louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05181774: Prediction of Bleeding Risk After Anticoagulant Therapy for Atrial Fibrillation Based on Proteomics and Metabolomics
Official title: Prediction of Bleeding Risk After Anticoagulant Therapy for Atrial Fibrillation Based on Proteomics and Metabolomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Bleeding
Anticoagulant Therapy
Keywords: Atrial Fibrillation
Bleeding
Anticoagulant therapy
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AF patients treated with oral anticoagulants were enrolled in this study. Blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. All patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants.

Brief summary: Objectives: Atrial fibrillation (AF) is the most common arrhythmia. Anticoagulation with warfarin or new oral anticoagulants in patients with AF can significantly reduce thromboembolic events. However, due to the lack of bleeding risk predictors of oral anticoagulants, the bleeding risk of patients with AF cannot be accurately evaluated. The purpose of this study is to screen biomarkers that can predict bleeding in patients with AF through proteomics and metabolomics, and construct the protein metabolic network pathway of anticoagulant bleeding in patients with AF.

Design: AF patients treated with oral anticoagulants were enrolled in this study. Blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. All patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants. Proteomic data were obtained by LC-MS/MS Analysis-DIA platform. Metabolomic data were obtained by UPLC-QTOF/MS platform. All of the omics data were used to compare proteins/enzymes with metabolic pathways. Quantitative changes of individual metabolites and proteins were calculated and graphed using the KEGG mapping tools.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or above
2. Admission with atrial fibrillation or clinic visit for atrial fibrillation
3. Receive routine anticoagulant therapy;
4. Signing the consent form

Exclusion Criteria:

1. Pregnant women;
2. Lactating women;
3. Severe mitral stenosis;
4. Severe impairment of liver function;
5. Severe renal insufficiency;
6. Thyroid dysfunction requiring treatment;
7. Have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.

Primary outcomes:
measure: Biomarkers predicting bleeding in AF patients through proteomics and metabolomics.
timeFrame: 1 year
Secondary outcomes:
measure: Protein metabolic network pathway of anticoagulant bleeding in patients with AF.
timeFrame: 1 year
Other outcomes:
Locations:
city: Harbin
country: China
facility: Yan
state: Heilongjiang
Study officials:
References:
Clinical trial NCT04682574: Role of Mega Dose of Vitamin C in Critical COVID-19 Patients
Official title: Effects of Mega Dose Vitamin C in Critically Ill COVID-19 Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin C (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. Considering these effects vitamin C should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ARDS). The current study is designed to assess the beneficial effects of Vitamin C in COVID-19 infected patients.


Eligibility criteria: Inclusion Criteria:

critically ill patients admitted in ICU

Exclusion Criteria:

allergic to Vitamin C didnt given the consent

Primary outcomes:
measure: Partial pressure of Oxygen in arterial blood to fraction of inspired Oxygen (P/F ratio)
timeFrame: 1 and 4th day
measure: Survival analysis
timeFrame: 28 days follow up
Secondary outcomes:
measure: Length of Hospital stay
timeFrame: Admission to discharge
measure: Need for intubation
timeFrame: 28 days
measure: Inflammatory markers
timeFrame: before the start of treatment (day 1) and on day 4
measure: APACHE II score
timeFrame: before the start of treatment (day 1) and on day 4
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Bahria Town International Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT04510974: RAAS and Arterial Stiffness in SCI
Official title: Orthostatic Blood Pressure and Arterial Stiffness in Persons With SCI: The Effect of RAAS System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Renin Angiotensin Aldosterone System
Orthostatic Hypotension
Spinal Cord Injury
Hypotension
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Kessler Foundation
name: Seton Hall University
First posted: 2020-08-12
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient individuals with SCI, flyers in town

Brief summary: The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.

Detailed description: The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. Arterial stiffness and blood pressure will be collected in the laying down position. A blood sample of norepinephrine and plasma renin will also be collected. The participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. Blood pressure and heart rate will be monitored at each angle. Another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.

Eligibility criteria: Inclusion Criteria:

* SCI participants:
* injured between C1-T1 and T6-T12
* wheelchair dependent
* AIS classification A, B or C
* Injured occurred more than 1 year ago

Exclusion Criteria:

* currently have an illness or infection
* current smoker of at least 1 year
* controlled or uncontrolled hypertension or diabetes mellitus
* Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
* cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)

Primary outcomes:
measure: Pulse Wave Velocity (m/s)
timeFrame: 2 years
Secondary outcomes:
measure: Systolic Blood Pressure (mmHg)
timeFrame: 2 years
measure: Plasma Renin (pg/ml)
timeFrame: 2 years
measure: Norepinephrine (pg/ml)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J Peters VAMC
state: New York
Study officials:
References:
Clinical trial NCT04570774: Effect of Cerebral and Cerebellar rTMS in Stroke Patient
Official title: Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Repetitive Transcranial Magnetic Stimulation
rTMS
Motor Recovery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.


Eligibility criteria: Inclusion Criteria:

* Hemiplegic stroke patients within 1 month after onset
* Moderate to severe motor impairment (Fugl-Meyer assessment \<85)
* Cognitive and language functions to perform more than one step of command
* More than 19 years old

Exclusion Criteria:

* Contraindicated to rTMS
* Progressive or unstable stroke
* Pre-existing and active major neurological disease or major psychiatric disease
* A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival \<1 year

Primary outcomes:
measure: Difference of upper limb motor score in Fugl-Meyer assessment
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04482374: Puberty Suppression and Cardiometabolic Health
Official title: Effects of Puberty and Pubertal Suppression on Insulin Sensitivity, Metabolic Rate and Vascular Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgenderism
Insulin Sensitivity/Resistance
Endothelial Dysfunction
Vascular Stiffness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 30
Sex: MALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 transgender females (male sex assigned at birth, female gender identity) and 15 cisgender males

Brief summary: This observational study will evaluate the effect of puberty suppression on insulin sensitivity, metabolic rate and vascular health among transgender female youth at baseline and 6 months after initiation of a gondoatropin releasing hormone agonist compared to matched cisgender male controls.


Eligibility criteria: Inclusion Criteria:

* Identify as a transgender female or cisgender male
* Age 9-14 years at the time of enrollment
* Tanner Stage 2-3 baseline pubertal development
* Plan to start gonadotropin releasing hormone analogue clinically in \< 2 months (for transgender females only)

Exclusion Criteria:

* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* Type 1 or 2 diabetes (by medical history)
* On any medications that affect insulin sensitivity (e.g. metformin, antipsychotics)
* Hypertension (resting BP ≥ 140/90 mm/Hg)
* Weight \> 400 lbs
* On estrogen- or progesterone-containing medications at baseline
* \>3 hours of moderate-to-vigorous physical activity on the 3DPAR at the screening visit

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in body composition (fat mass, fat-free mass)
timeFrame: Baseline, 6 months
measure: Change in resting metabolic rate
timeFrame: Baseline, 6 months
measure: Change in endothelial function
timeFrame: Baseline, 6 months
measure: Change in large elastic artery stiffness
timeFrame: Baseline, 6 months
measure: Change in cerebrovascular function
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Natalie J Nokoff, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03719274: Vitamin C Depigmenattion Versus Conventional Technique
Official title: Minimally Invasive Non-surgical Vitamin C Injection Versus the Conventional Surgical Depigmentation in Treatment of Gingival Hyperpigmentation of the Anterior Esthetic Zone: Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanin Hyperpigmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although physiologic gingival hyperpigmentation is not a pathologic condition, it is considered one of the main esthetic problems in dentistry. It was found that the attached gingiva is the most frequently pigmented intraoral tissues followed by the papillary gingiva and the alveolar mucosa

Detailed description: In addition to all of the previously mentioned actions of vitamin C, it was found to be involved in depigmentation due to several factors that not only depend on its direct effect on melanin and melanocytes but also due to the overall effect on the applied tissues. Melanin is one of the main reservoir for ROS, copper and calcium in the tissue cells . Once vitamin C is introduced to the target tissue, it binds efficiently to melanin due to the ROS, calcium and copper content which causes intracellular deficiency of these items and the inability of the cells to produce melanin. Calcium deficiency causes failure of melanocytes to perform cellular adhesion to keratinocytes as calcium is essential to form cadherins . Adhesion to keratinocytes is important stimulator to melanocytes in order to produce melanin, format dendrites and transfer the produced melanin to neighboring cells . Shortage of the intercellular copper limits the formation of tyrosin, tyrosinase enzyme and peroxidase enzyme which in turn stops the melanin production .

Therefore, the aim of the present study is to compare the clinical efficiency of the non-surgical intraepidermal injection of vitamin C in comparison to the gold standard surgical technique (scalpel technique) for gingival depigmentation.

Eligibility criteria: Inclusion Criteria:

* aged 18-50 y
* medically free;
* physiologic gingival hyperpigmentation related to esthetic region were selected.

Exclusion Criteria:

All the reasons that could provoke an inflammatory reaction were excluded such as:

* systemic diseases (especially auto-immune diseases and chemotherapy uptake);
* pregnant and lactating mothers;
* usage of chlorhexidine or povidone iodine;
* Local causes (smoking and periodontitis).

Primary outcomes:
measure: gingival color change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: msa university
name: nermin yussif
role: STUDY_DIRECTOR
References:
Clinical trial NCT00695474: Vitamin D and Type 2 Diabetes - a Cross Sectional Study
Official title: Vitamin D and Type 2 Diabetes - a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovitaminosis D
Type 2 Diabetes Mellitus
Keywords: Hypovitaminosis D
Type 2 diabetes
Glycemic control
Inflammation
Blood pressure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
First posted: 2008-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of Danish type 2 diabetics from the outpatient clinic at Silkeborg Hospital.

Brief summary: The purpose of the study is to describe vitamin D status among patients with type 2 diabetes and to determine the association between serum 25-hydroxyvitamin D and glycemic control, markers of inflammation and blood pressure

Detailed description: It has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the risk of fracture and causes muscle weakness. But there is now evidence that calcium malnutrition and hypovitaminosis D are predisposing conditions for various common chronic diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic disorders (metabolic syndrome, hypertension).

It has also been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus.

The purpose of this study is to determine vitamin D status among type 2 diabetics in our outpatient clinic and examine the relationship between vitamin D status , calcium and phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid profile.

Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun exposure and food intake.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Patients of Danish extraction
* Written consent

Exclusion Criteria:

* Renal failure (Urea \> 12 mmol/l)
* Age \< 18 years
* malabsorption

Primary outcomes:
measure: Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure.
timeFrame: December 08
Secondary outcomes:
measure: Lifestyle (exercise, sun exposure, food intake)
timeFrame: December 08
Other outcomes:
Locations:
Study officials:
affiliation: Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
name: Lotte Oeskov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172874: Cross-Cultural Validity of EDI-1 Among Clinical and Non-Clinical Taiwanese Population
Official title: Cross-Cultural Validity of EDI-1 Among Clinical and Non-Clinical Taiwanese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorders
Keywords: cross-cultural,
eating disorders,
EDI,
psychometrics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical patients with eating disorders, other psychiatric disorders, and students

Brief summary: The aim of the study is to understand the clinical characteristics of Taiwanese eating disorders as well as establishment of the psychometric properties of eating disorder-related questionnaires (EDI and BITE).

Detailed description: The study subjects include three group of population: 1st group is non-clinical nursing college students (N=800); 2nd group is clinical eating disorder patients (N=600) and 3rd group is age-, sex-matched clinical non-eating disorder patients (N=600). Clinical patients are screened by eating disorder module of the SCID and are grouped into eating disorder or non-eating disorder group. After written informed consent, eating disorder patients will receive clinical assessments which included important clinical characteristics and psychopathology of eating disorders by experienced senior psychiatrists. All clinical patients are asked to complete the self-rating scales which included eating and general psychological functioning questionnaires.

Eligibility criteria: Inclusion Criteria:

* patients with eating disorders,
* patients with non-eating disorders,
* nursing school students

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan Univetsity Hospital
name: Mei-Chih Tseng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03274674: Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype
Official title: New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontoclasia
Gingiva; Injury
Condition
Blood Clot
Gingiva Disorder
Keywords: PRF
I-PRF
Microneedle
Gingival Thickness
Injectable-Platelet-Rich-Fibrin
Platelet Rich Fibrin
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, Parallel group, Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures

Detailed description: Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .

Eligibility criteria: Inclusion Criteria:

* Never smokers
* Had no history of systemic disease
* Aged ≥18 years old

Exclusion Criteria:

* Patients with a history of diabetes mellitus or systemic disease
* Patients who were under any medication that was known to influence periodontal tissues
* Patients with hormonal changes such as pregnancy or lactation
* Toothless individuals
* Patients who were clotting disorders

Primary outcomes:
measure: Gingival thickness (mm)
timeFrame: 2 months
Secondary outcomes:
measure: Plaque Index (PI)
timeFrame: 2 months
measure: Gingival Index (GI)
timeFrame: 2 months
measure: Bleeding on probing (BOP)
timeFrame: 2 months
measure: Clinical attachment level (CAL)
timeFrame: 2 months
measure: Probing pocket depth (PD)
timeFrame: 2 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeliha Betül ÖZSAĞIR
Study officials:
affiliation: Bezmialem VU
name: Zeliha Betül Özsağır
role: STUDY_CHAIR
References:
citation: Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.