louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05556031: Ambulatory Heart Failure Service Model Study
Official title: The Reduction of Decompensation and Unnecessary Cardiac Failure Emergency Admissions: Ambulatory Heart Failure Service Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 500
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: Patient with heart failure with preserved ejection fraction (HFpEF, EF \> 50%) and heart failure with reduced ejection fraction (HFrEF, EF \<50%)

Brief summary: The aim of the study is to assess the efficacy of this new ambulatory service model in reducing heart failure hospitalization (HHF), improving clinical as well as functional outcomes of post-discharge patients with Heart Failure of reduced ejection fraction (HFrEF) and Heart failure with preserved Ejection Fraction (HFpEF).


Eligibility criteria: Inclusion Criteria:

* Dyspnoea (exertional or at rest) and 2 of the following signs:
* Congestion on chest X-ray
* Rales on chest auscultation
* Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale)
* Elevated jugular venous pressure
* NT-proBNP ≥300 pg/mL (Patients with AF: NT-proBNP ≥900 pg/mL)
* Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v loop diuretics)
* Ambulatory patients

Exclusion Criteria:

* Cardiogenic shock required inotropics
* Cardiac mechanical support implantation like LVAD
* Life expectancy less than 1 year due to underlying significant comorbidities like metastatic cancer or end-stage COPD
* Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study.
* End stage renal failure or eGFR \<15 mL/min/1.73m2 as measured during index hospitalization or requiring dialysis

Primary outcomes:
measure: Clinical outcome
timeFrame: 90 days
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)
timeFrame: 1 year
measure: NT-proBNP level
timeFrame: 1 year
measure: Risk of Heart failure
timeFrame: 1 year
measure: Change in overall Cardiac function
timeFrame: 90 days
measure: Major Adverse Cardiovascular Event
timeFrame: 1 year
measure: Hypertensive heart failure (HHF)
timeFrame: 90 days after initial hospital discharge
measure: Quality adjusted Life years gained
timeFrame: 1 year
measure: Change in 6 minute hall walk (6MHW)
timeFrame: 90 days
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Bryan Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00322231: A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
Official title: A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-05-05
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment

Exclusion Criteria:

* History of allergy to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Ability to defend against infection is suppressed by a medical condition or medication

Primary outcomes:
measure: Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
timeFrame: To Day 28 postvaccination
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
timeFrame: 4 weeks postvaccination
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
timeFrame: From prevaccination (baseline) to 4 weeks postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
Clinical trial NCT02889731: The "Suicide Guard Rail": A Structural Intervention for Hospitals Avoid Suicides by Jumping From Heights Buildings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide Jumps
Psychiatry
Keywords: Suicide
Heights
Suicide hot spots
Bridges
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
Collaborators: name: Police department at Baden
First posted: 2016-09-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in-patients and out-patients

Brief summary: Background: Suicides by jumping from the high buildings of acute hospitals are dramatic events which are highly traumatizing to families, staff and fellow pts. In the 10 years from1995 to 2010 the investigators have counted 10 suicide cases despite extensive measures taken to predict and avoid them.

The investigators hypothesized that constructive measures at the windows that would render access more difficult could discourage spontaneous suicidal behaviour and would reduce the suicide rates.

Intervention: Starting in 6/2004, a 20 mm diameter metal guard-rail (which resists 250kg) was installed at each window of a 360 bed acute hospital at a height of 113cm, 18cm above the window parapet with the aim to visually, psychologically and physically discourage potential suicidal impulses.


Eligibility criteria: Inclusion Criteria:

* person at risk for suicide

Exclusion Criteria:

* no

Primary outcomes:
measure: Number of Suicide Jumps over ten years
timeFrame: Between 1995 and 2010, measurement 180 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02680431: Analysis of Plasma for Diagnosis and Follow-up of Neurofibromatosis Type 1
Official title: Analysis of Plasma for Diagnosis and Follow-up of Neurofibromatosis Type 1
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurofibromatosis 1
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting Turku Neurofibromatosis Centre (Finland) for care of their disease. Controls are healthy volunteers from Turku area.

Brief summary: The purpose of this study is to find blood plasma based biomarkers of disease progression in neurofibromatosis type 1 (NF1). NF1 is associated with the development of benign cutaneous tumors as well as a variety of malignancies. Analysis of plasma DNA and chemical composition may provide tools for diagnosis and follow-up of NF1. The hypothesis of the study is that NF1-associated tumor burden and malignant transformation of tumors can be detected in plasma. To test this hypothesis, Finnish patients with NF1 are recruited and blood sample is taken. Blood plasma is separated and analyzed chemically. DNA is then also extracted and quantified.

Detailed description: Neurofibromatosis type 1 (NF1) is a dominant hereditary multiorgan disease that causes both benign cutaneous neurofibromas and malignant tumors. Timely detection of malignant transformation in NF1 tumors is of great clinical importance. Also methods to easily monitor individual's overall tumor burden would be useful. Blood plasma is collected from NF1 patients and age- and gender-matched controls. The samples are stored at -80 C until analysis. Free circulating plasma DNA is extracted and quantified using commercial reagents. Also a previously described chemical detection method to observe overall changes in plasma composition is utilized. The analysis results are compared between NF1 patients and healthy controls, and also correlated with NF1 tumor burden and diagnosis of malignancy during five-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Finnish-speaking
* 18-85 years old
* For NF1 group: Diagnosis of type 1 neurofibromatosis and visit to Turku Neurofibromatosis Centre
* For control group: Suitable as an age- and gender-matched control for some of the NF1 patients

Exclusion Criteria:

* Non-Finnish-speaking
* For control group: diagnosis of neurofibromatosis type 1 or cancer

Primary outcomes:
measure: Ability of free circulating plasma DNA concentration and unspecific chemical detection method to predict overall tumor burden
timeFrame: Up to 5 years
measure: Ability of free circulating plasma DNA concentration and unspecific chemical detection method to predict clinical diagnosis of malignancy
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Turku
name: Juha Peltonen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02222831: Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.
Official title: Optimizing IVF Treatment - the Impact of Time-lapse Culture and Preimplantation Factor (PIF) on Embryo Development.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In Vitro Fertilization
Assisted Reproductive Techniques
Keywords: IVF
Embryo Quality
Time Lapse Culture
Preimplantation factor
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of this study are to evaluate:

1. the possible effect of time-lapse culture from day zero (day of oocyte retrieval) on fertilisation rates and embryo quality in standard IVF.
2. the association between PIF status in embryo culture medium and embryo quality assessed by standard subjective parameters and morphokinetic development.


Eligibility criteria: Inclusion Criteria:

* Standard IVF treatment
* Body mass Index (BMI) between 18 and 30
* couples in which the male partner has normal sperm concentration and motility according to the World Health Organization (WHO, 2010)

Exclusion Criteria:

- Patients with less than four oocytes

Primary outcomes:
measure: Embryo Quality
timeFrame: Day 0-5 after oocyte pick-up
Secondary outcomes:
measure: Fertilisation rate
timeFrame: Day 1 after oocyte pick-up
Other outcomes:
measure: Clinical pregnancy rate
timeFrame: 7th week of gestation
Locations:
city: Skive
country: Denmark
facility: The Fertility Clinic Skive
Study officials:
affiliation: The Fertility Clinic, Skive Regional Hospital, Denmark
name: Betina B Povlsen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01649531: Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
Official title: Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.


Eligibility criteria: Inclusion Criteria:

* male and female patients 18 years to 80 years of age
* no general medical condition which represents a contraindication to implant treatment
* two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
* at least one tooth present adjacent to the edentulous space
* indication for implant treatment is given
* at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
* at least 4 mm of vertical bone height in the maxilla
* signed informed consent after being informed

Exclusion Criteria:

* smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
* poor oral hygiene after hygienic phase (Plaque Index over 30 %)
* active periodontal disease
* pregnancy or breastfeeding at date of inclusion

Primary outcomes:
measure: radiographic bone level
timeFrame: 5 years
Secondary outcomes:
measure: Radiographic bone level
timeFrame: 1, 3, 7, 10 years
measure: Implant survival and success
timeFrame: 1, 3, 5, 7, 10 years
measure: rate of technical complication
timeFrame: 1, 3, 5, 7, 10 years
measure: rate of biological complications
timeFrame: 1, 3, 5, 7, 10 years
measure: Soft tissue changes
timeFrame: 1, 3, 5, 7, 10 years
measure: Patient morbidity
timeFrame: 1, 3, 5, 7, 10 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Center of Dental Medicine Clinic of Reconstructive Dentistry
Study officials:
affiliation: Clinic of Reconstructive Dentistry
name: Daniel Thoma, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thoma DS, Wolleb K, Schellenberg R, Strauss FJ, Hammerle CHF, Jung RE. Two short implants versus one short implant with a cantilever: 5-Year results of a randomized clinical trial. J Clin Periodontol. 2021 Nov;48(11):1480-1490. doi: 10.1111/jcpe.13541. Epub 2021 Sep 22.
Clinical trial NCT04807231: Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.
Official title: Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Testosterone
Androgens
Keywords: testosterone
androgens
men
women
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study is a unique cohort of 270 patients, male and female, aged between 18 and 90 (included).

These patients have been included if there were being prescribed bioavailable testosterone by their physician in routine.

Brief summary: Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment.

Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA.

The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.


Eligibility criteria: Inclusion Criteria:

* Every men and women aged between 18 and 90 can be included

Exclusion Criteria:

* insufficient sample
* sample not send for RIA

Primary outcomes:
measure: Concordance between RIA and calculated testosterone level
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06139731: Changes in Function of the Upper Limb With Physiotherapy
Official title: Changes in Function of the Upper Limb With Physiotherapy for Acute Burns: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burn of Upper Limb, Except Wrist and Hand
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were invited to participate in the study when they came to the Department of Plastic and Reconstructive Surgery, the Kaunas Clinics, Lithuanian University of Health Sciences, for treatment of burns to the upper limb(s) or upper body. Data for this analysis were collected in 2020-2022.

Brief summary: This paper describes a pilot clinical study designed to compare changes in ROM, muscle strength and functional recovery of the upper limb during the inpatient treatment period of burn injury.

Detailed description: Patients with burns can face challenges throughout their recovery, including contractures and a reduced range of motion (ROM) in the upper limb (UL), upper and lower limb impairment. Restoring range of motion, muscle strength, and mobility is essential to reduce scarring formation and contractures. The study included 17 patients with unilateral or bilateral superficial, deep partial and full thickness burns to the upper limbs, with or without burns to the upper body, covering 10% or more of the total body surface area

Eligibility criteria: Inclusion Criteria:

* patients aged 18-69 years
* had burns on the upper limb(s) with or without burns on the upper body
* burns involving ≥ 10% total body surface area (TBSA) with the presence of deep partial thickness or full thickness burns
* who agreed to take part in the study

Exclusion Criteria:

* inability to perform or understand tests
* other injuries (fractures, brain injury)
* central and peripheral nervous system disorders
* amputation
* with burns on the head, hands, feet, and genital area

Primary outcomes:
measure: Upper limb range of motion
timeFrame: Day 0, 7,14,21, 28, 35, more 35 days
measure: Upper limb muscle strength
timeFrame: Day 0,14,35, more than 35 days
measure: Pain intensity
timeFrame: Day 0, 7,14,21, 28, 35, more than 35 days
measure: Activities of daily living
timeFrame: Day 0,14,35, more than 35 days
measure: Functional recovery of the upper limbs
timeFrame: Day 0,14,35, more than 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Brigita Siparytė-Sinkevičienė
Study officials:
affiliation: Lithuania LUHS hospital Kaunas Clinics, Department of Plastic and Reconstructive Surgery
name: Rytis Rimdeika, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479331: The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease and the Risk Involved.
Official title: The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease Stage 3 or Higher and the Risk Involved.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
CKD
Cardiovascular Diseases
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic kidney disease

Brief summary: This study explores the risk factors for sarcopenia in patients with chronic kidney disease and the effects of sarcopenia on cardiovascular disease. Treatment of sarcopenia and cardiovascular complications provides a basis for improving the quality of life and survival of patients with chronic kidney disease.

Detailed description: Sarcopeniais a syndrome characterized by the loss of skeletal muscle mass, muscle strength, and muscle dysfunction. The high incidence of sarcopenia in patients with chronic kidney disease (CKD) is strongly associated with poor quality of life, cardiovascular events, and increased all-cause mortality. At present, the cause of sarcopenia in patients with CKD is still unclear, and factors such as inflammation, malnutrition, and hormone metabolism disorders may affect the occurrence and development of sarcopenia. This topic explores the risk factors of sarcopenia in patients with chronic kidney disease and the correlation between sarcopenia and the risk of cardiovascular disease, and provides a basis for the prevention and treatment of sarcopenia and cardiovascular complications, with a view to improving the prognosis of CKD patients.

Eligibility criteria: Inclusion Criteria:

* Patients presented by the Nephrology Center during August 2019 and March 2021
* Age 18-75 years;
* Patients with CKD2 or above (eGFR≤60 ml/(min 1.73m2)

Exclusion Criteria:

* There are contraindications to bioelectrical impedance spectroscopy (BIS) . examination, such as amputation, metal implants in the body, etc.;
* Complicated with other serious diseases, such as malignant tumors, cirrhosis, systemic infections, etc.

Primary outcomes:
measure: Epicardial adipose tissue measured by ultrasound color doppler
timeFrame: the day when being recruited
measure: Intima-media thickness measured by ultrasound color doppler
timeFrame: the day when being recruited
Secondary outcomes:
measure: Baseline demographic, clinical and laboratory characteristics
timeFrame: the day when being recruited
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Baoshan Site of Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
name: Jiangzi Yuan, MD
role: STUDY_DIRECTOR
References: