louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03166488: MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair
Official title: Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.


Eligibility criteria: Inclusion criteria:

* Primary tricuspid valvular regurgitation (tricuspid valve disease not related to a left-sided cardiac abnormality) diagnosed by echocardiography
* Evidence of passive hepatic congestion. Patients with severe tricuspid regurgitation diagnosed at echocardiography will constitute evidence of passive hepatic congestion.
* Patient scheduled for surgical tricuspid valvular repair or replacement.

Exclusion criteria:

* Contraindication for MRI (implantable devices such as cardiac pacemaker, anxiety, inability to lay supine, etc).
* Additional conditions which may elevate their liver stiffness: hepatic fibrosis or cirrhosis, hepatic parenchymal disease (primary biliary cirrhosis, primary sclerosing cholangitis, etc), acute or chronic hepatitis (viral, substance or medication induced), disorders of hepatic vasculature, biliary obstruction or disease, primary or metastatic hepatic malignancy.
* Cannot agree to return for a follow up visit to complete the postsurgical imaging.

Primary outcomes:
measure: Change in liver stiffness between preoperative and postoperative MR elastography (MRE)
timeFrame: baseline, approximately 6 months postoperatively
measure: Change in tricuspid valve regurgitation measured by echocardiography
timeFrame: baseline, approximately 6 months postoperatively
Secondary outcomes:
measure: Change in Subject Functional Capacity
timeFrame: baseline, approximately 6 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Michael L Wells
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331888: To Compare the Efficacy Between 3 Fetal Monitoring Methods
Official title: A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fetal Heartbeat Tracings
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: OB-Tools Ltd.
First posted: 2015-01-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.

Detailed description: Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.

study design:

1. signing an informed consent at vas\<3
2. admittance to delivery room.
3. Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases.
4. Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously.
5. Recording fetal heart rate until delivery.
6. Disconnecting the patient from all devices if required according to clinical need.

Eligibility criteria: Inclusion Criteria:

1. Clinical indication to insert a scalp electrode for fetal heart rate tracing.
2. Maternal age\>18 years.
3. Reactive fetal heart rate monitoring and BPP (Biophysical Profile) 8/8 at enrollment.
4. Singleton pregnancy.
5. No fetal abnormality or chromosomal defect.
6. Subjects are willing and able to comply with the requirements of the protocol.
7. Fully understand all elements of, and have singed and dated the written informed consent form before initiation of protocol specified procedures, when vas\<3.

Exclusion Criteria:

1. Women who refuse to sign the informed consent form.
2. Maternal age\<18 years.
3. Multiple pregnancy.
4. Women with implanted electronic device of any kind.
5. Women with allergic to silver.
6. Irritated skin or open wound.

Primary outcomes:
measure: The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
timeFrame: 12 month
Secondary outcomes:
measure: Reliability
timeFrame: 12 months
measure: Reliability
timeFrame: 12 months
measure: Reliability
timeFrame: 12 months
measure: Accuracy
timeFrame: 12 months
measure: Accuracy
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Director, division of obstetrics and delivery ward Rabin medical center
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02157688: Impact of Staphylococcus Aureus on Folliculitis Decalvans
Official title: Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Folliculitis Decalvans
Staphylococcus Aureus
Keywords: folliculitis decalvans
Staphylococcus Aureus
antibiotics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Folliculitis Decalvans

Brief summary: The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on scalp. This disease is currently not curable, responsible for significant for patients. The pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role, never previously studied, and the study will attempt to clarify it.

Controversies in the literature on the pathophysiological hypotheses can be summed up as follows :

FD is it an infectious folliculitis where SA (almost always found on the lesions plays a direct role possibly aided by a lack of local immune protection , or is it a pustular inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ superinfection.

Our study has plans to bring new evidence to help decide between these two opposite but not mutually exclusive concepts .


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 yo)
* Alopecia
* folliculitis decalvans
* At least 6 months of evolution
* no antibiotics
* presence of pustules and crusts
* Adult (\>18 yo)

Exclusion Criteria:

* immunosuppression
* pregnancy

Primary outcomes:
measure: presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony)
timeFrame: 1 day
Secondary outcomes:
measure: presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment
timeFrame: 10 weeks
measure: presence of Staphylococcus Aureus in nasal swab (at least one colony)
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
Study officials:
References:
citation: Matard B, Donay JL, Resche-Rigon M, Tristan A, Farhi D, Rousseau C, Mercier-Delarue S, Cavelier-Balloy B, Assouly P, Petit A, Bagot M, Reygagne P. Folliculitis decalvans is characterized by a persistent, abnormal subepidermal microbiota. Exp Dermatol. 2020 Mar;29(3):295-298. doi: 10.1111/exd.13916. Epub 2019 May 15.
Clinical trial NCT02837588: Hyperthermy Endocavitary Treatment in Pelvic Pain
Official title: Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pelvic Pain
Keywords: chronic pelvic pain
trigger points
hiperthermy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Victoria
First posted: 2016-07-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS
* MJS electrode is effective for transvaginal treatment at pelvic pain patients
* Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment

Detailed description: This study analyzed the evolution of chronic pelvic pain, defined by the different map of myofascial trigger points assets presents the patient with medical treatment compared to treatment with radiofrequency endocavitary electrode MJS. The initial evaluator analyzed by the NIH-CPSI Scale questionnaire and symptoms of chronic pelvic pain Stanford Protocol for female or male quality of life of the patient before the doctor or radio frequency and a month since treatment. the patient to the Principal Investigator, specialist physiotherapist, who appreciates tenderness the presence of a taut band with a map of pain in endopelvic and exopelvic muscles, determining the activation of myofascial trigger points in each is derived. The Principal Investigator proceeds to address each active myofascial trigger points with the MJS electrode four 20-minute sessions twice a week. The MJS has a curved end pressure which favors the compression point plus the location and accurate approach Radiofrequency pathological point as outstanding feature. The high specificity of myofascial treatment offered by the MJS electrode involves no danger, besides having the computer screen conductivity meter and a temperature sensor on the head to control both parameters in real time during the treatment session

Eligibility criteria: Inclusion Criteria:

* Women with chronic pelvic pain

Exclusion Criteria:

* chronic pelvic pain or neurological degenerative etiology
* Presence of pathology or infectious processes genitourinary level
* possibility of pregnancy or lactating.
* Lack of informed consent, mental disorders, dementia, dependent people who need tutor.

Primary outcomes:
measure: NIH-CPSI questionnaire
timeFrame: four weeks
Secondary outcomes:
measure: pain measure questionnaire
timeFrame: four weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Marta Sainz
state: Málaga
Study officials:
affiliation: Universitat Central de Catalunya
name: Carolina Walker, Dr
role: STUDY_DIRECTOR
affiliation: Universidad Rey Juan Carlos
name: Marta Losa, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06764888: ERAS in Elderly Colorectal Cancer Surgery
Official title: Short-Term Outcomes of Minimally Invasive Surgery in Elderly Colorectal Cancer Patients in the Era of ERAS: is a "One-Size-Fits-All" Strategy Sufficient?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Colo-rectal Cancer
Elderly (people Aged 65 or More)
Minimally Invasive Surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 1392
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2018 to December 2022, comprehensive data on patients who underwent colorectal resection for malignancy at a single medical institute, Chang Gung Memorial Hospital, were prospectively collected and retrospectively reviewed.

Brief summary: Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. This is a retrospective study based on prospectively collected data. Patient privacy has been carefully protected throughout the research process, and no aspect of this study interfered with or altered the patients' treatment or clinical care.


Eligibility criteria: Inclusion Criteria:

* they underwent radical resection for colorectal cancer
* the procedure was minimally invasive surgery
* they were aged 65 or older
* they provided signed informed consent.

Exclusion Criteria:

* Patients who underwent emergency surgery for colorectal cancer.
* Patients with incomplete medical records or missing data relevant to the study.
* Patients with synchronous malignancies or a history of other cancers within the past five years.
* Patients with severe comorbidities (e.g., advanced cardiovascular, respiratory, or renal diseases) that contraindicate ERAS protocol implementation.
* Patients with preoperative metastatic disease or locally advanced tumors requiring palliative procedures.
* Patients who did not comply with or complete the ERAS protocol during the perioperative period.

Primary outcomes:
measure: Short-term postoperative complications rate.
timeFrame: 3 months
Secondary outcomes:
measure: Days of Hospital Stay and Time to First Passage of Flatus
timeFrame: 3 months
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05340088: Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Official title: Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stone, Kidney
Urolithiasis
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a DJ stent for passive dilatation and subsequent RIRC

Brief summary: Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.


Eligibility criteria: Inclusion Criteria:

* Patients with a DJ stent for passive dilatation and subsequent RIRC

Exclusion Criteria:

* Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor

Primary outcomes:
measure: BMI in kg/m^2
timeFrame: 3 Months
measure: serum creatinine mg/dl
timeFrame: 3 Months
Secondary outcomes:
measure: mm size of the stone
timeFrame: 3 Months
measure: localization of the stone in the kidney,
timeFrame: 3 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
References:
citation: Bai PD, Wang T, Huang HC, Wu Z, Wang XG, Qin JX, Wang HQ, Chen B, Hu MB, Xing JC. Effect of Preoperative Double-J Ureteral Stenting before Flexible Ureterorenoscopy on Stone-free Rates and Complications. Curr Med Sci. 2021 Feb;41(1):140-144. doi: 10.1007/s11596-021-2328-z. Epub 2021 Feb 13.
citation: Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.
Clinical trial NCT01323088: Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Official title: Physical Activity in Overweight Girls: Implications for Reversing Risk Factors for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Physical Activity
Keywords: Childhood obesity
Visceral fat
Insulin resistance
Liver fat
Skeletal muscle lipid
Regular exercise
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 44
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.


Eligibility criteria: Inclusion Criteria:

* Healthy overweight (BMI \>-95th) youth between 12 and 18 years of age
* Waist circumference \>-75th percentile
* Sedentary (no structured exercise \>2 times/week for past 6 months)
* Non-smokers, non-diabetic, no medical conditions
* Weight stable for past 3 months

Exclusion Criteria:

* Smokers
* Diabetes
* Psychiatric disorders
* Syndromic obesity
* Pregnancy
* Taking medications known to affect study outcomes

Primary outcomes:
measure: Abdominal obesity, visceral fat
timeFrame: 3 month
Secondary outcomes:
measure: insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy.
timeFrame: 3 month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: SoJung Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
citation: Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
citation: Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
Clinical trial NCT00745888: Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
Official title: Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Shock
Keywords: oxidative stress
intensive care
Postoperative intensive care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to surgical ICU

Brief summary: In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. There are some questions on the oxidative stress of the critical illness. First, the investigators want to search out the effects of the past history, smoking, alcohol drinking, use of antioxidants, different diseases, and different duration of SIRS on the degree of oxidative stress. Second, besides total count of ROS, the investigators used new techniques to determine superoxide(O2●-), hydrogen peroxide (H2O2), and hypochlorous acid(HOCl). Furthermore, we want to investigate the correlation of the degree of different reactive oxygen species and the severity of SIRS or shock. Third, we try to investigate the correlation between the change of oxidative stress and the prognosis of the patients.

The investigators wish this study will help them to investigate the effect of oxidative stress on critical ill patients, to modulate the oxidative stress, to decrease the occurrence of SIRS, shock, and multiorgan failure, and to improve the long term outcome of patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 y/o
* Admitted to surgical ICU

Exclusion Criteria:

* Patients with brain death

Primary outcomes:
measure: 28-day Survival
timeFrame: 28 days
Secondary outcomes:
measure: Days stay in ICU Days on ventilator SOFA score Complications
timeFrame: 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh
role: PRINCIPAL_INVESTIGATOR
References: