louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05104307: Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
Official title: Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Keywords: cardiovascular
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Sensydia Corporation
First posted: 2021-11-02
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for a standard echocardiogram

Brief summary: Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Detailed description: This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.

Eligibility criteria: Inclusion Criteria:

• Patients over 18 scheduled for a standard echocardiogram

Exclusion Criteria:

* Patients with heart transplant history
* Patients with a Implanted Left Ventricular Assist Device (LVAD)
* Patients who have surgical scars, wounds, or bandages at the site of sensor placement
* Inadequate TTE imaging windows in left lateral position
* Otherwise deemed by the investigator as medically unfit to participate
* Chest deformities including, for example, pectus excavatum

Primary outcomes:
measure: Cardiac Performance System electronic data for Ejection Fraction
timeFrame: 60 minutes during Echocardiography procedure
measure: Cardiac Performance System electronic data for Cardiac Output
timeFrame: 60 minutes during Echocardiography procedure
measure: Cardiac Performance System electronic data for Pulmonary Artery Pressure
timeFrame: 60 minutes during Echocardiography procedure
measure: Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure
timeFrame: 60 minutes during Echocardiography procedure
measure: Echocardiography electronic data for Ejection Fraction
timeFrame: 60 minutes during Echocardiography procedure
measure: Echocardiography electronic data for Cardiac Output
timeFrame: 60 minutes during Echocardiography procedure
measure: Echocardiography electronic data for Pulmonary Artery Pressure
timeFrame: 60 minutes during Echocardiography procedure
measure: Echocardiography electronic data for Pulmonary Artery Wedge Pressure
timeFrame: 60 minutes during Echocardiography procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Stephen L Esper, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04737707: Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders
Official title: Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 48
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: Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders. However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability. This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* ASD diagnosis according to the DSM-5
* IQ ≥ 70
* Suicidal ideas, suicidal attempts and/or self-harm behaviors 6 months prior to the inclusion
* Able to understand and consent to the research aims
* Membership in a health insurance fund

Exclusion Criteria:

* complete hospitalization
* ongoing CBT or DBT
* past DBT
* schizophrenia disorders
* under guardianship

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: baseline
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: at the end of therapy (5 months)
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 11 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie
Study officials:
References:
Clinical trial NCT05281107: Vitamin D Supplementation and PTH Response Among Malaysian Adults
Official title: Vitamin D Supplementation, Parathyroid Hormone (PTH) and Plasma Vitamin D Response Among Malaysian Female Adults: Double Blinded, Randomised Clinical Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: International Medical University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial was designed to determine the efficacy of vitamin D supplementation on plasma 25-hydroxyvitamin D \[25(OH)D\] and intact parathyroid hormone (PTH) concentrations of Malaysian female adults of child-bearing age after daily intake of vitamin D supplements containing either 0 IU, 600 IU, 1200 IU or 4000 IU vitamin D for 16 weeks.

Detailed description: After being informed regarding the study protocol and requirements, participants given informed consent were interviewed using a questionnaire for collection of background data and medical history as a screening process. Eligible participants were randomly assigned in a double-blind manner to receive daily 500 mg of calcium with either 0, 600 IU, 1200 IU or 4000 IU vitamin D supplement for 16 weeks. Questionnaires and anthropometric measurements were collected at baseline and post 16 weeks supplementation trial. Primary outcomes of plasma 25(OH)D and intact PTH were measured via fasting intravenous blood samples at baseline and post 16 weeks trial.

Eligibility criteria: Inclusion Criteria:

* three major ethnic groups (Malay, Chinese, Indian)
* age 20-45 years

Exclusion Criteria:

* any diseases or conditions that may affect vitamin D metabolism, such as diabetes, cardiovascular diseases, bone diseases, autoimmune diseases, had major gastrointestinal surgery and diagnosed primary hyperparathyroidism
* medications that might affect vitamin D metabolism, such as insulin, thiazide diuretics, prednisolone, biphosphonates, tamoxifen and phenytoin
* pregnant and lactating women

Primary outcomes:
measure: Change from baseline plasma 25-hydroxyvitamin D at week 16
timeFrame: Baseline and week 16
Secondary outcomes:
measure: Change from baseline intact parathyroid hormone at week 16
timeFrame: Baseline and week 16
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: International Medical University
name: Geok Lin Khor
role: STUDY_CHAIR
affiliation: International Medical University
name: Megan Chong
role: STUDY_DIRECTOR
References:
Clinical trial NCT00634907: Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Official title: Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Bleeding
Keywords: Genotyping
Warfarin dosing
arthroplasty
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 263
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: Several human genes affect how medications are metabolized by the body. It is believed that knowledge of variations of these genes can help health care providers better manage an anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems with bleeding or the development of blood clots. This study was designed to evaluate if genetic testing can improve warfarin initiation better than usual care.

Detailed description: This study was completed in 2008 and was published. Consult the citation link for more details.

Eligibility criteria: Inclusion Criteria:

* Participants were otherwise healthy adults (≥ 18 years of age) who were planning total hip or knee replacement or revision surgery at the University of Utah Hospital, and scheduled a pre-operative office visit at the University of Utah Orthopaedic Center.

Exclusion Criteria:

* Blood transfusion in previous two weeks
* Participant is already taking warfarin
* Pre-operative INR \> 4.0
* Pre-operative bilirubin \> 2.4 mg/dL
* Current active cancer diagnosis with ongoing treatment
* Concomitant medications known to exert a major interaction with warfarin such as septra, metronidazole, tramadol, amiodarone, ciprofloxacin, or cimetidine.

Primary outcomes:
measure: The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement
timeFrame: 90 days post surgery
Secondary outcomes:
measure: Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)
timeFrame: 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
measure: Percentage of Determinations Subtherapeutic (INR<1.8)
timeFrame: 2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty)
measure: Percentage of Determinations Supratherapeutic (INR>2.9)
timeFrame: 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Care
state: Utah
Study officials:
affiliation: ARUP Laboratories
name: Gwen McMillin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMillin GA, Melis R, Wilson A, Strong MB, Wanner NA, Vinik RG, Peters CL, Pendleton RC. Gene-based warfarin dosing compared with standard of care practices in an orthopedic surgery population: a prospective, parallel cohort study. Ther Drug Monit. 2010 Jun;32(3):338-45. doi: 10.1097/FTD.0b013e3181d925bb.
Clinical trial NCT06885307: Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China
Official title: Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease (CHD)
Keywords: Congenital Heart Disease (CHD)
Database
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 35000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with congenital heart disease confirmed by cardiac ultrasound examination

Brief summary: This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for children with congenital heart disease in China, establish a platform and mechanism for the collection and sharing of data on children with congenital heart disease in China, and create a real-world public database of children with congenital heart disease in China that benchmarks the international level, so as to provide a solid data foundation for high-quality research on children with congenital heart disease in China.


Eligibility criteria: Inclusion Criteria:

1. Age 0-18 years, regardless of gender;
2. Patients diagnosed with congenital heart disease confirmed by cardiac ultrasound examination;

Exclusion Criteria:

None

Primary outcomes:
measure: Change of condition
timeFrame: Extract the discharge prognosis in the discharge summary after the hospitalization at the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xining
country: China
facility: Qinghai Women & Children'S Hospital
state: Qinghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Yunnan
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
Study officials:
affiliation: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, Shanghai, 200092, China
name: Kun Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05880407: Pilot Study of Percutaneous Correction of Hallux Valgus
Official title: Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study with a randomized controlled design.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
* HVA (hallux valgus angle): 20°-40°
* IMA (intermetatarsal angle): 10°-20°

Exclusion Criteria:

* Patients with instability of the first metatarsophalangeal joint
* Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
* patients requiring additional surgical procedures
* patients with severe vascular and neurological systemic pathologies
* systemic pathologies that may impair bone consolidation

Primary outcomes:
measure: Visual Analog Score
timeFrame: baseline
measure: Visual Analog Score
timeFrame: 1 year
Secondary outcomes:
measure: American Orhtopaedic Foot and Ankle Society forefoot score
timeFrame: baseline and aftef 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT01881607: An Integrated Intervention to Reduce Secondhandsmoke in Children
Official title: Respiratory Symptoms, Asthma and Passive Smoking in Children: Effectiveness of an Integrated Individual, Family, and School-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Exposure
Smoking Status
Keywords: tobacco smoke pollution
Tobacco use
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Barcelona
name: Institut Municipal d'Investigació Mèdica
name: Fundació La Marató de TV3
First posted: 2013-06-19
Enrollment: 1779
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a community essay to assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools were assigned to the intervention or the controlgroup at random. The investigators assessed SHS exposure in different settings (at school, at home, on transportation and leisure time) and tobacco consumption by means of a questionnaire before and one year after the intervention. Based on a previously evaluated intervention to prevent smoking initiation (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program) including two new activities to prevent passive smoking to be applied at three levels: in the classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils and parents).


Eligibility criteria: Inclusion Criteria:

* all schoolchildren attending the school at the day of interview

Exclusion Criteria:

* absence of school
* language problems with questionnaire

Primary outcomes:
measure: Prevalence of exposure to secondhand smoke
timeFrame: 1 year
Secondary outcomes:
measure: Prevalence of current smokers
timeFrame: 1 year
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Catalan Institute of Oncology
state: Barcelona
Study officials:
References:
citation: Martin-Pujol A, Fernandez E, Schiaffino A, Moncada A, Ariza C, Blanch C, Martinez-Sanchez JM; RESPIR.NET research group. Tobacco smoking, exposure to second-hand smoke, and asthma and wheezing in schoolchildren: a cross-sectional study. Acta Paediatr. 2013 Jul;102(7):e305-9. doi: 10.1111/apa.12232. Epub 2013 Apr 16.
citation: Blanch C, Fernandez E, Martinez-Sanchez JM, Ariza C, Lopez MJ, Moncada A, Schiaffino A, Rajmil L, Salto E, Pascual JA, Nebot M; RESPIR.NET research group. Impact of a multi-level intervention to prevent secondhand smoke exposure in schoolchildren: a randomized cluster community trial. Prev Med. 2013 Nov;57(5):585-90. doi: 10.1016/j.ypmed.2013.07.018. Epub 2013 Aug 7.
Clinical trial NCT01524107: Complications: Urgent C Section VS Elective C Section
Official title: Comparison of Maternal and Fetal Complications After Urgent Caesarian Section for Prolapsed Cord Versus Elective Caesarian Section.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urgent Caesarian Section Secondary to Cord Prolapse
Keywords: Prophylaxis Antibiotics
Maternal Complications
Neonatal Complications
Cord Prolapse
Elective Caesarian Section
Maternal Morbidity
Neonatal Morbidity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing Urgent Caesarian Section for Prolapsed Cord and women undergoing Elective Caesarian Section at Hadassah Medical Center-Har HaTzofim.

Brief summary: The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.


Eligibility criteria: Inclusion Criteria:

* women undergoing urgent Caesarian Section for Prolapsed Cord.
* women undergoing Elective Caesarian Section.

Exclusion Criteria:

* preterm birth
* multiple gestation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Drorith Hochner-Celnikier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05814107: Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of CT-996 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Overweight or Obesity
Keywords: Type 2 Diabetes
Obesity
Overweight
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Carmot Therapeutics, Inc.
First posted: 2023-04-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

Detailed description: A multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Eligibility criteria: Inclusion Criteria:

* Participants 18-65 years old, inclusive
* BMI of 25 - 40, inclusive
* Stable body weight for two months

Exclusion Criteria:

* History of significant medical conditions and malignancy
* Uncontrollable hypertension
* History of alcoholism or drug addiction within 1 year prior to Screening
* Current or recent participation in an investigational clinical trial

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events in CT-996 participants
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Maximum observe drug concentration (Cmax) of CT-996
timeFrame: Baseline up to 28 days
measure: Effect of a High-Fat Meal on Plasma Concentration of CT-996
timeFrame: Baseline up to 14 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Carmot Clinical Research Unit 101
Study officials:
affiliation: Carmot Therapeutics, Inc.
name: Michael Elliott
role: STUDY_DIRECTOR
References: