louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05392231: Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM
Official title: Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: With a design of prospective observational study, this research was carried out in the Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences, in Istanbul, between September 2021 and April 2022, following the approval of the local ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki Declaration. After all the objectives of this work and context of all the procedures that could be undertaken were properly explained to each pregnant woman, the participant was requested to sign an informed written consent form.

Brief summary: The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).

Detailed description: The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

Eligibility criteria: Inclusion Criteria:

* Maternal age between 18 and 42 years
* Gestational age between 20 and 28 weeks

Exclusion Criteria:

* Multiple pregnancies
* Pregestational diabetes
* Fetal congenital malformations
* Placental and amniotic fluid abnormalities
* Preeclampsia
* Severe systemic disease
* Long-term systemic drug usage

Primary outcomes:
measure: Early prediction of gestational diabetes
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
References:
Clinical trial NCT05834231: Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity
Official title: Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 60
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: PREVENTION

Brief summary: Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.


Eligibility criteria: Inclusion Criteria:

histologically confirmed diagnosis of stage III colorectal cancer performance status \< 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)

Exclusion Criteria:

preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role

Primary outcomes:
measure: Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01367431: Xanthohumol and Metabolic Syndrome
Official title: Xanthohumol and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: Xanthohumol
Metabolic syndrome
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-06-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women in the Portland, Oregon area

Brief summary: The purpose of this study is to determine the pharmacokinetics (PK) of xanthohumol (XN). Small amounts of xanthohumol occur naturally in hops, used to make beer, and XN is also found in beer itself. Studies in animals have shown that XN can lower blood sugar and blood lipids such as triglycerides, which can contribute to heart disease. The purpose of this study is to see how much of the XN is absorbed into the blood and how fast it leaves the body when taken by mouth. Once the PK study has been done, the investigators' long-term goal is to learn if xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.


Eligibility criteria: * BMI 18-32 kg/m2 (to avoid confounders with extreme obesity).
* Smoking or non-smoking.
* Having normal or clinically acceptable physical examination and clinical laboratory tests.
* Willing to abstain from beer consumption for four days prior to and during the study because beer contains XN and related prenylated (PN) flavonoids, such as IX, 8-PN and 6-PN.
* Not currently taking prescription drugs.
* Not having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study.
* If female, not pregnant (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study, and using effective method of contraception (hormonal methods NOT permitted).
* If male with a partner of childbearing potential, willing to inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study.
* Not currently following an extreme diet, such as Atkin's, Zone or Ornish, and willing to maintain their current diet without extreme changes for the duration of the study.

Primary outcomes:
measure: Levels of xanthohumol and metabolites.
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Jan F Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Jon Q Purnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515631: Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review
Official title: Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alagille Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 25
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: Patients with Alagille Syndrome. The age range will be from birth through adulthood. There will be no gender or ethnic limitations to study.

Brief summary: Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.

Detailed description: The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. We also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well. For the third aim, we hope to learn about the different blood vessel abnormalities in the brain, and which abnormalities are most likely to lead to stroke.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alagille Syndrome

Exclusion Criteria:

* None

Primary outcomes:
measure: Assessment of PA in Alagille Patient
timeFrame: Open
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Jeffrey Feinstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01171131: A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
Official title: A Pilot Study to Identify Biomarkers Associated With Chronic TBI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: TBI
Brain Injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TIRR Clinics

Brief summary: The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.


Eligibility criteria: Chronic TBI patients:

Inclusion Criteria

Have a history of head trauma manifesting in one or more of the following:

* Loss of consciousness
* Post-traumatic amnesia
* Focal neurologic deficits, seizure
* Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
* Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)

Exclusion Criteria

Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Healthy volunteers:

Inclusion Criteria

* No significant medical history
* Take no medications (other than birth control pills)
* Fever free
* No history of head trauma or recent injury/infection
* No history of neurological or psychiatric disorders or alcohol or drug dependency.

Exclusion Criteria

* Inability to provide informed consent
* age/gender match not available in TBI cohort

Primary outcomes:
measure: Proteomic analysis of plasma
timeFrame: average of 6 months post injury
Secondary outcomes:
measure: Proteomic analysis of saliva
timeFrame: average of 6 months post injury
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Georgene Hergenroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00326131: A Phase I Study of a Single Dose of Radio-labeled BMS-275183 in Patients With Advanced Cancer
Official title: Pharmacokinetics and Metabolism of [14C] BMS-275183 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first purpose of this study is to determine how the body absorbs, metabolizes, and eliminates a single dose of BMS-275183 (labeled with radioactive carbon). Secondly, to measure the levels of BMS-275183 in your blood, study the safety of the drug, and to see what effects it has on your cancer.


Eligibility criteria: Inclusion Criteria:

* Non-hematological malignancy that has progressed on standard therapy
* No more that 3 prior chemotherapies given for advanced cancer
* Adequate renal, hepatic and hematologic function

Exclusion Criteria:

* Uncontrolled or significant pulmonary or cardiovascular disease
* Active Brain metastases
* Inability to swallow capsules
* Serious uncontrolled medical disorder or active infection

Primary outcomes:
measure: To assess the Pharmacokinetics, metabolism, and routes and extent of elimination of a single dose of [14C] BMS-275183 over a 10 day period.
Secondary outcomes:
measure: To assess the safety of a single dose of [14C] BMS-275183 followed by a therapeutic regimen of BMS-275183 administered twice weekly
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Local Institution
state: Texas
Study officials:
References:
Clinical trial NCT05795231: Clinical Outcome of Endotracheal Intubation in Non-trauma Patients
Official title: Clinical Outcome of Endotracheal Intubation in Non-trauma Patients in the Emergency Department of Alexandria Main University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effects of Endotracheal Intubation
Keywords: endotracheal intubation
clinical outcome
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-04-03
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 who meet the required criteria and consent to the study.

Brief summary: The study will involve all adult patients visiting the Alexandria University main hospitals' Emergency department for reasons other than trauma that will require assisted ventilation via endotracheal intubation. Those pre-intubated or intubated post CPR will not be included. The main aim is to evaluate the clinical outcome (complications) of emergency endotracheal intubation and to correlate the incidence and nature of complications associated with tracheal intubations to demographic data and patient characteristics.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both sex with a life threatening impairment of the cardiovascular, respiratory or neurological system requiring emergency endotracheal intubation in the emergency department of Alexandria Main University Hospital.

Exclusion Criteria:

* • Patients who are less than 18 years of age.

  * Patients intubated out of the hospital.
  * Trauma patients.
  * Patients intubated for cardiac arrest.
  * Failed intubation in the field

Primary outcomes:
measure: Major Adverse Events
timeFrame: 24 hours
Secondary outcomes:
measure: Moderate Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT00422331: Safety and Efficacy Study of Lithium in Bipolar Disorder
Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bipolar Disorder
Mania
Keywords: Bipolar I Disorder
Bipolar Disorder
Lithium
Lead sponsor: JDS Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 206
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: The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Bipolar 1 Disorder;
* Hospitalized or in the process of being hospitalized for a manic or mixed episode

Exclusion Criteria:

* History of rapid cycling;
* History of hypersensitivity or adverse reaction to lithium

Primary outcomes:
measure: change from baseline in YMRS score
Secondary outcomes:
measure: change from baseline in CGI-BP score
measure: change from baseline in MADRS score
Other outcomes:
Locations:
city: New York
country: United States
facility: JDS Pharmaceuticals
state: New York
Study officials:
References:
Clinical trial NCT01903460: Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Paediatric Patients With Alagille Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alagille Syndrome
Lead sponsor: Mirum Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Alagille Syndrome
2. Evidence of cholestasis
3. Moderate to severe pruritus
4. Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures

Exclusion Criteria:

1. Surgical disruption of the enterohepatic circulation
2. Liver transplant
3. History or presence of other concomitant liver disease
4. Females who are pregnant or lactating
5. Known HIV infection

Primary outcomes:
measure: Change From Baseline to Week 13 (End of Treatment) in Fasting Serum Bile Acid Level
timeFrame: Baseline to 13 weeks or end of treatment
Secondary outcomes:
measure: Change From Baseline to Week 13 (End of Treatment) in Liver Enzymes
timeFrame: Baseline to 13 weeks or end of treatment
measure: Change From Baseline to Week 13 (End of Treatment) in Pruritus as Measured by The Patient And Observer Itch Reported Outcome (ItchRO) Average Daily Scores
timeFrame: Baseline to 13 weeks or end of treatment
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: West Midlands
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
state: West Yorkshire
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Mirum
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06822660: Dreams or Implicite Memorization Under OFA
Official title: Dreams or Implicite Memorization Under OFA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Implicite Memorization
Keywords: implicite memorization
opioid free anesthesia
observationnal
monocentric
isolated forearm technique
explicite memorization
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We study patients 18-75 aged undergoing laparoscopic robotic surgery ( prostatectomy, hysterectomy, colectomy) with an ASA status from 1 to 3.

Brief summary: The Dreams study is an observational study aimed at evaluating the incidence of connected awareness after intubation, intraoperative explicit and implicit memorization, and postoperative well-being in patients receiving general anesthesia without opioids.

Outcomes

The primary objective is the evaluation of the incidence of connected consciousness after induction of general anesthesia without opioids and intubation. The secondary objectives are:

* Implicit and explicit memorization after intubation and during the procedure
* Post-operative well-being Pain in the recovery room and in the room, assessed by VAS;
* Total consumption of analgesics (paracetamol, diclofenac, tramadol): data collected during discharge
* Level of satisfaction, assessed using the EVAN scale
* Duration of hospitalization
* Estimated first mobilization


Eligibility criteria: Inclusion Criteria:

* laparoscopic robotic surgery
* ASA score 1 to 3

Exclusion Criteria:

* neurological and psychiatric diseases
* reflect memory disorders
* head trauma
* hearing disorders
* past or current use of medications affecting the central nervous system.

Primary outcomes:
measure: Implicite memorization incidence
timeFrame: From the operating room to one week after surgery
Secondary outcomes:
measure: explicite memorization
timeFrame: From the operating room to one week after surgery
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint Pierre
Study officials:
References: