louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06634121: Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
Official title: Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Valvular Heart Disease
Heart Failure
Keywords: Mitral Regurgitation
TEER
MitraClip
PASCAL
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.

Detailed description: In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.

Eligibility criteria: Inclusion Criteria:

* Age equal or above 18 years
* Written consent
* Heart Team recommends M-TEER

Exclusion Criteria:

* Mitral Stenosis (MV mean PG \> 5 mmHg)
* Cardiogenic shock or hemodynamic instability at the time of intervention
* Active endocarditis
* Participant in another interventional cardiology study

Primary outcomes:
measure: Postprocedural residual MR measured by 3D EROA
timeFrame: During the index procedure
Secondary outcomes:
measure: Reduction in MR EROA
timeFrame: During the index procedure
measure: Comparing EROA in complex vs. non-complex patients
timeFrame: During the index procedure
measure: Postprocedural MV opening area
timeFrame: During the index procedure
measure: Postprocedural MV inflow gradient
timeFrame: During the index procedure
measure: SLDA
timeFrame: During the index procedure, at 30-day follow-up and at 1-year follow-up
measure: Conversion to surgery or re-imaging of the MV
timeFrame: During the index procedure, at 30-day follow-up and at 1-year follow-up
measure: Stratification by MR etiology
timeFrame: During the index procedure, at 30-day follow-up and at 1-year follow-up
measure: Combined endpoint of mortality, repeat MV intervention or HHF
timeFrame: During the index procedure, at 30-day follow-up and at 1-year follow-up
measure: Quality of Life
timeFrame: At 30-day follow-up and at 1-year follow-up
measure: Exertional dyspnea
timeFrame: At 30-day follow-up and at 1-year follow-up
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
Study officials:
affiliation: LMU Klinikum
name: Jörg Hausleiter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: LMU Klinikum
name: Ludwig Weckbach, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279721: Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
Official title: Phase II Study of Intensity-modulated Radiation (IMRT)With Simultaneous Integrated Boost (SIB) as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Neoplasms
Keywords: thyroid neoplasms
intensity modulated radiation
radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-01-20
Enrollment: 40
Sex: ALL
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: Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control rate at 2 years will be recorded.

Detailed description: Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB. The acute toxicity and locoregional control rate at 2 years will be recorded.

Eligibility criteria: Inclusion Criteria:

* resected well-differentiated throid cancer with at least one high risk feature for locoregional recurrence

Exclusion Criteria:

* medullary or anaplastic thyroid cancer, unresectable

Primary outcomes:
measure: toxicity according to RTOG criteria
measure: locoregional control
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tom Baker Cancer Centre
name: Harold Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03846921: Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
Official title: Alpha-defensin as a Diagnostic Means to Distinguish Between Acute Bacterial and Viral Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infections
Viral Infection
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with fever attending pediatric emergency department or who have been hospitalized

Brief summary: This study aims to investigate the use of alpha-defensin as a diagnostic means to distinguish between acute bacterial and viral infections.


Eligibility criteria: Inclusion Criteria:

* Children with either bacterial or viral infections

Exclusion Criteria:

* All others

Primary outcomes:
measure: Rise in alpha-defensin
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Eias Kassem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706221: Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
Official title: Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2021-01-12
Enrollment: 200
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
Intervention model description: The study is a prospective, single-arm, non-randomized, non-controlled, single-center study enrolling adult subjects.
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

Detailed description: Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with study procedures and duration requirements
* 18 years of age or older
* Undergoing an abdominal or pelvic surgery within the next 10 days

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Participation in other clinical studies involving experimental drugs or devices
* Undergone an amputation of the left upper extremity
* Diagnosed with Dextrocardia
* Subjects who have a Pacemaker

Primary outcomes:
measure: Relative Index Change During PACU Stay
timeFrame: Length of PACU Stay (Range: 46 to 353 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
References:
Clinical trial NCT01018121: Behavioral Rx & Nutrition in Pediatric Chronic Disease
Official title: LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pediatric Obesity
Keywords: Behavioral Treatment
Preschool Children
Obesity Treatment
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Center for Research Resources (NCRR)
First posted: 2009-11-23
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:

H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.


Eligibility criteria: Inclusion Criteria:

1. child age between 2- 5 years;
2. child \> 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
3. medical clearance from pediatrician; and
4. at least one parent with a BMI \> 25. -

Exclusion Criteria:

1. non-English speaking;
2. living more than 50 miles from the medical center;
3. a disability/illness that would preclude engagement in at least moderate physical activity;
4. medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.

Primary outcomes:
measure: BMI z score
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Parent weight loss
timeFrame: baseline, 24 weeks, 48 weeks
measure: Child caloric intake
timeFrame: baseline, 6 months, 12 months
measure: Home food and activity environment
timeFrame: baseline, 6 months, 12 months
measure: Child physical activity
timeFrame: baseline, 6 motnhs, 12 months
measure: Parent-child mealtime interactions
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lori J Stark, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02236221: Effect of Vitamin D on Offspring Obesity
Official title: Mechanism of Vitamin D in Influencing Offspring Obesity During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Obesity
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with the early, mid and late pregnancy; Chilren

Brief summary: The purpose of this study is to observe the effect of lack or excess of Vitamin D in the first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.


Eligibility criteria: Inclusion Criteria:

* Pregnancy women
* children
* Chinese

Exclusion Criteria:

-

Primary outcomes:
measure: The level of Vitamin D of pregnancy women at second trimester
timeFrame: 20-24 weeks of pregnancy
Secondary outcomes:
measure: The level of Vitamin D of pregnancy women at first trimester
timeFrame: 12 weeks of pregnancy
measure: The level of Vitamin D of pregnancy women at third trimester
timeFrame: 28-40 weeks of pregnancy
measure: The birth weight, fat content and metabolism related hormone secretion of their offspring
timeFrame: At birth
measure: The weight, fat content and metabolism related hormone secretion of their offspring at one year old
timeFrame: One years old
measure: The weight, fat content and metabolism related hormone secretion of their offspring at 3 years old
timeFrame: 3 years old
measure: The weight, fat content and metabolism related hormone secretion of their offspring at 5-7 years old
timeFrame: 5-7 years old
measure: The weight, fat content and the secretion of metabolism related hormone of offspring at 18 years old
timeFrame: 18 years old
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Xirong Guo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778721: Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia
Official title: Psychiatric Co-morbidities (Seasonal Affective Disorder and Bipolar Disorder) and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia: Quantitative Study Following 48-hour Polysomnographic Recordings.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Hypersomnia
Mood Disorder
Bipolar Disorder
Keywords: demographic characteristic
psychiatric morbidity
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
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 idiopathic hypersomnia

Brief summary: This is a study of only patients with idiopathic hypersomnia. It is a rare and still poorly understood pathology. In clinical practice, we have found that the treatment and care offered were not always effective. The idea of this study to improve knowledge of this pathology by studying the demographic characteristics of patients and other co-morbidities, in particular psychiatric patients, to see if we can identify common factor to our patients and useful in their medical care. The main objective of this research is to allow a quantitative study of the demographic and psychiatric characteristics of patients with idiopathic hypersomnia.


Eligibility criteria: Inclusion Criteria:

* adult patients with a diagnosis of idiopathic hypersomnia according to the ICSD 3 criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today.

Exclusion Criteria:

* minors persons and under legal protection persons.

Primary outcomes:
measure: demographic characteristics
timeFrame: day 1
measure: psychiatric characteristics
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU Toulouse
name: Rachel DEBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836121: Anterior Mediastinum Teratoma: A Case Report
Official title: Case Report of a 39 Years Old Man That Has Been Cured by a Total Resection of a Anterior Mediastinum Teratoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Teratoma
Keywords: Teratoma
Mediastinum
Lead sponsor: Faculdade de Medicina de Catanduva
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 1
Sex: MALE
Minimum age (years): 39
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. Those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. They arise from totipotent cells and, therefore, are primarily found in gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues are immature to well differentiated and foreign to the anatomic site. Mature teratomas are either cystic or solid, although the cystic presentation predominates in gonadal sites. Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are potentially malignant tumors; their prognosis is influenced by the anatomic site of the tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign mediastinal teratoma includes complete surgical resection, with results in a excellent long-term cure rates. Complete resection of teratomas should be the goal of treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mediastinum teratoma

Exclusion Criteria:

* Tumor absent

Primary outcomes:
measure: cure
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Catanduva
country: Brazil
facility: Faculdade de medicina de Catanduva
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina de Catanduva
name: Stella MF Giolo, student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777621: Caloric Restriction, Exercise, and Glucoregulation in Humans
Official title: Caloric Restriction, Exercise, and Glucoregulation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-10-22
Enrollment: 69
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in similar effects on blood glucose and insulin. The purpose of this study is to assess the hypothesis that weight loss through caloric restriction plus exercise will result in greater improvements on glucose tolerance and insulin action than similar weight losses through CR or EX alone.

Detailed description: Participants are randomized into caloric restriction, exercise, and caloric restriction plus exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6% of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone density and body composition, physical activity levels, dietary intakes, and measures of arterial stiffness.

Eligibility criteria: Inclusion Criteria:

* females postmenopausal
* no diabetes, cardiovascular disease, cancer
* no orthopedic problems
* not currently exercising
* BMI between 25 and 29.9
* nonsmokers

Exclusion Criteria:

* current regular exercisers
* premenopausal women
* cardiovascular disease, lung disease, cancer, diabetes

Primary outcomes:
measure: Glucoregulatory function
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Edward P Weiss, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiss EP, Jordan RC, Frese EM, Albert SG, Villareal DT. Effects of Weight Loss on Lean Mass, Strength, Bone, and Aerobic Capacity. Med Sci Sports Exerc. 2017 Jan;49(1):206-217. doi: 10.1249/MSS.0000000000001074.
citation: Weiss EP, Albert SG, Reeds DN, Kress KS, McDaniel JL, Klein S, Villareal DT. Effects of matched weight loss from calorie restriction, exercise, or both on cardiovascular disease risk factors: a randomized intervention trial. Am J Clin Nutr. 2016 Sep;104(3):576-86. doi: 10.3945/ajcn.116.131391. Epub 2016 Jul 27.
citation: Weiss EP, Albert SG, Reeds DN, Kress KS, Ezekiel UR, McDaniel JL, Patterson BW, Klein S, Villareal DT. Calorie Restriction and Matched Weight Loss From Exercise: Independent and Additive Effects on Glucoregulation and the Incretin System in Overweight Women and Men. Diabetes Care. 2015 Jul;38(7):1253-62. doi: 10.2337/dc14-2913. Epub 2015 Apr 15.
Clinical trial NCT04157621: taVNS in Mild to Moderate Parkinson's Disease
Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

* Age: 40-79 y
* Idiopathic Parkinson's Disease Diagnosis
* Disease Stage: Hoehn and Yahr stage 2-3
* Patient requires a minimum of 3 doses of levodopa daily
* Willingness to be videotaped

Exclusion criteria:

* Dementia or Montreal Cognitive Assessment score \<24
* Parkinson's Disease psychosis
* Ear trauma
* Facial pain
* Traumatic Brain Injury or clinical history of stroke
* Metal implants above the shoulders
* History of myocardial infarction or arrhythmia, bradycardia
* Active respiratory disorder
* Alcohol or substance use disorders
* History of Deep Brain Stimulation (DBS) or other brain surgery
* Epilepsy
* Pregnancy
* B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs

Primary outcomes:
measure: Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: Baseline (Visit 1) to Day 14 (Visit 10)
Secondary outcomes:
measure: Change in Cognitive Function Score
timeFrame: Screening to Day 13 (Visit 9)
measure: Change in Cognitive Function Score
timeFrame: Screening to Day 13 (Visit 9)
measure: Change in Cognitive Function Score
timeFrame: Screening to Day 13 (Visit 9)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Vanessa Hinson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: