louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06759389: The VENTOR Clinical Study
Official title: The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest (CA)
Lead sponsor: CoLabs Medical
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during cardiopulmonary resuscitation (CPR) and respiratory arrests.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18-75 years, inclusive
2. IHCA (non-traumatic)
3. At least 4 feet in height

Exclusion Criteria:

1. Intubated with an endotracheal tube (ET)
2. Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
3. LAR or Family member objects to enrollment
4. Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
5. Responsive with an intact gag reflex
6. Blunt, penetrating, or burn-related injury, drowning, or electrocution
7. Known upper airway foreign body or mass
8. Lower airway obstruction
9. Dental gap of \< 2 cm
10. Ingested caustic substances
11. Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician.
12. Known esophageal disease or facial/perforating neck trauma defined as study candidates with the following medical history:

    1. Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures)
    2. Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil)
    3. Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood)
13. Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia)
14. History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation

Primary outcomes:
measure: Ability to provide oxygenation during CPR
timeFrame: From device insertion through 1 hour.
measure: Ability to provide ventilation during CPR
timeFrame: From device insertion through 1 hour
measure: Ability to provide oxygenation during CPR
timeFrame: From device insertion through 1 hour
measure: Number of participants with device-related adverse events
timeFrame: From device insertion through 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University Hospital
name: Jignesh Patel, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06461689: Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer
Official title: Comparison of Changes in Tumor Burden (Toral Tumor Volume [TMTV] and Total Lesion Activity [TLA]) in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in the Monitoring of Metastatic Castration-resistant Prostate Cancer Treated With 177Lutetium-PSMA-617
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer Metastatic
Keywords: prostate cancer
theragnostic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated with 177Lu-PSMA had post-therapy 68Ga-PSMA PET and 177Lu-PSMA-617 SPECT/CT.

Brief summary: To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Detailed description: Since few years, therapy by 177Lu-PSMA in nancy hospital began. A lot's of datas were collected. Prostate cancer is the number one killer in france and this is very important to find a diagnostic tool.

The hypothesis of this study is to demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

Eligibility criteria: Inclusion Criteria:

* patient who received a dose of 177lu-PSMA
* patient who had imaging by 68Ga-PSMA
* patient treated in Nancy hospital for its cancer prostate

Exclusion Criteria:

* no social security
* no acceptation to participating in retrospective study

Primary outcomes:
measure: Measurement of TMTV (total metabolic tumor volume)
timeFrame: 12 months
measure: Measurement of TLA (total lesion activity)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU de NANCY
Study officials:
References:
Clinical trial NCT01730989: Estromineral Serena Plus and Symptomatic Menopause
Official title: Controlled Clinical Study on the Activity of the Combination of Isoflavones, Agnocastus and Magnolia Extract in Menopause
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: menopause
Kupperman
hot flushes
isoflavones
magnolia
chaste tree
Lead sponsor: Rottapharm
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oestrogen hormone deficiency in menopause leads to symptoms of which hot flushes, night sweats, insomnia and mood changes are the most frequent and, ultimately, worsen the quality of life. The gradual decline of oestrogen from peri-menopause results in altered function of many neurotransmitters, such as dopamine, melatonin and neuropeptides including beta-endorphins, which modulate the function of the hypothalamus and are involved in body thermoregulation.

In post-menopause, dopaminergic activity is significantly reduced and stimulus of the D2 receptors is effective in relieving hot flushes and in reducing the accompanying psychological symptoms.

The use of hormone replacement therapy, which is generally prescribed in the case of moderate or severe symptoms, is limited due to real contraindications or simply the woman's refusal to take the therapy, despite the presence of symptoms requiring its use.

A food supplement, named Estromineral (E), based on natural ingredients such as isoflavones, the absorption of which is increased by the presence of Lactobacillus sporogenes, and Vitamin D3 and calcium, strengthening bone mineralization, has been found to be effective at reducing vasomotor symptoms.

To potentiate the effect of E on the most frequent symptoms in menopause, it was considered rational to add the extracts of magnolia, active on psycho-affective symptoms, and chaste tree, acting on both hot flushes and psychological symptoms and a new food supplement was developed: Estromineral Serena Plus (ESP).

Estromineral Serena Plus is an association of isoflavones with added Lactobacillus, chaste tree and magnolia, active on menopausal vasomotor symptoms and on psycho-affective symptoms.


Eligibility criteria: Inclusion Criteria:

* female menopausal age
* more than 5 hot flushes/day
* mood or sleep changes

Exclusion Criteria:

* hormone replacement therapy

Primary outcomes:
measure: Kupperman index
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Siena University
Study officials:
affiliation: Siena University
name: Vincenzo De Leo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06167889: A Study of Gender-specific Impact Factors on Elderly Disability and Cognitive Impairment
Official title: Gender-specific Impact Factors on Elderly Disability and Cognitive Impairment: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Elderly
Disability
Cognitive impairment
Gender-specific
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 23640
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The elderly aged 65 and above in the China Longitudinal Healthy Longevity Survey (CLHLS) database and the elderly with health care neurology visits recorded in Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform

Brief summary: Elderly disability and cognitive impairment rates were different between elderly man and woman. Sex-specific risk factors and observed gender differences across the lifespan were associated with different degrees of cognitive and activity of daily living function decline between men and women. However, some of these viewpoint remains controversial.

The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly.

Detailed description: With the rapid increase in the aging population in China, age-related cognitive impairment and disability has become a pressing public health concern. A number of large-scale studies in China and abroad have shown that the average life expectancy of women elderly is higher than men, but the rates of disability and cognitive impairment are higher. However, it is lack of exploration of the factors associated with the gender-specific of disability and cognitive impairment.

The aim of this study is to explore the gender differences and influencing factors of disability and cognitive impairment among the elderly. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to collect data. And the data from the China Longitudinal Healthy Longevity Survey (CLHLS) was used to further validate the results.

Eligibility criteria: Inclusion Criteria:

1.The elderly aged 65 and above.

Exclusion Criteria:

1. Lack of diagnostic information.
2. Missing key influencing factors such as gender and age.
3. Hearing or linguistic impairment.
4. Comatose patients.

Primary outcomes:
measure: Disability
timeFrame: 2002-2023
measure: Cognitive impairment
timeFrame: 2002-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Fang Tang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104089: Post-market Observational Study Zenith® t-Branch™
Official title: Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Thoracoabdominal
Keywords: Thoracoabdominal aortic aneurysm
Endovascular
Fenestration
Branch
Off-the-shelf
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals

Brief summary: The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.

Detailed description: Both retrospective and prospective patients will be enrolled

Eligibility criteria: Inclusion Criteria:

* Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
* Signed informed consent

Exclusion Criteria:

* Inability or refusal to give informed consent by the patient or a legally authorized representative

Primary outcomes:
measure: Rate of mortality and morbidity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitäts Krankenhaus Eppendorf
city: Münster
country: Germany
facility: St. Franziscus Hospital-GmbH
city: Malmö
country: Sweden
facility: Skaane University Hospital
Study officials:
affiliation: St. Franziscus Hospital-GmbH
name: Giovanni B Torsello, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosiers M, Kolbel T, Resch T, Tsilimparis N, Torsello G, Austermann M. Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. J Vasc Surg. 2021 Oct;74(4):1081-1089.e3. doi: 10.1016/j.jvs.2021.01.070. Epub 2021 Mar 5.
Clinical trial NCT05936489: Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
Official title: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Diseases
Presbyopia
Refractive Errors
Brimonidine Tartrate
Aceclidine
Ophthalmic Solutions
Lead sponsor: LENZ Therapeutics, Inc
Sponsor class: OTHER
Collaborators: name: ORA, Inc.
First posted: 2023-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic profile of LNZ101 and LNZ100.

Detailed description: To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100 ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia

Eligibility criteria: Inclusion Criteria:

* Each subject must:

  1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
  2. Be able and willing to follow all instructions and attend all study visits;
  3. Be 45-75 years of age of either sex and any race or ethnicity;
  4. Be presbyopic in both eyes;

Exclusion Criteria:

* Each subject must not:

  1. Have known contraindications or sensitivity to the use of the investigational drug or its components, or any other medications required by the protocol;
  2. Have any active systemic or ocular disorder other than refractive disorder;
  3. Have prior, current or anticipated use of any contact lenses during study participation;
  4. Have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that could affect ophthalmic drop absorption;
  5. Have anticipated inability to stay confined on required study days;

Primary outcomes:
measure: Cmax
timeFrame: Day 1 and Day 8
measure: Tmax
timeFrame: Day 1 and Day 8
measure: AUC0-t
timeFrame: Day 1 and Day 8
measure: AUC0-inf
timeFrame: Day 1 and Day 8
measure: T1/2
timeFrame: Day 1 and Day 8
Secondary outcomes:
Other outcomes:
measure: Safety: adverse event reporting
timeFrame: up to 37 days
Locations:
city: Newport Beach
country: United States
facility: Site #101
state: California
Study officials:
affiliation: LENZ Therapeutics
name: Kris Gameblin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03950089: Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC)
Official title: Optical Coherence Tomography Angiography (OCT-A) Quantitative Assessment of Choriocapillaris Blood Flow in Central Serous Chorioretinopathy (CSC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute, recurrent or persistent forms of central serous chorioretinopathy

Brief summary: Optical Coherence Tomography Angiography (OCT-A) is a noninvasive imaging technique that allows one to see blood vessels in the retina. The investigating team used this approach in patients with acute, recurrent and persistent subtypes of Central Serous Chorioretinopathy (CSC) to check for possible Choriocapillaris hypoperfusion. The presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. The possibility of a correlation between Choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. This study was conducted in an effort to improve one's understanding of this disease and other pachychoroid disorders.


Eligibility criteria: Inclusion Criteria:

* Patients with acute, recurrent or persistent forms of central serous chorioretinopathy

Exclusion Criteria:

* Patients with chronic central serous chorioretinopathy were not eligible for inclusion

Primary outcomes:
measure: Total number average individual area of flow signal voids
timeFrame: 2 months
measure: Total area of flow signal voids
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Thibaud Mathis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03086889: Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke
Official title: Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.


Eligibility criteria: Inclusion Criteria:

1. having had an ischemic stroke in the first time
2. age 30 to 80 years old
3. first stroke within 2 month
4. GCS score \>8
5. the upper-limb function BrunnstromⅡ、Ⅲ

Exclusion Criteria:

1. hemorrhage or transient ischemic attack(TIA)
2. important organs such as heart, lung, liver, kidney function decline or failure
3. previous history of brain neurosurgery or epilepsy
4. had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators
5. with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning

Primary outcomes:
measure: Change from Baseline Arm Movement Ability at 3 months
timeFrame: Baseline and at 3 months
Secondary outcomes:
measure: Change from Baseline Activities of Daily Living (ADL) at 3 months
timeFrame: Baseline and at 3 months
measure: Change from Baseline Cognitive Function at 3 months
timeFrame: Baseline and at 3 months
measure: Change from Baseline Cortical and Subcortical Activation Patterns at 3 months
timeFrame: Baseline and at 3 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Songhe Jiang
state: Zhejiang
Study officials:
References:
citation: Huang Q, Wu W, Chen X, Wu B, Wu L, Huang X, Jiang S, Huang L. Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial. Trials. 2019 Feb 6;20(1):104. doi: 10.1186/s13063-019-3177-y.
Clinical trial NCT00001189: The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Official title: The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Neoplasms
Keywords: Adjuvant Radiotherapy
Low-Grade Sarcoma
Radiotherapy
Randomized Study
Sarcoma
Surgery
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.

Detailed description: This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.

Arm I: Radiotherapy. Involved-field irradiation.

Arm II: No further treatment.

Eligibility criteria: DISEASE CHARACTERISTICS:

Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:

Abdominal and extra-abdominal fibromatosis (desmoid,

aggressive fibromatosis),

Dermatofibrosarcoma protuberans,

Intramuscular lipoma (infiltrating lipoma),

Diffuse lipomatosis,

Leiomyoma of deep soft tissue,

Diffuse giant cell tumor of tendon sheath (proliferative synovitis).

No clinical evidence of metastases in regional nodes or more distant sites.

No primary intraperitoneal or retroperitoneal tumors.

Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).

No von Recklinghausen's disease.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy: No prior chemotherapy for sarcoma.

Endocrine Therapy: Not specified.

Radiotherapy: No prior radiotherapy for sarcoma.

Surgery: No more than 4 months since definitive surgery for

primary lesion or recurrence.

No prior amputation.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: Not specified.

Hematopoietic: Not specified.

Hepatic: No cirrhosis.

Renal: No evidence of severe renal impairment.

Cardiovascular: No ischemic heart disease.

OTHER:

No prior malignancy except basal cell carcinoma.

No serious infection.

No active bleeding disorder.

No severe concomitant disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. doi: 10.1148/124.1.225.