louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05746143: The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Official title: The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Spine Fusion
Lumbar Spine Degeneration
Pain, Postoperative
Lumbar Spine Spondylosis
Keywords: Lumbar Spine Fusion
Zolpidem
Postoperative Outcomes
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 140
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.

Detailed description: Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.

Eligibility criteria: Inclusion Criteria:

* degenerative lumbar disease
* age of 18-75
* undergoing open primary one- to three-level lumbar fusion

Exclusion Criteria:

* currently use a sleep aid nightly
* diagnosed with insomnia or sleep apnea
* history of delirium with opiates or zolpidem
* allergic to opiates or zolpidem
* had previous lumbar spine surgery
* undergoing minimally invasive lumbar fusion,
* undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Postoperative day five
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
measure: Morphine Equivalents
timeFrame: Postoperative day one, two, three, four, five, and two weeks
measure: Quality of Recovery - 40 (QoR-40) questionnaire
timeFrame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
measure: Epworth Sleepiness Score (ESS)
timeFrame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
measure: Hospital Length of Stay
timeFrame: Postoperative two-weeks
measure: Postoperative complications
timeFrame: Postoperative two-years
measure: Visual analog scale (VAS)
timeFrame: preoperative, postoperative day one, three, as well as two weeks and six weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
Study officials:
References:
Clinical trial NCT05971043: Skin Disease in Methamphetamine Abuse
Official title: Skin Disorders in Patients Using Methamphetamine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Methamphetamine Abuse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cross-sectional, questionnaire-based, study including clinical assessment of diseases severity.

Brief summary: 1. To detect the skin diseases in patients using methamphetamine

Detailed description: Methamphetamine is a stimulant drug that associated with a broad spectrum of health conditions, include addiction, mental health disorders, and overdose. The Drug Enforcement Agency (DEA) classifies it as a Schedule II drug. This means that the drug has a high potential for misuse. The drug is also called crystal meth, ice, and blue.

Methamphetamine use has increased in Egypt especially in upper Egypt. Literature on cutaneous manifestations among methamphetamine users is limited, although cellulitis, delusion of parasitosis (DOP), hyperhidrosis, formication and prurigo nodularis (PN) have been attributed to methamphetamine users. While the relationship between skin lesions and substance use in not fully defined, there is some evidence that points to the development of these itchy, red lesion also known as meth sore after meth use. Meth sores often look like small round red patches on your skin, they can often be confused with acne when they appear on the face or a rash when they appear on other parts of the body.

Meth sores form as a result of heavy meth misuse. other signs of meth abuse at the stage where sores likely to develop include:

* Weight loss
* Paranoia
* Hallucinations
* Aggressive behavior
* Being easily distracted
* Tooth and gum decay
* Changes in brain structure

Eligibility criteria: Inclusion Criteria:

* Patients using methamphetamine

Exclusion Criteria:

* 1. Pregnant and lactating patients. 2. Patients with chronic diseases

Primary outcomes:
measure: skin disorders in patients using methamphetamine
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ahmed Shawkey gomaa, Lecturer
role: STUDY_DIRECTOR
References:
citation: Barnes AJ, Smith ML, Kacinko SL, Schwilke EW, Cone EJ, Moolchan ET, Huestis MA. Excretion of methamphetamine and amphetamine in human sweat following controlled oral methamphetamine administration. Clin Chem. 2008 Jan;54(1):172-80. doi: 10.1373/clinchem.2007.092304. Epub 2007 Nov 2.
Clinical trial NCT01526343: Medtronic Reveal XT Study
Official title: A Comparison of Traditional Arrhythmia Assessment With the Use of Continuous Monitoring to Quantify Postoperative Arrhythmia Burden Following Surgical Treatment of Atrial Fibrillation- Medtronic Reveal XT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: Patients
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2012-02-03
Enrollment: 47
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: While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for AF in patients undergoing either lone or concomitant heart surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or as a concomitant cardiac operation.
2. Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (PVI).
3. Patients 18 years or older.
4. All eligible patients will be considered, regardless of gender or race.
5. Patients able and willing to provide informed consent and willing to comply with the required interval follow-up.

Exclusion Criteria:

1. Patients with a preoperative permanent pacemaker.
2. Patients with a projected lifespan of less than six months.
3. Patients requiring emergent cardiac surgery.
4. Patients unwilling or unable to give written informed consent.
5. Patients undergoing a right atrial or left atrial lesion set procedure.

Primary outcomes:
measure: Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
timeFrame: ILR monitoring obtained at 3, 6 and 12 months
measure: Freedom From Atrial Tachyarrhythmias (ATAs)
timeFrame: ILR monitoring at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ralph J Damiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554743: Plant-Based Defaults
Official title: Using Defaults to Reduce Harmful Environmental Impacts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choice Behavior
Dietary Habits
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, participants at six different academic events were randomly assigned to one of two conditions: (1) a default meat group, where the default choice was a meal with meat and participants had the option of opting out and choosing a plant-based meal; and (2) a default veg group, where the default choice was a plant-based meal with the option of opting out and choosing a meal with meat. Based on the success of prior studies that implemented plant-based defaults through preselection, we hypothesized that more participants would choose the plant-based meal when that option was set as the default, and we hypothesized that the default intervention would be equally effective across academic institutions. We also hypothesized that the default intervention would be equally effective across demographic groups, which would help to further demonstrate the generalizability of our plant-based default intervention.


Eligibility criteria: Inclusion Criteria:

* Academic event attendee

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of participants selecting the plant-based meal
timeFrame: Immediately during the completion of the event RSVP form
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT04100343: Detection of Pattern of Some Unusual Signs and Symptoms of Multiple Sclerosis
Official title: Detection of Pattern of Unusual Signs and Symptoms of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients daignosed as multiple sclerosis attending at Assiut university hospital within the prescribed time

Brief summary: Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on International Headache Society (IHS) recommendations


Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. Age:30-50 years
3. Accepting all study requirement

Exclusion Criteria:

1. comorbid patient e.g (diabetic, hypertensive.......etc )
2. opposition of the patient or their family

Primary outcomes:
measure: Fatigue severity scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00160043: Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Official title: Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Non small cell lung cancer, Stage IIIB or Stage IV
* One and only 1 prior platinum-based chemotherapy
* No other uncontrolled concurrent illness
* Use of highly effective birth control methods in males or females with reproductive potential

Exclusion Criteria:

* Previous participation in another trial within the last 4 weeks
* Surgery within 10 days prior to the start of study treatment
* Brain metastases
* Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
* Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
* Breast feeding

Primary outcomes:
measure: Tumor response rate (complete or partial response according to RECIST).
timeFrame: At baseline and every 8 weeks afterwards
Secondary outcomes:
measure: Time to disease progression.
timeFrame: At baseline and every 8 weeks afterwards
Other outcomes:
Locations:
city: Paris
country: France
city: Paris
country: France
city: Villejuif
country: France
city: Göttingen
country: Germany
state: Niedersachsen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.
Clinical trial NCT02783443: Effect General and Regional Anesthesia on Glycocalyx
Official title: Effect General and Regional Anesthesia on Glycocalyx
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Glycocalyx
Perfused Boundary Region
Keywords: Anesthesia, glycocalyx, perfused boundary region
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2016-05-26
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: Adult patients ASA 2-3 undergoing elective total knee replacement surgery

Brief summary: Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Detailed description: Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.

The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.

Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.

Eligibility criteria: Inclusion Criteria:

Adult patients ASA 2-3 undergoing elective total knee replacement surgery

Exclusion Criteria:

None

Primary outcomes:
measure: Change in Perfused Boundary Region (PBR)
timeFrame: Change from baseline PBR at 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Hradec Kralova, Czech Republic
name: Vladimir Cerny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871243: Children Vaccination From 11 to 14 Years Old
Official title: Qualitative Study Evaluating Opinions Regarding HPV Vaccinnation in Boys' Parents Aged From 11 to 14 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination Refusal
Opinions
Keywords: human papilloma virus
vaccination
Lead sponsor: Centre Hospitalier Eure-Seine
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed-up by a general practitioner that participate in the study

Brief summary: The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

Detailed description: This qualitative study evaluates parents' opinion regarding the vaccination and the HPV. Parent's eligible to participate in this study are those with boys between 11 and 14 years old.

The anti-HPV vaccination is perceived favorably in 38% of parents, but 42% of parents are undecided.

The investigators would like to evaluate qualitatively the opinions and the obstacles in this vaccination, using interviews in parents of boys aged between 11 and 14 years old.

Eligibility criteria: Inclusion Criteria:

* parents having boys between 11 and 14 years old, followed-up by a general practitioner that participate in the study
* signed inform consent form

Exclusion Criteria:

* language barrier that could prevent the understanding or formulation of opinions during the interview

Primary outcomes:
measure: Evaluation of knowledge and understanding of papillomavirus and opinions related to anti-HPV vaccination
timeFrame: 4 months
Secondary outcomes:
measure: Concept identification to ameliorate the vaccination coverage by overcoming the obstacles
timeFrame: 4 months
Other outcomes:
Locations:
city: Évreux
country: France
facility: CH Eure-Seine
Study officials:
References:
Clinical trial NCT01504243: Association Between cd163 Gene Polymorphisms and Sepsis Among Chinese Han Population
Official title: Association Between cd163 Gene Polymorphisms and Sepsis Among Chinese Han Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: CD163;
SNPs;
prognosis;
control（normal person）
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between September 2009 and October 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Brief summary: CD163 is a member of the scavenger receptor cysteine-rich family (SRCR) is exclusively expressed on cells of the monocyte lineage.CD163 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. This study was designed to investigate whether CD163 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with CD163 gene of seventeen exons by PCR sequencing. When analyzing the results of sequencing, we found five gene polymorphisms located in exon-2,exon-5 and exon-11, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs3210140, two polymorphisms located in exon-5 are synonymous variations rs4883264 and rs4883263, the last two located in exon-11 are synonymous variations rs61729512 and rs150018775 . Five common polymorphisms (rs2234237,rs2234246) within the CD163 gene were detected in 200 patients with severe sepsis and in 200 healthy control subjects. This study was explored that whether or not polymorphisms detected within the CD163 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.


Eligibility criteria: Inclusion Criteria:

* Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.

Exclusion Criteria:

* (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (\< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Respiratory Disease Department of chinese PLA General Hospital
name: Li xin Xie, MD
role: STUDY_DIRECTOR
References: