louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03651453: OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
Official title: Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Substance Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A controlled un-blinded pilot study.
Primary purpose: PREVENTION

Brief summary: To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.

Detailed description: To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.

Eligibility criteria: Inclusion Criteria:

* Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).

Exclusion Criteria:

* Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent

Primary outcomes:
measure: PrEP Uptake
timeFrame: 12 months
Secondary outcomes:
measure: PrEP Adherence by Self Report
timeFrame: 12 months
measure: PrEP Adherence by Pharmacy Refill
timeFrame: 12 months
measure: Changes in PrEP receptiveness
timeFrame: 12 months
measure: Changes in HIV risk behaviors
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale AIDS Program
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaimie P Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03212053: Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
Official title: Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombocythemia Essential
Keywords: Essential thrombocythemia
Multiplate
ROTEM
haemorrhage
thrombosis
Vasodilatator Stimulated Phosphoprotein (VASP)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed.

The aim of this study is to demonstrate a correlation between biological tests of haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors


Eligibility criteria: Inclusion Criteria:

* Adult aged more than 18 years old
* Patient followed in consultation for an Essential Thrombocythemia at diagnosis or during the follow-up
* Collection of the informed consent
* Patient affiliated to Social Security

Exclusion Criteria:

* Patients aged less than 18 years old
* Refusal of signature of the informed consent
* Patients under guardianship

Primary outcomes:
measure: Occurrence of thrombotic complications
timeFrame: every 4 months, up to 18 months
measure: Occurrence of haemorrhagic complications
timeFrame: every 4 months, up to 18 months
Secondary outcomes:
measure: Occurrence of thrombotic complications
timeFrame: every 4 months, up to 18 months
measure: Occurrence of haemorrhagic complications
timeFrame: every 4 months, up to 18 months
measure: Changes of tests results according to medical treatments
timeFrame: every 4 months, up to 18 months
measure: Description of platelet physiopathology
timeFrame: the day of inclusion
measure: Description of platelet physiopathology
timeFrame: the day of inclusion
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Fiorenza BARRACO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573753: The Effects of Sleep on Human Microbiota: Implications for Health and Disease
Official title: The Effects of Sleep on Human Microbiota: Implications for Health and Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover; Single group
Primary purpose: PREVENTION

Brief summary: The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.


Eligibility criteria: Inclusion Criteria:

* Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol

Primary outcomes:
measure: Changes in human microbiota induced by sleep manipulation in healthy subjects
timeFrame: 1 year
measure: Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04856553: Acute Effects of Handgrip on Blood Pressure in Hypertensive Adults
Official title: Acute Effects of Handgrip on Vascular Function and Ambulatory Blood Pressure in Hypertensive Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Exercise
Blood pressure
Strength training
Vascular function
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The effect of handgrip training on blood pressure reduction has been demonstrated in several studies. However, acutely, there is still divergence regarding the effects of isometric handgrip exercise on blood pressure responses, especially when it is performed at different times of the day. It is suggested that the magnitude of blood pressure reduction after a single exercise session is able to predict long-term blood pressure behavior. Thus, understanding the effects of isometric handgrip exercise, performed at different times of the day, on blood pressure in adult hypertensive individuals acutely may help to understand the effects of this type of exercise chronically.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of hypertension controlled by up to three antihypertensive medications;
2. SBP levels ≤ 180 mmHg and/or DBP ≤110 mmHg;
3. no serious heart disease;
4. no upper limb musculoskeletal injury that prevents the handgrip.

Exclusion Criteria:

1. diagnosis of other cardiovascular diseases or diabetes during the study;
2. change the class and/or dose of antihypertensive medication during the study;
3. worsening of the disease (BP \> 180 or use of four or more medications).

Primary outcomes:
measure: Change in Ambulatory Blood Pressure
timeFrame: 24 hours after the session
Secondary outcomes:
measure: Change of clinical blood pressure from pre to post session
timeFrame: Before, immediately after, 15 minutes and 30 minutes after the session.
measure: Change in vascular function from pre to post session
timeFrame: Before, immediately after and 30 minutes after the session.
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Universidade Federal de Santa Catarina
name: Aline M. Gerage, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137253: Autonomic Nervous System and Nitric Oxide Interactions
Official title: The Autonomic Nervous System, Nitric Oxide and TPA Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endothelial Dysfunction
Keywords: Nitric Oxide
Autonomic Nervous System
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigators are interested in the role of the autonomic nervous system in the regulation of endothelial function among obese hypertensive subjects. In particular, the investigators will study how endothelial function (response to intra-arterial acetylcholine) changes during autonomic withdrawal.


Eligibility criteria: For lean healthy volunteers:

* 20 subjects (10 males and 10 females) aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \< 25Kg/m2 .
* Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.

For Obese subjects with high blood pressure.

* 20 subjects (10 males and 10 females) aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \> 30 and less than 40 Kg/m2

  \*High blood pressure (systolic=130 and diastolic = 85 mmHg)
* Female volunteers of childbearing potential will undergo serum HCG pregnancy test at screening and urine HCG pregnancy test again on the study day.

Exclusion criteria:

* Pregnant females
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs or anemic
* Subjects with a recent medical illness
* Subjects with a history of coronary heart disease
* Subjects with known kidney or liver disease
* Subjects with recent weight loss or consuming low carbohydrate diet

Primary outcomes:
measure: Endothelial Function
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT06277453: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy
Official title: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy: Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Locally Advanced Gastric Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with node-negative gastric cancer following neoadjuvant chemotherapy

Brief summary: To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy.

Detailed description: We analyzed clinicopathological data from patients with lymph node-negative gastric cancer who underwent neoadjuvant chemotherapy at four institutions between 2010 and 2020. The 3-year OS was assessed using landmark analysis. Independent risk factors associated with 3-year OS were identified using a Cox proportional hazards regression model.

Eligibility criteria: Inclusion Criteria:

* (1) preoperative neoadjuvant chemotherapy; (2) primary gastric adenocarcinoma, diagnosed by gastroscopic pathology findings before neoadjuvant chemotherapy in complete pathological remission (pCR) cases or via postoperative pathology findings in all other instances; (3) absence of distant metastases in the liver, lungs, or abdominal cavity, as confirmed by preoperative chest radiography or chest computed tomography (CT), abdominal ultrasonography, abdominal CT, and other imaging; (4) radical gastric cancer surgery (R0) and D2 lymph node dissection; and (5) postoperative pathologic verification of no lymph node metastasis (i.e., lymph node-negative).

Exclusion Criteria:

* (1) preoperative radiotherapy or radiochemotherapy, (2) discovery of distant metastases preoperatively or intraoperatively, (3) coexistence of other malignant tumors, (4) residual gastric cancer, and (5) perioperative patient mortality.

Primary outcomes:
measure: 3-year overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Gastric Surgery， Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852553: Neurohumoral Control of Intestinal Electrical and Mechanical Activity
Official title: Neurohumoral Control of Intestinal Electrical and Mechanical Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: intestinal
smooth
muscle
GI
motility
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients having elective bowel resections

Brief summary: A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine.

Detailed description: Segments of intestine from patients undergoing elective gastric bypass for morbid obesity or resections for non-obstructive neoplasms at the UC Davis Medical Center will be used. Samples will be taken from tissue normally removed and sent to Pathology or discarded. Full thickness segments of intestine (10 mm x 1 mm) will be prepared for recording either intracellular electrical activity or mechanical contraction. The effects of putative non-adrenergic, non-cholinergic neurotransmitters (e.g., nitric oxide) will be studied. The source of the tissue will not be identified either directly or indirectly through identifiers associated with the measured responses.

Eligibility criteria: Inclusion Criteria:

* All patients having elective bowel resection

Exclusion Criteria:

* Entire resected segment required for pathology
* Ischemic/necrotic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Reno
country: United States
facility: University of Nevada School of Medicine
state: Nevada
Study officials:
affiliation: Professor
name: Neal W. Fleming, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083953: Optimal End-Tidal (ET) Sevoflurane and Desflurane Concentration for Extubation of Supreme Laryngeal Mask Airway (LMA) in Adults
Official title: Optimal End-Tidal Concentration of Sevoflurane and Desflurane for Removal of Supreme Laryngeal Mask Airway in Anaesthetized Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complications
Keywords: end tidal concentration
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Malaysian Society of Anaesthesiologists
First posted: 2010-03-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the optimal volatile anaesthetic (sevoflurane and desflurane) to remove a Supreme LMA in adults in which there is minimal airway response.

Null hypothesis: there is no significant difference between the optimal end tidal concentration of sevoflurane and desflurane for Supreme LMA removal.

Detailed description: The manufactures' instructions for removal of the LMA recommend waiting until protective reflexes have returned. However, the appropriate timing for removal remains controversial. A more frequent incidence of airway hyperreactivity and complications has been reported by some studies when the LMA was removed in the awake state versus the anesthetized state. Techniques that reduce the time from LMA removal to the return of protective airway reflexes would minimize the risk of aspiration, contamination, or airway obstruction.

With increasingly common use of Supreme LMA in anaesthetic practice, a safe and suitable depth for removal of the Supreme LMA requires research.

Thus the determination of the optimal end-tidal concentration of commonly used volatile agents ie. Sevoflurane and Desflurane for Supreme LMA removal requires research, both for patient safety and minimising anaesthetic costs in dealing with airway complications.

Eligibility criteria: Inclusion Criteria:

1. ASA 1-2 patients
2. Age 18 - 49 years old
3. Elective surgery of short duration ( \< 2 hours ) which require local anaesthetic infiltration

Exclusion Criteria:

1. Upper respiratory tract symptoms in the previous 10 days
2. Risk of gastric oesophageal reflux or regurgitation
3. Known or predicted difficult airway
4. Poor dentition with high risk of damage
5. BMI \> 30 kg/m2
6. Refusing to participate

Primary outcomes:
measure: Optimal end tidal concentration of sevoflurane/ desflurane
timeFrame: 6 months
Secondary outcomes:
measure: presence of airway response
timeFrame: 10 mins after surgery
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: Department of Anaesthesiology, UMMC
name: Cindy Thomas Joseph
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448653: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)
Official title: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polyps of Colon
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.

The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.

The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).


Eligibility criteria: Pre-inclusion criteria:

* Major patient with a colonoscopy scheduled in one of the participating hospitals (CHD Vendée and CHU Nantes).
* Patient who agreed to participate in the study and gave his express consent
* Patient affiliated with a social security system or beneficiary of a scheme

Inclusion Criteria:

* Patient with 1 or more polyps less than 20 mm observed during colonoscopy

Exclusion Criteria:

* Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms
* Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis
* Patient with familial adenomatous polyposis
* Pregnant or lactating woman
* Minor patient
* Major patient under tutorship, curatorship, or deprived of liberty
* Patient unable to understand protocol and / or give express consent
* Patient not affiliated with a social security system or beneficiary of such a scheme
* Patient hospitalized or treated without their consent

Primary outcomes:
measure: Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
timeFrame: An average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Nantes
Study officials:
affiliation: Centre Hospitalier Départemental Vendée
name: Vincent MACE
role: STUDY_DIRECTOR
References: