louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06744361: Ketamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest
Official title: KETamine Sedation As Neuroprotective Agent Following Out-of-hospital Cardiac Arrest (OHCA) - the KETOHCA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Out-of-hospital Cardiac Arrest (OHCA)
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 282
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: OHCA is a critical medical emergency with significant mortality and morbidity primarily due to hypoxic-ischemic brain injury (HIBI). Despite advances in resuscitation techniques, the neurological outcomes for survivors remain poor. Current post-resuscitation practices lack specific neuroprotective strategies. Ketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, has shown potential neuroprotective properties in preclinical and clinical studies due to its ability to inhibit excitotoxicity and reduce neuronal apoptosis. This trial hypothesizes that ketamine, when used for sedation in OHCA patients, may offer superior neuroprotective benefits compared to the commonly used sedative propofol. By comparing the effects of ketamine and propofol on neuronal damage markers and long-term neurological outcomes, this study aims to identify a potentially effective intervention to improve the prognosis of OHCA patients.


Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years) AND
* resuscitated OHCA of presumed cardiac cause with a shockable first recorded heart rhythm AND
* mean arterial pressure (MAP) \>40 mmHg AND
* a decision to perform prehospital intubation.

Exclusion Criteria:

* Advanced life support termination-of-resuscitation (TOR) criteria met
* Systolic blood pressure \>190 mmHg
* Known allergy to ketamine or propofol
* Chronic diseases making 180-day survival unlikely
* Body temperature \<30° C.

Primary outcomes:
measure: Neuron-specific enolase (NSE) measured 48 hours after OHCA
timeFrame: 48 hours after OHCA
Secondary outcomes:
measure: Death from any cause
timeFrame: 180 days after cardiac arrest
measure: Neurological outcome: modified Rankin Score (mRS)
timeFrame: At 2 weeks (at discharge)
measure: Neurological outcome: Cerebral Performance Categories (CPC)
timeFrame: At 2 weeks (at discharge)
measure: Neurological outcome: modified Rankin Score (mRS)
timeFrame: At 180 days after OHCA.
measure: Neurological outcome: modified Rankin Score (mRS)
timeFrame: At 240 days after OHCA.
measure: Neurological outcome: Cerebral Performance Categories (CPC)
timeFrame: At 180 days after OHCA.
measure: Neurological outcome: Cerebral Performance Categories (CPC)
timeFrame: At 240 days after OHCA.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Rigshospitalet
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT03708861: Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
Official title: Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: HIV Infection
Keywords: maraviroc
atazanavir
ritonavir
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.

Detailed description: The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.

Eligibility criteria: Inclusion Criteria:

* age\>18 years;
* confirmed HIV-antibodies positivity;
* signed informed consent;
* HIV-RNA \<20 cp/ml for the last 24 months;
* no virological failures to PI regimens;
* no major PI resistance associated mutations;
* genotypic tropism for CCR5 co-receptor.

Exclusion Criteria:

* active opportunistic infections or neoplasms;
* need for drugs with known drug-drug interactions with included drugs;
* liver cirrhosis;
* any evidence of tropism for CXCR4 or dual infection;
* pregnancy;
* self-reported adherence\<90%;
* HBsAg positivity;
* detectable HCV RNA.

Primary outcomes:
measure: maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
timeFrame: within the first 16 weeks after switch
Secondary outcomes:
measure: viral suppression evaluation
timeFrame: week 60
measure: CD4 count evaluation
timeFrame: week 60
measure: bone density evaluation
timeFrame: week 60
measure: bone metabolism markers evaluation
timeFrame: week 60
measure: glomerular and tubular renal function evaluation
timeFrame: week 60
measure: lipid metabolism markers evaluation
timeFrame: week 60
measure: bilirubin evaluation
timeFrame: week 60
Other outcomes:
Locations:
city: Torino
country: Italy
facility: University of Torino
Study officials:
References:
Clinical trial NCT00018161: Treatment to Quit Smoking
Official title: Combined Pharmacologic/Behavioral Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: Nicotine
addiction
cigarette smoking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
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: This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.

Detailed description: Previous studies have found that nicotine/mecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports the hypothesis that nicotine/mecamylamine treatment prior to smoking cessation partially blocks the rewarding effects of cigarette smoking and hence promotes extinction of the smoking habit, facilitating subsequent abstinence. The behavioral approach employed is also an extinction strategy and involves having smokers switch to de-nicotinized tobacco cigarettes for two weeks prior to quitting smoking. It is hypothesized that the use of de-nicotinized cigarettes might provide more complete extinction than provided by the partial pharmacologic blockade using nicotine/mecamylamine alone. The pharmacologic treatment was expected to increase compliance with the de-nicotinized cigarette smoking regimen, because subjects' usual brands of cigarettes will be less appealing than in the absence of nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking.

Eligibility criteria: * Smokers,
* Ages 18-65, wanted to quit smoking.
* Must be in good health
* Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Veterans Affairs Medical Center
state: North Carolina
Study officials:
name: Eric C Westman, M.D.
References:
Clinical trial NCT02184728: Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia
Keywords: end-tidal CO2
capnometer
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread use of capnometry on-site at emergency and trauma fields. So, portable device can be used usefully.


Eligibility criteria: Inclusion Criteria:

* patients who anticipated arterial gas analyze intraoperatively

Exclusion Criteria:

* patients who didn't get arterial line

Primary outcomes:
measure: End-tidal CO2
timeFrame: During operation (2-4 times)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital, Seoul, Korea
state: Jung-Gu,
Study officials:
References:
citation: Kim KW, Choi HR, Bang SR, Lee JW. Comparison of end-tidal CO2 measured by transportable capnometer (EMMA capnograph) and arterial pCO2 in general anesthesia. J Clin Monit Comput. 2016 Oct;30(5):737-41. doi: 10.1007/s10877-015-9748-x. Epub 2015 Aug 12.
Clinical trial NCT00078728: Family-Based Prevention Program for Childhood Anxiety
Official title: Family-Based Prevention for Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Detailed description: Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care.

Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Eligibility criteria: Inclusion Criteria:

* Mothers with a current, primary anxiety disorder
* 7-12 year old children without an anxiety disorder

Exclusion Criteria:

* Mothers that do not have a current, primary anxiety disorder
* 7-12 year old children with an anxiety disorder
* 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study

Primary outcomes:
measure: Number of Children With Child Anxiety Diagnosis
timeFrame: 12 month
measure: Child Anxiety Diagnoses
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Golda S. Ginsburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308828: The Prevalence of Osteoporosis in Hemodialysis Patients
Official title: Prevalence of Osteoporosis in Hemodialysis Patients and Relevance With Renal Bone Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
First posted: 2006-03-30
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on hemodialysis

Brief summary: The purpose of this study is to determine the prevalence and severity of osteoporosis in hemodialysis patients and to evaluate potential correlations with renal bone disease indices


Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis
* Age \> 18-year old

Exclusion Criteria:

* Prior specific osteoporosis treatment except vitamin D and calcium supplement administration; active malignancy
* Recent pregnancy
* Immobilization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
affiliation: Papageorgiou General Hospital
name: Efstathios Mitsopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520228: The Purpose of This Study is to Reveal the Influence of Active Video Games on Children's Motor Coordination
Official title: Effects of Active Video Games on Motor Coordination of Early Childhood--Focusing on Children in Zhengzhou, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Study Demonstrated the Effect of Active Video Games on Motor Coordination in Children Over a 12-week Intervention
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of the study was to understand the effects of active video games on motor coordination in children. The main questions it aims to answer are:

The effect of positive video games on children's motor ability.

Researchers will compare traditional physical activities to see if active video games are effective in improving motor coordination in children.

Participants will:

Play active video games twice a week for 12 weeks Data were collected during the first and twelfth weeks


Eligibility criteria: Inclusion Criteria:

1. Children who meet the age requirements；
2. Have basic language skills;
3. Not require medication;
4. The parents agrees to participate.

Exclusion Criteria:

1. Those with the eye, ear, or physical disabilities or other physical health problems that prevent them from participating in training.
2. Those with severe organic diseases of the heart, liver, kidneys, and other organs
3. Patients with severe central system pathology.
4. Patients with acute infectious diseases, Etc., who are not suitable to participate in training.

Primary outcomes:
measure: baseline
timeFrame: The first week of the experiment.
Secondary outcomes:
measure: post test1
timeFrame: The 12th week of the experiment.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Lu Chenxi
state: Henan
Study officials:
References:
Clinical trial NCT05255328: Clinical Long Term Evaluation of Glutamine Supplement in MELAS Syndrome
Official title: Clinical Long Term Evaluation of Glutamine Supplement in MELAS (Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes) Syndrome in Order to Prevent Neurological Damage.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MELAS Syndrome
Keywords: MELAS
Glutamine
Oral supplements
Amino acids
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Glutamine oral supplementation
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.

Detailed description: Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) syndrome is a genetically heterogeneous disorder. The most common mutation is in the mtDNA gene MT-TL1 encoding the mitochondrial tRNALeu (UUR). For understanding the development of seizures in patients with mitochondrial disease, a study has recently emphasized the deficiency of astrocytic glutamine synthetase, creating a disinhibited neuronal network for seizure generation. The investigators propose to evaluate nine patients with mitochondrial DNA mutation and MELAS. Patients will receive oral supplementation with 12-18 g/day of glutamine (adjusted for weight and plasma concentrations). The primary outcome measures modification in clinical scales.

Eligibility criteria: Inclusion Criteria:

* MELAS syndrome Clinically and genetically confirmed.
* Patients have already participated in GLN-9-MIT study

Exclusion Criteria:

* subjects harboring a MELAS-related pathogenic mtDNA mutation no fulfilling the complete diagnostic criteria for the MELAS phenotype

Primary outcomes:
measure: Clinical efficacy; JMDRS
timeFrame: 36 months
measure: Clinical efficacy; MMSE
timeFrame: 36 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 36 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 Octubre
name: Jesús González de la Ajeja Tejera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00091728: Hormonal Contraception and Risk of Chlamydia and Gonorrhea
Official title: Hormonal Contraception, Cervical Ectopy, and STDs
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chlamydia Infection
Neisseriaceae Infection
Keywords: epidemiology
relative risk
cervical ectopy
hormonal contraceptives
sexually transmitted infections
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2004-09-20
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: There are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease. The evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results.

This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women: those using combined oral contraceptives (birth control pills); those using the injectable hormone (brand name Depo Provera); and those women using non-hormonal contraceptive methods.

Detailed description: The study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of Chlamydial and Gonococcal sexually transmitted infections, and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy.

Eight hundred and nineteen women, ages 15 to 45 years, were recruited from an inner city clinic and from a nearby suburban clinic. The women were classified into three groups based on type of contraceptive used. One group used oral contraceptives; the second used injectable depo-medroxyprogesterone acetate (DMPA); and the third group used non-hormonal contraceptive methods. Women from each group were followed at 3, 6, and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present.

Eligibility criteria: Inclusion Criteria:

* Female age 15 to 45 years
* no hormone use at enrollment
* not pregnant or planning pregnancy

Exclusion Criteria:

* Cervical cancer presently or in history
* hysterectomy, cone biopsy, or cervical cryotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Family Health International, RTP, N.C.
name: Charles Morrison, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Planned Parenthood
name: Paul Blumenthal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246828: Glucagon in MODY (Maturity Onset Diabetes of the Young)
Official title: Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MODY1
MODY3
Keywords: gliclazide
glucagon
diabetes
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2017-08-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HNF1-alpha or HNF4-alpha MODY.
* Currently on gliclazide treatment

Exclusion Criteria:

* Currently taking any anti-diabetic medication other than gliclazide and metformin
* Oral steroid treatment 30 days prior to the start or at any time during the study period.
* Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
* Felt to be unsuitable to participate in the study in the opinion of the Chief Investigator.
* Currently participating in a clinical trial involving an anti-diabetic medication

Primary outcomes:
measure: Change in plasma glucagon from baseline (0min)
timeFrame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Secondary outcomes:
measure: Change in plasma c-peptide from baseline (0min)
timeFrame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
measure: Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
timeFrame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
measure: Continuous glucose monitor recordings
timeFrame: 12 days
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Clinical Research Unit, OCDEM, Churchill Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Ioannis Spiliotis, MD
role: PRINCIPAL_INVESTIGATOR
References: