louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02602990: Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
Official title: Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Arteriovenous Malformations
Keywords: Cerebral
Arteriovenous
Malformation
Embolization
Endovascular
Lead sponsor: Emboflu
Sponsor class: INDUSTRY
Collaborators: name: Archer Research
First posted: 2015-11-11
Enrollment: 50
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: Patients with a cerebral AVM for whom endovascular treatment is indicated.

Brief summary: A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.

Detailed description: This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.

Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.

Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).

For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.

Eligibility criteria: Inclusion Criteria:

1. Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
2. The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
3. The patient is at least 18 years old.

Exclusion Criteria:

1. Patient is pregnant.
2. Patient with renal insufficiency (GFR \< 45 ml/min/1.73 m²)

Primary outcomes:
measure: Incidence of complications / adverse events (Safety)
timeFrame: From the start of the procedure until 30 days after procedure
Secondary outcomes:
measure: Clinical outcome measurement with mRS (Efficacy)
timeFrame: At 6 months after the last treatment session, compared to baseline
measure: Degree of targeted portion of AVM occlusion
timeFrame: 6 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg (ZOL)
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
Study officials:
References:
Clinical trial NCT00003390: 6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer
Official title: A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.

Detailed description: OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed after every 2 treatment courses.

PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of metastatic disease Bidimensionally measurable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception No prior malignancy within 5 years and at low risk for recurrence Must have undergone potentially curative therapy for prior malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Sanofi
name: William Berg, MD
role: STUDY_CHAIR
References:
Clinical trial NCT07006090: Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog® Scanner.
Official title: A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog® Scanner in Multiple Disease Areas.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner
Whatever the Disease Area
Keywords: Histolog Scanner
Lead sponsor: SamanTree Medical SA
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 5000
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: The study population will consist of adult patients undergoing a surgery or a medical procedure with use of Histolog Scanner.

Brief summary: The goal of this observational study is to gather real-world evidence on the performance and safety of the Histolog® Scanner (HLS) when used as intended. HLS is a real time intraoperative tissue imaging device for assessment of surgical margins.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old at the time of consenting
* Undergoing a surgery or a medical procedure with use of Histolog® Scanner
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Active participation in a drug, device, or other medical intervention study that has not reached its primary endpoint at the time of consenting
* Patients under judicial protection, legal guardianship or curatorship.

Primary outcomes:
measure: Number of confirmed medical interventions based on Histolog® image readings.
timeFrame: From enrolment to diagnosis confirmation at post surgery follow-up visit (V2: 37 days after enrolment)
Secondary outcomes:
measure: Concordance between the assessment of Histolog® images and the final pathology assessment expressed as sensitivity, specificity, positive predictive value, and negative predictive value
timeFrame: From enrolment to post surgery follow-up visit (V2: 37 days after enrolment)
measure: Re-operation rates if Histolog® used for intra-operative assessment
timeFrame: From surgery (V1: Day 0) to post surgery follow-up visit (V2: +30 days)
measure: Cancer-free survival up to 5 years of follow-up
timeFrame: From enrolment to the end of 5 years follow-up
measure: Evaluation of usage patterns across different indications and application profiles.
timeFrame: From enrolment to the end of 5 years follow-up.
measure: Device deficiency defined as any inadequacy in the identity, quality, durability, reliability, safety or performance of a device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
timeFrame: From first patient surgery visit (V1: Day 0) to last patient surgery visit.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02346890: A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722
Official title: A Phase 1, Single-center, Randomized, 2-way Crossover, Open Label Study to Evaluate the Effect of Renvela on the Pharmacodynamics of AZD1722 in Healthy Volunteeers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteer
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2015-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.


Eligibility criteria: Inclusion Criteria:

* Healthy man or woman
* Body mass index between 18 and 29.9 kg/m2

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
* Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.

Primary outcomes:
measure: Sodium levels in stool and urine
timeFrame: 4 days
Secondary outcomes:
measure: Evaluate the safety of AZD1722, measured by Adverse events
timeFrame: 8 days
measure: Evaluate the safety of AZD1722, measured by clinical laboratory changes
timeFrame: 8 days
measure: Plasma drug concentration to calculate AUC
timeFrame: 8 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries, LLC
state: Texas
Study officials:
affiliation: Ardelyx, Inc.
name: David P Rosenbaum, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01214590: Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Official title: Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: VascuActive LTD
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 15
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: The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes.

Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus (type 1 or 2)
* Age 18 years or older
* No changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes
* Painful diabetic neuropathy \> 3 months, but not more than 5 years
* Pain level ≥ 4 on an 11 point Numerical Pain Rating Scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment)
* Loss of protective sensation by the 5.07 Semmes-Weinstein Monofilament (SWM, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot)

Exclusion Criteria:

* Known or suspected radiculopathy (based on patient's record and anamnesis)
* Any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive
* Severe cardiac disease or surgery within last 3 months, e.g., Acute Myocardial Infarction, Congestive Heart Failure grade 3 or higher
* Any major infectious, malignant or other severe systemic disease, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis, Creutzfeldt-Jakob disease
* Patient is incompetent to comply with study requirements (in the investigator's opinion)

Primary outcomes:
measure: Diabetic neuropathic pain
timeFrame: 2, 4, 5, 12 weeks from start of treatment
Secondary outcomes:
measure: Sensation impairment
timeFrame: 2, 4, 5, 12 weeks from start of treatment
measure: Nerve conduction velocity
timeFrame: 4, 12 weeks from start of treatment
Other outcomes:
Locations:
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center, Diabetic Foot Clinic
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Arie Bass, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: Robert Slater, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06778590: Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar
Official title: Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar: Assessment of Post-operative Sequelae
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Disease
Piezoelectric Technique
Tooth Impacted
Tooth Extraction Status Nos
Tooth Avulsion
Facial Swelling
Germectomy
Keywords: third molar surgery
facial swelling
3D facial swelling evaluation
Piezoelectric technique
tooth impacted
piezosurgery
germectomy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars

Detailed description: The main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. Post-operative swelling is analyzed using a photogrammetry facial scanner (Marathon MT-4000).

Eligibility criteria: Inclusion Criteria:

* Patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons
* Good quality of radiographic investigations (CBCT)
* Good health status

Primary outcomes:
measure: Facial swelling qualitative analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - volumetric differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - linear differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes:
measure: Trismus analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Pain analysis with Visual analogue scale (VAS)
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University of Catanzaro
Study officials:
References:
Clinical trial NCT01937390: Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Post-Marketing Observational Study of the Impact of Adherence to Treatment With Once-Daily Administered Long-Acting Bronchodilators (LABAs / LAMAs) on Patients Health Related Quality of Life in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 645
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasians

Brief summary: The objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists \[LABAs\] / long-acting muscarinic antagonists \[LAMAs\]) on patients health related quality of life (HR-QoL) and to assess the relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease (COPD) maintenance therapy


Eligibility criteria: Inclusion criteria:

1. Male or female, above 40 years of age
2. Patients clinically diagnosed of COPD with no history suggestive of asthma:

   1. by scores \>=5 in the COPD Population Screener,
   2. by a clinical diagnosis of COPD made by pulmonologists or internists,
   3. by a Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC6) ratio of \<=0.70 and a FEV1 \<=80% of the predicted value as assessed by copd-6 (Vitalograph, UK);
3. Maintenance treatment-naïve COPD patients who have been prescribed once daily long-acting bronchodilators (LABAs / LAMAs) for the first time at enrolment into the study
4. Patients who are able to provide signed informed consent
5. Patients who agree to be contacted for telephone/ SMS reminders via call center

Exclusion criteria:

1. Patients with contraindications to the prescribed medication
2. Patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion
3. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception

Primary outcomes:
measure: Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13
timeFrame: Baseline and 13 Month
measure: CCQ Total Score at Month 13 (Visit 4)
timeFrame: 13 months
measure: Number of COPD Exacerbations Leading to Hospitalization, Per Patient
timeFrame: 13 months
measure: Number of COPD Exacerbations, Per Patient
timeFrame: 13 months
Secondary outcomes:
measure: Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients
timeFrame: 13 months
Other outcomes:
Locations:
city: Ingelheim am Rhein
country: Germany
facility: CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06259890: Influence of Sodium Intake in spondyLoarthriTes
Official title: Sodium Intake in spondyLoarthriTes: Analysis of the Influence on the Activity of the Disease and the Therapeutic Response to Anti IL-17A Agents.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondyloarthritis, Axial
Arthritis, Psoriatic
Keywords: Sodium intake
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: French Society of Rheumatology
First posted: 2024-02-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

* patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis
* women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)

Exclusion Criteria:

* catient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists.
* current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old.
* patients on systemic corticosteroids with corticosteroid therapy \> 10 mg prednisone equivalent
* pregnant woman

Primary outcomes:
measure: sodium intake
timeFrame: day of inclusion, monday and tuesday following
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHUBEsancon
Study officials:
References: