louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04225104: Yogic Breathing and IBS
Official title: Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 14
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: Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.


Eligibility criteria: Inclusion Criteria:

* Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.

Exclusion Criteria:

* 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease

Primary outcomes:
measure: IBS Symptoms
timeFrame: Once at baseline
measure: IBS Symptoms
timeFrame: Once at the end of week 2
measure: IBS Symptoms
timeFrame: Once at the end of week 4
measure: Autonomic function
timeFrame: Once at baseline
measure: Autonomic function
timeFrame: Once at the end of week 2
measure: Autonomic function
timeFrame: Once at the end of week 4
measure: Autonomic function
timeFrame: Once at baseline
measure: Autonomic function
timeFrame: Once at the end of week 2
measure: Autonomic function
timeFrame: Once at the end of week 4
measure: Microvascular function
timeFrame: Once at baseline
measure: Microvascular function
timeFrame: Once at the end of week 4
Secondary outcomes:
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Stacy Hunter
state: Texas
Study officials:
affiliation: Texas State University
name: Stacy D Hunter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katherine Jurek M, Seavey H, Guidry M, Slomka E, Hunter SD. The effects of slow deep breathing on microvascular and autonomic function and symptoms in adults with irritable bowel syndrome: A pilot study. Neurogastroenterol Motil. 2022 May;34(5):e14275. doi: 10.1111/nmo.14275. Epub 2021 Oct 1.
Clinical trial NCT00540904: Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Official title: Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: contrast
nephropathy
bicarbonate
prevention
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2007-10-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a GFR \<60 and \>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* cancer diagnosis
* GFR \< 60 and \> 30 ml/min/1,73m2 by MDRD formula or diabetic
* CT with contrast

Exclusion Criteria:

* dialysis needed
* uncontrolled hypertension
* changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
* recent exposure to radiographic contrast agents (within previous two days of the study)
* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study

Primary outcomes:
measure: Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed
timeFrame: 2 days
Secondary outcomes:
measure: change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level
timeFrame: 2 days
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital do Cancer de Barretos - Fundação PIO XII
state: São Paulo
Study officials:
affiliation: Hospital do Cancer de Barretos - Fundação PIO XII
name: Ricardo G Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
Clinical trial NCT00587704: Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
Official title: Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary aim:

1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.

Secondary aims:

1. Compare VAS pain scores in the two groups of patients over the first 24 hours.
2. Compare opioid intake over the first 24 hours in the two groups of patients.


Eligibility criteria: Inclusion Criteria:

* Unilateral open inguinal herniorrhaphy
* Patient must be \>18 years of age
* ASA physical status of I, II, or III
* Patient competent to provide informed consent

Exclusion Criteria:

* Patient \< 18 years of age
* Pregnant or lactating women
* Patient unwilling or unable to provide informed consent
* Contraindications to regional anesthesia
* Allergy to amide local anesthetics

Primary outcomes:
measure: Successful full block at T11-L1
timeFrame: Every 10 minutes until full block achieved
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Steven R. Clendenen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502304: Concurrent Training and Prediabetes Control
Official title: Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Keywords: Metabolic syndrome
Obesity
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad de Los Lagos
name: Healthcare Center Tomas Rojas
name: Universidad del Rosario
First posted: 2018-04-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral
Primary purpose: PREVENTION

Brief summary: Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Interested in improving health and fitness.

Exclusion Criteria:

* Cardiovascular contraindications to exercise,
* History of stroke, asthma or chronic obstructive pulmonary disease,
* Muscle-skeletal disorders, and
* Smoking.
* A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.

Primary outcomes:
measure: Fasting glucose
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Lipoproteins
timeFrame: Baseline and 20-weeks immediately after the interventions ends
Secondary outcomes:
measure: Body mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Waist circumference
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Fat mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Lean mass
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Heart rate at rest
timeFrame: Baseline and 20-weeks immediately after the interventions ends
measure: Six minutes walking test
timeFrame: Baseline and 20-weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Los Lagos
country: Chile
facility: Cristian Alvarez
state: Osorno
Study officials:
affiliation: Universidad de Los Lagos
name: Cristian Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004804: Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: hepatitis C
immunologic disorders and infectious disorders
rare disease
viral infection
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Tulane University School of Medicine
First posted: 2000-02-25
Enrollment: 57
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C.

II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.

Detailed description: PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio.

The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued.

The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative
* No decompensated cirrhosis

--Prior/Concurrent Therapy--

* No concurrent immunosuppressives At least 1 year since interferon

--Patient Characteristics--

* Hepatic: No other cause of liver disease
* Other: Not HIV positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tulane University School of Medicine
name: Anna S. F. Lok
role: STUDY_CHAIR
References:
Clinical trial NCT04222504: Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot
Official title: Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Exposure Prophylaxis
STI
Contraceptive Usage
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Adrenergy Research Innovations
First posted: 2020-01-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators propose to offer a package of evidence-based health services to women in two hair salons in the Umlazi township of Durban. Based on community feedback in previous survey and qualitative work, the package has been designed to include daily PrEP, family planning/contraceptives, and STI screening. Interested salon clients at intervention salons will elect which services to use. An additional salon will serve as control, offering no health services to clients. Surveys will be conducted in both salon groups. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services. Recruitment in intervention salons will conclude when 100 clients uptake PrEP, not inclusive of clients who enroll at intervention salons who accept other services through the study. Approximately 250 participants will be recruited in control salons. The study team anticipates an overall total enrollment of 500.


Eligibility criteria: Inclusion Criteria:

* Female
* 18 years or older
* English or Zulu speaking
* Able and willing to consent

Exclusion Criteria:

* Symptoms of acute HIV viral syndrome
* Known pregnancy at baseline

Primary outcomes:
measure: Uptake of Preventative Sexual Health Services
timeFrame: Months 4 to 16
Secondary outcomes:
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Adrenergy Research Innovations
Study officials:
affiliation: Massachusetts General Hospital
name: Ingrid V. Bassett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293304: Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
Official title: Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.

Detailed description: Randomized clinical trials of performance of universal adhesive in primary molars

Eligibility criteria: Inclusion Criteria:

* active carious lesion in middle dentin limited to the occlusal or occluso-proximal surfaces of primary molars;
* children (male or female) in good general health.

Exclusion Criteria:

* children who refuse or fail to cooperate with the completion of clinical procedure; - teeth without antagonist;
* carious lesions in inner half of dentin;
* presence of painful symptoms or signs of pulpal changes.

Primary outcomes:
measure: Longevity of restoration
timeFrame: 18-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Rachel Rocha, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02360904: A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy
Official title: A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Sleep Disturbances
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* History of stage I-III breast cancer
* Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers
* Eastern Cooperative Oncology Group Performance status of \<3
* Ability to understand English

5.2 Exclusion Criteria:

* Planning to start yoga on their own within the next 12 weeks
* Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
* Severe chronic obstructive pulmonary disease
* Class III or IV heart failure
* Child C cirrhosis
* End-Stage renal disease

Exclusion Criteria:

* Planning to start yoga on their own within the next 12 weeks
* Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
* Severe chronic obstructive pulmonary disease
* Class III or IV heart failure
* Child C cirrhosis
* End-Stage renal disease

Primary outcomes:
measure: change in quality of life
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medcial Center
name: Theresa Shao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977104: Maestro Handheld Cardiac Monitor Validation
Official title: Maestro Handheld Cardiac Monitor Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.

Detailed description: The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy.

Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result.

Eligibility criteria: Inclusion Criteria:

* ability to provide informed consent

Exclusion Criteria:

* implanted pacemakers
* open wounds or abrasions on their hands
* prior damage to hands or thumbs precluding obtaining an ECG tracing

Primary outcomes:
measure: Sensitivity and Specificity of atrial fibrillation detection
timeFrame: 6 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cardiovascular Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rakesh Latchamsetty, MD
role: PRINCIPAL_INVESTIGATOR
References: