louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02013284: Is Our Microbiome a Predictor of Cardiac Risk
Official title: Is Our Microbiome a Predictor of Cardiac Risk?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 700
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: Consenting participants who are undergoing coronary angiography.

Brief summary: The purpose of this study is to determine a relationship between a person's flora/bacteria in their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut.

Detailed description: Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut. This research is being done because Investigators believe that there is a connection between the way food is digested by a person's gut bacteria and the development of atherosclerosis (hardening of the arteries) and cardiovascular disease. The ultimate goal of this research is to eventually determine if changes to the gut bacteria can prevent cardiovascular disease or disease progression.

Eligibility criteria: Inclusion Criteria:

Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.

Exclusion Criteria:

1. Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
2. Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
3. Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
4. Patients who are unable to provide a stool sample to Mayo Clinic within 24 hours of collection utilizing Fed Ex overnight mail (i.e. people overseas who are unable to provide a sample before leaving the USA.)

Primary outcomes:
measure: 50 cc blood obtained during angiogram and used for Endothelial Progenitor Cells analysis using antibodies for inflammatory markers. Plasma collection will be done for antibody analysis. Buffy coats will be frozen and stored for future genetic analysis.
timeFrame: Blood samples will be obtained during the diagnostic angiogram.
Secondary outcomes:
measure: Stool samples will be collected to compare the fecal microbiota of patients with mild, moderate and severe coronary artery disease.
timeFrame: Two weeks after the angiogram
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165384: Hummingbird TTS Ear Tube Delivery Study
Official title: Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: tympanostomy
myringotomy
otitis media
ear tubes
ear infection
Lead sponsor: Preceptis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-17
Enrollment: 199
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

Detailed description: The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.

Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo tympanostomy tube insertion.
2. At least 6 months old.
3. Subject is able and willing to comply with follow-up requirements.
4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.

Exclusion Criteria:

1. Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
2. Significantly atrophic tympanic membrane.
3. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
4. Anatomy precludes sufficient visualization and access to the tympanic membrane.

Primary outcomes:
measure: Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
timeFrame: intra operative
measure: Number of Participants With Intra-operative Adverse Events
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Maple Grove
country: United States
facility: Fairview Maple Grove Surgery Center
state: Minnesota
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Frank Rimell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02764684: The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
Official title: The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Objective:

In this study the investigators aim at investigating:

1. probiotics ability to modulate the microbiome and microbial translocation,
2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and
3. if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract.

Design:

The study is a prospective clinical intervention trial of 40 HIV-infected patients.

Method:

The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.


Eligibility criteria: Inclusion Criteria:

* age over 18
* confirmed HIV
* no HIV treatment
* cluster of differentiation 4+ cell count over 350

Exclusion Criteria:

* antibiotic or probiotic in last 2 month
* drugs that influence gut motility
* diabetes
* Inflammatory bowel disease
* cancer
* autoimmune diseases

Primary outcomes:
measure: change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
timeFrame: Will be measured before and after eight weeks of intervention.
Secondary outcomes:
measure: change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention.
timeFrame: Will be measured before and after eight weeks of intervention.
measure: change in inflammation around the gut measured with positron emission tomography-magnetic resonance scans of the abdomen ( size of the lymph nodes and positron emission tomography-activity)
timeFrame: Will be measured before and after eight weeks of intervention.
measure: Changes in of high sensitive C-reactive protein (unit mg/l) from baseline and after eight weeks of intervention
timeFrame: Will be measured before and after eight weeks of intervention.
measure: Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention
timeFrame: Will be measured before and after eight weeks of intervention.
measure: Changes in the gut microbiota composition (454 pyrosequencing of fecal samples) from baseline to eight weeks after intervention (end of study)
timeFrame: Will be measured before and after eight weeks of intervention.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, danmark
name: Susanne D Nielsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288884: The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Official title: The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Complications
Cesarean Section
Wound
Infection (Following Delivery)
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 100
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: The purpose of this study is to determine the effect of a silver containing dressing (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean section wound complications in obese women (BMI \>35).

Detailed description: Women scheduled for an elective cesarean section at term will be recruited to participate in this study. The investigators plan to recruit 100 women. Baseline demographic information will be obtained at the pre-op visit. Eligible subjects will be randomized to received a silver containing dressing (Acticoat PostOp) or the standard dressing (OpSite PostOp). A randomization table will be computer generated in blocks of 20. A sealed opaque envelope containing the assigned dressing will accompany the patient to the operating room. Standard antibiotic prophylaxis will be provided prior to skin incision. A subcuticular suture will be used for skin closure. At the time of skin closure, the envelope will be opened and the assigned dressing will be applied. The dressing will only be changed if it is saturated. The dressing will be removed at the time of discharge from hospital. A questionnaire regarding wound complications will be completed at the time of discharge from hospital, at 2 weeks post-op and 6 weeks post-op.

Eligibility criteria: Inclusion Criteria:

* Women scheduled for elective cesarean section
* BMI \>35 at the pre-op visit
* consent to participate

Exclusion Criteria:

* allergy to silver
* immunocompromised (HIV/AIDS, on immunosuppressive medications)

Primary outcomes:
measure: Wound complication
timeFrame: 6 weeks post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
Study officials:
References:
Clinical trial NCT04364984: ARB, ACEi, DRi Effects on COVID-19 Course Disease
Official title: Effects of RAS Inhibitors (ARB, ACEi, DRI) in People With Hypertension 1-2 Stages on the Course of COVID-19 (BIRCOV Trial: ARB, ACEI, DRi Effects on COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
COVID-19
Keywords: ACEi, ARB, DRI
Clinical features
CKD
Lead sponsor: Medical Practice Prof D. Ivanov
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with proved COVID-19 and preliminary documented hypertension 1-2 stage on RASi at the onset and COVID-19 course during 3 weeks

Brief summary: It is supposed to monitor hypertensive patients who are infected or have clinical manifestations of COVID-19 for 1 month after the onset of the disease. Three groups will be considered: 1. receiving ACE inhibitors 2. receiving ARBs 3. receiving DIR.

Detailed description: POEM (Patient-Oriented Evidence that Matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from COVID-19 who have been receiving iRAS, either ACEi, ARB or DRi as basic antihypertensive therapy.

COVID-19 is confirmed by a PCR test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks.

Primary Outcome Measure: BP was known one week before COVID-19 and is tested during the disease onset on weeks 2, 4, 12, 24. Secondary Outcome Measures are clinical features. Subanalysis in patients with CKD is additionally performed for those who have CKD.

Eligibility criteria: Inclusion Criteria:

* Hypertensive person, stage 1-2

Exclusion Criteria:

* Hypertensive subjects, stage 3, HF (NYHA) 3-4

Primary outcomes:
measure: Level of BP in mm Hg
timeFrame: estimated at 2, 4, 12, 24 weeks after the start of COVID-19; data for 24 weeks are reported
Secondary outcomes:
measure: Number of Patients With Fever Above 37.2 on COVID-19 Course
timeFrame: estimated at 2, 4, 12 weeks after the COVID-19 onset
measure: Number of Patients With Cough in COVID-19 Course
timeFrame: on 2,4 and 12 week from COVID-19 onset
measure: Number of Patients With Throat Pain in COVID-19 Course
timeFrame: estimated at 2, 4, 12 weeks after the COVID-19 onset
measure: Number of Patients With Diarrhea Inf COVID-19 Course
timeFrame: estimated at 2, 4, 12 weeks after the COVID-19 onset
measure: Number of Patients Who Need to Apply to Hospital in COVID-19 Course
timeFrame: estimated at 2, 4, 12 weeks after the COVID-19 onset
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Medical Practice Prof D.Ivanov
state: Please Select
Study officials:
affiliation: Nephrology clinic
name: Iryna Zavalna, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03993184: The Effects of Hot Yoga on Vascular Function
Official title: The Effects of Bikram (Hot) Yoga on Vascular Health in Hypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Elevated Blood Pressure
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. The investigators are seeking individuals with slightly elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.

Detailed description: This study will examine the effects of a 12 week hot yoga intervention on vascular health by assessing changes of pre-intervention and post-intervention measurements in ambulatory blood pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and 65. The investigators are seeking individuals with elevated blood pressure and stage I hypertension who are not currently taking blood pressure medications or exercising regularly. Participants will receive 12 weeks of free yoga for their participation.

Eligibility criteria: Inclusion Criteria:

* Elevated blood pressure or stage I hypertension;
* sedentary (not currently exercising regularly);
* not currently taking blood pressure medications.

Exclusion Criteria:

* Pregnancy;
* renal disease;
* prior heart attack;
* known coronary artery disease;
* history of stroke,
* heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (COPD);
* recent chest pain;
* heat intolerance;
* body mass index of 40 or more.

Primary outcomes:
measure: Averages in ambulatory blood pressure and vascular function
timeFrame: 24 hours
Secondary outcomes:
measure: Perceived stress
timeFrame: 5 minutes
measure: Brachial artery endothelial function
timeFrame: 15 minutes
measure: Arterial Stiffness
timeFrame: 10 minutes
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Texas State University
state: Texas
Study officials:
affiliation: Texas State University IRB
name: Monica Gonzales
role: STUDY_CHAIR
References:
Clinical trial NCT00351884: Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes
Official title: A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Hemoglobin A1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-07-13
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.


Eligibility criteria: Inclusion Criteria:

* Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
* Body mass index in the range 22-40
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* History of type 1 diabetes
* Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Safety of vildagliptin in combination with metformin during 24 weeks of treatment
timeFrame: 24 weeks
measure: Change from baseline in fasting plasma glucose at 24 weeks
timeFrame: 24 weeks
measure: Patients with endpoint HbA1c < 7% after 24 weeks
timeFrame: 24 weeks
measure: Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks
timeFrame: 24 weeks
measure: Change from baseline in body weight at 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.
Clinical trial NCT05533684: A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Official title: A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Keywords: anal surgery,
gabapentin,
postoperative pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups are included in the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Single dose 600 mg gabapentin will be given preoperatively in anal surgeries

Detailed description: Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively

Eligibility criteria: Inclusion Criteria:

1. ASA physical status I or II
2. Aged from 18 to 65 years
3. Scheduled for anal surgeries at Minya University Hospital

Exclusion Criteria:

1. Presence of contraindications to neuraxial anesthesia
2. Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
3. The use of neuropathic analgesic or antiepileptic drugs

Primary outcomes:
measure: postoperative pain
timeFrame: first 12 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Sarah Omar
Study officials:
affiliation: Minia University
name: Sarah Omar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386084: Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain
Official title: Efficacy of Motor Control Treatment Combined With Resistive Capacitive Diathermy in Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: capacitive resistive diathermy
motor control
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale.

This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.


Eligibility criteria: Inclusion Criteria:

* Acute low back pain (no more of 4 weeks)
* Spanish speaker
* Between 18-65 years

Exclusion Criteria:

* Patients in whom diathermy is a contraindicated therapy
* Pacemaker
* Pregnant
* Not intact skin
* Thrombophlebitis
* Hypotension
* Anticoagulated patient or with local surgical intervention

Primary outcomes:
measure: Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Disability
timeFrame: 4 weeks
measure: Satisfaction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Sebastián De Los Reyes
country: Spain
facility: FisioWork
state: Madrid
Study officials:
References: