louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02542150: Effects of Acetate and Alcohol on Brain Function
Official title: Effects of Acetate and Alcohol on Brain Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Blood Flow
Brain Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.

Detailed description: This study plans to learn more about how alcohol and its metabolite, acetate, affect brain function.

Eligibility criteria: Inclusion Criteria-all:

1. Subjects who are age 21-55,
2. Subjects who are proficient in English ,
3. Subjects who understand the nature of the study,
4. Subjects who have signed an informed consent,
5. Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),

Inclusion Criteria-moderate drinkers:

1. Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).
2. Subjects who have drunk at least 2 drinks in one hour in the past, and have no history of dependence on drugs or alcohol

Inclusions-AUD:

(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)

Exclusion Criteria-all:

1. Subjects who have a "facial flushing" response to alcohol,
2. Subjects who are pregnant or nursing,
3. Subjects who have major medical problems including diabetes, high blood pressure (\> 150/90), prior neurological or psychiatric history (schizophrenia, bipolar, or current major depressive disorder), epilepsy (alcohol withdrawal seizures is not an exclusion),
4. Subjects who have been told they have or been diagnosed with liver or kidney disease,
5. Subjects who have chronic gastrointestinal disease,
6. Subjects who are obese (BMI\>30 kg/m2),
7. Subjects who take psychoactive medications,
8. Subjects who have prior head trauma resulting in loss of consciousness \>15 minutes,
9. Subjects who have Magnetic Resonance (MR) exclusions which include claustrophobia, intracranial, orbital, or spinal metal implants, pacemakers, cochlear implants, cardiac stents or other non-MR-compatible implants or devices.

Primary outcomes:
measure: Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
timeFrame: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jody L Tanabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tanabe J, Yamamoto DJ, Sutton B, Brown MS, Hoffman PL, Burnham EL, Glueck DH, Tabakoff B. Effects of Alcohol and Acetate on Cerebral Blood Flow: A Pilot Study. Alcohol Clin Exp Res. 2019 Oct;43(10):2070-2078. doi: 10.1111/acer.14173. Epub 2019 Aug 24.
Clinical trial NCT03521050: LUKS-Leads Registry on Long-term Performance of ICD Leads
Official title: LUKS-Leads Registry on Long-term Performance of ICD Leads
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Defibrillators
Electrical Shock
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical indication for an ICD

Brief summary: All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

Detailed description: All patients having an ICD implanted and having follow-up at the investigators center are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

The following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems

Eligibility criteria: Inclusion Criteria:

* all patients being implanted with a Defibrillator lead from 2006 onwards

Exclusion Criteria:

* documented refusal of data collection for scientific purposes

Primary outcomes:
measure: performance of lead impedance
timeFrame: regular clinical controls within 10 years
measure: performance of lead threshold
timeFrame: during regular clinical controls within 10 years
measure: performance of lead sensing
timeFrame: during regular clinical controls within 10 years
measure: lead parameters
timeFrame: during regular clinical controls within 10 years
measure: performance of defibrillator
timeFrame: during regular clinical controls within 10 years
measure: control system of defibrillator
timeFrame: during regular clinical controls within 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Heart Centre
Study officials:
affiliation: Luzerner Kantonsspital
name: Richard Kobza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02440750: Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uterine Fibroids
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion Criteria:

* pregnancy
* other hormonal therapy in the previous 8 weeks
* hepatic or renal impairment
* any medical condition that would increase the surgical risk
* refusal or unable to sign written consent

Primary outcomes:
measure: Endometrial thickness
timeFrame: Change in mm from baseline after farmacological therapy
Secondary outcomes:
measure: Ovarian follicle dimensions
timeFrame: Change in mm from baseline after farmacological therapy
measure: Endometrial appearance
timeFrame: Change from baseline after farmacological therapy
measure: Operative time
timeFrame: Within 2 hours after the end of the hysteroscopy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03276650: Admission of Adult-onset Still Disease Patients in the ICU
Official title: Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult-Onset Still Disease
Critically Ill
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 45
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: Adult AOSD patients admitted to ICU

Brief summary: Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.


Eligibility criteria: Inclusion Criteria:

* AOSD (history of newly diagnosed)
* ICU admission between January 2001 and June 2017

Exclusion Criteria:

* adults under protection
* admission in step-down unit

Primary outcomes:
measure: number of patients
timeFrame: At inclusion
Secondary outcomes:
measure: APACHE II
timeFrame: 24hour after ICU admission
measure: Mortality
timeFrame: through study completion, maximum 17,5 years after admission
measure: Number of rehospitalisation in ICU
timeFrame: through study completion, maximum 17,5 years after admission
measure: number of hospitalisation in internal medicine ward
timeFrame: through study completion, maximum 17,5 years after admission
measure: recurrent relapses
timeFrame: through study completion, maximum 17,5 years after admission
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
References:
Clinical trial NCT06262750: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
Official title: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Splanchnic Vein Thrombosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients referred to the Fondazione Policlinico Universitario Agostino Gemelli IRCCS for SVT, either as inpatients or outpatients, and requiring anticoagulant therapy will be eligible for inclusion in this study

Brief summary: Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients


Eligibility criteria: Inclusion Criteria

* age ≥ 18 years
* ability to provide informed consent;
* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in liver cirrhosis (with or without hepatocarcinoma);
* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in absence of liver cirrhosis (with or without portal cavernoma);
* pregnant patients will be eligible for inclusion in the study;
* ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux

EXCLUSION CRITERIA

* splanchnic vein tumor thrombosis;
* absence of antithrombotic prophylaxis

Primary outcomes:
measure: Incidenze of bleedings events
timeFrame: through study completion, an average of 1 year
measure: Incidence of venous and arterial thromboembolic events
timeFrame: through study completion, an average of 1 year
measure: Rate of progress /stable /regressive
timeFrame: every six months, up to 2 years
measure: incidence of liver related events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UOC Servizio e DH Ematologia
Study officials:
References:
Clinical trial NCT06275750: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain
Official title: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain and Sciatica: a 2-month Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Sciatica
Lumbar Disc Herniation
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.

The main questions it aims to answer were:

* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?
* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?

Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55 years old.
* Chronic (at least six months) low back pain (LBP) and/or sciatica.
* Abnormalities of intervertebral disc on magnetic resonance imaging (MRI).

Exclusion Criteria:

* Patients with prior spine surgery.
* Vertebral instability.
* Cancer.
* Current infectious disease.
* Pregnancy.
* Kinesiophobia.
* Fibromyalgia.

Primary outcomes:
measure: Self-reported disability
timeFrame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
measure: Pain intensity
timeFrame: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Hospital Civil de Guadalajara
name: Tonatiuh Avila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06128850: Peri-implant Conditions Mimic Periodontal Conditions
Official title: Examining Peri-İmplant and Periodontal Conditions Co-occur: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Peri-implant Mucositis
Peri-implant Health
Periodontitis
Gingivitis
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.

Brief summary: Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. In all implant patients, the health scale ranged from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth depth, loss of clinical attachment, and dental implants. The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.

Inclusion Criteria:

* Patients between the ages of 18- 70
* Drugs that have a systemically healthy and controlled treatment situation
* Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading Among these groups, it was checked whether periodontitis was seen in patients with peri-implantitis, gingivitis in patients with peri-implant mucositis, and whether healthy gums were seen in individuals with peri-implant health.

To determine the health and disease status of individuals' implants, plaque index (Silness Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket depth measurements, and clinical attachment level were collected.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18- 70
* Drugs that have a systemically healthy and controlled treatment situation
* Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading

Exclusion Criteria:

* Bruxism
* Uncontrolled medical conditions

Primary outcomes:
measure: Plaque index
timeFrame: Baseline
measure: Gingival index
timeFrame: Baseline
measure: Bleeding on probing
timeFrame: Baseline
Secondary outcomes:
measure: Periodontal pocket depth
timeFrame: Baseline
measure: Clinical attachment level
timeFrame: Baseline
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University
Study officials:
References:
Clinical trial NCT00206050: Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po
Official title: A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of the 24-Hour Intragastric pH Profile After 5 Days of Once Daily Oral Administration of Either Esomeprazole 40 mg or Pantoprazole 40 mg Following Once Daily Infusion of Intravenous Pantoprazole 40 mg for 5 Days in Healthy Volunteer Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent.
* Males and females aged 18 to 70 years, inclusive.
* Male or non-pregnant, nonlactating female healthy volunteer subjects. Females must be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
* Previous enrollment or randomization of treatment in the present study.
* Received an experimental drug or used an experimental device within 28 days preceeding the screening visit.

Primary outcomes:
measure: The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.
Secondary outcomes:
measure: The percent time of intragastric pH>4.0 on oral dosing Day 1 and the mean hourly cumulative IGA during the 24-hour intragastric pH monitoring periods (on oral dosing Days 1 and 5.
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
Study officials:
References:
Clinical trial NCT03721250: Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
Official title: Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia, Postoperative
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing thoracotomy

Brief summary: Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy


Eligibility criteria: Inclusion Criteria:

lung cancer

Exclusion Criteria:

patient refusal bleeding diathesisi emergency cases

-

Primary outcomes:
measure: verbal analog score
timeFrame: postoperative 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
Clinical trial NCT04676750: MBSR for Work Active Seniors
Official title: Mindfulness-baseret Forebyggelse og Sundhedsfremme i Den Sidste Del af Arbejdslivet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Promotion and Stress Prevention
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2020-12-21
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Testing Mindfulness-based Stress Reduction (MBSR) in 60-65 year old senior employees.

Detailed description: Outcome measures: HRV, blood pressure, weight, structural and functional brain scans, questionnaire

Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* psychosis

Primary outcomes:
measure: self-perceived stress
timeFrame: 2 years
Secondary outcomes:
measure: Heart rate variability
timeFrame: 2 years
measure: blood pressure
timeFrame: 2 years
measure: weight
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dansk Center for Mindfulness
state: Brabrand
Study officials:
References: