louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01527318: The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)
Official title: The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neutral Lipid Storage Disease
Keywords: NLSDM
Lipid accumulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to cardiac failure. Not much is known about the underlying mechanisms, though recently it was discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased mitochondrial function, lipid accumulation and cardiac failure resulting in death at young age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced mortality rates in these mice. These findings may have a major impact for patients with NLSDM if these results can be translated to humans. Therefore, the investigators would like to evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac function in patients with NLSDM.

Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements will be performed prior to the study and after treatment. Cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity will be assessed during these baseline measurements.


Eligibility criteria: Inclusion Criteria:

* suffering from NLSDM

Primary outcomes:
measure: mitochondrial function
timeFrame: 28 weeks
measure: lipid accumulation
timeFrame: 28 weeks
measure: Cardiac function
timeFrame: 28 weeks
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
citation: Haemmerle G, Moustafa T, Woelkart G, Buttner S, Schmidt A, van de Weijer T, Hesselink M, Jaeger D, Kienesberger PC, Zierler K, Schreiber R, Eichmann T, Kolb D, Kotzbeck P, Schweiger M, Kumari M, Eder S, Schoiswohl G, Wongsiriroj N, Pollak NM, Radner FP, Preiss-Landl K, Kolbe T, Rulicke T, Pieske B, Trauner M, Lass A, Zimmermann R, Hoefler G, Cinti S, Kershaw EE, Schrauwen P, Madeo F, Mayer B, Zechner R. ATGL-mediated fat catabolism regulates cardiac mitochondrial function via PPAR-alpha and PGC-1. Nat Med. 2011 Aug 21;17(9):1076-85. doi: 10.1038/nm.2439.
Clinical trial NCT00840918: Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
Official title: The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardiac surgery
Lidocaine
Quality of life
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

Detailed description: Subjects undergoing cardiac surgery are randomized into one of two groups.

* Group 1: Intravenous Lidocaine Group
* Group 2: Intravenous placebo Group

Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.

Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18-90 years old
* Scheduled for cardiac surgery requiring cardiopulmonary bypass
* Written informed consent

Exclusion Criteria:

* Off-pump surgical procedures
* Anticipated deep hypothermic circulatory arrest
* Any contraindications to the proposed interventions including lidocaine allergy
* History of preoperative atrial fibrillation
* Baseline Screening revealing preexisting dementia or delirium
* Preoperative liver failure defined as Child-Pugh Score \> 6

Primary outcomes:
measure: atrial fibrillation
timeFrame: postoperatively
measure: mortality
timeFrame: 30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: SAL Hospital
state: Gujarat
Study officials:
affiliation: The Cleveland Clinic
name: Martin Grady, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06129318: :Effects of Pharmaceutical Care in Stroke Patients
Official title: Investigation of the Effects of Pharmaceutical Care Provided by a Clinical Pharmacist on Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the effects of the 1-year pharmaceutical care program offered by the clinical pharmacist to the patients admitted to the neurology service with the diagnosis of stroke, on medication adherence, quality of life, and clinical outcomes of the patients.

Detailed description: The study was conducted as a parallel randomized controlled study in the Neurology Clinic of a University Hospital in Turkey. Patients were randomly assigned to intervention and usual care groups. While the patients in the usual care group are given routine health services by the neurologist during their hospitalization and for 1 year after discharge; In addition to these routine services, the intervention group was provided with pharmaceutical care by a clinical pharmacist during the same period. The study was always conducted by the same neurologist and clinical pharmacist. Patient medication adherence, quality of life, and clinical parameters were evaluated at the beginning of the study and at the 12th month.

Eligibility criteria: Inclusion Criteria:

* being diagnosed with stroke,
* being 18 years old or older,
* being in the cognition to receive the training to be given

Exclusion Criteria:

* Not having adequate cognitive function such as dementia,
* being pregnant, lactating,
* having cancer.

Primary outcomes:
measure: Blood pressure
timeFrame: 1, 3, 6, 9 and 12 months
measure: Medication Adherence
timeFrame: 3, 6, 9 and 12 months
measure: HbA1c
timeFrame: 1, 3, 6, 9 and 12 months
measure: LDL cholesterol
timeFrame: 1, 3, 6, 9 and 12 months
measure: Triglyceride
timeFrame: 1, 3, 6, 9 and 12 months
measure: Body mass index
timeFrame: 1, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Measuring Quality of Life
timeFrame: 3, 6 and 12 months
measure: The National Institutes of Health Stroke Scale
timeFrame: 24 hours before discharge, 3, 6, 9 and 12 months
measure: Stroke Recurrence
timeFrame: 1 year
measure: Drug Related Problem
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
Study officials:
References:
Clinical trial NCT06680518: Tourniquet Use in Hallux Valgus Surgery
Official title: Prospective, Randomized Study of Tourniquet Use in Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Keywords: hallux valgus
tourniquet
Lead sponsor: Clinique Saint Jean, France
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patient will be his or her own control, with one foot operated with a tourniquet and the other without.

Once the patient has been included, the surgeon will open the randomization envelope to determine which foot will receive the tourniquet. He will operate on the left foot first.
Primary purpose: OTHER

Brief summary: Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 who has been informed and has signed the consent form
* Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides.
* Surgery planned on the same day for both feet

Exclusion Criteria:

* Arthritic hallux valgus requiring arthrodesis
* Inflammatory pathology (rheumatoid arthritis, etc.)

Primary outcomes:
measure: Average pain in the first week after surgery
timeFrame: first week after surgery
Secondary outcomes:
measure: Edema
timeFrame: Day 10 after surgery
measure: Complications
timeFrame: first week after surgery
Other outcomes:
Locations:
city: Saint Jean de Vedas
country: France
facility: Clinique St Jean Sud de France
Study officials:
References:
Clinical trial NCT02170818: Improving Faculty's Ability to Speak Up to Others in the Operating Room
Official title: Improving Faculty's Ability to Speak Up to Others in the Operating Room: A Simulation Based Randomized Controlled Trial of an Educational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faculty, Medical
Keywords: Education
Curriculum
Anesthesiology
Operating Rooms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Anesthesia Patient Safety Foundation
First posted: 2014-06-23
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions of others within the team can have direct, immediate, and preventive effect on adverse outcomes. However, little is known about the hurdles and enablers of this behavior in healthcare, especially within the operating room setting.

Objective

1. Determine if an educational workshop would improve speaking-up behaviors of practicing anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the self-reported hurdles and enablers for speaking-up in those situations encountered.

Design Randomized controlled experiment of an educational workshop intervention on communication behaviors in a simulated case. Qualitative analysis of debriefing conversations following the simulated case.

Setting Established academic simulation center

Participants Seventy-one practicing anesthesiologists from four academic medical centers and one community hospital

Intervention Fifty minute educational workshop on speaking-up that included rationale, conversational techniques, a rubric for speaking-up, and role-play.

Detailed description: Main Outcomes and Measures

1. Observed communication in a simulated case that included a surgeon falling asleep during surgery, inappropriate activation of a speakerphone by a nurse, and an incorrect treatment order by a colleague in response to a venous air embolism. 2. Transcribed conversation during a structured debriefing, analyzed for hurdles and enablers.

Eligibility criteria: Inclusion Criteria:

* Attending Anesthesiologist

Exclusion Criteria:

* Prior exposure to test case

Primary outcomes:
measure: Speaking-Up Behavior
timeFrame: Immediate
Secondary outcomes:
measure: Speaking-up Behaviors
timeFrame: Immediate
measure: Self-reported hurdles and enablers of speaking-up
timeFrame: 1 hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel B Raemer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847418: Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Official title: Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: pharmacokinetics
ketamine
Anesthetics, Dissociative
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-02-19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.


Eligibility criteria: Inclusion Criteria:

* male
* age ≥18 years ≤ 45 years
* healthy
* non-smoking
* BMI 18-27

Exclusion Criteria:

* abuse of drugs
* known or supposed hypersensitivity and/or contraindication against ketamine or additives
* participation of another clinical study within the last 30 days
* chronic obstructed nose breathing or nasal polyps
* dug allergy
* blood donation within the last two months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Research Center, University Hospital Basel
state: BS
Study officials:
affiliation: Clinical Pharmacology and Toxicology, University Hospital Basel
name: Manuel Haschke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000318: Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1
Official title: Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 1999-09-21
Enrollment: 202
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Opioid and cocaine use
timeFrame: 26 weeks
measure: Social and psychological functioning
timeFrame: 26 weeks
measure: AIDS risk behavior
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02476318: A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Official title: A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Disease
Lead sponsor: Tenaxis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 32
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: A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.


Eligibility criteria: Inclusion Criteria:

1. The subject must be ≥ 18 years old
2. The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
4. The subject is willing and able to be contacted for minimum of 6 weeks follow up.
5. The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.

Exclusion Criteria:

1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
3. The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
4. ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.

Primary outcomes:
measure: Number of anastomoses with immediate sealing of the suture line
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Krankenhaus Dresden Friedrichstadt
city: Koln
country: Germany
facility: Klinikum der Universitat zu Koln
city: Ulm
country: Germany
facility: Chirugische Uni Klinikum
Study officials:
affiliation: Krankenhaus Dresden Friedrichstadt Dresden, Germany
name: Hans J Florek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541018: Different Treatments With the TRV Reposition Chair
Official title: Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: TRV Reposition Chair
Epley Maneuvre
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 100
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: To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.

Detailed description: Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years of age
* Medical history compatible with BPPV
* Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

Exclusion Criteria:

* Former treatment with a repositional Chair
* Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair

Primary outcomes:
measure: Evaluation by VNG Measurements
timeFrame: 2 years
measure: Subjective vertigo
timeFrame: 2 years
Secondary outcomes:
measure: Dizziness Handicap Inventory (DHI) questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology, Head & Neck Surgery and Audiology
state: North Denmark Region
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Dan D Hougaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06024018: Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
Official title: Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss

Detailed description: sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months

Eligibility criteria: Inclusion Criteria:

* men with central obesity
* BMI 30-34.9 kg/m2

Exclusion Criteria:

* metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses

Primary outcomes:
measure: subcutaenous abdominal fat thickness
timeFrame: 12 weeks
Secondary outcomes:
measure: visceral abdominal fat thickness
timeFrame: 12 weeks
measure: body mass index
timeFrame: 12 weeks
measure: waist circumference
timeFrame: 12 weeks
measure: cortisol
timeFrame: 12 weeks
measure: high density lipoprotein
timeFrame: 12 weeks
measure: low density lipoprotein
timeFrame: 12 weeks
measure: triglycerides
timeFrame: 12 weeks
measure: cholesterol
timeFrame: 12 weeks
measure: appearance of abdomen subscale of Body Q questionnaire
timeFrame: 12 weeks
measure: health related-quality-of-life subscale of Body Q questionnaire
timeFrame: 12 weeks
measure: eating related concerns subscale of Body Q questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: STUDY_DIRECTOR
References: