louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03995979: Inflammation and Protein Restriction
Official title: Short-Term Dietary Protein Restriction Modulation of Skeletal Muscle Bioenergetics and Innate Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Restriction
Diet
Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Malcom Randall VA Medical Center
First posted: 2019-06-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is strong scientific data that supports that short-term protein restrictive diets reduce surgical stress responses. The investigators are hoping to use the information collected from the blood serum and muscle tissue of healthy subjects to help understand the baseline and early changes in muscle energetic and cell-mediated inflammation. The study team hopes to use the data collected in this pilot study to compare with patients undergoing open abdominal aortic aneurysm (AAA) repair in a future study

Detailed description: Modulation of a patient's diet, specifically via short-term dietary protein restriction, can impact changes in cell energetics and dampen the normal subclinical inflammatory state. These changes can provide benchmarks for future research focused on using nutritional interventions aimed at improving the probability of a successful outcome following open aortic aneurysm surgery. The investigators will conduct a short term dietary restriction protocol to characterize these changes in a normal control cohort to be compared to patients which undergo surgery, to identify the optimal time points for sampling in the surgical population. These changes will be characterized by looking at inflammatory cells in the blood, proteins excreted in the urine, changes in microbiome signature identified by stool sample and oral swab, as well as changes in muscle energetics in small muscle biopsies.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 70 years of age

Exclusion Criteria:

* Age less than 18 years.
* The presence of any significant medical condition that might significantly confound the collection of biological data in the study including cancer, diabetes, inflammatory bowel disease (IBD), Advanced Renal Disease, Nut Allergy
* Unwilling to follow protocol
* Participation in another interventional clinical trial.
* Prisoners, pregnancy, or direct employees of the investigative team

Primary outcomes:
measure: Changes in the Human Intestinal Microbiome That Result From Short Term Dietary Adjustment.
timeFrame: Day 2; Day 4; Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
city: Gainesville
country: United States
facility: UF Health---Vascular Surgery
state: Florida
Study officials:
affiliation: University of Florida
name: Salvatore Scali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604484: Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Official title: Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Detailed description: The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.

A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta \>3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

Eligibility criteria: Inclusion Criteria:

* patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

Exclusion Criteria:

* presence of pacemaker lead through the tricuspid valve
* acute endocarditis
* minimally invasive approach
* Functional mitral valve insufficiency

Primary outcomes:
measure: Incidence of more than mild tricuspid insufficiency
timeFrame: 5 year
Secondary outcomes:
measure: VO2 max
timeFrame: 1 year
measure: Right ventricular function
timeFrame: 5 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04479384: The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.
Official title: The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: Hypertension
Manual techniques
Blood Pressure
Osteopathy
Treatment
Lead sponsor: International Academy of Osteopathy
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults.

Detailed description: 30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg), were randomly assigned into one of two equally sized groups; a non- intervention and an intervention group in which patients received 4 manual techniques. Outcome measures included systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way mixed ANOVA was used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Adults 18-60 years old.
* Primary hypertension.
* Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and diastolic BP from 85-104 mmHg.

Exclusion Criteria:

* Hypertension grade 3, defined as: Systolic BP from \>175 mmHg and diastolic BP \>105 mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.
* Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions of the heart.
* History of liver, kidney or known heart diseases, diagnosed by family physician as these conditions can contribute to secondary hypertension.
* Presence of contraindications for manual treatment, such as (but not limited to); infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis, pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or corticosteroids.

Primary outcomes:
measure: Systolic and diastolic blood pressure baseline
timeFrame: Baseline
measure: Systolic and diastolic blood pressure post 1-minute
timeFrame: Post 1-minute
measure: Systolic and diastolic blood pressure post 5-minute
timeFrame: Post 5-minute
measure: Systolic and diastolic blood pressure post 10-minute
timeFrame: Post 10-minute
Secondary outcomes:
Other outcomes:
Locations:
city: Næstved
country: Denmark
facility: Næstved Rygcenter
Study officials:
affiliation: International Academy of Osteopathy
name: Mette Pedersen, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04864184: Effects of Breathing Patterns on Post-prandial Vascular Function
Official title: The Effects of Different Breathing Styles on Post High-Fat Meal Blood Vessel Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Breathing
Yogic breathing
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will complete 2 different sessions in random order.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is investigate the effects of two different breathing styles on postprandial vascular function and oxidative stress markers. Participants will complete 2 breathing conditions in random order.


Eligibility criteria: Inclusion Criteria:

• Male participants ages 18-35 years

Exclusion Criteria:

* Infection within the previous 4 weeks
* Renal disorders
* Any cardiovascular disorders such as prior myocardial infarction, known coronary artery disease, personal history of stroke, heart failure, cardiac arrhythmias
* Chronic obstructive pulmonary disease
* Diabetes
* Inflammatory bowel disease
* HIV, rheumatoid arthritis, chronic or other inflammatory conditions
* Currently taking steroids or other anti-inflammatory medications
* Current use of nonsteroidal anti-inflammatory drugs
* Smoking
* Stage 2 hypertension or higher (systolic BP of 140 mm Hg or higher and/or diastolic BP of 90 mm Hg or higher)
* Lactose intolerance

Primary outcomes:
measure: Change in flow-mediated dilation
timeFrame: At baseline and at again 1, 2, 4 hours post high-fat meal consumption
measure: Changes in oxidative stress
timeFrame: Once at baseline and again at 1, 2, and 4 hours post high-fat meal consumption.
Secondary outcomes:
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Cardiovascular Physiology Laboratory-Texas State University
state: Texas
Study officials:
References:
citation: Hunter SD, Bernardi L, McAllister MJ, John D, Rahimi M, Lopez MR. Device-guided slow breathing alters postprandial oxidative stress in young adult males: A randomized sham-controlled crossover trial. Nutr Metab Cardiovasc Dis. 2023 Jan;33(1):203-209. doi: 10.1016/j.numecd.2022.10.002. Epub 2022 Oct 10.
Clinical trial NCT00189579: Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
Official title: A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: HERCEPTIN
Carboplatin
Paclitaxel
Relapse
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.


Eligibility criteria: Inclusion Criteria:

* 18 years or older; patients with histologically proven diagnosis of ovarian cancer.
* Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry)
* Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel.
* Patients who have received at minimum one line of chemotherapy
* 3 weeks minimum since last treatment with chemotherapy must have elapsed
* Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 \> 1.25 x upper limit of normal (ULN)
* Patients must have ECOG of 2 or less
* Left ventricular ejection fraction (LVEF) of 50% or better
* Patients have given their signed and verbal consent

Exclusion Criteria:

* Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa)
* Another experimental treatment in the previous 30 days
* No overexpression of HER2 receptors
* Patients having received high-dose chemotherapy or stem-cell interventions
* Other cancers within the last 5 years
* Patients with dyspnea at rest or requiring oxygen therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Hotel-Dieu
Study officials:
affiliation: Hopital Hotel-Dieu
name: Eric Pujade-Lauraine, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03375879: Bandage Contact Lens in Post Operative Ptosis Patients
Official title: The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ptosis
Blepharoptosis
Keywords: Ptosis
Blepharoptosis
bandage contact lens
fasanella servat procedure
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Robert Adam
name: Forough Farrokhyar
name: Sivisan Suntheralingam
First posted: 2017-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary.

Detailed description: This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. The investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. This is a randomized control trial in which patients undergoing bilateral ptosis surgery (Fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.In this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. Follow up will occur in one week where the outcomes will be obtained through questionnaires.

Eligibility criteria: Inclusion Criteria:

* patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this

Exclusion Criteria:

* patient having any other eye related pathologies

Primary outcomes:
measure: Patient's pain/discomfort
timeFrame: One week post-operation.
Secondary outcomes:
measure: Blurry vision
timeFrame: One week post-operation.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Hospital Hamilton
state: Ontario
Study officials:
References:
Clinical trial NCT01267279: Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Official title: Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary elective total hip replacement

Exclusion Criteria:

* Osteoporosis (BMD ≤-2.5)
* Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
* Severe renal impairment
* Use of any medications affecting BMD
* Known sensitivity to bisphosphonates
* Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods

Primary outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: 2 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01360879: Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
Official title: Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Chronic Hepatitis C
Keywords: Hepatitis B virus
Hepatitis C virus
Chronic hepatitis
Liver cirrhosis
Liver stiffness
Liver fibrosis
Lead sponsor: Kindai University
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic hepatitis B or C, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.

Brief summary: This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.

Detailed description: The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.

If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C
* Subject is willing to fast for 8 hours prior to each study visit

Exclusion Criteria:

* History of alcohol abuse (alcohol intake \> 20g/day)
* Evidence or history of chronic hepatitis not caused by HBV or HCV
* During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
* Pregnant or lactating patients
* Contraindications of liver biopsy or liver resection

Primary outcomes:
measure: Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
timeFrame: one year
Secondary outcomes:
measure: Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker
timeFrame: one year
measure: Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®
timeFrame: one year
Other outcomes:
Locations:
city: Osaka-sayama
country: Japan
facility: Kinki University Faculty of Medicine
state: Osaka
Study officials:
affiliation: Kinki University Faculty of Medicine
name: Masatoshi Kudo, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01486979: Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
Official title: A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 58
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.


Eligibility criteria: Inclusion Criteria:

* Subjects who are able to use German language in speaking and writing
* Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
* Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
* Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
* Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
* Availability of a normal mammogram within one year prior to trial start
* Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Known, suspected or past history of breast cancer
* Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
* Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
* Abnormal genital bleeding of unknown etiology
* Previous estrogen and/ or progestin hormone replacement therapy

Primary outcomes:
measure: Area under the curve (AUC)
Secondary outcomes:
measure: Average plasma concentration (C average)
measure: Maximal concentration (Cmax)
measure: Minimal concentration (Cmin)
measure: Time of maximal concentration (tmax)
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Eugster-Hausmann M, Waitzinger J, Lehnick D. Minimized estradiol absorption with ultra-low-dose 10 microg 17beta-estradiol vaginal tablets. Climacteric. 2010 Jun;13(3):219-27. doi: 10.3109/13697137.2010.483297.