measure: Voice recovery
timeFrame: 9 to 12 months after paralysis
measure: Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs
timeFrame: 9 to 12 months after paralysis
measure: Central auditory processes
timeFrame: Within 3 months after paralysis
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: SSS/MEDE and SSS/IONS/NEUR
name: Gauthier Desuter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06287177: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
Official title: Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients from Italy, who have received Inclisiran as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria, at time of enrollment

Brief summary: Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population


Eligibility criteria: Inclusion Criteria:

* Patients under Inclisiran treatment

Exclusion Criteria:

* Age \< 18 years o \> 80 years
* Patients who refuse to participate and to sign informed consent

Primary outcomes:
measure: Description of adherence to treatment with Inclisiran in a real-life Italian population
timeFrame: 3-6-12 months
measure: Description of persistence to treatment with Inclisiran in a real-life Italian population
timeFrame: 3-6-12 months
measure: Description of efficacy of treatment with Inclisiran in a real-life Italian population
timeFrame: 3-6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II University of Naples, Department of Advanced Biomedical Sciences
Study officials:
References:
Clinical trial NCT06931353: Effect of the Anticholinergic Drug Burden on Postoperative Delirium in Elderly Chinese Patients: A Nested Case-Control Study
Official title: Effect of the Anticholinergic Drug Burden on Postoperative Delirium in Elderly Chinese Patients: A Nested Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium - Postoperative
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 10536
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 65 years

Brief summary: This study aims to investigate the association between preoperative anticholinergic drugs burden and postoperative delirium in elderly Chinese patients.


Eligibility criteria: Inclusion Criteria:

* patients over 65 years; Undergoing general anesthesia; Inpatients who had surgery between Aprill 1, 2020 and Aprill 1, 2022.

Exclusion Criteria:

* ASA grade V; preoperative Mini-Mental State Examination (MMSE) score \<24;history of neurological disorders (such as cerebrovascular disease or dementia); emergency surgeries; operative duration ≤30 minutes, and cases with \>5% missing data.

Primary outcomes:
measure: postoperative delirium
timeFrame: 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Medical Center of Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT00752453: Uremic Toxins in the Intensive Care Units (ICU): Patients With Lactate Acidosis
Official title: Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients With Lactate Acidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Keywords: ICU
patients
lactate
acidosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients with lactate acidosis. The sampling of blood and dialysate will be done during dialysis with different durations (4, 6 and 8 h)


Eligibility criteria: Inclusion Criteria:

* Includes ICU patients with lactate acidosis with acute renal failure

Exclusion Criteria:

Primary outcomes:
measure: Toxin removal
timeFrame: During dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930353: Psychometric Validation of a French-language Version of the PERMA-Profiler: Tools for Assessing Multidimensional Subjective Well-being
Official title: Psychometric Validation of a French-language Version of the PERMA-Profiler: Tools for Assessing Multidimensional Subjective Well-being
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psychiatric Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general population

Brief summary: The main objective of this study is to carry out the psychometric validation of the PERMA-Profiler in a population representative of the general French population and in comparison with the reference questionnaire The PERMA-Profiler.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years).
* Person able to read and understand French
* Person willing to participate in this study

Exclusion Criteria:

* The person does not understand the French language
* Person has a history of traumatic brain injury
* The person refuses to participate in the study

Primary outcomes:
measure: PERMA PROFILER French Version: diagnostic properties
timeFrame: DAY 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: Chu de Nimes
Study officials:
References:
Clinical trial NCT00667953: Study of Temzolomide and Gleevec in Advanced Melanoma
Official title: Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Advanced Melanoma
Keywords: Temzolomide
Gleevec
Melanoma
Advanced melanoma
Phase II
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-04-28
Enrollment: 32
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 study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
* Measurable disease
* Performance status \<= 2
* Life expectancy greater than 3 months

Exclusion Criteria:

* No prior treatment with temozolomide or imatinib mesylate
* Organ allografts
* Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
* Pregnancy or lactation
* History of second cancer
* Known hypersensitivity to temozolomide or imatinib
* Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment

Primary outcomes:
measure: Safety - Grade 3 or 4 Adverse Events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Response
timeFrame: through study completion, an average of 1 year
measure: To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide
timeFrame: through study completion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Rogel Cancer Center
name: Leslie Fecher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abramson CC
name: tara mitchell, MD
role: STUDY_DIRECTOR
References:
citation: Bajor DL, Xu X, Torigian DA, Mick R, Garcia LR, Richman LP, Desmarais C, Nathanson KL, Schuchter LM, Kalos M, Vonderheide RH. Immune activation and a 9-year ongoing complete remission following CD40 antibody therapy and metastasectomy in a patient with metastatic melanoma. Cancer Immunol Res. 2014 Nov;2(11):1051-8. doi: 10.1158/2326-6066.CIR-14-0154. Epub 2014 Sep 24.
Clinical trial NCT06165653: Guided Meditation During Radiation Therapy for Brain Tumors
Official title: An Interventional Trial Using Guided Meditation During Radiation Therapy for Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Neoplasms
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 30
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 goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors.

The main question it aims to answer is:

• What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions?

Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.


Eligibility criteria: Inclusion Criteria:

* Participant aged ≥ 18 years.
* Radiologically confirmed tumor of the brain. Note: Participants may have tumor resected after diagnosis.
* Eligible to undergo radiation treatment for brain tumor for 25-33 treatments.
* Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment.
* Karnofsky performance score ≥ 60 or ECOG performance score ≤ 2.
* MoCA mini score ≥ 11
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Active suicidal ideation or active psychotic state in the opinion of the investigator.
* An unstable illness that, in the opinion of the investigator, would interfere with study treatment.
* Prior radiation therapy to the brain.
* Inability to understand and/or speak the English language.

Primary outcomes:
measure: Change in acute anxiety, measured by score on individual item derived from GAD-2, in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
timeFrame: 7 weeks
Secondary outcomes:
measure: Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care, measured using the total score of the GAD-2 scale prior to RT
timeFrame: 7 weeks
measure: Change in anxiety during RT and in everyday life as measured by the modified MPoD
timeFrame: 7 weeks
measure: Change in self transcendence and the magnitude/degree of change in self transcendence as measured by total score of the Nondual Awareness Dimensional Assessment (NADA.)
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Lindsay Burt, MD
role: PRINCIPAL_INVESTIGATOR
References: