louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06747143: Short-term Immunomodulatory Effects of Lactobacillus Casei DN-114001: Impacts on Gut Microbiota Composition and Systemic Immune Biomarkers in Healthy Adults
Official title: "Study of Immunological Biomarkers in Response to Probiotic Intake"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Modulation
Keywords: lactobacillus casei
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2024-12-24
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential intervention
Primary purpose: BASIC_SCIENCE

Brief summary: The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at \>0.90 for males and \>0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if \<30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 29.99;
* Waist-to-Hip Ratio with thresholds set at \>0.90 for males and \>0.85 for females for individuals with normal weight (eutrophic)
* Percentage of body fat: Considered within normal range if \<30% for individuals with normal weight.

Primary outcomes:
measure: Fecal flora cultures (Count of colonies/mL)
timeFrame: From enrollment to the end of treatment at 45 days weeks, every 15 days
measure: Serum immunoglobulins
timeFrame: From enrollment to the end of treatment at 45 days weeks, every 15 days
measure: Lymphocyte Subpopulations
timeFrame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01339143: Compare the Effect of DPP-IV Inhibitor or TZD on Glycemic Variability and Oxidative Stress in Patient With 2 Diabetes
Official title: An Open-label, Randomized, Active-controlled Study to Compare the Effect of DPP-IV Inhibitor and TZD as add-on Therapy to Metformin on Glycemic Variability and Oxidative Stress in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Oxidative Stress
Keywords: Vildagliptin
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2011-04-20
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: TREATMENT

Brief summary: The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.

Detailed description: Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.

Eligibility criteria: Inclusion Criteria:

* Male or female with age 18-80 years
* Type 2 diabetes mellitus
* On stable dose of metformin (more than 1000mg) for at least 1 month
* HbA1c 7\~10%
* Subjects on statins, ACE inhibitors, ARBs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study
* BP under control - no change required to BP medications
* Agreement to maintain prior diet \& exercise

Exclusion Criteria:

* Type 1 DM or Any kind of secondary DM
* Pregnant or lactating women.
* Treatment with sulfonylurea, α-glucosidase inhibitor, glinide, GLP-1 analogues, DPP-IV inhibitors or insulin therapy within 1 month prior to informed consent.
* Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent.
* HbA1c \<7% or \>10%
* Uncontrolled hypertension ( BP \> 160/100 mmHg)
* Congestive heart failure (NYHA class I to IV).

Primary outcomes:
measure: Glycemic Variability
timeFrame: 16 weeks
Secondary outcomes:
measure: Oxidative stress
timeFrame: 16 weeks
measure: HbA1C
timeFrame: 16 weeks
measure: hypoglycemia
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT01469143: A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 1 hour
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours
measure: Maximum observed serum insulin aspart concentration
timeFrame: From 0 to 12 hours
measure: Time to maximum observed serum insulin aspart concentration
timeFrame: From 0 to 12 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04521543: Laparoscopic Sleeve Gastrectomy Under General Anesthesia in Severely Obese Patients: a Retrospective Study
Official title: Laparoscopic Sleeve Gastrectomy Under General Anesthesia in Severely Obese Patients: a Single-centered Retrospective Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: severely obese
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severely obese patients underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia with multidisciplinary collaboration.

Brief summary: With the improvement of living standards and changes in living habits in China, obesity has become an important issue. The latest data show that the number of obese people in China has exceeded 100 million. Laparoscopic sleeve gastrectomy (LSG), which reduces the volume of the stomach and maintains the original anatomical structure of the gastrointestinal tract, has been widely used in weight loss surgery for obese patients to improve glucose metabolism and other metabolic disease comorbidities.Anesthesiologists face specific challenges for obese patients: difficult venous and airway access and the risk of obesity-related comorbidity.

Since 2015, the investigator's center has performed LSG and gradually formed a multidisciplinary collaboration procedure for the perioperative management of obese patients. This study aims to summarize the clinical characteristics, anesthesia management and outcomes to optimize the perioperative management and accelerate the recovery of these patients.


Eligibility criteria: Inclusion Criteria:

1. patients aged\>18 years
2. American Society of Anesthesiologists (ASA) status I-III
3. receiving selective laparoscopic sleeve gastrectomy (LSG) under general anesthesia

Exclusion Criteria:

1.BMI\<35 kg/m2

Primary outcomes:
measure: The rate of one-time intubation success
timeFrame: during the anesthesia
Secondary outcomes:
measure: number of participants with anesthesia-related complications
timeFrame: Perioperative period
measure: the hospital stay (days)
timeFrame: Perioperative period
measure: the hospitalization cost（Yuan）
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06481943: A Prospective Research Investigation of Ischemia Using MCG
Official title: A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Keywords: Magnetocardiography
MCG
Lead sponsor: SB Technology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2024-07-01
Enrollment: 150
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: Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS).

Brief summary: PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction
* Ability for participant to comply with study requirements
* Patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities
* Written informed consent

Exclusion Criteria:

* Present STEMI
* Pregnant or breastfeeding
* Having an active atrial fibrillation episode as seen on most current 12-lead ECG
* Active thoracic metal implant
* Poor access to follow-up

Primary outcomes:
measure: Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
timeFrame: Data taken within 24 hours of each other
Secondary outcomes:
measure: Sponsor MCG device safety
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: SB Technology, Inc.
name: Kit Yee Au-Yeung, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02723643: Potential Associated Factors of Uncontrolled Hypertension
Official title: Initial Investigation on Potential Associated Factors of Uncontrolled Hypertension in Outpatient Department: A Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension,Essential
Keywords: Hypertension
Essential hypertension
Blood pressure
Cardiovascular diseases
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient populations with clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).

Brief summary: The incidence and prevalence of hypertension is increasing while the controlled rate is extremely low in China. A substantial percentage of participants with uncontrolled hypertension are correctable if potential associated factors are identified and corrected. Therefore, it is clinically relevant to investigate and identify these potential associated factors of uncontrolled hypertension so as to increase controlled rate and reduce hypertension-associated health and economic burdens in the future. Investigators plan to conduct a prospective registry study in a single-center to initially investigate the potential associated factors of uncontrolled hypertension in cardiovascular outpatient department. Furthermore, investigators plan to evaluate the effects of potential associated factors correction on hypertension controlled rate and cardiovascular outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).

Exclusion Criteria:

* Known secondary hypertension,
* Pregnant women,
* Chronic kidney disease (CKD) 3 or higher,
* Has a history of connective tissue diseases,
* Has a history of any type of cancer,
* Cognitive disorder which could not finish home blood pressure monitoring,
* Has a history of coronary heart disease,ischemic stroke,transient ischemic attack or heart failure.

Primary outcomes:
measure: Hypertension controlled rate in participants after potential associated factors are corrected
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute,Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04122443: Acetaminophen (APAP) +/- Oxycodone
Official title: A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Musculoskeletal Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen


Eligibility criteria: Inclusion Criteria:

* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria:

* Use of an non-steroidal anti-inflammatory drug within the previous six hours
* Use of acetaminophen within the previous six hours
* Use of an opioid within the previous ten days
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Gout

Primary outcomes:
measure: Change in Pain Assessment
timeFrame: 2 hours following treatment
Secondary outcomes:
measure: Sustained Pain Relief
timeFrame: Up to 48 hours following medication administration
measure: Adequacy of Analgesia
timeFrame: 2 hours following treatment
measure: Satisfaction With Medication
timeFrame: 2 hours following treatment
measure: Medication-related Adverse Events
timeFrame: 2 hours following treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT06670443: Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients
Official title: Electrical Stimulation for Respiratory and Leg Muscles Impact on Pulmonary Function and Leg Restless Syndrome in COPD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles

Detailed description: Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).

Active stimulation consisted of a ∼30-second ramp-up to the titrated intensity value at the start of stimulation, ∼30 minutes at the titrated intensity, and a 10-second ramp-down at the end of stimulation.

Eligibility criteria: Inclusion Criteria:

* Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including

  1. an urge to move legs that is usually associated with paresthesia.
  2. alleviation of the symptoms by moving the legs.
  3. aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
  4. worsening of the signs at night. patients with diagnosed with grade I and grade II COPD their ages ranged between 45-55 o All patients will be clinically and medically stable when attending the study

Exclusion Criteria:

* History of Deep venous thrombosis

  * History of Bleeding disorders
  * Have an implantable device like a pacemaker
  * Recent Infected wound
  * History of allergic response to the electrodes, gel or tape
  * patients who participating in any other exercise program
  * Loss of sensation or numbness

Primary outcomes:
measure: dynamic gait index
timeFrame: 10 weeks
Secondary outcomes:
measure: pulmonary functions
timeFrame: 10 weeks
measure: Dyspnea
timeFrame: 10 weeks
measure: International restless leg syndrome questionnaire
timeFrame: 10 weeks
measure: visual analogue scale
timeFrame: 10 weeks
measure: Sleep quality
timeFrame: 10 weeks
measure: Chronic Respiratory Disease Questionnaire
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT04353843: Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery
Official title: Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: Cataract surgery
Phakoemulsification
Pain
Biometry
Anesthesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
name: Beziers Champeau Clinic
name: Montpellier Beau Soleil Clinic
name: Montpellier Ophtalmology Center
First posted: 2020-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care population from two clinics and two university hospitals from 3 cities in total, who undergo cataract surgery

Brief summary: Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc.

There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

Detailed description: Adults who undergo cataract surgery, excepting under general anesthesia, will be asked to rate a Visual Analog Scale grading the pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: Visual analog scale of pain according to the surgeon (before recording the patient), type of anesthesia, duration of surgery, machines used, time of ultrasound used for phakoemulsification, preoperoative visual acuity and intraocular pressure, biometry, iris color, preoperative donesis, preoperative capsular pseudoexfolliation, unexpected events, particularities noticed by the surgeon as Floppy iris syndrome, Lens-iris diaphragm retropulsion syndrome There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

Eligibility criteria: Inclusion criteria:

* Undergoing a cataract surgery during the period of inclusion, and by one of the surgeons of the study
* Majority 18 years and more

Exclusion criteria:

- General anesthesia

Primary outcomes:
measure: Pain during cataract surgery
timeFrame: 1 day
Secondary outcomes:
measure: assess the rate of intraoperative complications over the series
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Vincent Daien, MD, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References: