louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06770478: A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours
Official title: 68Ga-MY6349 A Clinical Study of the Diagnostic Efficacy of PET/CT for Tumours of Epithelial Origin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumour of Epithelial Origin
68Ga-MY6349
Keywords: 68Ga-PSMA
68GA-MY6349
18F-FDG
PET/CT
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: before-after study in the same patient
Primary purpose: DIAGNOSTIC

Brief summary: This is a study using an autocontrol approach, enrolling 40 patients with tumours of epithelial origin, who underwent 68Ga- MY6349 and 68Ga-PSMA/18F-FDG PET/CT imaging of patients with tumours of epithelial origin to compare the ability to diagnose, stage and monitor recurrence of tumours of epithelial origin using the pathological findings as the gold standard.


Eligibility criteria: Inclusion Criteria:

- Age ≥ 18 years; Patients with pathologically confirmed tumour and proposed surgical resection/exploration (including primary or recurrent metastatic tumour); Expected survival \> 3 months, as judged by the doctor; Voluntarily sign the informed consent form; willing and able to follow the study protocol

Exclusion Criteria:

- Persons with a known history of hypersensitivity to 68Ga-MY6349 and 68Ga-PSMA or 18F-FDG and their excipients; Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); Patients who have received anti-tumour therapy before the examination or neoadjuvant chemotherapy/targeted therapy for tumour reduction after the examination and up to the preoperative period; Pregnant and lactating women; Practitioners who need to be exposed to radioactive conditions for a long time; Serious diseases of heart, kidney, lung, vascular, neurological and psychiatric systems, immunodeficiency diseases and hepatitis/cirrhosis; Have participated in other interventional clinical trials within 1 month prior to screening; Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.

Primary outcomes:
measure: Maximum Standardized uptake value (SUVmax)
timeFrame: 1 day from injection of the tracer
measure: Tumor to Background Ratio(TBR)
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China
state: Shaanxi
Study officials:
References:
Clinical trial NCT02943278: Sleep Therapy for Insomnia and Depression
Official title: Sleep Therapy for Insomnia and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Insomnia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to see how these sleep therapies help insomnia in people with depression.

Detailed description: The first group is the sleep hygiene group. If you are assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things you can do to improve your sleep.

The second group is the intensive sleep retraining group. If you are in this group you will spend about 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period you will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes if you fall asleep.

For both groups, after the treatment session, you will complete questionnaires online and talk with a study clinician who will ask you questions about your mood every two weeks for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Experiencing depression
* Experiencing chronic insomnia
* Have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. This medication must be prescribed by a doctor at the University of Michigan. OR not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks.

Exclusion Criteria:

* Have psychiatric conditions or sleep disorders other than depression or insomnia
* Have a chronic medical condition that could negatively affect your sleep or mood
* Are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)

Primary outcomes:
measure: Change from Baseline Score of the Hamilton Depression Rating Scale at 8 weeks
timeFrame: 8 weeks after administration of intervention
Secondary outcomes:
measure: Change from Baseline Score of the Insomnia Severity Index at 8 weeks
timeFrame: 8 weeks after administration of intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leslie Swanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00130078: Trial of SAVVY Vaginal Gel and HIV in Nigeria
Official title: Randomized Controlled Trial of SAVVY and HIV in Nigeria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV Seronegativity
HIV transmission
Lead sponsor: Biosyn
Sponsor class: INDUSTRY
Collaborators: name: FHI 360
name: United States Agency for International Development (USAID)
First posted: 2005-08-15
Enrollment: 2142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Detailed description: Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Eligibility criteria: Inclusion Criteria:

* 18 to 35 year old women
* HIV negative
* More than one sexual partner in past 3 months
* Average 3 coital acts per week
* Willing to use vaginal gel and condoms for 12 months

Exclusion Criteria:

* HIV positive
* Pregnant

Primary outcomes:
measure: Combined incidence of HIV-1 and HIV-2
Secondary outcomes:
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: Department of Medical Microbiology & Parasitology, College of Medicine, University of Ibadan
city: Lagos
country: Nigeria
facility: Nigerian Institute of Medical Research
Study officials:
affiliation: FHI 360
name: Paul Feldblum
role: STUDY_CHAIR
References:
citation: Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, Olayemi MO, Wang L, Nanda K, Rountree W. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS One. 2008 Jan 23;3(1):e1474. doi: 10.1371/journal.pone.0001474.
Clinical trial NCT06974578: Capsular Tension Ring With Hydeophilic Intraocular Lesnes to Decrease Posterior Capsule Opacification Versus Hydrophobic Ones
Official title: Assessment of the Outcomes of Routine Insertion of Capsular Tension Ring (CTR) With Hydrophilic Versus Hydrophobic Intraocular Lenses (IOLs) Alone After Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Lens Complication
Keywords: CTR
IOLs
Phacoemulsification
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: evaluate the clinical outcomes of routine CTR insertion in conjunction with hydrophilic versus hydrophobic IOLs following phacoemulsification.

Detailed description: Phacoemulsification with intraocular lens (IOL) implantation is the standard surgical approach for cataract extraction. The choice between hydrophilic and hydrophobic IOLs has been debated, with studies suggesting differences in posterior capsule opacification (PCO) rates and capsular bag stability. Capsular tension rings (CTRs) are devices designed to stabilize the capsular bag, particularly in cases with zonular weakness. While CTRs are beneficial in complex cases, their routine use remains controversial. Understanding the interaction between CTRs and IOL materials could inform surgical practices and improve patient outcomes

Eligibility criteria: Inclusion Criteria:

* • Adults aged 40-80 years.

  * Visually significant cataract (≥3+ on Lens Opacities Classification System III "LOCSIII").
  * Clear cornea.

Exclusion Criteria:

* • Previous ocular surgery.

  * Zonular instability requiring CTR insertion beyond routine practice.
  * Complicated cataract cases (e.g., traumatic cataract).
  * Active intraocular inflammation or infection.

Primary outcomes:
measure: Change in BCVA (LogMAR)
timeFrame: at 1, 3, and 6 months postoperatively.
measure: Refractive error measurements (spherical equivalent)
timeFrame: at 1, 3, and 6 months postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Faculty of Medicine
Study officials:
References:
Clinical trial NCT00590278: A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
Official title: A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inoperable or Recurrent Rectal Cancer
Keywords: Tomudex
inoperable rectal cancer
recurrent rectal cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-01-10
Enrollment: 49
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 pilot study is designed to investigate the value of Neo-adjuvant Tomudez in combination with radiotherapy in patients with inoperable or recurrent rectal cancer in terms of response rate and increasing the resectability of initially inoperable rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of inoperable/recurrent rectal cancer
* Age \> 18 years
* At least 1 measurable lesion should be present
* WHO performance score \< 2
* Life expentancy of at least 12 weeks
* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
* Documented informed consent to participate in the trial

Exclusion Criteria:

* Previous systemic chemotherapy
* Previous radiotherapy to the planned exposure area
* Subjects with distant metastases
* (a)white blood cell \< 4.0x109/L (unless absolute neutrophil count is \>2.0x109/L or (b) Platelet count \< 100x109/L
* Serum creatinine above the upper limit of the normal range
* (a) Serum bilirubin \> 1.25 times the upper limit of the normal range or (b) Asparate aminotransferase(AST) or Alanine amiontransferase (ALT) \>2.5 times the upper limit of the normal range
* Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial period
* Pregnancy or breast feeding. Women of childbearing age must use effective contraception
* Previous or current malignancies at other sites, with the exception of adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
* Patient participation in other studies

Primary outcomes:
measure: This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Research Site
Study officials:
affiliation: Okmeydani Hospital Istanbul
name: Tayfun Hancilar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03508778: Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)
Official title: CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular lens
Eye surgery
Lead sponsor: PowerVision
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.

Detailed description: Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.

Eligibility criteria: Key Inclusion Criteria:

* Require cataract extraction by phacoemulsification;
* Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
* Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.

Key Exclusion Criteria:

* Use of current medications that may affect accommodation or confound study results;
* Systemic disease that may increase the operative risk or confound results;
* Ocular conditions or degenerative disorders that may predispose the subject to future complications;
* Monocular subjects or significant permanent visual function loss in 1 eye;
* Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.

Primary outcomes:
measure: Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
timeFrame: Month 6 postoperative
Secondary outcomes:
measure: Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
timeFrame: Month 6 postoperative
measure: Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
timeFrame: Month 6 postoperative
measure: Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
timeFrame: Month 6 postoperative
Other outcomes:
Locations:
city: Somerset West
country: South Africa
facility: PowerVision Investigative Site
Study officials:
References:
Clinical trial NCT03117478: Brain and Mindfulness
Official title: The Impact of Meditation Practice on Attention and Emotion Regulation :Studies on Neural Correlation in Brain Imagery and Biomarkers of Stress and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 169
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. By investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG), ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI; including Diffusion tensor - DTI). These brain measures will then be linked to behavioral measurements. Experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.


Eligibility criteria: Inclusion Criteria:

* Age : 25-70
* Being affiliated to a social security system.
* Motivated to participate in this study.

Exclusion Criteria:

* Medication acting on the central nervous system
* Opioids, Antidepressive Agents.
* Actual or previous neurological or psychiatric illnesses
* Chronic pain or any other medical condition which is related to pain or an increased sensitivity to pain.
* Not having a personal or family history of epilepsy
* Alcohol or drugs consumption 2 days before or during the study.

Primary outcomes:
measure: Anatomical MRI scan
timeFrame: Day 1
measure: Functional MRI scan
timeFrame: Day1
measure: EEG
timeFrame: Day 1
Secondary outcomes:
measure: Behavioral measure : Accuracy of the performed task actions
timeFrame: Day 1
measure: Psychophysics: Pain threshold
timeFrame: Day 1
measure: Psychophysiology : Respiration
timeFrame: Day 1
measure: Subjective experience of the participant
timeFrame: Day 1
measure: Studies biomarkers of inflammation
timeFrame: Day 1
measure: Behavioral measure : Speed of the performed task actions
timeFrame: Day 1
measure: Psychophysiology : Heart
timeFrame: Day 1
measure: Psychophysiology : Heart rate variability
timeFrame: Day 1
measure: Psychophysiology : Muscles
timeFrame: Day 1
measure: Psychophysiology : Eyes
timeFrame: Day 1
measure: Psychophysiology : Pupillar response
timeFrame: Day 1
measure: Electrogastrogram
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Le Vinatier
Study officials:
affiliation: Le Vinatier
name: Sandrine SONIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938778: Think FAST Research Study
Official title: Prolonged Nightly Fasting (PNF) in Older Adults With Age-related Cognitive Decline: A Pilot Study Exploring Changes in Neurocognitive Function (Public Name:Think FAST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).


Eligibility criteria: Inclusion Criteria:

* 65 or older
* Self-identified age-related cognitive decline (ARCD)
* Has a text capable phone and access to wifi

Exclusion Criteria:

* Diagnosed with an eating disorder in the past 20 years
* Works a night shift
* Cannot participate in a 14 hour fast
* Has diabetes

Primary outcomes:
measure: Memory and Attention Phone Screener (MAPS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Rapid Eating Assessment for Participants Scale (REAPS)
timeFrame: 8 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 8 weeks
measure: Mindful Eating Scale (MES)
timeFrame: 8 weeks
measure: Creature of Habit Scale (COHS)
timeFrame: 8 weeks
measure: Salivary Cortisol
timeFrame: 8 weeks
measure: Body Mass Index (BMI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT04295278: Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
Official title: An Observational Phase 0 Study to Assess the Performance and Real-world Feasibility of Implementing the MicroKine Dx Biomarker-based Risk Stratification of Critically-ill Pediatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Organ Failure
Lead sponsor: PreDxion Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-04
Enrollment: 25
Sex: ALL
Minimum age (years): 38
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric critically-ill patients 38-weeks gestation to 21 years of age admitted to a pediatric intensive care unit within the last 24-hours, with \>1 indwelling central catheter, and meeting ≥2 age-adapted SIRS criteria.

Brief summary: This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

Detailed description: This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.

Eligibility criteria: Key Inclusion Criteria:

1. Age 38 weeks gestation to 21 years of age
2. Admitted to the PICU within the prior 24 hours
3. Indwelling catheters for obtaining blood
4. Meet ≥2 age-adapted SIRS criteria

Key Exclusion Criteria:

1. Anticipated pediatric intensive care unit admission \<24 hours
2. Primary immunodeficiency
3. Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PreDxion Bio, Inc.
name: Clinical Trial Information
role: STUDY_DIRECTOR
References: