louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03739034: Evaluation of a Lifestyle Medicine Practice
Official title: Evaluation of a Lifestyle Medicine Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lifestyle Related Disease
Diabetes
Overweight and Obesity
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are being treated with established lifestyle medicine modalities, tailored to the individual patient need and situation.
Primary purpose: TREATMENT

Brief summary: This project will evaluate the success of the PI's lifestyle medicine practice.

Detailed description: The main objective of the study is to evaluate the effectiveness of the PI's lifestyle medicine practice over time.

Sub-objectives are:

1. Understand variables that affect success in application of lifestyle medicine to lead to improved patient outcomes.
2. Develop a model for practice evaluation that can be utilized for board certification of providers and practices that utilize lifestyle medicine.
3. Evaluate the reimbursement success of lifestyle medicine services as a factor of billing codes and insurance providers.

Eligibility criteria: Inclusion Criteria:

* Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.

Exclusion Criteria:

* none

Primary outcomes:
measure: Weight
timeFrame: 1 year
measure: Systolic Blood Pressure
timeFrame: 1 year
measure: Diastolic Blood Pressure
timeFrame: 1 year
measure: Glycosylated hemoglobin
timeFrame: 1 year
measure: Total cholesterol
timeFrame: 1 year
measure: low density lipoprotein cholesterol
timeFrame: 1 year
measure: triglycerides
timeFrame: 1 year
measure: high density lipoprotein cholesterol
timeFrame: 1 year
Secondary outcomes:
measure: steps
timeFrame: 1 year
measure: exercise
timeFrame: 1 year
measure: fiber
timeFrame: 1 year
measure: legumes
timeFrame: 1 year
measure: full plate
timeFrame: 1 year
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: David S Drozek, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03531034: Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women
Official title: Ambulatory and Blood Pressure Variability Responses to Combined Exercise in Normotensive and Hypertensive Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Exercise
Blood Pressure, High
Keywords: Blood Pressure Variability
Ambulatorial Blood Pressure Monitoring
Combined Exercise
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 26
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the differences between normotensive and hypertensive menopausal women in ambulatory and blood pressure variability responses to combined aerobic and resistance exercise.

Detailed description: The differences in hypotensive and cardioprotective responses of exercise among menopausal hypertensive and normotensive women are still not very clear, mainly the responses of blood pressure variability. In this way, were evaluated 6 indices related to the variability of 24 hour ambulatory pressure measurements in these women before and after 12 weeks of combined exercise training.

Eligibility criteria: Inclusion Criteria:

* amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers

Exclusion Criteria:

* history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers

Primary outcomes:
measure: Changes in Ambulatorial Blood Pressure
timeFrame: Before and within 72 hours after 10 weeks of exercise training
Secondary outcomes:
measure: Changes in Ambulatorial Blood Pressure Variability
timeFrame: Before and within 72 hours after 10 weeks of exercise training
measure: Changes in Heart Rate Variability
timeFrame: Before and within 72 hours after 10 weeks of exercise training
measure: Changes in salivary oxidative stress
timeFrame: Before and within 72 hours after 10 weeks of exercise training
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Guilherme Morais Puga
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Guilherme M Puga, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226134: Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Official title: Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Gastric Emptying
Gastric Accommodation
Keywords: Functional Dyspepsia
Itopride
Gastric Emptying
Gastric Accommodation
Dyspeptic Symptoms
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 30
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: Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.

Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.

Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.

This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients

Detailed description: phase3 clinical trial

Eligibility criteria: Inclusion Criteria:

1. All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered
2. Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.
3. duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology
4. A normal upper abdominal ultrasound
5. Willing to participate and give consent for participation in the study.

Exclusion Criteria:

1. Age \<18 years
2. Helicobacter Pylori positive on gastric biopsy and / or UBT.
3. Taking other medications that alter gastric motility like macrolide

   * anti-emetics and antibiotics .
4. Pregnant or breast-feeding females.

Primary outcomes:
measure: To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
timeFrame: 18 months
Secondary outcomes:
measure: To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
timeFrame: 18 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Shahab Abid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195234: Study Evaluating Vaccine in Adults With HIV
Official title: A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 60
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: The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.

A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.


Eligibility criteria: Inclusion Criteria:

* 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
* CD4 T-cell count greater than and equal to 350/mm3 at screening
* No reported CD4 T-cell count less than 350/mm3 at any time before screening
* Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening

Exclusion Criteria:

* Any chronic symptomatic infection other than HIV
* Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
* Any malignancy that may require systemic therapy
* Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG

Primary outcomes:
measure: To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
Secondary outcomes:
measure: To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
Other outcomes:
Locations:
city: Sacramento
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02908334: Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Official title: Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Coccidioidomycosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study patients will be randomized 1:2 to receive either standard of care treatment or standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for treatment of disseminated and meningeal coccidioidomycosis.

Detailed description: Sertraline has been demonstrated to have in-vitro activity against coccidioides, and in-vivo activity against cryptococcal meningitis in clinical trials. Disseminated and meningeal coccidiodes infections require lifelong treatment, have poor outcomes, and new treatment options are needed. In this study the investigators will determine safety and tolerability of adjunctive sertraline (grade 4-5 adverse reactions) compared to standard coccidioidomycosis therapy alone.

Eligibility criteria: Inclusion Criteria:

* Severe coccidioidomycosis infection, manifest as by one of:

  * Coccidioidal meningitis;
  * Severe pulmonary infection requiring intensive care unit level of care;
  * Disseminated infection (in clinical opinion of the investigator); or
  * Clinical progression after \>2 months of high dose fluconazole.
* Laboratory confirmation of Coccidioides infection by culture, histopathology, coccidioides polymerase chain reaction, positive complement fixation titer, or Coccidioides antigen

Exclusion Criteria:

* Age \< 18 years
* Cannot or unlikely to attend regular clinic visits
* Presence of jaundice or known liver cirrhosis
* Pregnancy

  * If there is a concern of pregnancy, a negative urine (or serum) pregnancy test before study entry is required.
  * Women of childbearing potential will have pregnancy test at enrollment and will be recommended to use contraception and referred to family planning services as necessary. (Refer to informed consent document.)
* Currently breastfeeding
* Active drug use (amphetamine or cocaine) or requirement for concomitant medications that raise the risk of serotonin syndrome
* Prolonged corrected QT interval or Left Bundle Branch Block on baseline electrocardiogram

Primary outcomes:
measure: Adverse Reactions
timeFrame: 2 years
Secondary outcomes:
measure: Mycoses Study Group Score
timeFrame: 2 years
measure: Depression Screening
timeFrame: 2 years
measure: Functional Assessment
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: UCSF - Fresno
name: Simon Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196934: Expanded Use of Cannabidiol Oral Solution
Official title: A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Refractory Epilepsy
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2017-06-23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT

Brief summary: To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

Detailed description: To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.

Eligibility criteria: Inclusion Criteria:

1. Completed the Insys 030 protocol
2. Compliant in drug study procedures
3. Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended

Exclusion Criteria:

1. Failure to follow study procedures in Insys 030
2. Pregnant females

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04922034: Outcome of Patients After a Negative Oral Challenge to Amoxicillin
Official title: Study of Patient's Outcomes After a Negative Reintroduction Test for Amoxicillin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Negative Challenge to Amoxicillin
Keywords: penicillins
reintroduction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-06-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospective, single-center, non-interventionnel study of patients with a negative oral challenge to Amoxicillin at Angers University Hospital between 2017 and 2019.

An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone one month after the information letter is sent, to answer the questionnaire. This questionnaire, filled in during the telephone interview, concerns the resumption or not of penicillins since the reintroduction test.

This study concerns all patients, agreeing to participate in this study, who had a negative challenge test to Amoxicillin at the CHU of Angers from 2017 to 2019.

The potential inclusion is approximately 200 individuals.

Brief summary: This study aims to evaluate the outcome of patients who had a negative oral challenge to Amoxicillin

Detailed description: This is a prospective, single-center, non-interventional study of patients with negative Amoxicillin oral challenge performed at Angers University Hospital between 2017 and 2019.

An information letter indicating the purpose of the study is sent to eligible patients. If they do not object, patients are contacted by telephone to answer the questionnaire. This questionnaire concerns the reintroduction of penicillins at home after the challenge.

Eligibility criteria: Inclusion Criteria:

* Patients whith a negative challenge to Amoxicillin in the Allergology Department of the CHU of Angers between 2017 and 2019.
* Major patients.

Exclusion Criteria:

* Poor comprehension of the French language or cognitive disorders affecting the reliability of the questionnaire
* Person objecting to participate in this research and to the processing of their medical data

Primary outcomes:
measure: Resumption of Amoxicillin after a negative oral challenge to Amoxicillin
timeFrame: Oral challenge test oxxuring between 2017 and 2019, and follow-up until the day of the call
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
state: Maine Et Loire
Study officials:
References:
Clinical trial NCT03631134: Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin
Official title: Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.


Eligibility criteria: Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
3. Patients had relatively constant diet and exercise in 2 month before the study.
4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/L

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
2. Patients with severe infectious diseases;
3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
5. Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
6. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Primary outcomes:
measure: Changes of glycemic variation
timeFrame: Week 1-5
Secondary outcomes:
measure: Change of insulin dose
timeFrame: Week 1-5
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02745834: The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability
Official title: The Influence of Dual Task and Gait Speed on Gait Variability in Patients With Chronic Ankle Instability - a Case-control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Instability of Joint
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
Collaborators: name: Ariel University
First posted: 2016-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Case-control study to evaluate gait parameters during different conditions between patients who suffer from chronic ankle instability and healthy individuals.

Detailed description: This case-control study will compare the different gait parameters such as stride time and stride length variability in different gait conditions (e.g., normal speed, normal speed with dual task, fast speed and fast speed with dual task) between healthy individuals and patients who suffer from chronic ankle instability.

the measurements will be collected using the OPTOGait system installed on a treadmill.

Eligibility criteria: Inclusion Criteria:

* history of at least one significant ankle sprain which occurred at least 12 months prior to enrolment in the study and was diagnosed by a physician or a physical therapist using clinical examination classifications described by Malliaropoulos et al
* history of at least two episodes of 'giving way', and feelings of ankle joint instability in the previously injured ankle joint of 1 year post-initial sprain
* the most recent injury occurred more than 6 weeks prior to the study enrolment
* the ability to apply full weight bearing on the injured lower extremity with no more than mild discomfort

Exclusion Criteria:

* evidence of a concomitant injury (such as a bony injury or significant muscular/tendon injury)
* previous ankle surgery
* other pathological conditions or surgical procedures in lower extremity
* neurological/vestibular or any other balance disorder.

The control group included healthy participants with no current or previous conditions that could affect proprioception.

Primary outcomes:
measure: Stride time variability
timeFrame: Day 1
measure: Stride length variability
timeFrame: Day 1
Secondary outcomes:
measure: Dual task general score
timeFrame: Day 1
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: IDF Medical Corp
Study officials:
affiliation: Researcher
name: Shmuel Springer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Springer S, Gottlieb U. Effects of dual-task and walking speed on gait variability in people with chronic ankle instability: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jul 21;18(1):316. doi: 10.1186/s12891-017-1675-1.