louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03231748: Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter
Official title: Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 12
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 sepsis and acute kidney injury who require renal replacement therapy.

Brief summary: This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy.

The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.

Detailed description: In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor.

Eligibility criteria: Inclusion Criteria:

* adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis
* clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary

Exclusion Criteria:

* lack of consent
* pre-existing dialysis dependent renal failure
* life expectancy \<24 hours
* patients with haemoglobin \<7g/dL (unless transfused for clinical reasons)
* need for extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: Removal of inflammatory mediators
timeFrame: 48 hours
Secondary outcomes:
measure: Adsorption of inflammatory mediators
timeFrame: 48 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas Hospital
Study officials:
affiliation: Guy's & St Thomas Hospital London
name: Marlies Ostermann, PhD
role: STUDY_DIRECTOR
References:
citation: Lumlertgul N, Hall A, Camporota L, Crichton S, Ostermann M. Clearance of inflammatory cytokines in patients with septic acute kidney injury during renal replacement therapy using the EMiC2 filter (Clic-AKI study). Crit Care. 2021 Jan 28;25(1):39. doi: 10.1186/s13054-021-03476-x.
Clinical trial NCT03357848: Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery
Official title: Impact of Caloric and Protein Adequacy on Postoperative Clinical Outcomes of Patients Undergoing Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Postoperative Complications
Cancer
Energy Supply; Deficiency
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-11-30
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 undergoing major abdominal surgery at the University Hospital of University Federal of Minas Gerais

Brief summary: The role of nutritional therapy (TN) in the surgical patient is well described in the literature and is associated with reductions in postoperative complications, length of hospital stay, and mortality. Adequate determination of caloric and protein requirements is an essential step in the TN institution, avoiding hypoalimentation and hyperalimentation. Thus, it is essential to understand the changes in energy expenditure after surgery and its relation with nutritional status. In addition, little is known about the effect of nutritional therapy and caloric adequacy on parameters such as phase angle and dynamometry. Thus, the objective of this study is to evaluate the changes in energy expenditure after major abdominal surgeries and to evaluate the phase angle and dynamometry as possible markers of nutritional therapy. Energy expenditure will be assessed by indirect calorimetry. Functionality will be assessed by means of dynamometry and 6-minute walk test. Nutritional diagnosis will be given through subjective global assessment. Energy and protein intake will be monitored and registered daily. Phase angle will be obtained by performing bioelectrical impedance.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Patients admitted for major abdominal surgery
* Sign the consent form

Exclusion Criteria:

* Length of hospital stay less than 3 days
* Pregnancy
* Patients who, for any reason, can not perform indirect calorimetry

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Phase angle
timeFrame: 24 hours pre-surgery, 3 and 7 days after surgery
measure: Body composition
timeFrame: 24 hours pre-surgery, 3 and 7 days after surgery
measure: Nutritional status
timeFrame: 24 hours pre-surgery and 7 days after surgery
measure: Functional status
timeFrame: 24 hours pre-surgery, 3 and 7 days after surgery
measure: Energy expenditure
timeFrame: 3, 5 and 7 days after surgery
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital of Clinics of the University Federal of Minas Gerais
state: Minas Gerais
Study officials:
References:
Clinical trial NCT00677248: LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Official title: A Phase II, Placebo-Controlled, Double-Blind, Randomised, 10-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Ezetimibe Treatment in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Eprotirome
KB2115
dyslipidemia
hypercholesterolemia
hypertriglyceridemia
Lead sponsor: Karo Bio AB
Sponsor class: INDUSTRY
First posted: 2008-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases.

The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 to 75 years
* Patient with primary hypercholesterolemia with an LDL-cholesterol \> 3.0 mmol/L
* At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study

Exclusion Criteria:

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study

Primary outcomes:
measure: LDL cholesterol
timeFrame: 10 weeks
Secondary outcomes:
measure: Triglycerides
timeFrame: 10 weeks
Other outcomes:
Locations:
city: HUddinge
country: Sweden
facility: Karo Bio AB
Study officials:
affiliation: Karo Bio AB
name: Jens D Kristensen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06107348: COVID-19 Post-Vaccination Observation
Official title: COVID-19 Post-Vaccination Observation on Immune Exhaustion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Immune System Diseases
COVID-19 Vaccine Adverse Reaction
Immune System Disorder
Lead sponsor: Pachankis, Yang I., M.D.
Sponsor class: INDIV
First posted: 2023-10-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is currently focused on Asians.

Brief summary: The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention.


Eligibility criteria: All COVID-19 vaccinated are eligible for inclusion.

Primary outcomes:
measure: Chemiluminescent Immunoassay for Human Immunodeficiency Virus
timeFrame: 7 months
measure: Carcinoembryonic Antigen
timeFrame: 7 months
measure: Alpha Fetoprotein
timeFrame: 7 months
measure: Carbohydrate Antigen 19-9
timeFrame: 7 months
measure: Mucin-16
timeFrame: 7 months
measure: Cancer Antigen 15-3
timeFrame: 7 months
measure: Prostate-Specific Antigen
timeFrame: 7 months
measure: Leukocytes
timeFrame: 7 months
measure: Leukocyte Percentage
timeFrame: 7 months
measure: Cholesterol
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Residential Address
state: Chongqing
Study officials:
References:
citation: Pachankis YI. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.
Clinical trial NCT01526148: Gao Bipolar Spectrum Lithium/Quetiapine Study
Official title: Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 42
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: This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent before beginning any study-specific procedures
* Male and female patients at least 18 years of age
* Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s)
* Willing to be randomized to either Lithium or Quetiapine
* If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
* Women with reproductive potential must have a negative urine pregnancy test

Exclusion Criteria:

* Unwilling to comply with study requirements
* Patients who have had severe adverse reaction to Lithium or Quetiapine
* Patients who require inpatient care
* Drug/alcohol dependence requiring immediate acute detoxification
* Pregnancy as determined by serum pregnancy test or breastfeeding
* History of nonresponse to Lithium at doses \>900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.

Primary outcomes:
measure: Time to Study Discontinuation
timeFrame: Week 16
Secondary outcomes:
measure: Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Screening and Week 16
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Mood Disorders Program
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Keming Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799448: Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes
Official title: Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy


Eligibility criteria: Inclusion Criteria:

* HbA1c: 7.5-11.0% on current therapy
* OHA (oral hypoglycaemic agent) treatment for a minimum of two years
* BMI (body mass index): 25-32 kg/m2

Primary outcomes:
measure: HbA1c
timeFrame: after 20 weeks of treatment
Secondary outcomes:
measure: Fasting blood glucose (FBG)
measure: Incidence of hypoglycaemic episodes
measure: Adverse events
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04045548: Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery
Official title: Benefits of Vaginal Dinoprostone Administration Prior to Levonorgestrel-releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to dinoprostone.
* Women refuse to participate in the study

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550548: Incretin Action in Physiology and Diabetes
Official title: Incretin Action in Physiology and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Secretion
Keywords: Incretins
GLP-1
GIP
hyperglycemic clamp
Glucagon
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-09-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project is designed to advance understanding of the incretin effect in health and disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired in T2DM, and amenable to therapeutic intervention. However, there are important gaps in understanding incretin function that limit application of this system; this project will address several of these. A secondary, but critical aspect of this research is focus on inter-individual variation in the physiology of the incretin system. This is a novel direction for research in this field and is critical to advancing the concept of individualized medical care in diabetes by establishing whether there is a physiologic basis for predicting the existence of responders and non-responders to incretin therapies.

Currently, we have described only Aim 1 from this grant in this protocol registration. While Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from this Aim and / or the publication of other results in the field may affect the approach to Aims 2 and 3.


Eligibility criteria: Inclusion Criteria:

* healthy adult volunteers
* fasting plasma glucose value ≤ 95 mg/dL, measured at screening visit
* HbA1c ≤ 5.9%, measured at screening visit

Exclusion Criteria:

* history of diabetes diagnosis, including gestational diabetes
* presence of Type II diabetes mellitus among any first degree family members
* rheumatoid arthritis
* inflammatory bowel disease
* unstable angina or uncompensated heart failure
* pulmonary disorders including COPD and asthma
* malabsorptive GI disease, such as celiac disease, or gastric bypass
* significant hepatic disease
* renal insufficiency (eGFR \< 60 mL/kg/min)
* anemia (hematocrit \< 34%) as measured at screening visit
* pregnancy
* uncontrolled hypertension
* consumption of daily medications that alter glucose metabolism or GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)

Primary outcomes:
measure: Beta cell sensitivity
timeFrame: 30 minute infusion periods
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Living
state: North Carolina
Study officials:
References:
Clinical trial NCT05735548: Tumors of the Peripheral Nervous System
Official title: Prognostic Factors in Tumors of the Peripheral Nervous System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor of Peripheral Nerve
Keywords: outcome, neurosurgery
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 100
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 confirmed histology of peripheral nerve tumor, operated at our hospital during the 10 years before the study started.

Brief summary: The goal of this observational study is to individuate tumors' and patients' features influencing the outcome after surgical tumor removal.

Detailed description: Patients operated because of removal of Peripheral Nervous System (PNS) tumor will be recruited accordingly to the inclusion criteria: the aims of the study will be illustrated and the informed consent signed.

All the clinical and neuroradiological perioperative documents of the enrolled patients will be analyzed. As follow-up, thorough neurological exam wil be performed and specific surveys about after surgery social and working life will be administered; neuroradiological imaging will be performed.

Then, the results will be investigated to individuate which factors were related to the outcome.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 y.o.
* neurosurgical removal of peripheral nerve tumor at our University Hospital "Fondazione Policlinico Universitario Agostino Gemelli (FPG)" during the previous 10 years
* signed consent to study participation

Exclusion Criteria:

* \< 18 y.o.
* neurosurgical treatment because other causes (chronic entrapment syndromes, acute nerve lesion)
* denied consent to study participation

Primary outcomes:
measure: oncological outcome
timeFrame: through study completion, an average of 3 years
measure: functional outcome
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: