louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01924221: Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy
Official title: Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Patients Undergoing CRT-D Device Implantation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart Failure Patients undergoing implantation of cardiac resynchronization therapy defibrillator

Brief summary: Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.


Eligibility criteria: Inclusion Criteria:

* patients undergoing implantation of a CRT-D

Exclusion Criteria:

* age \< 18 y
* pregnancy or planned pregnancy

Primary outcomes:
measure: correlation between electrical and mechanical remodeling
timeFrame: 6 months after CRT implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Larisa Tereshchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00554021: Infections Related Central Venous Catheters
Official title: Infections Associated With the Use of Central Venous Catheters Related in Critical Care Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SIRS
Keywords: Central venous catheter
nosocomial infection
Lead sponsor: National Defense Medical College, Japan
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critical Care staff

Brief summary: The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory response syndrome) and the infection associated with the use of central venous catheters at Critical Care center in National Defense Medical College, Japan.

Detailed description: The doctor would remove the inserted catheter from the patient, if the patient shows SIRS. At the same time, the tip of used catheter and blood from the patient are checked whether the pathogenic bacteria exists or not by general bacterial protocol and blood culture test on a routine application. Unfortunately, these tests not always clarified their cause of SIRS. Therefore we conduct this investigation to establish the useful protocol for pathogenic bacteria. We check the pathogenic bacteria not only tip but through the whole catheter in Central Venous Catheter using general bacterial protocol and SEM observation. Additionally, we compared that sputum, urine, skin and blood from the patient for bacteria check.

Eligibility criteria: Inclusion Criteria:

* A patient has been inserted with central venous line over 24 hours.

Primary outcomes:
measure: Culture of bacteria with in central venous catheter. Morbidity and mortality of a patient with multiple resistant bacteria associated with use of the catheter.
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokorozawa
country: Japan
facility: Department of Traumatology and Critical Care of Medicine
state: Saitama
Study officials:
affiliation: National Defense Medical College
name: Kahoko NISHIKAWA, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03754621: Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
Official title: What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid
Thyroid Dysfunction
Hypothyroidism
Pregnancy Early
Keywords: TSH
Lead sponsor: Bartin State Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Turkish pregnant women living in Bartin Region of Turkey

Brief summary: Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.

The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs.

The investigator's objective is to establish a rational reference range of serum TSH for diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.

Detailed description: Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Free of pre-existing thyroid disease
* That do not use thyroid interfering medication
* That did not undergo IVF treatment
* TPOAb negative

Exclusion Criteria:

* Adolescent pregnancy

Primary outcomes:
measure: TSH
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartin State Hospital
Study officials:
affiliation: Bartin State Hospital
name: Murat Yassa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korevaar TIM. The upper limit for TSH during pregnancy: why we should stop using fixed limits of 2.5 or 3.0 mU/l. Thyroid Res. 2018 May 21;11:5. doi: 10.1186/s13044-018-0048-7. eCollection 2018.
Clinical trial NCT02670421: Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
Official title: Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Will the intervention (Heart SMART program) be feasible in moderate or high stress patients, who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?

Detailed description: The Heart SMART Program is designed to offer a practical and efficacious stress management and resiliency intervention. It involves making participants aware of practices to enhance present moment awareness and engagement. It teaches learners to train their attention, and refine interpretation; utilizing principles of gratitude, compassion, acceptance, higher meaning and forgiveness. Participants will choose to use one of two delivery methods (either the face to face method or the on-line method) of the Heart SMART program.

Eligibility criteria: Inclusion Criteria:

1. Women age 25-75 years.
2. Able to speak English and complete questionnaire.
3. Self-reported Stress Scale 6 - 10 (visual analog scale of 1 to 10 with 1 being lowest stress and 10 being highest stress)
4. Women in face to face session will have to be able to attend the SMART session.
5. Women in the online group will be required to have the ability to use internet to access the online training material.

Exclusion Criteria:

1. Self-reported Stress Index \<6
2. Pregnant women will be excluded from participation in the study. Pregnancy test is not required because the intervention in this study poses no risk
3. Unable to give written consent
4. Inability or refusal to cooperate with study procedures

Primary outcomes:
measure: Change in Heart SMART Program survey score
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Participant's adherence survey score to Heart SMART program
timeFrame: 16, 20 and 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Anjali Bhagra, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03601221: Seroprevalence Hepatitis E Infection in Healthy Blood Donors
Official title: Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis E
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Swiss Transfusion SRC
name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2018-07-26
Enrollment: 1447
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and voluntary blood donors

Brief summary: This is a HEV seroprevalence in the health donors in the Canton Ticino study. The pre-donation sampling pouch of each blood donor coming form the Cantone Ticino region will be collected and tested for HEV serology (IgM and IgG).

Detailed description: Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).

Eligibility criteria: Inclusion Criteria:

* Healthy and voluntary blood donors
* Subjects living in the Canton Ticino
* Inclusion criteria for blood donation
* Signed informed consent of the STCRS SI for blood donation

Exclusion Criteria:

* Exclusion criteria for blood donation

Primary outcomes:
measure: HEV blood incidence
timeFrame: One year
Secondary outcomes:
measure: change in the blood incidence of HEV
timeFrame: Five years
measure: Geogarphical distribution of the HEV measured in the blood sample
timeFrame: Five years
measure: Trend of the HEV infection measured in the blood sample
timeFrame: One year
Other outcomes:
Locations:
city: Lugano,
country: Switzerland
facility: Swiss Transfusion SRC Canton Ticino
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Florian Bihl, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02416921: Preventing Weight Gain in African American Reproductive-Aged Women
Official title: Preventing Weight Gain in African American Reproductive-Aged Women: Pilot Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Women's Health
Obesity
Keywords: Facebook
Weight Gain Prevention
Women's Health
Online
Weight Gain
Weight Loss
Female Contraception
Obesity
Body Weight
Internet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Missouri, Kansas City
name: University of Massachusetts, Worcester
First posted: 2015-04-15
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to evaluate the effect of a Facebook-delivered weight-gain prevention program versus a Facebook-delivered program with general women's health information.

Detailed description: Weight gain is an important health concern, and disparities in the prevalence of obesity between African American and White women increase throughout the reproductive period. This study is a randomized, controlled trial testing the feasibility and acceptability of a peer-coach-administered, Facebook-delivered intervention to prevent weight gain in overweight and obese African American women. Study visits lasting approximately 1 hour will occur at baseline, post-intervention, and 1-month follow-up, to assess effectiveness and acceptability. The core intervention will occur over a 4-week period. Educational content in both the weight-gain prevention program and women's health program will be delivered via Facebook, with new content posted each weekday related to that week's topics. The peer coaches may contact participants via private messaging, when needed, to provide support and encourage engagement. If successful, this intervention could be easily disseminated to populations in under-served and community settings.

Eligibility criteria: Inclusion Criteria:

* African American
* Has Facebook account and uses it, on average, at least once a day
* Body Mass Index (BMI) of 25-45
* Has access to the internet
* Able to consent in English

Exclusion Criteria:

* Currently pregnant or breastfeeding, recently postpartum (within 6 weeks)
* Diagnosis of Diabetes Mellitus
* History of contraindicated medical conditions or conditions that can affect weight
* Current use of certain medications

Primary outcomes:
measure: Program satisfaction, as measured by the OWN Program Satisfaction Survey
timeFrame: 9 weeks, beginning with start of cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rick Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079221: Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: exercise
Knee extensor
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: COPD patients have a reduced exercise tolerance due to a ventilatory limitation.

Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients.

Detailed description: Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contribute to this impairment as well. Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction.

Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation.

In this study we investigate training effects in patients with moderate to severe COPD with special focus on skeletal muscle.

COPD patients will perform high intensity aerobic interval knee-extensor exercise training 3 days/week for six weeks . At baseline and follow-up, muscle oxygen consumption and mitochondrial respiration will be measured.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosis with FEV1\<70% exp, FEV1%FVC \<70 %
* Age\> 50 years

Exclusion Criteria:

* Heart failure
* Symptomatic coronary artery disease
* Cancer
* Alcohol and drug abuse
* Severe mental illness
* Lower respiratory illness
* Participation in exercise- or lung rehabilitation program last 3 months
* pregnancy
* oral steroid use

Primary outcomes:
measure: Peak power
timeFrame: At inclusion and after 6 weeks of training
Secondary outcomes:
measure: Mitochondrial respiration, Vmax
timeFrame: At inclusion and after 6 weeks of training
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, PhD prof.
role: STUDY_DIRECTOR
References:
citation: Bronstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Haberg AK, Ingul CB, Wisloff U, Steinshamn S. High-intensity knee extensor training restores skeletal muscle function in COPD patients. Eur Respir J. 2012 Nov;40(5):1130-6. doi: 10.1183/09031936.00193411. Epub 2012 Mar 9.
Clinical trial NCT01340521: Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
Official title: FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Keywords: Pituitary Hormone Response
Clomiphene Citrate
Follicle Stimulating Hormone
Luteinizing Hormone
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2011-04-22
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to quantitatively evaluate pituitary hormone response, follicle stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in normally fertile women.

Detailed description: Empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance fecundity in women with unexplained infertility. No clinical trials have examined the efficacy of such treatment in the patient population, although certain studies have shown that active ovulation induction can be effective in women with unexplained infertility, and that cycle fecundity is improved for normally cycling women with active ovulation management in a program of artificial insemination. Since clomiphene citrate can have paradoxical effects on fertility through its anti-estrogenic mode of action, the benefit or lack of benefit from treatment with clomiphene citrate in this patient group needs to be evaluated. We aim to establish a dose response of FSH and LH to various low doses of clomiphene citrate in normally cycling women of known fertility, that is women with an intact hypothalamic-pituitary-ovarian-axis. The significance of this information is that it may help to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in patients with unexplained infertility as it is currently being used empirically.

Eligibility criteria: Inclusion Criteria:

* Normal cycling healthy women with known fertility
* Regular menses every 24 - 35 days
* 18 to 35 years of age
* be within 20% of ideal body weight
* normal TSH, prolactin and mid luteal phase progesterone

Exclusion Criteria:

* Women with Infertility issues
* Irregular menstrual cycles

Primary outcomes:
measure: LH Concentration
timeFrame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles
Secondary outcomes:
measure: FSH Concentration
timeFrame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: a State University Hershey Medical Center /Mayo Clinic when study was conducted
name: Carol L Gnatuk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05196321: Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method
Official title: Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-surgical Hematoma, Hip Replacement , Surgery
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population is made up of patients who have undergone hip prosthesis surgery with the presence of post-surgical hematoma who are included in the hospital rehabilitation program lasting at least 5 days following this intervention.

Brief summary: The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T


Eligibility criteria: Inclusion Criteria:

* Gender: male and female
* Age: 35-85 years include
* Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
* Absence in history of neurological or psychiatric disorders.
* Signature of the Informed Consent and consent to collaborate in all the procedures of the study

Exclusion Criteria:

* Presence of severe neurological / psychiatric pathologies
* to sign the Informed Consense
* of serious cardiological pathologies that can compromise patient safety
* of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
* of active tumors in the treatment area

Primary outcomes:
measure: change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF
timeFrame: at the end of Cycle 5 ( every cycle during 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi -San Siro
Study officials:
affiliation: IRCCS istituto ortopedico galeazzi -sede san siro
name: cristina beretta
role: PRINCIPAL_INVESTIGATOR
References: