louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05102292: The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
Official title: An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Anaplastic Thyroid Cancer
ATC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 25
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 was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).


Eligibility criteria: Inclusion Criteria:

1. Age\>=18Y;
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Advanced BRAF V600 ATC that have been diagnosed histologically;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Previous treatment with BRAF inhibitors or MEK inhibitors;
3. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin;
4. Severe active infections requiring systemic anti-infective therapy.

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Affiliated Oncology Hospital
Study officials:
References:
Clinical trial NCT06189092: Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Official title: Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Malformations
Keywords: Electrosclerotherapy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by low-flow vascular malformations

Brief summary: Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
* Non-indication for embolizing treatment
* Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.

Exclusion Criteria:

* Previous treatment for \< 30 days
* Pregnancy and lactation status
* Patients of childbearing age without contraceptive use
* Presence of metal synthetic media
* COPD with FiO2 \< 30 mmHg
* Impaired renal function with eGFR\<30 ml/min/1.73mq
* Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
* Patients who have already received a cumulative dose of Bleomycin ≥100 mg
* Patients who have undergone prior thoracic radiotherapy
* Patients with a history of seizures and epilepsy

Primary outcomes:
measure: Volume reduction in cm
timeFrame: 1 year
Secondary outcomes:
measure: Reduction of pain (VAS score)
timeFrame: 1 year
measure: Improvement in quality of life ( EuroQol-5D questionnaire)
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Emilia Romagna
Study officials:
References:
Clinical trial NCT06446492: Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
Official title: Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Understanding of Consent in Clinical Research
Implementation of Video-Consent in Clinical Research
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).


Eligibility criteria: Inclusion Criteria:

* Parents/legal guardians of extremely preterm infants (\<28 weeks gestational age or \<1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298)

Exclusion Criteria:

* Parents/legal guardians deaf or blind
* Parents/legal guardians unable to consent for the VIDES study

Primary outcomes:
measure: ViDES trial consent rate
timeFrame: Within 1 week of the intervention
measure: Participants' understanding of the ViDES study as assessed by a questionnaire
timeFrame: Within 48 hours of the intervention
measure: Participants' satisfaction with consent approach as assessed by a questionnaire
timeFrame: Within 48 hours of the intervention
measure: Participant's opinions related to participation in research as assessed by a questionnaire
timeFrame: Within 48 hours of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: McGovern Medical School at UTHealth Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houston (UTHealth Houston)
name: Maria del Mar Romero López, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791192: Study of FTY720 in Patients With Uveitis
Official title: A Multicenter, Randomized, Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of FTY720 in Patients With Acute, Noninfectious Intermediate, Posterior and Pan Uveitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Noninfectious Posterior, Intermediate, or Pan Uveitis
Keywords: Uveitis, Fingolimod, Phase II, Visual Acuity, Vitreous Haze, OCT
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and efficacy of FTY720 in patients with acute, noninfectious intermediate, posterior and pan uveitis


Eligibility criteria: Inclusion Criteria:

* Acute noninfectious posterior, intermediate, or pan uveitis
* Vitreous haze score of 1+ or more in the study eye at screening and baseline visits

Exclusion Criteria:

* Vaso-occlusive vasculitis involving the retinal macula
* Behçet's uveitis
* Patients requiring corticosteroid or another systemic immunosuppressive medication for any other disease (e.g., asthma or some other autoimmune disease) that would contraindicate tapering (topical steroids permitted)
* Other protocol defined inclusions and/or exclusions may apply.

Primary outcomes:
measure: Change in Vitreous Haze Score in the Study Eye at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Change in Vitreous Haze Score in the Study Eye on Study Examination Days
timeFrame: Days 2, 4, 29, 57
measure: Changes in Visual Acuity (Number of letters) in the Right and Left Eyes on Study Examination Days
timeFrame: Days 2, 4, 8, 29 and 57
measure: Changes in Macular Thickness (Thickness at the Center of the Retina) in the Right and Left Eyes on Study Examination Days
timeFrame: Days 2, 4, 8, 29 and 57
measure: Measures of the Safety and Tolerability of the Study Medication FTY720; Also Measures of Whether the Patients Required Rescue Medication for their Uveitis.
timeFrame: Days 2, 4, 8, 29 and 57
measure: Levels of FTY720 and FTY720-P Blood Concentrations Measured in the Patients on Study Examination Days
timeFrame: Days 2, 29 and 57
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01229592: Ethanol in the Prevention of Central Venous Catheter Infections
Official title: Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheter Related Infection
Keywords: infection
catheter
bacteriaemia
ethanol
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success \[1-10\].

Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.

Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.

Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).

Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).


Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* Signed informed consent
* central Venous catheter more than 48 hours placed

Exclusion Criteria:

* pregnancy
* denial Informed consent Form
* ethanol intolerance
* Liver cirrhosis

Primary outcomes:
measure: catheter infectionrelated incidence rates
timeFrame: 2 years
Secondary outcomes:
measure: cathether bacteriaemia related rate
timeFrame: 2 years
measure: antimicrobial consume
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Microbiología y Enfermedades Infecciosas. Hospital GU Gregorio Marañon
Study officials:
References:
citation: Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Rabadan PM, Pernia MS, Bouza E. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial. PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.
Clinical trial NCT01278992: Rhodiola Rosea for Mental and Physical Fatigue
Official title: A Randomized Trial of Rhodiola Rosea for Mental and Physical Fatigue in Nurses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fatigue
Keywords: fatigue
adaptogen
Rhodiola rosea
Lead sponsor: Government of Alberta
Sponsor class: OTHER_GOV
Collaborators: name: University of Alberta
First posted: 2011-01-19
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this trial is to assess whether Rhodiola rosea improves fatigue when compared to placebo in nurses involved in shift work.


Eligibility criteria: Inclusion Criteria:

* Fourth year nursing students enrolled in NURS 495 (Nursing Practice)
* Participating in permanent overnight (between 11 pm and 7 am) or rotating shift work
* otherwise healthy
* consent to participate in the study

Exclusion Criteria:

* nurses aged 18 years or younger
* breastfeeding or pregnant women, as confirmed by a blood test
* female participants with child bearing potential not practicing a form of birth control throughout the trial
* presence of a primary medical condition associated with fatigue (e.g. cardiac, gastrointestinal, respiratory, renal, rheumatologic, or oncologic disease)
* presence of schizophrenia, bipolar disorder, dementia, eating disorders, insomnia or substance abuse
* presence of diabetes
* concurrent utilization of hypoglycaemic or agents for raising or lowering blood pressure
* known allergy or hypersensitivity to Rhodiola rosea or Sedum family extracts or pollen
* know allergy to microcrystalline cellulose or silicone dioxide
* concurrent utilization of stimulant drug such as methylphenidate (Ritalin), amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and pemoline (Cylert)
* concurrent utilization of other rhodiola or ginseng products (both fall in the same therapeutic category known as an "adaptogen")
* any significant medical condition
* any neurological or mental health condition
* taking medication that has central nervous system effects
* aged 55 years or older
* low blood pressure or history of significant dizziness

Primary outcomes:
measure: Fatigue
timeFrame: 42 days
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 42 days
measure: Individualized Outcomes
timeFrame: 42 days
measure: Adaptive Capacity
timeFrame: 42 days
measure: Adverse Event Monitoring
timeFrame: 42 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD FRCPC MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Punja S, Shamseer L, Olson K, Vohra S. Rhodiola rosea for mental and physical fatigue in nursing students: a randomized controlled trial. PLoS One. 2014 Sep 30;9(9):e108416. doi: 10.1371/journal.pone.0108416. eCollection 2014.
Clinical trial NCT04336592: Pain Management Intervention Preparatory to a Future Pragmatic Trial
Official title: Pilot Testing a Pain Management Intervention Preparatory to a Future Pragmatic Trial (NOHARM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Pharmacological Pain Management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-04-07
Enrollment: 128
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 scheduled to receive a surgical procedure at Mayo Clinic and their clinicians involved in the care.

Brief summary: Researchers are promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure at Mayo Clinic.

Detailed description: This is a pilot study to test promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure. This pilot study will confirm the feasibility of patient-facing as well as clinician-facing decision support components of an electronic health record (EHR) imbedded evidence-based bundle.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to receive a surgical spine procedure at Mayo Clinic
* Surgeons, Physician pain specialists and allied health caring for patients meeting patient inclusion criteria

Exclusion Criteria:

* None

Primary outcomes:
measure: Non-Pharmacological options participation
timeFrame: 1 month post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Mankato
country: United States
facility: Mayo Clinic Health System in Mankato
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System - Eau Claire
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System - Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Jon Tilburt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06901492: The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture
Official title: The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PSMA PET/CT
Prostate Cancer
MpMRI
Keywords: Prostate cancer
PSMA PET/CT
mpMRI
Prostate biopsy
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy


Eligibility criteria: Inclusion Criteria:

1. Age ≥40 years, male;
2. Serum PSA level 4-20 ng/mL;
3. Serum PSA level 4-20 ng/mL;
4. No contraindications to PSMA-PET/CT or MRI;
5. Signed informed consent.

Exclusion Criteria:

1. Serum PSA \>20 ng/mL;
2. History of prostate surgery/radiotherapy;
3. Acute prostatitis;
4. Coagulation disorders or active infection;
5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions;
6. Allergy to local anesthetics;
7. Inability to tolerate the biopsy procedure.

Primary outcomes:
measure: Biospy outcome
timeFrame: 12 months
Secondary outcomes:
measure: Duration of puncture operation
timeFrame: 12 months
measure: Patient's pain level
timeFrame: 12 months
measure: Blood loss
timeFrame: 12 months
measure: Complication
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05593692: Gender Differences and Age Related Differences in Emergency Department Admission
Official title: Gender Differences and Age Related Differences in Emergency Department Admission
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergencies
Gender
Age Problem
Keywords: sex
gender
age
emergency department
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to ED

Brief summary: The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

Detailed description: Objectives: Medicine is progressively becoming aware of the clinical difference among patients who present different age, gender, and comorbidities. Our goal is to examine how often different groups of patients access the Emergency Department and for which causes, as well as their different hospitalization and death rates.

Materials and methods: The investigators will collect and analyze data from all patients evaluated at the emergency department of "Fondazione Policlinico Agostino Gemelli" and "Istituto Clinico Humanitas di Milano" from January 2014 to December 2023, the sample obtained will be divided into four groups: younger than 50 years old, 50-65 years old, 66.75 years old, older than 75; each of these groups is divided between males, females and people who do not identify with either of those genders

Eligibility criteria: Inclusion Criteria:

* Age over 18 y
* Admitted to emergency department

Exclusion Criteria:

* Age under 18 y

Primary outcomes:
measure: Death
timeFrame: 30 days
Secondary outcomes:
measure: length of stay
timeFrame: 180 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCSS Fondazione Policlinico Agostino Gemelli
state: Lazio
Study officials:
References:
Clinical trial NCT05674292: An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Official title: An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumference Reduction
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 25
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 clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.

Detailed description: The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.

Eligibility criteria: Inclusion Criteria:

* BMI is 30 or less
* 18 years of age or older

Exclusion Criteria:

* Pregnant
* Open wounds (sores, cuts, ulcers, etc.)
* Individuals with or being treated for any cancerous growth

Primary outcomes:
measure: Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomfield Hills
country: United States
facility: Tracey Hishon
state: Michigan
city: Marquette
country: United States
facility: Jamie Thayer
state: Michigan
Study officials:
References: