louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06451042: FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
Official title: FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma Multiforme
Keywords: FET-PET
Glioblastoma
GBM
0-(2-18F-Fluoroethyl)-L-Tyrosine (FET)
Glioma
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 15
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 both males and females over 18 years of age post maximally safe resection of glioblastoma multiforme and intent to treat with stereotactic radiation.

Brief summary: Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.


Eligibility criteria: Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to participate in this study:

* ≥ 18 years of age
* Diagnosis of glioblastoma multiforme
* Post-maximally safe surgical resection
* No prior radiation or systemic treatment for high grade glioma
* Able to tolerate PET/MRI scan with intravenous contrast
* Willing to provide informed consent

Exclusion Criteria:

All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:

* MRI contraindication
* Creatinine clearance \< 30mL/min
* Inability to lie still for 60 minutes
* Gadolinium allergy
* Positive pregnancy test
* Breastfeeding
* Patient unable to follow the protocol for any reason

Primary outcomes:
measure: Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Difference in pre- and post-treatment metabolic tumor volume as determined by FET-PET.
timeFrame: 12 months
measure: Overall and recurrence-free survival post radiation treatment.
timeFrame: 12 months
measure: Quality of life changes pre and post radiation treatment.
timeFrame: 12 months
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Amit Singnurkar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06986642: Core Stability Exercises and General Exercises in Patients With Low Back Pain
Official title: Effectiveness of Core Stability Exercises and General Exercises in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effectiveness of core stability exercises and general exercises in patients with low back pain

Detailed description: The study focuses on understanding core stability exercises and general exercises in patients with low back pain Low back pain (LBP) is an common state with a lifetime occurrence reported to be as high as about 80% . About 5-10% of patients have chronic pain (cLBP), responsible for high direct and indirect (lost production and lost household productivity) costs highly person suffering from disability

Eligibility criteria: Inclusion Criteria:

1. Adults (30-45 years)
2. Chronic low back pain (\>3 months)
3. Pain intensity ≥ 4/10 on Numeric Pain Rating Scale (NPRS)
4. Ability to perform exercises
5. Willingness to participate and provide informed consent
6. No planned spinal surgery or injection within study duration

Exclusion Criteria:

1. Severe spinal pathology (fracture, tumor, infection)
2. Neurological deficits (numbness, weakness, paralysis)
3. Recent spinal surgery or injection (\<6 months)
4. Pregnancy or breastfeeding
5. . Severe mental health conditions (e.g., depression, anxiety)

Musculoskeletal Conditions:

1. Severe osteoporosis
2. Spinal stenosis
3. Scoliosis
4. Recent musculoskeletal injury (\<6 months)
5. Fibromyalgia or widespread pain syndr

Primary outcomes:
measure: Numerical rating scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Back pain functional score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Malakand
country: Pakistan
facility: Riphah international University malakand campus
state: KPK
Study officials:
affiliation: Riphah International University
name: Ataur Rahman, MS-PT (CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07007806: Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir
Official title: A Phase 1, Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Omeprazole on the Single-Dose Pharmacokinetics of Bemnifosbuvir/Ruzasvir Fixed-Dose Combination in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR)


Eligibility criteria: Inclusion Criteria:

* Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18.5-30 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: PK of BEM/RZR
timeFrame: Day 1, 8, 13, 18
measure: PK of BEM/RZR
timeFrame: Day 1, 7, 8, 13, 18
measure: PK of Omeprazole
timeFrame: Day 7, 8
measure: PK of Omeprazole
timeFrame: Day 7, 8
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Atea Study Site
state: California
Study officials:
References:
Clinical trial NCT03428906: Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks
Official title: Effects of Intranasal Oxytocin on Male's Functional Brain Network in Resting-state and Tasks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: intranasal oxytocin
functional brain network
multiple tasks
resting state
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.

Detailed description: In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* with MRI Contraindications

Primary outcomes:
measure: Functional network organization alterations in brain under resting state fMRI after drug administration
timeFrame: 70~85 minutes after drug administration
measure: Behavior,brain activities and representation patterns in the emotional judgement task after drug administration
timeFrame: 60~75 minutes after drug administration
measure: Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration
timeFrame: 35~60 minutes after drug administration
measure: Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration
timeFrame: 60~85 minutes after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Brain and Cognitive Sciences, Beijing Nornal University
state: Beijing
Study officials:
affiliation: School of Brain and Cognitive Sciences, Beijing Nornal University
name: Yina Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00037206: A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).
Official title: An Open Label Non-Comparative Study of the Safety and Efficacy of Intravenous Anidulafungin Plus AmBisome® [(Amphotericin B) Liposome for Injection] as a Treatment for Invasive Aspergillosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aspergillosis
Keywords: Invasive Aspergillosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Vicuron Pharmaceuticals
First posted: 2002-05-17
Enrollment: 30
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 combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
* Life expectancy: greater than 72 hours

Exclusion Criteria:

* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
* Aspergilloma-in the absence of invasive disease
* Abnormal blood chemistries:

Bilirubin \> 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)\> 5 times the upper limit of normal

* Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
* Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Versicor, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05918406: Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya
Official title: A Phase 4, Single Center, Open Label Study Evaluating the Safety of the Nasal Guide Utilized During Administration With Tyrvaya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keratoconjunctivitis Sicca
Lead sponsor: Oyster Point Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

Detailed description: Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age
2. Have provided verbal and written informed consent
3. Willing to comply with all study related visits and procedures

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Edison
country: United States
facility: United States, New Jersey
state: New Jersey
city: Woodland Park
country: United States
facility: United States, New Jersey
state: New Jersey
Study officials:
affiliation: Oyster Point Pharma
name: Marian Macsai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02022306: TD-6450 SAD and MAD in Healthy Subjects
Official title: A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hepatitis C
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level \>40 IU/L
* Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Exclusion Criteria:

* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has an estimated creatinine clearance of \<90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Primary outcomes:
measure: Adverse events
timeFrame: 28 days max
Secondary outcomes:
measure: Cmax
timeFrame: 28 days max
measure: Tmax
timeFrame: 28 days max
measure: AUC
timeFrame: 28 days max
measure: T1/2
timeFrame: 28 days max
measure: Food effect on AUC value
timeFrame: 15 days max
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00367406: Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
Official title: Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pertrochanteric and Subtrochanteric Femur Fractures
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-08-22
Enrollment: 100
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: Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail.

Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.


Eligibility criteria: Inclusion Criteria:

* Pertrochanteric or subtrochanteric femur fracture

Primary outcomes:
measure: Consolidation of the fracture
timeFrame: From surgery untill healing
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: René Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929706: Pre-genotype NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease
Official title: Effectiveness of Thiopurine Dose Optimization by NUDT 15 R139C on Reducing Thiopurine-induced Leucopenia in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thiopurine-induced Leukopenia
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
First posted: 2016-10-11
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: NUDT15 R139C was comfirmed to be associated with thiopurine-induced leukopenia inflammatory bowel disease (IBD) cohort.The present study aim to explor the following questions:can optimizing thiopurine dose by NUDT15 genotype reduce thiopurine-induced leucopenia?What is the influence of this optimizing strategy on clinical outcome?Thus,we conduct a randomised controlled study.Subject in the conventional group detect NUDT15 genotype before thiopurine use and optimise dosage according to the genotype.While the subjects in the control group follow the conventional monitor strategy.The primary endpoint was the rate of leukopenia.The secondary endopoint was the efficacy of thiopurine.The follow up duration was 1 year.

Detailed description: We included patients diagnosis of IBD (\>18 yrs old) with indication of the use of thiopurine.Group A (intervention): AZA dose optimization by testing for NUDT15 R139C- testing results will be informed.Group B (control):AZA dose optimization according to standard guideline - testing results will not be informed.The participants will be followed for 9 month. The incidence of adverse events and efficacy will be analyzed.

Eligibility criteria: Inclusion Criteria:

* diagnosis of IBD with indication of the use of thiopurine

Exclusion Criteria:

* Contraindication of thiopurine
* Previous use of thiopurine
* co-treatment with 5-ASA or allopurinol

Primary outcomes:
measure: difference of incidence of leucopenia ADR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Chao K, Huang Y, Zhu X, Tang J, Wang X, Lin L, Guo H, Zhang C, Li M, Yang Q, Huang J, Ye L, Hu P, Huang M, Cao Q, Gao X. Randomised clinical trial: dose optimising strategy by NUDT15 genotyping reduces leucopenia during thiopurine treatment of Crohn's disease. Aliment Pharmacol Ther. 2021 Nov;54(9):1124-1133. doi: 10.1111/apt.16600. Epub 2021 Sep 25.
Clinical trial NCT06031506: Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants
Official title: Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants to Support Immediately Loaded Hybrid Prosthesis.One Year Evaluation of Occlusal Contact and Ridge Resorption
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph.

All implants will be surgically installed guided by steriolethognathic stents

- Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration.

Final prosthesis will be delivered 6-8 months later
Primary purpose: TREATMENT

Brief summary: This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants

Detailed description: The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.

Eligibility criteria: Inclusion Criteria:

* All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records.

Exclusion Criteria:

* All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.

Primary outcomes:
measure: patient satisfaction
timeFrame: one year
measure: marginal implant bone loss
timeFrame: one year
Secondary outcomes:
measure: posterior area index
timeFrame: one year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University ,Faculty of dentistry
Study officials:
References: