louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06307262: European Registry of Transcatheter Repair for Tricuspid Regurgitation
Official title: European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Valvular Heart Disease
Heart Failure
Keywords: Tricuspid regurgitation
TEER
edge-to-edge repair
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve)

Brief summary: To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

Detailed description: Background and Rationale:

Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.

Objectives:

To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.

Eligibility criteria: Inclusion Criteria:

* Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
* Age ≥ 18 years

Primary outcomes:
measure: All-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Technical success
timeFrame: 5 years
measure: Procedural Safety
timeFrame: 5 years
measure: Heart Failure Biomarker
timeFrame: 5 years
measure: Dyspnea on exertion
timeFrame: 5 years
measure: Functional capacity
timeFrame: 5 years
measure: Right ventricular size
timeFrame: 5 years
measure: Right ventricular function
timeFrame: 5 years
measure: Tricuspid regurgitation reduction
timeFrame: 5 years
measure: Tricuspid valve stenosis
timeFrame: 5 years
measure: Pulmonary hypertension
timeFrame: 5 years
measure: Right heart congestion
timeFrame: 5 years
measure: Hospitalization for heart failure
timeFrame: 5 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
Study officials:
References:
Clinical trial NCT06374862: Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population
Official title: Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Manipulations
Range of Motion
Muscle Strength
Peripheral Joints in Upper Quarters
Keywords: Musculoskeletal Manipulations
Range of Motion
Muscle Strength
peripheral joints in upper quarters
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results


Eligibility criteria: Inclusion Criteria:

* Ages 18 to 65,
* healthy volunteer,
* membership in a social security scheme

Exclusion Criteria:

* Severe spinal trauma within the last 6 months
* history of low back pain, back pain, and/or neck pain within the last 6 months,
* history of spinal surgery,
* history of chronic systemic disease (cardiac, respiratory, diabetes, etc.),
* volunteer with Pacemaker, history of rheumatological pathology (rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, etc.),
* patient under guardianship,curatorship, safeguard of justice, patient deprived of liberty, pregnant woman and patient without Red Flags Social Security described in literature.

Primary outcomes:
measure: electrical activity assessment of the spine extensor muscles using EMG
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT00532662: Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery
Official title: Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Analgesia
Keywords: Epidural
Intravenous
Ketamine
Analgesia
Caudal
Pediatric
Regional
Local Anesthetics
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.

Detailed description: After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.

Eligibility criteria: Inclusion Criteria:

* Children aged \< = 12 years
* Children scheduled for elective orthopedic surgery with caudal block
* ASA score \< = 3

Exclusion Criteria:

* Contraindication for caudal block such as vertebral defect or infection at the site of block
* Disagreement of parents
* Patient's age \> 12 years
* ASA score \> = 4

Primary outcomes:
measure: pain score
timeFrame: 24 hours after anesthesia
Secondary outcomes:
measure: analgesic request
timeFrame: 24 hours after anesthesia
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: orthopedic ward of Imam Khomeini hospital
city: Tehran
country: Iran, Islamic Republic of
facility: orthopedic surgery room- Imam Khomeini hospital
Study officials:
affiliation: Imam Khomeini hospital- tehran university of medical sciences
name: Ramin Espandar, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00922662: Database of Patients Undergoing Cardiac Computed Tomographic Angiography at William Beaumont Hospital (CT DATABASE)
Official title: Database of Patients Undergoing Cardiac Computed Tomographic Angiography (CCTA)at William Beaumont Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Chest Pain
Keywords: coronary artery disease
chest pain
CCTA
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Both genders
* Retrospective CCTA subjects who have undergone CCTA in the past 5 years at this institution
* Prospective subjects who will have a CCTA at this institution (ongoing)

Brief summary: The purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific reasons.

Detailed description: The principal goal of his project is to enable the study investigators to organize WBH research activity in the field of CCTA by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. It will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.

Eligibility criteria: Inclusion Criteria:

* all retrospective patients who under went a CTA and were granted a waiver of consent
* all prospective patients CTA patients who gave informed consent.

Exclusion Criteria:

* Non CTA patients
* Patients who refused participation.

Primary outcomes:
measure: To establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all WBH patients undergoing CCTA testing for clinical or scientific reasons.
timeFrame: annually for 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System - Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospital-Royal Oak
name: Kavitha Chinnaiyan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128062: Canthaxanthin Retinopathy: A Long-term Observation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Canthaxanthin Retinopathy
Keywords: Canthaxanthin retinopathy
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a history of oral tanning agents should report at the University Eye hospital for examination.

Brief summary: Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first described in 1982 by Cortin et al. In Germany the office of the federal board of health refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time the long-term course of the disease was not known. 25 years later the investigators did these long-term follow-up examinations.


Eligibility criteria: Inclusion Criteria:

* patients using oral tanning agents for at least 2 months.
* patients of 18 years or older

Exclusion Criteria:

* none.

Primary outcomes:
measure: all eye diseases
timeFrame: 2008 and 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Eye Hospital, University of Cologne
state: NRW
Study officials:
References:
Clinical trial NCT06853262: Manual Therapy in Parkinson's Disease
Official title: Influence of Manual Therapy on the Motor and Non-motor Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of La Laguna
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An experimental study will be carried out to examine how a manual therapy protocol can influence a series of parameters related to motor and non-motor symptoms in patients who have Parkinson's disease / Parkinsonism.

To do this, an intervention will be carried out that will last a minimum of 6 weeks. In addition to their ongoing treatment, the study subjects will receive a maximum of 2 sessions of manual therapy each week. They will undergo a series of measurements both before and after the intervention related to gait, balance, non-motor symptoms, and some more specific parameters of gait.

The study's main objective is to obtain information about possible treatment models based on manual therapy for Parkinson's disease. It is also hoped to compile a series of results that will lead to conclusions and benefit the development of physiotherapy for this disease. It is also hoped that this will help those affected so that the treatment is as comprehensive as possible and that the physiotherapist can use as many tools as are available to them to address the pathology.


Eligibility criteria: Inclusion Criteria:

* People aged between 40 and 75 who voluntarily agree to take part in this study

Exclusion Criteria:

* People with Dementia and established cognitive impairment with scores on the Montreal Cognitive Assessment Test (MoCA) of less than 25

Primary outcomes:
measure: Autonomic nervous system activity
timeFrame: Baseline and every six weeks for up to 6 months from the start
Secondary outcomes:
measure: PD NMS Quest
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Mini-BESTest
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Berg Balance Scale
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Timed Up and Go (TUG)
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Tinetti scale
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Range of Motion (ROMs)
timeFrame: Baseline and every six weeks for up to 6 months from the start
measure: Walk Measure
timeFrame: Baseline and every six weeks for up to 6 months from the start
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Facultad de Ciencias de la Salud
state: Santa Cruz de Tenerife
Study officials:
References:
Clinical trial NCT04615962: Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.
Official title: A Phase I, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability Profile of Topical Cream SNG100 for 14 Days of Treatment in Moderate Atopic Dermatitis Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Seanergy Dermatology Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aimed to understand better the efficacy in a randomized, double-blind, intraindividual design trial in 66 participants with AD treated with SNG100, and 2 different strengths of topical steroids hydrocortisone and the medium potent mometasone furoate cream.


Eligibility criteria: Inclusion Criteria:

1. Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist
2. Any child age 6 to 18 with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written informed consent must be given by parent/guardian.
3. Capable of complying with study requirements and study procedure.
4. Investigator Global Assessment (IGA) of 3.
5. The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points.
6. Child-bearing potential women must use a proper contraception method.

Exclusion Criteria:

1. As determined by the study doctor, a medical history that may interfere with study objectives.
2. Atopic dermatitis lesions that occur only on the face and scalp.
3. Presence of a secondary infection with bacteria, fungi, or virus.
4. Recent or current participation in another research study.
5. Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study.
6. Prior wound, tattoo, pigmentation or infection in the treated area.

Primary outcomes:
measure: Side Effects AE's and SAE's
timeFrame: 4 weeks
Secondary outcomes:
measure: Usability
timeFrame: 4 weeks
Other outcomes:
measure: Change from baseline in the SCORAD index
timeFrame: 4 weeks
measure: Eczema Area and Severity Index (EASI) Score
timeFrame: 4 weeks
measure: NRS score
timeFrame: 4 weeks
measure: Investigator's Global Assessment (IGA) Score
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: Seanergy Ltd.
name: Yuval Ramot, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03140462: Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant
Official title: The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: Tacrolimus
Pharmacokinetics
Genetic polymorphisms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: liver transplant patients' donors

Brief summary: To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Detailed description: This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

Eligibility criteria: Inclusion Criteria:donors' recipients

* Living liver transplant during 20070101 \~ 20151231 and only received liver transplantation
* Lab data at least 8 months,
* Receiving tacrolimus as immunosuppressive drugs
* Transplantation at 20 \~ 65 years old

Exclusion Criteria: donors' recipients

* Retransplantation or multi-organ transplantation
* Non-Asian
* Positive for human immunodeficiency virus.

Primary outcomes:
measure: Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation
timeFrame: Within the first 6 months post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Rey-Heng Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02951962: A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin
Official title: A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 60
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase 1, open label, two-cohort, single-sequence, crossover study

Detailed description: This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
* Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)

Primary outcomes:
measure: Telmisartan, Amlodipine, Rosuvastatin AUCτ
timeFrame: 0 - 24 hr
measure: Telmisartan, Amlodipine, Rosuvastatin Cmax
timeFrame: 0 - 24 hr
Secondary outcomes:
measure: Telmisartan, Amlodipine, Rosuvastatin Tmax
timeFrame: 0 - 24 hr
measure: Telmisartan, Amlodipine, Rosuvastatin Cmin
timeFrame: 0 - 24 hr
Other outcomes:
Locations:
city: Chunju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim
role: PRINCIPAL_INVESTIGATOR
References: