louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03582254: Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years
Official title: Role of [18F]-FDG Brain PET in Newly Diagnosed Primary Cerebral Lymphoma, in Immunocompetent Patient Older Than 60 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients older than 60 years account for half of cases of Primary Central Nervous System Lymphoma (PCNSL) and have a poorer outcome. No prognostic or predictive factors exist for survival after initial remission. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - Positron Emission Tomography (\[18F\]FDG-PET) plays a key role in grading and therapy monitoring of systemic diffuse large B-cell type.

LOCALYZE is an ancillary Positron Emission Tomography / Magnetic Resonance (PET/MR) clinical study from BLOCAGE 01 (Pr Hoang-Xuan). The aim is to evaluate the usefulness of \[18F\]FDG-PET to monitor treatment response in PCNSL older than 60 years (n=56), in complement to multiparametric Magnetic Resonance Imaging (MRI).

Hypothesis The investigators assume that the development of new imaging biomarker extracted from PET imaging and multiparametric MRI, could improve the assessment of treatment response in PCNSL.

Detailed description: \[18F\]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital:

* prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1),
* after two chemotherapy cycles (PET#2),
* at the end of the first-line chemotherapy regimens (PET#3).

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed primary cerebral lymphoma
* Age ≥60 years
* Pathology proven diagnosis or positive cytology of the Cerebrospinal Fluid (CSF) or vitreous
* Karnofsky Performance Status ≥40
* No evidence of systemic Non-Hodgkin lymphomas (NHL) (body CT scan, bone marrow biopsy)
* Adequate haematological, renal and hepatic function
* Calculated creatinine clearance \> 40 ml/min

Exclusion Criteria:

* Uncontrolled diabetes with fasting glycaemia \> 200 mg/dL
* Sensitivity to active substance in \[18F\]-FDG
* Calculated creatinine clearance \< 40 ml/min
* No contraindication to MRI (magnetic resonance imaging)

Primary outcomes:
measure: Progression free survival calculated from the date of completion of the end of chemotherapy PET
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpêtrière Hospital
Study officials:
References:
Clinical trial NCT00073554: Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
Official title: A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arterial Occlusive Diseases
Peripheral Vascular Diseases
Thrombosis
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Health Decisions
First posted: 2003-11-26
Enrollment: 100
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: This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).


Eligibility criteria: * Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days)
* Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow)
* Age 18 or above
* Able to consent
* Able to follow up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
citation: Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.
Clinical trial NCT03029754: Effect of Passive Leg Raise for Pediatric Peripheral IV Placement
Official title: Effect of Passive Leg Raise for Pediatric Peripheral IV Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Access
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 87
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.


Eligibility criteria: Inclusion Criteria:

* pediatric participants undergoing dental procedures under general anesthesia

Exclusion Criteria:

* Children who already have adequate IV access

Primary outcomes:
measure: Mean change in peripheral vein diameter
timeFrame: at 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jonathan Gamble, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646354: To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Hypertension
Primary Hypercholesterolaemia
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 125
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia

Detailed description: This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.

This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 19
* Patients with Essential Hypertension and Primary Hypercholesterolemia

Exclusion Criteria:

* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
* Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: baseline and week 8
measure: Mean sitting systolic blood pressure (MSSBP)
timeFrame: baseline and week 8
Secondary outcomes:
measure: change of other Lipid profile
timeFrame: 0, 4, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
References:
Clinical trial NCT05300854: Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief
Official title: Serratus Anterior Plane Block Versus Paravertebral Plane Block for Post Thoracotomy Pain Relief: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 60
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: This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB.


Eligibility criteria: Inclusion Criteria:

* patients more than 18 ys undergoing thoracotomy operation

Exclusion Criteria:

* morbid obesity (Body mass index \> 40)
* impossibility of anatomical structures US identification in a satisfactory way
* opioids treatment before surgery or substance abuse,
* sepsis and/or infection at the puncture sites

Primary outcomes:
measure: prevention of post-operative pain
timeFrame: 72 hours
measure: reduction of analgesic requirement
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
Clinical trial NCT05147454: MRI & QST Analysis in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain
Official title: Assessing Somatosensory System Damage in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain Through Neuroimaging and Quantitative Sensory Testing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Facial Pain
Lead sponsor: Walton Centre NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients attending The Walton Centre Clinics

Brief summary: Patients with a definite diagnosis of classical TGN and PIFP will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with MRI measures.

Detailed description: Patients with a definite diagnosis of classical TGN and PIFP (according to the 2020 ICOP Classification) will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with the presence and the geometry of neurovascular compression at MRI. Moreover quantitative structural neuroimaging analysis, such as trigeminal root volume, will be performed in each patient and correlated with clinical and QST data.

Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia or Persistent Idiopathic Facial Pain according to the latest ICOP 2020 Criteria
* Naive to any surgical procedures

Exclusion Criteria:

* Any major chronic painful or other neurological disease
* Diagnosis of Secondary Trigeminal Neuralgia
* Diagnosis of other facial pain syndromes
* Cognitive disturbances

Primary outcomes:
measure: Sensory Profile
timeFrame: Baseline, at the time of visit
Secondary outcomes:
measure: Presence of Neurovascular Compression
timeFrame: Baseline, at the time of visit
measure: Trigeminal Root Volume
timeFrame: Baseline, at the time of visit
measure: Geometry of Neurovascular Compression
timeFrame: Baseline, at the time of visit
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02210351: Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
Official title: Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Symptomatic Aortic Stenosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-08-06
Enrollment: 45
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: The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.


Eligibility criteria: Inclusion Criteria:

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography.
2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
3. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Inability to sign written informed consent.
2. Abnormal Apical dysfunction at baseline
3. LVEF \< 20%
4. Pregnancy or breast feeding.
5. Need for emergency surgery for any reason.
6. Any case in which the practicing physician asserts that enrollment in the protocol will

Primary outcomes:
measure: Change in left ventricle ejection fraction
timeFrame: two months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Leviev Heart Center, Sheba Medical Center
Study officials:
References:
Clinical trial NCT02974751: Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Official title: Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: BPH
Keywords: Aquablation
AQUABEAM
BPH
LUTS
Lead sponsor: PROCEPT BioRobotics
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 178
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.

Brief summary: The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).


Eligibility criteria: Inclusion Criteria:

* Male.
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
* Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
* Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
* History of gross haematuria.
* Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
* Contraindication to both general and spinal anesthesia.
* Any severe illness that would prevent complete study participation or confound study results.
* Subject is unwilling to accept a transfusion should one be required.

Primary outcomes:
measure: IPSS score change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Surrey
Study officials:
References:
Clinical trial NCT03455751: Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
Official title: Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Diverticular Disease
Crohn Disease
Ulcerative Colitis
Keywords: Pain Management
Pharmacogenomics
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 10
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: SUPPORTIVE_CARE

Brief summary: The primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Subject capable of giving consent
* Age 18-80
* Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)

Exclusion Criteria:

* Patient does not speak English
* Patient with substance-use disorder (including alcohol)
* Patient diagnosed with major depression
* Patient currently taking opioids
* Previous long-term opioid use (\> 3 months)
* Previous opioid use with a dose of \>100 milligram morphine equivalent (MME)
* Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
* Documented allergy to pain medication

Primary outcomes:
measure: Post-operative opioid use
timeFrame: Post-op day 1
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: Post-op day 1
Secondary outcomes:
measure: Length of stay
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Functional status
timeFrame: 4 weeks and 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: David Liska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706351: Arabic Version of Identification of Functional Ankle Instability Questionnaire
Official title: The Arabic Version of Identification of Functional Ankle Instability Questionnaire(IdFAI-Ar)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment
Keywords: Arabic
questionnaire
ankell instability
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female college students

Brief summary: Testing the validity and reliability of IdFAI

Detailed description: reliability \& validity of Identification Functional Ankle Instability Questionnaire (IdFAI) Arabic version were assessed in reference to Lower Extremity Functional Scale among repeated ankle sprains college students in Cairo. These college students were randomly selected from different colleges in Cairo University

Eligibility criteria: Inclusion Criteria:

* eighty six male and female college students will voluntarily participate in the study

Exclusion Criteria:

* Previous ankle surgery.
* History of any ankle surgery.
* History of fracture within the last 6 months.
* Been involved in any previous strengthening or athletic training program.

Primary outcomes:
measure: Validity
timeFrame: 3 months
measure: Reliability
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03984851: Hemostasis Using Surgicel in Pediatric Tonsillectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsil; Injury
Surgical Blood Loss
Keywords: tonsillectomy
primary hemostasis tonsillectomy
surgicel
Lead sponsor: Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 203
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any patient under the age of 12 who underwent tonsillectomy due to either recurrent tonsillitis or OSA by the 3 consultant otolaryngology surgeon authors in the study

Brief summary: Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy. The patient that were enrolled in this retrospective study were patients who underwent tonsillectomy and achieved hemostasis either by Surgicel (group A) or bipolar cautery (group B). Our results showed that there was no statistical significant difference between the two techniques in terms of post-operative bleeding events.

Detailed description: Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy.

The study was a retrospective cohort in three tertiary care centers in xxxx, from January 2016 to August 2018. All patients underwent at least tonsillectomy, with a proportion undergoing additional adenoidectomy, myringotomy, or tube insertion as indicated, were enrolled in the study. Patients were stratified to 2 groups according to the surgeons preference for the hemostasis technique, one was subjected to cold dissection tonsillectomy and achieved hemostasis via the application of Surgicel to the surgical site, and the other underwent cold dissection tonsillectomy and attained hemostasis through bipolar cautery.

Eligibility criteria: Inclusion Criteria:

* Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy
* patients must have went tonsillectomy

Exclusion Criteria:

* age more than 12

Primary outcomes:
measure: Primary Post-operative tonsillectomy bleeding
timeFrame: 24 hours post-op
measure: Secondary Post-operative Tonsillectomy bleeding
timeFrame: after 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: