louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02534207: Basmisanil Positron Emission Tomography Study in Japanese Volunteers
Official title: A Single-Centre, Non-Randomised, Open Label, Positron Emission Tomography Imaging Study to Assess Occupancy of α5-Containing GABAA Receptors by RO5186582 in Healthy Volunteers of Japanese Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-27
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the relationship between basmisanil plasma concentrations and the occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5) subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging sessions. In the first imaging session, participants will have a baseline Positron Emission Tomography (PET) scan. In the second imaging session, participants will receive a single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese healthy volunteer, who was born in Japan, has 4 ethnically Japanese grandparents and has lived outside Japan for no longer than 5 years
* A body mass index (BMI, Quetelet index) in the range 18.0 to 32.0 kilograms per square meter (kg/m\^2)
* Willingness and ability to comply with study restrictions

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury, or other structural brain abnormality
* Pregnant or lactating or not using acceptable contraception
* Presence or history of severe adverse reaction to any drug or a history of sensitivity to basmisanil or the PET radioligand (RO15-4513)
* Significant exposure to radiation within the previous 12 months
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Primary outcomes:
measure: Percentage of Brain α5 Subunit-Containing GABAA Receptors Occupied by Basmisanil (Receptor Occupancy) Following a Single Dose of Basmisanil in Selected Regions of Interest (ROIs) Assessed by PET Imaging
timeFrame: Day 1
measure: Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors
timeFrame: Day 1
Secondary outcomes:
measure: Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging
timeFrame: Day 1
measure: Percentage of Participants With Adverse Events
timeFrame: From Baseline up to 7-14 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research; Central Middlesex Hospital
city: London
country: United Kingdom
city: London
country: United Kingdom
facility: Imanova Limited
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01681407: Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications
Official title: Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depression
Keywords: Depression
Selective Serotonin Reuptake Inhibitors
MicroRNAs
Proteome
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at community or hospital settings. Patients were clinically evaluated for suspected depression.

Brief summary: A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in depressive patients, treated with SSRI medications. It is an observational clinical bio-markers laboratory controlled research with no device.

The research includes two groups; one for patients diagnosed of having depression, and will get a standard SSRI medication regimen. Second group is for control subjects without depression. An option for a third group is planned to include first degree relatives of the depressed patients. After giving their informed consents, subjects and patients will go through standard clinical psychiatric interview, and routine clinical lab tests. Clinical standard, specific depression and anxiety questionnaires will be held at four follow-up meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked to give blood samples at these points of time for the lab processing: Complete plasma proteomics and specific micro-RNA levels.


Eligibility criteria: Inclusion Criteria:

* Depressed patients,over 18 yo
* Untreated with SSRI, in the last 3 months

Exclusion Criteria:

* Bipolar patients or another major psychopathology
* Depressive disorder clearly due to general medical condition, or drug related
* BMI under 18.5 or above 40
* Pregnant patients
* Active suicidality

Primary outcomes:
measure: Depressive symptoms remission or response rates, under usual SSRI treatment.
timeFrame: 10 weeks of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
References:
Clinical trial NCT03531307: Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery
Official title: Lactate Levels at Beginning of Surgery Correlates With Ki-67 Labeling Index in Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Anesthesia
Keywords: Lactate
Ki-67
Mitotic index
Brain tumor
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Craniectomy cases for tumoral and non-tumoral surgery with lactate levels and biopsy information.

Brief summary: In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a marker of tumor mitotic activity.

This research aims to describe the correlation between lactate levels and the Ki-67 index in patients with brain tumor.

Detailed description: Lactate levels are used in the evaluation of perfusion status in critical care. Increases not related to a hypoperfusion state are observed in the patient with brain tumors. These increases have been related to type and tumor grade. This observation does not fully explain the variation within the same tumor grade.

Ki-67 label index is a marker of mitotic activity that can be used as proliferation index. It has been associated with histologic grade and survival rate. Provides a quantitative measure of the tumor proliferation status.

The investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. The study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.

Eligibility criteria: Inclusion Criteria:

* Neurosurgical craniectomy cases
* June 2017 - February 2018
* Valid lactate information after anesthesia induction
* Ki-67 label index informed in biopsies
* Tumor type information confirmed in biopsies

Exclusion Criteria:

* Incomplete lactate or Ki-67 index information

Primary outcomes:
measure: Evaluate the correlation between Lactate levels and Ki-67 Index
timeFrame: Within 1 week after data acquisition
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Anesthesia department, Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Ricard Valero, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686607: Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Official title: A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Fungal Infections
Keywords: Hepatic toxicity
Renal toxicity
Micafungin
Hepatocellular carcinoma
Antifungals (parenteral)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: World Health Information Science Consultants, LLC
First posted: 2012-09-18
Enrollment: 40110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with parenteral antifungals in tertiary referral centers across the United States.

Brief summary: This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.

Detailed description: All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.

Eligibility criteria: Inclusion Criteria:

* hospitalized and treated with parenteral antifungal medication
* first time treatment of the patient with parenteral antifungal in the medical center was anytime from 2005 through 2012

Exclusion Criteria:

* prior diagnosis of hepatocellular carcinoma
* had received parenteral antifungal therapy during the 6 months prior to index hospitalization

Primary outcomes:
measure: Treatment-emergent hepatic injury or dysfunction
timeFrame: Up to 30 days after termination of the index treatment
measure: Treatment-emergent renal failure or dysfunction
timeFrame: Up to 30 days after termination of the index treatment
measure: Rehospitalization for the parenteral treatment of fungal infections
timeFrame: Up to 30 days after termination of the index treatment
measure: Death from hepatocellular carcinoma (HCC)
timeFrame: Up to 13 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Site US4
state: Maryland
city: Boston
country: United States
facility: Site US2
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site US6
state: Michigan
city: Durham
country: United States
facility: Site US3
state: North Carolina
city: Philadelphia
country: United States
facility: Site US5
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US1
state: Pennsylvania
Study officials:
affiliation: WHISCON, LLC
name: Lead Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05465707: A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of CM313 in subjects with systemic lupus erythematosus

Detailed description: This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.

About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.

The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.

Eligibility criteria: Inclusion Criteria:

* 18 years old ≤ age ≤ 65 years old.
* Positive autoantibody serology test at screening.
* Contraception.
* Voluntarily sign the ICF.

Exclusion Criteria:

* With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
* Possibly active Mycobacterium tuberculosis infection.
* With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
* Heavy drinking in the 3 months prior to screening.
* With depression or suicidal thoughts.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs).
timeFrame: Baseline up to Day 113
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03003507: Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients
Official title: Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Keywords: Hyperglycemia
Fructose
Diabetes mellitus
Enteral Nutrition
Glycemic Variability
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.

Detailed description: Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values\> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.

Eligibility criteria: Inclusion Criteria:

* Critical Illness
* Exclusive enteral diet
* Enteral diet with full nutritional value
* Hyperglycemia ≥180 mg / dl

Exclusion Criteria:

* Oral feeding
* NPT (Total or Partial Parenteral Nutrition)
* Patient without indication of use of study diets

Primary outcomes:
measure: Glycemic Variability
timeFrame: four days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00469807: Ghrelin Levels in Early IVF Pregnancies
Official title: Maternal Serum Ghrelin Levels in Early IVF Pregnancies: Lack of Prognostic Value for Gestational Outcome and Altered Post-Prandial Responses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Ghrelin
Pregnancy outcome
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-05-07
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: In this study, we have assessed the potential prognostic value for gestational outcome of maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin responses to meal intake were explored at early gestation.

Detailed description: Ghrelin is a pleiotropic hormone recently involved in the control of growth and metabolism, whose circulating levels fluctuate in relation to food intake and body mass index. Ghrelin has been detected in the decidualized endometrium, as well as in human and rat placenta, with a distinctive temporal pattern of expression along pregnancy.

Comparison(s): A total of 106 patients undergoing IVF procedures were prospectively recruited. On d-16 and 23 after oocyte retrieval, the patients were subjected to blood sampling after overnight fasting, for determination of serum ghrelin, hCG and progesterone levels. In addition, ghrelin levels were assayed in these groups, 2-h after ingestion of a fixed-calorie meal.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Antonio Pellicer, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04191707: Metabolomic Markers of Fatigue in Inflammatory Bowel Disease
Official title: Metabolomic Markers of Fatigue in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn Disease
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 18
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: This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent.

Brief summary: Fatigue is a common symptom and a leading concern in patients with inflammatory bowel disease (IBD) and often persists despite clinical and endoscopic remission.

This study evaluates the metabolomic profile of fatigued patients with IBD.

Detailed description: To date, there is only one non-published study using metabolomics in quiescent IBD patients with and without fatigue.

The investogators designed this study to examine if there are metabolomics factors associated to fatigue in IBD patients.

This study was performed with plasma samples from IBD patients recruited in a previous study after informed consent. (1) IBD outpatients attending the Hospital de Sabadell Gastroenterology Day-care unit were consecutively included for analytical monitoring of immunosuppressant treatment or infliximab infusion.

The investigators recorded demographic data, IBD classification according to the Montreal classification, and history of drug administration. In addition, clinical activity of the disease was measured using the Harvey-Bradshaw score for Crohn's disease (CD) and the modified Mayo score for ulcerative colitis (UC). The "Functional Assessment of chronic Illness Therapy-Fatigue" (FACIT-F) was used to assess fatigue.

Eligibility criteria: Inclusion Criteria:

- Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) .

Exclusion Criteria:

* Age below 18 years.
* Refusal to give written informed consent prior to participation
* Active infection at the time of inclusion.
* Concomitant diseases not related to IBD (e.g., cancer, heart disease, pulmonary disease) that might contribute to the presence or the severity of fatigue.
* Active flare of IBD in the last 3 months.

Primary outcomes:
measure: changes in metabolomic profile
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Parc Tauli Hospital
name: Diana Horta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.
Clinical trial NCT04845607: Prophylactic Amiodarone for Shockable Cardiac Arrest
Official title: Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiac Arrest
Ventricular Arrythmia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.

Detailed description: Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest.

However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care.

Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR.

In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.

Eligibility criteria: Inclusion Criteria:

* Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER

Exclusion Criteria:

* age \< 18 yr
* pregnancy
* non cardiac caused arrest such as hanging
* previous amiodarone continuous infusion before radomization
* sustained ventricular arrhythmia recurrence after ROSC
* extracorporeal membrane oxygenation
* contra indication for amiodarone
* disagree with this research

Primary outcomes:
measure: Number of patients with re-arrest by shockable rhythm
timeFrame: 5 days from return of spontaneous circulation
Secondary outcomes:
Other outcomes:
measure: 3 month survivor
timeFrame: 3 months after the time of hospital discharge
measure: 3 months neurological outcome
timeFrame: 3 months after the time of hospital discharge
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: