louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03459027: Nitrate Supplementation and Muscle Blood Flow
Official title: Nitric Oxide Bioavailability and Dynamics of Blood Flow and Vasodilation With Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasodilation
Blood Pressure
Active Hyperemia
Aging
Keywords: exercise hyperemia
vasodilation
nitric oxide
dietary nitrate
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effects of an acute dose of dietary nitrate in the form of beetroot juice on skeletal muscle blood flow in response to dynamic knee extension exercise in healthy older adults. All subjects will receive active (rich in dietary nitrate) or placebo (devoid of nitrate) supplementation.

Detailed description: Dietary nitrate (beetroot juice) is reduced to nitrite and nitric oxide within the digestive system of humans. Nitric oxide exerts potent vasodilator effects, which have been shown to reduce blood pressure and enhance exercise economy in humans. This pressure reducing effect may have implications within the regulation of blood flow during dynamic exercise in older adults.

Eligibility criteria: Inclusion Criteria:

* Healthy older adults 60-80 years of age

Exclusion Criteria:

* Hypertension,
* Smoking,
* Heart disease,
* Diabetes,
* Body mass index (BMI) ≥ 30 kg/m2,
* Autonomic disorders and other conditions that may alter blood pressure or vascular function
* Medications that might normally alter blood pressure or vascular function.
* Older women taking hormone replacement therapy medications.

Primary outcomes:
measure: Change in Skeletal Muscle Blood Flow within the Leg via Doppler Ultrasound
timeFrame: Pre and 2 hours post acute ingestion of dietary nitrate and placebo with at least 5 days of separation between visits.
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Medical Education Building
state: Iowa
Study officials:
References:
Clinical trial NCT04554927: Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer
Official title: Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Web-application
Breast Cancer
Hormono Therapy
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 438
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesize that the implementation of a Web-application in patients initiating adjuvant hormone therapy for breast cancer brings a benefit on treatment adherence and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Breast cancer patient candidate for adjuvant hormone therapy
* Mastery of the French language
* Patient with a cell phone and an Internet connection
* Patient able to use a computer, smartphone, or tablet.
* Patient affiliated to a social security system
* Signing of informed consent prior to any specific study-related procedure

Exclusion Criteria:

* Patient who has previously received hormone therapy for cancer.
* Patient not trained in the use of the application
* Any associated medical or psychiatric condition that might compromise the patient's ability to participate in the study
* Patients with locoregional or metastatic recurrence
* Other history of cancer.
* Patient deprived of liberty, under guardianship or curatorship
* Simultaneous participation in a therapeutic clinical trial or other clinical study involving a connected tool
* Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons

Primary outcomes:
measure: Observance of hormontherapy
timeFrame: 18 months
Secondary outcomes:
measure: Quality of life with self questionnaires
timeFrame: 18 months
measure: Quality of life with self questionnaires
timeFrame: 18 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François baclesse
Study officials:
References:
Clinical trial NCT05552560: Access to Sperm Donation for Female Couples and Unmarried Women
Official title: Access to Sperm Donation for Female Couples and Unmarried Women: First Descriptive Data at the Toulouse University Hospital. PLEIAD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 300
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: Heterosexual couples, women or single women who have requested sperm donation

Brief summary: The Bioethics Law of August 2, 2021 now authorizes, in addition to heterosexual couples, access to sperm donation for female couples and unmarried women.

According to the Ministry of Health, since the opening of sperm donation to these new populations, requests at the national level (7000 during the first 6 months) have greatly exceeded the predicted figures (3000 per year). Welcoming this new patient population requires us, health professionals, to know it well. Indeed, to date, there is no reliable assessment in France of the life course, particularly reproductive, nor of the socio-demographic characteristics, nor of the psychological well-being of these patients.

This study via a pseudonymised questionnaire aims to fill this lack of information in order to help professionals build relevant care pathways.


Eligibility criteria: Inclusion Criteria:

* Heterosexual couples, OR couples of women OR single women who have requested a sperm donation at the Center for Reproductive Medicine at the Toulouse University Hospital
* Patients who have given their consent (oral or written) after clear and fair information

Exclusion Criteria:

* First consultation with the centre's psychologist already carried out.
* Not fluent in French
* Protected adults (safeguard of justice, guardianship, curatorship)

Primary outcomes:
measure: Socio-demographic characteristics
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: CHU Toulouse
name: Roger LEANDRI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01694160: Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
Official title: Consultant in Nephrology. MD., Ph.D.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proteinuria
Keywords: kidney transplant patients
Albuminuria
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

Detailed description: 77 randomized, 37 paricalcitol, 40 no treatment

Eligibility criteria: Inclusion Criteria:

* kidney transplant patients

Exclusion Criteria:

* Previously transplanted

Primary outcomes:
measure: Change in albumin/creatinine ratio from baseline to end of study.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Renal Section, Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Hallvard Holdaas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pihlstrom HK, Ueland T, Michelsen AE, Aukrust P, Gatti F, Hammarstrom C, Kasprzycka M, Wang J, Haraldsen G, Mjoen G, Dahle DO, Midtvedt K, Eide IA, Hartmann A, Holdaas H. Exploring the potential effect of paricalcitol on markers of inflammation in de novo renal transplant recipients. PLoS One. 2020 Dec 16;15(12):e0243759. doi: 10.1371/journal.pone.0243759. eCollection 2020.
citation: Ussif A, Pihlstrom H, Pasch A, Holdaas H, Hartmann A, Smerud K, Asberg A. Paricalcitol supplementation during the first year after kidney transplantation does not affect calcification propensity score. BMC Nephrol. 2018 Aug 22;19(1):212. doi: 10.1186/s12882-018-1000-8.
Clinical trial NCT02263560: Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
Official title: Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Gait Assessments
Lead sponsor: University of Fribourg
Sponsor class: OTHER
Collaborators: name: Dr Titus Bihl, Hopital Cantonal Fribourgeois
First posted: 2014-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selected patients will be described by following parameters:

* Parameters in relation to the person: age, gender.
* Parameters in relation to the pathology: NIHSS, exact localisation, time since start of the symptoms, FIM (functional independence measure) visual field (ophthalmological examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation Task), visuo-spatial short term working memory (Corsi span), visual motor integration (3-D cub subtest MoCA)
* Parameters in relation to hospital stay: length of stay.

Brief summary: Many neurological patients express enhanced deficits while walking in a dark room (or during the night): the supraspinal structures involved in this navigational deficit have not been identified yet. In this project, the investigators will study post-stroke gaits of human patients and compare them to those of a control population during a goal-oriented task performed in different visual conditions.

The investigators want to test the hypothesis that during simple goal-oriented locomotor tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express navigational deficits.


Eligibility criteria: Inclusion Criteria (for matching controls):

* Adult male and female subjects (18--\>85 years old)

Exclusion Criteria (for matching controls):

* Persons with history of an acquired or congenital neurological disorder, e.g. stroke, multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;
* Persons injured at the time of the experiments (fractures,...);
* Persons having reported repetitive spatial troubles/disorders;
* Persons with eye disorders and non-corrected vision problems;
* Pregnant women.

Primary outcomes:
measure: Walking stability indices of post-stroke patients
timeFrame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
measure: Spatial accuracy of walking trajectories in post-stroke patients
timeFrame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
Secondary outcomes:
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: University (UNIFR) and Hospital of Fribourg (HFR)
Study officials:
References:
Clinical trial NCT05670860: Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
Official title: Comitial Prophylaxis in Neurosurgery in Patients Who Have Undergone Intracranial Surgery Programmed Supratentorial Surgery (Exeresis or Biopsy) Between 2019 and 2022
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti-epileptic Prophylaxis in Intracranial Neurosurgery
Keywords: anti-epileptic prophylaxis
intracranial neurosurgery
epileptic seizures
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent a supratentorial intracerebral elective surgery (resection or biopsy) over the period from January 01, 2019 to September 01, 2022.

Brief summary: JUSTIFICATION Anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries. Since 2021, European guidelines no longer recommend this prophylaxis and practices have evolved.

We therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.The first group consists of patients treated between January 2019 and late 2020 who were given systematic prophylaxis. Patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis.

The secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes...), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years old
* Expressed non-opposition
* Patient who underwent supratentorial intracranial surgery (either resection or biopsy) at Brest University Hospital from January 01, 2019 to September 01, 2022.

Exclusion Criteria:

* Refusal to participate
* Patient under legal protection

Primary outcomes:
measure: The number of epileptic seizures during the first postoperative month (between D-0 and D-30) of neurosurgery patients treated for elective supratentorial intracranial procedures.
timeFrame: the first postoperative month (between D-0 and D-30)
Secondary outcomes:
measure: Commencement of anti-epileptic treatment Length of prophylaxis Treatment's side effects Neurological outcome at 3 and 6 months (RANKIN modified score)
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References:
Clinical trial NCT01904760: Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Official title: The Effect of Dexmedetomidine on Agitation and Delirium in Patients After Free Flap Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Delirium
Keywords: agitation
delirium
dexmedetomidine
head and neck surgery
microvascular free tissue transfer
flap
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap.

Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved.

The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing selected maxillofacial surgery with free flap reconstruction
* American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria:

* bradycardia (\< 50 bpm)
* severe heart block
* low blood pressure(SBP\<80mmHg)
* Known allergy to alpha 2 agonists

Primary outcomes:
measure: Agitation in PACU
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 12 hours
Secondary outcomes:
measure: Postoperative Delirium
timeFrame: on each of the 5 days postoperatively
Other outcomes:
measure: Patients' Vital Signs in PACU
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 12 hours
measure: Use of Analgesics and Sedatives in PACU
timeFrame: participants will be followed for the duration of PACU stay, an expected average of 12 hours
measure: Pain Score in PACU
timeFrame: at 8 am the next day
measure: Sleep Quality in PACU
timeFrame: at 8am the next day
measure: Overall Feeling in PACU
timeFrame: at 8am the next day
measure: Sleep Quality Within 5 Days Postoperatively
timeFrame: on each of the 5 days postoperatively
measure: Pain Score Within 5 Days Postoperatively
timeFrame: on each of the 5 days postoperatively
Locations:
city: Beijing
country: China
facility: School and Hospital of Stomatology
state: Beijing
Study officials:
References:
Clinical trial NCT01361360: Permissive Hypercapnia and Brain Development in Premature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature infants with birth weight 401-1000 g (gestational age \< 30 weeks)

Brief summary: In the US, every year approximately 30,000 infants are born very prematurely, with birth weight less than 1000 grams. These infants usually require ventilators to help them breath normally during the first few weeks of life. Although the ventilator is lifesaving, it can also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury. Importantly, there is new research showing that high carbon dioxide may cause brain injury. In our proposed research, we will use magnetic resonance imaging methods to evaluate the brain in 40 very premature infants at term-equivalent age (Half of them had permissive hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse effect on brain development.


Eligibility criteria: Inclusion Criteria:

* Premature infants with birth weight 401-1000 g

Exclusion Criteria:

* Those with complex congenital anomalies, central nervous system malformations, chromosomal abnormalities, or hydrops fetalis

Primary outcomes:
measure: MRI
timeFrame: 0
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
References:
Clinical trial NCT03575260: 500mg Fulvestrant Versus Exemestane in MBC
Official title: 500mg Fulvestrant Versus Exemestane in Metastatic Breast Cancer (MBC) Resistant to Adjuvant Non-steroidal Aromatase Inhibitors in Clinical Practice- a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Fulvestrant
Exemestane
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: 500mg Fulvestrant versus Exemestane in MBC

Detailed description: 500mg Fulvestrant versus Exemestane in Metastatic Breast Cancer (MBC) resistant to adjuvant Non-steroidal Aromatase Inhibitors in clinical practice- a multicenter retrospective study

Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman, age \> 18 years old
* Diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
* Adjuvant treatment of Non-steroidal Aromatase Inhibitors
* First line of Metastatic Breast Cancer is 500mg Fulvestrant or Exemestane for at least one month, starting from 2014.01.01-2017.06.01
* Available medical history

Exclusion Criteria:

* Incomplete medical history

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Biyun Wang, MD
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie Y, Li Y, Zhang Y, Zhang S, Li W, Guan X, Zhao Y, Gong C, Hu X, Zhang J, Cao E, Wang L, Ge R, Wang B. Fulvestrant 500 mg Versus Exemestane in Postmenopausal Women With Metastatic Breast Cancer Resistant to Adjuvant Nonsteroidal Aromatase Inhibitors in Clinical Practice: A Multicenter Retrospective Study. Clin Breast Cancer. 2019 Jun;19(3):e452-e458. doi: 10.1016/j.clbc.2019.01.015. Epub 2019 Feb 7.