louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04615351: A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
Official title: A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gestational Diabetes
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Pilot of Metformin Postpartum

Detailed description: The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.

Eligibility criteria: Inclusion Criteria:

* Gestational Diabetes

Exclusion Criteria:

* Cannot tolerate metformin

Primary outcomes:
measure: Prediabetes or Diabetes
timeFrame: 1 year postpartum
Secondary outcomes:
measure: Prediabetes or diabetes at 15 months postpartum
timeFrame: 15 months after delivery and study initiation
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT03316651: Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis
Official title: A Multicenter Clinical Study of the Sequential Therapy With Whole Lung Lavage/Inhaling Granulocyte-macrophage Colony Stimulating Factor in Adult Patients With Severe Autoimmune Pulmonary Alveolar Proteinosis in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pulmonary Alveolar Proteinosis
Treatment
Keywords: pulmonary alveolar proteinosis
granulocyte-macrophage colony-stimulating factor
whole lung lavage
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 60
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 the study is to evaluate the effectiveness of the sequential therapy with whole lung Lavage (WLL)/inhaling granulocyte-macrophage colony stimulating factor, compared to WLL only, for adult patients with severe autoimmune pulmonary alveolar proteinosis in China over a two-year period.


Eligibility criteria: Inclusion Criteria:

* Comfirmed diagnosis of autoimmune pulmonary alveolar proteinosis
* Disease severity score (DSS) is 4-5

Exclusion Criteria:

* The acute respiratory infection
* Heart failure (such as cardiogenic pulmonary edema)
* The serious liver and kidney dysfunction (creatinine or ALT were equal to or more than 2 times of the upper limit of normal range);
* Pregnancy;
* The patients with hereditary and secondary factors (inhalation of dust, hematological diseases, autoimmune diseases, etc.);
* DSS is 1-3;
* The patient is allergic to the drugs that be used in our research;
* The patients with poor compliance, or suffering from mental illness;
* The patients have not signed informed consent;
* They were treated with whole lung lavage or regular GM-CSF therapy (treatment for more than 2 weeks) within 3 months before the enrollment.

Primary outcomes:
measure: Time to the first relapse (the date: day/month/year)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Relapse rate
timeFrame: Up to 2 years
measure: FEV1 difference
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hispital
Study officials:
References:
Clinical trial NCT03858751: Pharmacological Activation of HMN for OSA Aim 2
Official title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.


Eligibility criteria: Inclusion Criteria:

* AHI \> 10 events/h during NREM supine sleep

Exclusion Criteria:

* Any medical condition other than well controlled hypertension and mild diabetes.
* Any medication known to influence breathing, sleep/arousal, or muscle physiology.
* Claustrophobia.
* Inability to sleep supine.
* Allergy to any of the medications tested in the protocol.
* History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.
* Individuals with underlying cardiac disease, such as arrhythmias.
* Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.
* For women: Pregnancy.
* Pulmonary hypertension
* Severe OSA with a mean SaO2 lower than 88%

Primary outcomes:
measure: Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
timeFrame: 3 nights (treatment duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00005751: Endothelial Vasomotor Function in the Framingham Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.

Detailed description: BACKGROUND:

Current research suggests that loss of the vasodilator, anti-thrombotic, and anti-inflammatory properties of the vascular endothelium plays a dynamic role in the pathogenesis of cardiovascular disease. Impaired endothelial function, including impaired nitric oxide-dependent vasodilation is associated with cardiovascular disease risk factors. Further, there is growing evidence that endothelial function can be improved by risk modification. However, the available studies have not definitively resolved the issue of the cross-sectional correlates of endothelial dysfunction because they have been limited to small samples of highly selected patients. For example, it remains unclear whether hypercholesterolemia, hypertension, or elevated glucose levels are independent determinants of endothelial dysfunction. Most importantly, no study has shown a relation between endothelial dysfunction and increased cardiovascular risk. Such a demonstration would increase our understanding of the pathogenesis of cardiovascular disease and aid clinicians in identifying high risk individuals who would benefit most from intervention.

DESIGN NARRATIVE:

Using non-invasive brachial artery ultrasound, endothelial function was examined in about 3,800 men and women of the Framingham Heart Study. The cross-sectional correlates of endothelial function with known coronary risk factors were examined and cross-sectional analyses were performed on the relation of endothelial function to prevalent cardiovascular disease. Observations were made of the adjusted relation of endothelial function to incident and recurrent cardiovascular events. The central hypothesis was that the presence of endothelial dysfunction was an independent risk factor for cardiovascular disease events.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Emilia Benjamin
References:
citation: Vita JA, Keaney JF Jr. Endothelial function: a barometer for cardiovascular risk? Circulation. 2002 Aug 6;106(6):640-2. doi: 10.1161/01.cir.0000028581.07992.56. No abstract available.
citation: Benjamin EJ, Larson MG, Keyes MJ, Mitchell GF, Vasan RS, Keaney JF Jr, Lehman BT, Fan S, Osypiuk E, Vita JA. Clinical correlates and heritability of flow-mediated dilation in the community: the Framingham Heart Study. Circulation. 2004 Feb 10;109(5):613-9. doi: 10.1161/01.CIR.0000112565.60887.1E.
Clinical trial NCT01828151: Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers
Official title: Noninvasive Positive Airway Pressure Ventilation and Risk of Facial Pressure Ulcers in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Keywords: Pressure ulcer
Noninvasive ventilation
Lead sponsor: Ospedale S. Giovanni Bosco
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 170
Sex: ALL
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 admitted to our high dependency unit for an episode of acute respiratory failure and treated with noninvasive ventilation.

Brief summary: To assess risk of skin pressure lesions in patients treated with noninvasive mechanical ventilation.

Detailed description: Noninvasive ventilation improves the outcome of patients with acute respiratory failure; however patient's discomfort may be responsible for up to a fifth of failures. Scant literature exists on NIV-related pressure ulcers and their determinants.

Aim of the study is to seek for determinants, if any, associated with the development of pressure ulcers related to noninvasive ventilation.

Study design: observational. Patients treated with NIV from December 2009 to December 2011 will be analyzed. Main end-points: to seek for variables associated to the development of NIV-related pressure ulcers in patients with acute respiratory failure.

Eligibility criteria: Inclusion Criteria:

* severe dyspnea at rest
* respiratory rate \> 30 per minute
* PaO2/FiO2 \< 200 (despite oxygen with Venturi with a FiO2 og 0.5)
* use of accessory respiratory muscles
* pH \< 7.35 \> 7.10

Exclusion Criteria:

* STEMI
* NSTEMI/Unstable angina
* Hemodynamic instability
* Need for immediate endotracheal intubation
* Inability to protect the airways
* Impaired sensorium
* Pulmonary embolism
* Gastrointestinal bleeding
* Hematological malignancy or neoplasms with ECOG performance status \> 2

Primary outcomes:
measure: Risk of skin pressure ulcers in patients treated with noninvasive ventilation for acute respiratory failure.
timeFrame: Risk of pressure ulcers within 72 hours from noninvasive ventilation beginning.
Secondary outcomes:
measure: Incidence of skin pressure ulcers in patients treated with noninvasive ventilation.
timeFrame: Incidence of skin pressure ulcers. Patients will be followed during duration of high dependency unit stay for an average length of stay of 7 days.
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Medicina d'Urgenza - Terapia Subintensiva. Ospedale S. Giovanni Bosco
Study officials:
affiliation: Ospedale S. Giovanni Bosco
name: Giovanni Ferrari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213551: Glutamine and Intestinal Protein Metabolism
Official title: Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated.

Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, male and female, aged between 18 and 50 years, negatives for HIV1, 2 and for HVC and HVB
* BMI between 20 and 24 kg/m²,
* giving their written informed consent
* no-smokers
* no allergic and digestive antecedents

Exclusion Criteria:

* smokers
* Allergic and digestive antecedents,
* pregnancy

Primary outcomes:
measure: Impact on protein synthesis rate and proteolytic activities in intestine.
timeFrame: at the end of infusion (hour 5)
Secondary outcomes:
measure: Comparison of protein expression pattern and glutathione synthesis.
timeFrame: at the end of infusion (hour 5)
Other outcomes:
Locations:
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Pierre Déchelotte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goichon A, Coeffier M, Claeyssens S, Lecleire S, Cailleux AF, Bole-Feysot C, Chan P, Donnadieu N, Lerebours E, Lavoinne A, Boyer O, Vaudry D, Dechelotte P. Effects of an enteral glucose supply on protein synthesis, proteolytic pathways, and proteome in human duodenal mucosa. Am J Clin Nutr. 2011 Sep;94(3):784-94. doi: 10.3945/ajcn.110.009738. Epub 2011 Jul 27.
Clinical trial NCT01007851: Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infertility
Keywords: GnRH agonist
GnRH antagonist
IVF
ICSI
assisted reproduction
luteal phase
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2009-11-04
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.


Eligibility criteria: Inclusion Criteria:

* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
* Embryo transfer performed on day 3

Exclusion Criteria:

* Participation in another trial that was being conducted in our unit at the same time.
* Preimplantation genetic screening cycles.
* Day 5 embryo transfers.

Primary outcomes:
measure: Ongoing pregnancy beyond 20th gestational week
Secondary outcomes:
measure: clinical pregnancy rate
measure: Embryo implantation rate
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: American Hospital
Study officials:
References:
Clinical trial NCT05794451: Developing an Artificial Intelligence System to Detect Cognitive Impairment
Official title: Developing an Artificial Intelligence System to Detect Mild Cognitive Impairment and Alzheimer's Disease Dementia Through Self-Figure Drawing: An Innovative Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Healthy Aging
Mild Cognitive Impairment
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2023-04-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 60 or above, who live in Israel.

Brief summary: Alzheimer's disease dementia (AD) is a debilitating and prevalent neurodegenerative disease in older adults globally. Cognitive impairment, a hallmark of AD, is assessed through verbal tests that require high specialization, and while accepted as screening tools for AD, general practitioners seldom use them. AD can be diagnosed with expensive, invasive neuroimaging and blood tests, but these are usually conducted when cognitive functioning is already severely impaired. Thus, finding a novel, non-invasive tool to detect and differentiate mild cognitive impairment (MCI) and AD is a prime public health interest. Self-figure drawings (a projective tool in which individuals are asked to draw a picture of themselves), are easy to administer and have been shown to differentiate between healthy and cognitively impaired individuals, including AD. Convolutional Neural Network (CNN) (a type of deep neural network, applied to analyze visual imagery) has advanced to assess health conditions using art products. Therefore, the proposed study suggests utilizing CNN-based methods to develop and test an application tailored to differentiate between drawings of individuals with MCI, AD, and healthy controls (HC) using 4,000 self-figure drawings. This


Eligibility criteria: Inclusion Criteria:

* Adults aged 60 and above with subtle signs of risk of future cognitive decline, residing in the community or in nursing homes with a minimum of 10 years of education.

Exclusion Criteria:

* Current or past psychiatric illness, the presence of congenital/organic cognitive condition, severe visual or motor impairment, and terminal illness (to avoid the effect of comorbidities).

Primary outcomes:
measure: Cognition
timeFrame: One day
measure: Cognition for adults diagnosed with Alzheimer's disease
timeFrame: One day
measure: Self-figure drawing -Cognition
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Johanna Czamanski-Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517551: Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy
Official title: The Effect of Low-flow and Normal-flow Desflurane Anesthesia on Respiratory Parameters in Robotic-assisted Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Flow Anesthesia
Normal Flow Anesthesia
Robotic Surgery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery

Brief summary: Robot-assisted laparoscopic radical prostatectomy has gained increasing popularity compared to open radical prostatectomy with its advantages such as low blood loss, reduced blood transfusion rate, low complication rate, and shortened hospital stay. Since robot-assisted laparoscopic radical prostatectomy should be performed in the limited retroperitoneal area, insufflation of the abdomen with carbon dioxide (CO2) (pneumoperitoneum) and steep Trendelenburg position are required to provide better surgical vision.

Low-flow anesthesia warms and moistens the inhaled gases, creating a more physiological breathing atmosphere during anesthesia. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. Studies show that long-term minimal flow anesthesia is safe and advantageous for non-laparoscopic surgery.

The aim of this study is to compare low-flow (1L/min) with normal flow (3lt/min) desflurane anesthesia in terms of hemodynamic and respiratory parameters, inhalation agent consumption and soda lime consumption for robotic assisted laparoscopic radical prostatectomy surgery.

The secondary aim of the study is to compare the effects of low-flow and normal-flow anesthesia in the steep trendelenburg position (45°) used for robotically assisted laparoscopic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

- ASA I-II risk group

Exclusion Criteria:

* ASA III, IV, V,
* concomitant serious cardiac, respiratory, hepatic, renal disturbance,
* mental status disorder and hearing problem,
* anxiety and depression and/or other psychiatric disorders,
* patient's refusal

Primary outcomes:
measure: inspiratory O₂ concentration
timeFrame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
measure: partial oxygen pressure
timeFrame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
Secondary outcomes:
measure: desflurane consumption
timeFrame: perioperative
measure: changes in liver and kidney function tests from the preoperative values to 48 hours postoperative
timeFrame: during operation and 48 hours postoperative
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: