louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03891017: Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
Official title: Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrostatic Vacuum Casting
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate research study is to compare hydrostatic and vacuum casting techniques using patient mobility indicators, volume displacement, comfort, and overall satisfaction outcomes in trans-tibial amputees.

Detailed description: Visit 1

* Informed Consent
* Subject will be casted using both the hydrostatic and vacuum system techniques

Visit 2 (7-10 days after Visit 1)

* One of two sockets will be randomly assigned and fitted/aligned by investigators
* Subject will be asked to perform a Timed Up and Go Test followed by a Six-Minute Walk Test
* Subject will fill out a comfort questionnaire for the prosthesis worn

Visit 3 (7 to 10 days after Visit 2)

• Subject will be asked to do the same testing as you performed in Visit 2

Eligibility criteria: Inclusion criteria :

* 18 years of age or older
* Trans-tibial amputation, unilateral
* Able to walk for a six-minute minimum w/o a break
* Amputation history of at least 6 months

Exclusion criteria:

* Syme amputation
* Physical disability or injury affecting a natural gait pattern
* Ulcers or blisters on the residual limb

Primary outcomes:
measure: Six-Minute Walk Test
timeFrame: between 7-10- days after study enrollment
Secondary outcomes:
measure: Volume Calculation
timeFrame: between 7-10- days after study enrollment
measure: Volume Calculation
timeFrame: between 14-20 days after study enrollment
measure: Six-Minute Walk Test
timeFrame: between 14-20 days after study enrollment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Heather Appling, MSOP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04340817: Fatty Liver Disease in Nordic Countries
Official title: Fatty Liver Disease in Nordic Countries (FLINC): a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to include patients with suspected or verified non-alcoholic fatty liver disease

Brief summary: A prospective cohort study, which aims to systematically evaluate biomarkers and potential targets in NAFLD and NASH.


Eligibility criteria: Inclusion Criteria:

* Non-alcoholic fatty liver disease and
* Healthy volunteers

Exclusion Criteria:

* Other liver diseases than non-alcoholic fatty liver disease
* Lack of informed consent

Primary outcomes:
measure: Fibrosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Gastrounit, Copenhagen University Hospital Hvidovre
state: Capital Region Denmark
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre, Denmark
name: Lise L Gluud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184817: Radiological Analysis on Patients With Achondroplasia Disorder
Official title: Retrospective Clinical Study to Evaluate of Cranio-vertebral Abnormalities Through Radiological Analysis in Patients With Achondroplasia Treated/Followed at the Hôpital Femme Mère Enfant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Achondroplasia
Keywords: Achondroplasia
cranio-vertebral abnormalities
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 60
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: Patients with Achondroplasia

Brief summary: Achondroplasia is a genetic disorder characterized by disproportionate short stature. It affects about 1 in 2500 live births in the world. The cause of Achondroplasia was identified to be a gain-of-function mutations in the fibroblast growth receptor 3 (FGFR3). In these children compression of the spinal cord at the foramen magnum stenosis can occur in early childhood which, can lead to central sleep apnea. It can lead to morbidity and mortality. A surgical intervention may be indicated in patients who present a foramen magnum stenosis. However, surgical indications are still under discussion. The objective of this retrospective study is to analyse the degree of stenosis and its clinical tolerance/evolution from radiological data monitored at the Hospital Femme Mère Enfant.


Eligibility criteria: Inclusion Criteria:

* Boys and girls.
* Aged from 0 to 18 years old.
* Subjects with an Achondroplasia diagnosis.
* Patients or parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion Criteria:

- Patients or patient's parents or legal guardian whose have an objection for using their data.

Primary outcomes:
measure: Evaluation of the degree of foramen magnum stenosis, its clinical tolerance and its evolution by radiological clinical data of the patients with Achondroplasia
timeFrame: MRI results in children with Achondroplasia will be collected through study completion an average of 2 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Federico DI ROCCO, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Massimiliano Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01580917: Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study
Official title: Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Ulcer, Diabetic
Keywords: laser doppler anemometry
dynamic testing of tissue mechanical property
diabetic foot complications
ulcer genesis
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A community sample

Brief summary: The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.

The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.


Eligibility criteria: Inclusion Criteria:

* between ages 40 and 75
* history of diabetic neuropathic plantar ulcer (test subjects)
* no history of diabetes (control subjects)
* no peripheral sensory neuropathy (control subjects)

Exclusion Criteria:

* amputation or surgery on right Great Toe

Primary outcomes:
measure: Latency time after occlusive loading
timeFrame: approximately 2.75 minutes after start of collection protocol
Secondary outcomes:
measure: Response time to baseline
timeFrame: 2.75 seconds after start of collection protocol
measure: Response time to Maximum Flow
timeFrame: At least 2.75 seconds after the start of collection protocol.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine Gait Study Center
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Jinsup Song, DPM, PhD
role: STUDY_DIRECTOR
affiliation: Temple University
name: James A Furmato, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078917: Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
Official title: Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endovascular Treatment
Keywords: Endovascular Treatment
acute ischemic stroke
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 1196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included.

Brief summary: To investigate the Endovascular Treatment difference between Chinese city and country hospital.

Detailed description: Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.

Eligibility criteria: Inclusion Criteria:

(1) age ≥18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN\[6\] or DEFUSE's\[7\] criteria.

Exclusion Criteria:

(1) Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.

Primary outcomes:
measure: The modified Rankin Scale score at 90 days
timeFrame: 90 days
measure: Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography
timeFrame: 90 days
measure: Successful reperfusion
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
Study officials:
affiliation: Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
name: Wen-huo Chen, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02622217: Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills
Official title: Impact of Sleep Deprivation on Anesthesiology Residents' Non-technical Skills: a Simulation Based Randomised Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: anesthesiology
non technical kills
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sleep deprivation is common in anaesthesiology residents. Its effects on technical skills have been reported with controversial results. Non-technical skills (team working, situation awareness, decision making and task management) contribute to safe and efficient task performance. They have a crucial role in anaesthetic practice, especially during crisis management. The investigators hypothesized that sleep deprivation was associated with a reduced mobilisation of non-technical skills in anaesthesiology residents.

Detailed description: The scenario consisted in a rapid sequence induction for emergency general anaesthesia in case of acute peritonitis complicated by an anaphylactic shock secondary to the injection of succinylcholine. All scenarios were performed with the assistance of an anaesthetist nurse, facilitator of the scenario. In a second time, after patient stabilisation (defined as oxygen saturation by pulse oximetry (SpO2) \> 95%, mean arterial pressure (PAM) \> 65 mmHg and heart rate (HR) \< 100 bpm for at least 2 minutes) consecutive to an expected injection of 100 µg of epinephrine decided by the participant, a surgeon entered the operating room to create a dilemma regarding patient destination (continue surgery or intensive care unit admission)

Eligibility criteria: Inclusion Criteria:

* Anesthesiology residents from Paris academic hospitals

Exclusion Criteria:

* Chronic sleep disorder

Primary outcomes:
measure: Anesthetists non technical skills (ANTS) scale
timeFrame: day 0 during procedure
Secondary outcomes:
measure: Technical skills
timeFrame: day 0 during procedure
Other outcomes:
Locations:
Study officials:
References:
citation: Neuschwander A, Job A, Younes A, Mignon A, Delgoulet C, Cabon P, Mantz J, Tesniere A. Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial. Br J Anaesth. 2017 Jul 1;119(1):125-131. doi: 10.1093/bja/aex155.
Clinical trial NCT01554917: A Study of Iguratimod in Patients With Active Rheumatoid Arthritis
Official title: A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Iguratimod
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 1759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

Detailed description: This is a multi-center, open, single arm study.

Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of RA
* Subjects who have active RA at the time of screening
* Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening
* Written informed consent

Exclusion Criteria:

* Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
* Pregnant or lactating women
* ALT\>1.5×ULN, AST\>1.5×ULN, Cr\>135umol/L
* WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
* Subjects with uncontrolled infection
* Patients with active gastrointestinal diseases (such as gastric ulcer, etc.)
* Allergic to any of the study drugs
* History of alcoholism
* Subjects receiving live vaccines within 3 months prior to study entry
* Subjects participating in other clinical study within 3 months prior to study entry

Primary outcomes:
measure: Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20)
timeFrame: week 24
measure: Incidence of adverse events
timeFrame: up to 28 weeks
Secondary outcomes:
measure: Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50)
timeFrame: week 24
measure: Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70)
timeFrame: week 24
measure: Change from baseline in Disease Activity Score 28 (DAS28)
timeFrame: week 24
measure: Change from baseline in Health Assessment Questionnaire (HAQ)
timeFrame: week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Zhanguo Li, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mu R, Li C, Li X, Ke Y, Zhao L, Chen L, Wu R, Wu Z, Zuo X, Xie Y, Chen J, Wei W, Liu Y, Li Z, Dai L, Sun L, Liu X, Li Z. Effectiveness and safety of iguratimod treatment in patients with active rheumatoid arthritis in Chinese: A nationwide, prospective real-world study. Lancet Reg Health West Pac. 2021 Mar 22;10:100128. doi: 10.1016/j.lanwpc.2021.100128. eCollection 2021 May.
Clinical trial NCT04170517: Serum Progesterone Levels on the Day of Frozen Embryo Transfer (FET) and Pregnancy Outcomes
Official title: Serum Progesterone Levels on the Day of Frozen Embryo Transfer (FET) and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Infertility, Female
IVF
Lead sponsor: CARE Fertility UK
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 402
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women undergoing ART with FET.

Brief summary: Frozen embryo transfer (FET) cycles have become more common in recent years due to a push towards elective single embryo transfer (SET). While it is known that progesterone supplementation during the luteal phase improves clinical pregnancy rates, there is a paucity of prospective data on the impact of serum progesterone levels on pregnancy outcomes in FET cycles. This multicentre prospective cohort study aims to investigate the association between serum progesterone levels on the day of FET and pregnancy outcomes, and to determine a serum progesterone cut-off value above which clinical pregnancy and live birth are more likely to occur. Women undergoing ART-FET cycles at CARE Fertility clinics in the UK will be recruited and their serum progesterone measured on the day of frozen embryo transfer. Follow-up data will be stored in electronic patient records and analysed to determine whether a low serum progesterone level on the day of FET adversely affects ART outcomes.


Eligibility criteria: Inclusion Criteria:

* All women undergoing ART with FET.

Exclusion Criteria:

* None. We aim to study the "every day" patient undergoing FET, and for this we intend to keep the population of the study as unselected as possible.

Primary outcomes:
measure: Live birth rate per participant
timeFrame: 18 months
Secondary outcomes:
measure: Miscarriage rate per participant and per pregnancy
timeFrame: 18 months
measure: Implantation rates per participant
timeFrame: 18 months
measure: Biochemical pregnancy rate per participant
timeFrame: 18 months
measure: Clinical pregnancy rate per participant
timeFrame: 18 months
measure: Ectopic pregnancy rate per participant
timeFrame: 18 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: CARE Fertility Birmingham
Study officials:
affiliation: CARE Fertility UK
name: Arri Coomarasamy, MBChB MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05955417: A Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis.
Official title: The Development and Validation of a Novel Equation for Estimating Sodium Intake in Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dietary Sodium Intake
Keywords: Dietary Sodium Intake
Peritoneal Dialysis
Equation
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peritoneal Dialysis Patients

Brief summary: This study aims to develop a novel equation for estimating sodium intake in anuric peritoneal dialysis patients, and then to validate its precision and accuracy.

Detailed description: Dietary sodium intake is closely associated with the prognosis of chronic kidney disease (CKD) patients. Previous studies have developed an equation for estimating dietary sodium intake through 24-hour urine sodium in CKD, which are not applicable in peritoneal dialysis patients. This study aims to develop a novel equation for estimating dietary sodium intake in 20 anuric peritoneal dialysis patients, using accurately measured dietary sodium as the dependent variable and peritoneal sodium clearance and its related variables as independent variables, and then to validate the precision and accuracy of the novel equation in another 20 anuric peritoneal dialysis patients.

Eligibility criteria: Inclusion Criteria:

* Peritoneal dialysis vintage \>3 months.
* 18-80 years old.
* No residual renal function (urine volume\<200ml/day).
* Continuous ambulatory peritoneal dialysis or manual intermittent peritoneal dialysis.

Exclusion Criteria:

* Peritonitis in the past month.
* Acute systemic infection, cardio-cerebrovascular complications and surgical trauma in the past month.
* Uncorrected hyponatremia (blood sodium\<130mmol/L).
* Prescribed with sodium bicarbonate and other drugs containing sodium.
* Prescribed with glucocorticoids and aldosterone antagonists.
* Dysfunction of peritoneal dialysis catheter.
* Malignant tumor receiving radiotherapy and chemotherapy, severe dyspepsia or eating disorder.
* Body fluid loss due to vomit, diarrhea, massive sweating, or other causes.
* Cannot follow the research scheme.
* Refuse to participate in this study.

Primary outcomes:
measure: determination coefficient of the novel equation
timeFrame: July 3, 2023, to March 1, 2024
measure: bias of the novel equation
timeFrame: July 3, 2023, to March 1, 2024
measure: precision of the novel equation
timeFrame: July 3, 2023, to March 1, 2024
measure: accuracy of the novel equation
timeFrame: July 3, 2023, to March 1, 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Jie Dong, Professor
role: PRINCIPAL_INVESTIGATOR
References: