louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02471274: PK Study of Sotagliflozin in Subjects With Hepatic Impairment
Official title: A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Sotagliflozin in Male and Female Subjects With Mild, Moderate, and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of mild, moderate, or severe hepatic impairment on the pharmacokinetics (PK) of a single dose of 400 mg sotagliflozin (2 x 200-mg tablets) compared with healthy, demographically-matched subjects.


Eligibility criteria: Inclusion Criteria:

* Adult male and female subjects ≥18 to ≤70 years of age
* Body mass index ≥18.0 to ≤36.0 kg/m2, inclusive, at Screening
* Subjects with mild, moderate, or severe hepatic impairment
* Control group of matched healthy subjects
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of sotagliflozin
* History of any major surgery within 6 months
* History of renal disease, or significantly abnormal kidney function test
* Women who are breastfeeding or are planning to become pregnant during the study

Primary outcomes:
measure: Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
timeFrame: Day 1 to Day 5
Secondary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Day 1 to Day 8
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Miami
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Orlando
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: Lexicon Investigational Site
state: Minnesota
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05302674: Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
Official title: Short- and Long-term Health Consequences of Workers During Consecutive Days of Heat Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat Stress
Fatigue
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure fatigue and indicators of acute kidney injury during consecutive days of work in a hot environment.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Regularly completes aerobic exercise at least 60 min per week

Exclusion Criteria:

* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* Hypertensive or tachycardic during the screening visit (Systolic Blood Pressure \> 139 mmHg, Diastolic Blood Pressure \> 89 mmHg, heart rate \> 100 bpm)
* Current tobacco or nicotine use or previous regular use within the past 2 years
* Current or previous musculoskeletal injury limiting physical activity
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* A positive pregnancy test at any point during the study or currently breastfeeding
* Study physician discretion based on any other medical condition or medication

Primary outcomes:
measure: Change from baseline in fatigue
timeFrame: Hour 4
measure: Biomarkers of acute kidney injury
timeFrame: Hour 4
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Education in Special Environments
state: New York
Study officials:
affiliation: University at Buffalo
name: Riana R Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541420: Eribulin in mTNBC Patients
Official title: An Observational, Retrospective Study of Eribulin in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Eribulin
TNBC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 208
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the efficacy and safety of Eribulin in patients with advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
2. Eribulin treatment of advanced breast cancer for at least one cycle, between Dec 2019 and Aug 2020.
3. Available medical history.

Exclusion Criteria:

1. Incomplete medical history.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709120: Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
Official title: Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Comorbidities and Coexisting Conditions
Risk Factor, Cardiovascular
Death
Diabetes
COPD
Atrial Fibrillation
DVT
CKD
Keywords: Covid19
Comorbidities and Coexisting Conditions
Risk Factor
SARS-CoV-2
COVID-19 Second Wave
COVD-19 First Wave
Death
Lead sponsor: Eurasian Association of Therapists
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 2968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020

Brief summary: Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Detailed description: Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 in first and second waves of the novel coronavirus infection in cohort of Russian adult patients.

Retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.

Eligibility criteria: Inclusion Criteria:

Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)

Exclusion Criteria:

1. Unwillingness to participate in the study;
2. Age under 18.

Primary outcomes:
measure: death
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of cases of Acute Kidney Injury depending on Coexisting Conditions
timeFrame: 4 weeks
measure: Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
timeFrame: 4 weeks
measure: Number of cases of Cytokine Storm depending on Coexisting Conditions
timeFrame: 4 weeks
measure: Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
timeFrame: 4 weeks
measure: Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
timeFrame: 4 weeks
measure: Rate of cases of health status worsening occured during hospitalisation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Eurasian Association of Therapists
Study officials:
affiliation: Eurasian Association of Therapists
name: Grigoriy Arutyunov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Eurasian Association of Therapists
name: Ekaterina Tarlovskaya, MD, PhD
role: STUDY_CHAIR
affiliation: Eurasian Association of Therapists
name: Aleksander Arutyunov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03734120: Cryogenic Preservation of Spermatozoa
Official title: Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility
Spermatic Parameters
Keywords: Cryo preservation
Spermatic nuclear quality
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand

Brief summary: The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.

Detailed description: Objective: To evaluate the effects of cryopreserved sperm in dry and liquid phase nitrogen at 3 and 6 month on sperm numeration, motility, vitality, morphology, acrosomal integrity and DNA fragmentation.

Design: Experimental study, investigator was blinded to the type of Cryopreservation.

Patient(s): Semen samples were collected from patients who came in laboratory for semen analysis

Intervention: Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature.

Eligibility criteria: Inclusion Criteria:

* Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand

Exclusion Criteria:

* women

Primary outcomes:
measure: Sperm DNA integrity
timeFrame: at 3 months
measure: Sperm DNA integrity
timeFrame: at 6 months
Secondary outcomes:
measure: Sperm parameter post cryopreservation
timeFrame: at 3 and 6 months
measure: Lab parameter post cryopreservation
timeFrame: at 3 and 6 months
measure: Spermatic DNA Compaction
timeFrame: at 3 and 6 months
measure: Acrosomal integrity
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Florence BRUGNON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01756820: Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial
Official title: Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
transverse ligament
carpal tunnel release
endoscopic
minimal invasive
mini-open
median nerve
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.


Eligibility criteria: Inclusion Criteria:

* primary Carpal Tunnel Syndrome
* no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)

  * electrophysiological examination confirms the Carpal Tunnel Syndrome

Exclusion Criteria:

* Secondary Carpal Tunnel Syndrome
* Pregnancy
* Rheumatoid diseases
* Previous trauma at hand or other condition that may effect the anatomy (eg infections)

Primary outcomes:
measure: Overall Satisfaction
timeFrame: at 1 and 6 months postoperatively
measure: Complications
timeFrame: up to 6 months postoperatively
Secondary outcomes:
measure: Pain
timeFrame: at 1 and 6 months postoperatively
measure: Grip strength
timeFrame: at 1 and 6 months postoperatively
measure: key pinch
timeFrame: at 1 and 6 months postoperatively
measure: Time to return to Activities of Daily Living (ADL) and return to work
timeFrame: up to the end of the study
measure: Recurrences and reoperations
timeFrame: up to the end of study
measure: Symptom Severity Scale (SSS)
timeFrame: at 1 and 6 months postoperatively
measure: Function Severity Status (FSS)
timeFrame: at 1 and 6 months postoperatively
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
Study officials:
affiliation: Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
name: Haris S Vasiliadis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
name: Theodoros Xenakis
role: STUDY_CHAIR
affiliation: Department of Orthopaedics, School of Medicine, University of Ioannina, Greece
name: Grigorios Mitsionis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00647920: Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Official title: Study of the Human Anti-TNF-Antibody Adalimumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate


Eligibility criteria: Inclusion Criteria:

* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.

Exclusion Criteria:

* A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).

Primary outcomes:
measure: ACR20
timeFrame: Week 12
Secondary outcomes:
measure: ACR50
timeFrame: Week 12
measure: ACR70
timeFrame: Week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
Study officials:
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Clinical trial NCT02445820: HES and Acute Kidney Injury in Adult Cardiac Surgery
Official title: The Association Between Hydroxyethyl Starch 130/0.4 and Acute Kidney Injury After Cardiopulmonary Bypass: a Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury After Adult Cardiac Surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 697
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients undergoing cardiac surgery

Brief summary: This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 yo
* Having on pump cardiac surgery at CHU of Liège between April 2013 and June 2014

Exclusion Criteria:

* Off pump surgery
* Use of Blood or Albumin in the cardiopulmonary bypass priming solution
* Preoperative dialysis

Primary outcomes:
measure: AKIN SCr
timeFrame: Forty eight hours
Secondary outcomes:
measure: AKIN SCr+UO
timeFrame: Forty eight hours
measure: Postoperative dialysis
timeFrame: 30 days
measure: Respiratory complication
timeFrame: 30 days
measure: ICU stay
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05090020: Hypernatremia in Hydatid Cyst Treatment
Official title: Systematic Review of Hypernatremia Following Hydatid Cyst Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echinococcosis, Hepatic
Keywords: Echinococcosis
Hepatic
hypernatremia
Lead sponsor: Trabzon Kanuni Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated who hydatid cyst with hypertonic saline

Brief summary: Hypertonic saline (HS) is one of the most widely used scolocidal agents in the treatment of hydatid cysts. Hypernatremia is one of the complications associated with the use of HS. It can cause hypernatremia, acid-base disorder, impaired lung, renal, cardiac and neurological functions and even death. Therefore, caution should be exercised in the use of HS, and open technique should be preferred in surgery.


Eligibility criteria: Inclusion Criteria: Patients who developed hypernatremia (plasma sodium value above 145 mmol/L) due to HS use in the treatment of hydatid cyst were included to study -

Exclusion Criteria:Patients who developed hypernatremia due to other treatments were excluded from the study.

-

Primary outcomes:
measure: Prevention of hypernatreima
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Aydıin Aktas
state: Ortahisar
Study officials:
affiliation: Kanuni Training and Research Hospital
name: Aydin Aktas
role: STUDY_CHAIR
References:
Clinical trial NCT01798420: Corticosteroids and Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
Official title: The Impact of Corticosteroid Treatment on Hemoglobin A1C Levels in Diabetic Patients With COPD Exacerbation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Chronic Obstructive Pulmonary Disease
Keywords: COPD
Diabetes
steroids
Hemoglobin A1C DIFFERENCE
Lead sponsor: The Nazareth Hospital, Israel
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 42
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: Diabetic patients with COPD ecaxerbation who are admitted to the hospital

Brief summary: Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels

Detailed description: HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients with COPD exacerbation

Exclusion Criteria:

* Patients treated with steroids during the previous 3 months

Primary outcomes:
measure: Hemoglobin A1C LEVEL
timeFrame: 3 MONTHS
Secondary outcomes:
measure: Glucose levels
timeFrame: 3 months
Other outcomes:
measure: Weight
timeFrame: 3 months
Locations:
city: Nzareth
country: Israel
facility: Department of medicine
state: Nazareth
Study officials:
References: