louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05718336: Atrial Fibrillation Trial To Eliminate Risk-factors
Official title: Atrial Fibrillation Trial To Eliminate Risk-factors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with documented atrial fibrillation, either paroxysmal, persistent, or permanent.

Brief summary: The goal of this prospective-enrolling cohort study is to test and observe the effect of an integrated multi-discipline care program in patients with atrial fibrillation. The main questions it aims to answer are:

1. to understand the baseline characteristics and to explore the occult risk factors of the patients with AF;
2. to monitor the treatment efficacy of the patients undergoing integrated care and potentially concur the clinical obstacles that prevent the best care for patients with AF.

Participants will be treated by an integrated multi-discipline team that led by an electro-physiologist.

Detailed description: Atrial fibrillation (AF) is a heart condition that potentially leads to heart failure and ischemic stroke. The prevalence of AF is increasing due to aging population and improved treatment in other cardiovascular field. This study is to execute integrated multi-discipline care in a tertiary hospital, and to observe the effect and the obstacle that the program might ensue.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old, who have been diagnosed with atrial fibrillation by a cardiologist with an electrocardiogram

Exclusion Criteria:

1. Unable to complete the initial assessment and cooperate with the tracker
2. Those who refuse to sign the subject's consent

Primary outcomes:
measure: AF burden
timeFrame: 0~24 months
Secondary outcomes:
measure: MACE, major adverse cardiovascular event
timeFrame: 0~24 months
Other outcomes:
Locations:
city: Taipei,
country: Taiwan
facility: National Taiwan University Hospita
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Chieh Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393236: Heart Rate Variability During Sleep After Fast-track Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Variablity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We selected patients undergoing fasttrack hip and knee arthoplasty in fast-track setip. The underwent sleep monotoring for 1 preoperative night and continously during hospitalisation, and for 1 night at home after surgery.

Brief summary: Based on prior findings concerning sleep disturbances, in particular REM sleep disturbances, after fast-track hip and knee arthroplasty (H-2-2010-011) we performed a supplemental analysis of heart rate variablity after arousals during sleep. We compared preoperative and postoperative results.


Eligibility criteria: Inclusion criteria (for the control group):

* Age \> 60 years

Exclusion criteria:

* surgery within the last 2 months
* known sleep disorder (eg. sleep apnea)
* daily beta blocker treatment
* daily dopamine treatment

This protocol only concentrates on the healthy controls for the patient described in H-2-2010-011.

Primary outcomes:
measure: heart rate variability
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lene Krenk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05719636: Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Official title: Effects of Progressive Resistance Exercise Training on Endurance and Functional Mobility in Children With Spina Bifida
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida
Keywords: resistance exercise
endurance
functional mobility
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research the effects of progressive resistance exercise training on endurance and functional mobility in children with spina bifida are assessed.


Eligibility criteria: Inclusion Criteria:

* 8 to 16 year.
* Male and female both are included.
* Lower extremity weakness (less than 2).
* Knee and hip flexion contractures

Exclusion Criteria:

* Bowel and bladder dysfunction.
* Children having absent tone.
* Children having bone fracture

Primary outcomes:
measure: Patient Specific Functional Scale for lower extremity functional status
timeFrame: 6th week
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 6th week
measure: sit to stand test
timeFrame: 6th Week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fareeha Kausar, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606736: Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle
Official title: Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventricular Premature Complexes
Keywords: right ventricular outflow tract arrhythmia
sex hormone level
menstrual cycle
Gonadal Hormones
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 20 to 45 years with regular menstrual cycles.

Brief summary: The purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle

Detailed description: The predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic RVOT arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for RVOT-VT initiation indicated that women have RVOT-A initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with RVOT arrhythmia ,20 healthy volunteers) will be screened, the Participants will undergo ECG monitoring and their blood samples will be collected at various times throughout the study.

Eligibility criteria: Inclusion Criteria:

* Must be female
* Aged 20 to 45 years, with regular menstrual cycles.
* With normal BMI
* Without organic heart disease
* Healthy volunteers and women with RVOT arrhythmia are both being recruited.

Exclusion Criteria:

* Pregnancy
* Use of hormonal therapy including birth control pills or other drugs

Primary outcomes:
measure: number and duration of right ventricular outflow tract arrhythmia
timeFrame: one month
Secondary outcomes:
measure: sex hormone levels
timeFrame: one month
Other outcomes:
Locations:
city: Harbin
country: China
facility: Cardiology Department of the 4Th Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: the fourth hospital of harbin medical university
name: Xueqi Li, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06420336: QL vs LAI for Palatoplasty
Official title: Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-operative Pain
Opioid Use
Cleft Palate
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.


Eligibility criteria: Inclusion Criteria

* Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest.
* Ages 6-18 years of age
* Planned admission post-op
* ASA Status Range: 1-3

Exclusion Criteria

* Contraindication to QL blocks or LAI which may include:
* overlying infection skin at the block needle insertion site
* coagulopathies
* known bleeding disorders
* Allergy to local anesthetic
* Cognitive or developmental impairment that would limit ability to report pain.
* Non-English Speaking/Writing
* Subjects or their parent/guardian unable or choose to not give informed consent/assent.

Primary outcomes:
measure: Pain Scores
timeFrame: 0-48 hours after surgery ends
Secondary outcomes:
measure: Time to block resolution
timeFrame: up to 7 days after surgery ends
measure: Opioid Consumption up to 48 hours after surgery ends
timeFrame: From the pre-operative phase up to 48 hours after surgery ends
measure: Number of complications associated with each intervention
timeFrame: From the time the intervention is administered up to 48-hours after surgery ends.
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: Nicole McCoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340636: Residual Plasma Concentration of Sorafenib and Adverse Events in CHC
Official title: Relationship Between the Residual Plasma Concentration of Sorafenib and the Occurrence of Adverse Events in Patients Treated for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced or Metastatic Hepatocellular Carcinoma
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with underlying cirrhosis hepatocellular carcinoma treated with Sorafenib

Brief summary: To date, Sorafenib is the only drug therapy to have demonstrated a benefit in overall survival in patients with advanced or metastatic hepatocellular carcinoma. However, this treatment causes many adverse effects that may limit its prescription.

Under these conditions, predicting and therefore potentially preventing the adverse effects of sorafenib is a major issue in the management of patients with hepatocellular carcinoma treated with this drug.

Currently, there is little data available on the correlation between the pharmacokinetics of sorafenib and the side effects of this drug in patients treated for hepatocellular carcinoma.

Investigators propose an observational cohort study evaluating the correlation between residual plasma concentration of sorafenib and the risk of severe adverse effects (grades 3-5) in treatment in patients treated for hepatocellular carcinoma on cirrhosis.

This study should include 60 patients over an expected duration of 12 months. The aim of this work is to determine whether there is a correlation between the residual plasma concentration of sorafenib and the occurrence of severe adverse effects (grades 3-5) at treatment in patients treated for hepatocellular carcinoma on cirrhosis as well as potential influence of the etiology of cirrhosis on this relationship. The ultimate ambition is to be able to anticipate and thus prevent these adverse effects in order to increase the safety of the drug and potentially its effectiveness.


Eligibility criteria: Inclusion Criteria:

* Major Patients.
* Patients with hepatocellular carcinoma on cirrhosis.
* Patients treated for the first time with sorafenib for hepatocellular carcinoma.
* Informed information about the study.

Exclusion Criteria:

* Patients with contraindications to sorafenib.
* Pregnant or lactating woman

Primary outcomes:
measure: residual plasma concentration of sorafenib
timeFrame: from baseline over 6 month
measure: occurrence of severe adverse effects (grades 3-5)
timeFrame: from baseline over 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT04495036: Acceptance of Telemedicine in Dermatology Patients, Physicians and Medical Staff
Official title: Acceptance of Telemedicine in Dermatology Patients, Physicians and Medical Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatologic Disease
Keywords: Teledermatology
Telemedicine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in the Department of Dermatology of the Cantonal Hospital Aarau and the University Hospitals Basel and Zürich and Dermatologists, other physicians and medical staff of the Department of Dermatology of the Cantonal Hospital Aarau and the University Hospitals Basel and Zürich.

Brief summary: This study is to investigate the current use and intention to use of teledermatology in Swiss dermatology patients, dermatologists, other physicians and medical staff.

Detailed description: Telemedicine, the use of telecommunication and information technology to provide clinical health care from a distance, has become an increasing role in basic medical care internationally. Telemedicine is particularly suitable for skin diseases. In order to improve the use of evidence-based telemedicine, the Swiss patients' preferences regarding teledermatology versus face-to-face consultations and the patients' and physicians' determinants of acceptance for teledermatology are investigated in this study. Dermatology patients are asked to complete a newly-created 21-items-survey; Swiss dermatologists, other physicians and medical staff on telemedicine will complete a similar newly-created, 23-items-questionnaire. A descriptive statistical analysis (e.g. gender, age, place of residence (city or country), waiting time) will be performed.

Eligibility criteria: Inclusion Criteria:

* patients treated in the Department of Dermatology of the Cantonal Hospital Aarau and the University Hospitals Basel and Zürich
* dermatologists, other physicians and medical staff of the Department of Dermatology of the Cantonal Hospital Aarau and the University Hospitals Basel and Zürich

Exclusion Criteria:

-

Primary outcomes:
measure: descriptive analysis: deviation in influencing factors for the acceptance of teledermatology
timeFrame: at baseline
measure: descriptive analysis of the impact of medical education for the acceptance of telemedicine among dermatologists vs. other physicians vs. medical staff vs. patients
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Lara Valeska Maul, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03583736: Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Uterine Cancer
Official title: Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Patients With Uterine Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Uterine Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction.

Detailed description: Time to treatment (time from disease diagnosis to initiation of treatment) impacts outcomes in uterine cancer. When controlled for stage, patients with longer time to treatment tend to have less favorable outcomes. Similarly, longer time to treatment has a negative impact on patients' quality of life and markers for anxiety. Our experience at this institution suggests that the time to referral (time from uterine cancer diagnosis and the patients' first encounter with the oncologist) is variable and presents the greatest opportunity for decreasing time to treatment. Among the factors that contribute to the time to referral are the time taken by the referring provider to relay the diagnosis to the patient, time taken to schedule an appointment with the specialist, and the patient's availability to keep an appointment.

Virtual visits provide an opportunity to expedite consultation with the treating oncologist by removing some of the barriers that delay face-to-face visits. Among these barriers are patients' availability for a short notice face-to-face visit based on their work or family obligations, access to transportation, and mental preparedness.

Eligibility criteria: Inclusion Criteria:

* Uterine cancer diagnosis on biopsy read by Cleveland Clinic Pathology Department
* Patients must be willing to participate in a virtual visit as the initial meeting with an oncologist at the Cleveland Clinic.
* Receive care at Fairview Hospital, Hillcrest Hospital or Cleveland Clinic Main Campus
* Internet connected smartphone or internet connected computer with webcam
* Participants must have email access
* English speaking
* Competent to make clinic decisions

Exclusion Criteria:

* No diagnosis of uterine cancer

Primary outcomes:
measure: Time to treatment following diagnosis to treatment initiation
timeFrame: 30 days
Secondary outcomes:
measure: Amount of anxiety demonstrated when virtual visits are added
timeFrame: 30 days
measure: Number of patients willing to pay for a virtual visit
timeFrame: 30 days
measure: Number of patients with improved satisfaction scores
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Jason Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238236: Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus
Official title: Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Drug Use-Results Survey of Alesion® Dry Syrup-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 3793
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients without experience in Treatment with epinastine are selected by physicians at medical institutions

Brief summary: Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus


Eligibility criteria: Inclusion Criteria:

* All the patients who:

  * haven't treatment experience of epinastine product;
  * have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, urticaria

Exclusion Criteria:

* Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient was hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: up to 3 years
measure: Incidence of adverse drug reactions classified by patient's background/treatment factors
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall assessment of efficacy by investigator on a 3-point scale
timeFrame: At 12 weeks and 52 weeks
Other outcomes:
Locations:
Study officials:
References: