louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00371332: Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Keywords: chronic periodontitis, mouth
Moderate to advanced chronic periodontitis
Lead sponsor: OraPharma
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 128
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease


Eligibility criteria: Inclusion Criteria:

* Generalized moderate to advanced chronic periodontitis, five sites with probing depths of \>5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants

Exclusion Criteria:

* Allergy to tetracycline
* Subjects with aggressive periodontitis
* Acute necrotizing ulcerative gingivitis, or gross decay
* Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
* Individuals requiring prophylactic antibiotics
* Any periodontal therapy within the previous 3 months (excluding maintenance therapy)
* Systemic or local antibiotic therapy within three months

Primary outcomes:
measure: The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary outcomes:
measure: Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Buffalo
country: United States
state: New York
city: Memphis
country: United States
state: Tennessee
Study officials:
References:
Clinical trial NCT01861132: Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women
Official title: Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Changes in Pregnancy
Keywords: Pregnancy, cesarean delivery, blood pressure, cardiac output
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy singleton pregnancies at term scheduled for cesarean delivery under spinal anesthesia

Brief summary: Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.

Detailed description: Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion Criteria:

* Twins, or multiple gestation, pre-eclampsia, gestational hypertension
* Reynaud phenomenon

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 15 minutes
Secondary outcomes:
measure: Cardiac output
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Omenas IN, Tronstad C, Rosseland LA. Accuracy and trending abilities of finger plethysmographic blood pressure and cardiac output compared to invasive measurements during caesarean delivery in healthy women: an observational study. BMC Anesthesiol. 2020 Jun 27;20(1):157. doi: 10.1186/s12871-020-01078-8.
Clinical trial NCT02173132: Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Work Stress
Work Ability
Work Performance
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 94
Sex: ALL
Minimum age (years): 33
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.


Eligibility criteria: Inclusion Criteria:

* overt hepatic encephalopathy (HE) or a history of overt HE

Exclusion Criteria:

* history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Primary outcomes:
measure: work stress
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
Study officials:
References:
Clinical trial NCT00246532: Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Official title: Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Opioid-induced Hyperalgesia
Lead sponsor: National Institute of General Medical Sciences (NIGMS)
Sponsor class: NIH
First posted: 2005-10-30
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.


Eligibility criteria: Inclusion Criteria:

* opioid naïve (or less than 4 vicodin equiv/day)
* 18-70 years old
* candidate for opioid therapy for nonmalignant pain.

Exclusion Criteria:

* history of substance abuse or severe psychiatric disease
* use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
* neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy

Primary outcomes:
measure: Pain Tolerance
timeFrame: 1 month
measure: Pain Threshold
timeFrame: 1 month
Secondary outcomes:
measure: Opioid Titration
timeFrame: 1 month
measure: Pain Intensity
timeFrame: 1 month
measure: Roland-Morris Disability Index
timeFrame: 1 month
measure: Beck Depression Inventory
timeFrame: 1 month
measure: Follow-Up Survey
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Lawrence F Chu, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184132: The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.
Official title: The Effects of Different Interior Decorations in a Psychiatric Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Intensive care units
Emergency services, psychiatric
Interior Design and Furnishings
Intensive Care
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: County of South Trøndelag
First posted: 2005-09-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare effects of treatment of patients acutely admitted to a Psychiatric Intensive Care Unit (PICU) with either a sparsely decorated interior or interior decorations like an ordinary, Norwegian home.

Detailed description: The PICU in Østmarka psychiatric department, St. Olavs Hospital contains 2 identical parts. Each part contains 2 beds. The PICU had a traditional sparsely decorated interior. In cooperation with architects and the county building authorities one of the parts were redecorated to an interior like an ordinary Norwegian home. All patients admitted the the PICU were semi-randomized to either traditional or "Norwegian home" interior decorations. Symptoms, behaviour, and treatment were evaluated at admittance, day 3 and discharge from the PICU

Eligibility criteria: Inclusion Criteria:

* All patients acutely admitted to the PICU, St. Olavs Hospital, Østmarka dep.

Exclusion Criteria:

* Patients with dementia or mental retardation to an extensive degree.
* Patients not speaking Norwegian or English

Primary outcomes:
measure: Length of stay in days
timeFrame: 1 month
measure: Scores on general psychiatric rating scale
timeFrame: 3 days
measure: Scores on violent or threatening incidents
timeFrame: 3 days
Secondary outcomes:
measure: Therapeutic steps daily
timeFrame: 3 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Olav M Linaker, Professor
role: STUDY_CHAIR
References:
citation: Vaaler AE, Morken G, Linaker OM. Effects of different interior decorations in the seclusion area of a psychiatric acute ward. Nord J Psychiatry. 2005;59(1):19-24. doi: 10.1080/08039480510018887.
citation: Vaaler AE, Iversen VC, Morken G, Flovig JC, Palmstierna T, Linaker OM. Short-term prediction of threatening and violent behaviour in an Acute Psychiatric Intensive Care Unit based on patient and environment characteristics. BMC Psychiatry. 2011 Mar 18;11:44. doi: 10.1186/1471-244X-11-44.
citation: Flovig JC, Vaaler AE, Morken G. Effects of legal and illegal use of benzodiazepines at acute admission to a psychiatric acute department. BMC Res Notes. 2010 Oct 19;3:263. doi: 10.1186/1756-0500-3-263.
Clinical trial NCT06888232: Safety and Efficacy of Immunomodulator Drug Thalidomide in Multi-transfused Thalassemia Patients
Official title: Safety and Efficacy of Immunomodulator Drug Thalidomide in Multi-transfused Thalassemia Patients: A Single Center Experience From South Punjab, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalassemia
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 121
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the safety and efficacy of thalidomide in multi-transfused thalassemic children.

Detailed description: Given the significant burden of transfusion dependency, an effective and safe inducer is needed that could improve quality of life and reduce the healthcare costs associated with frequent transfusions and iron chelation therapy. If this study could establish the safety of thalidomide in terms of teratogenicity along with its efficacy, it would be a great support to multi-transfused thalassemic children.

Eligibility criteria: Inclusion Criteria:

* Children of both genders
* Aged 2-5 years
* With transfusion-dependent thalassemia (TDT)
* Whose parents/guardians showed willingness to adhere to follow-up visits

Exclusion Criteria:

* Children with uncontrolled infections
* Significant hepatic or renal dysfunction
* Malignancy
* Known contraindications to thalidomide

Primary outcomes:
measure: Efficacy of treatment
timeFrame: 6 months
measure: Safety of treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: The Children's Hospital & Institute of Child Health
state: Punjab
Study officials:
affiliation: Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
name: Muhammad Aslam, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
name: Sara Rubab, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215332: CHARITE™ vs. ALIF 5-Year Follow-up
Official title: Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: arthroplasty
lumbar
disc
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 367
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).

Detailed description: This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.

This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.

Eligibility criteria: Inclusion Criteria:

* Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
* Still have the original implant they received in their index surgery.

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall Success
timeFrame: 5 Years
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: 5 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charite Site 13
state: California
city: Golden
country: United States
facility: Charite Site 06
state: Colorado
city: Chicago
country: United States
facility: Charite Site 11
state: Illinois
city: Louisville
country: United States
facility: Charite Site 03
state: Kentucky
city: Towson
country: United States
facility: Charite Site 02
state: Maryland
city: Boston
country: United States
facility: Charite Site 15
state: Massachusetts
city: Lockport
country: United States
facility: Charite Site 14
state: New York
city: New York
country: United States
facility: Charite Site 10
state: New York
city: Columbus
country: United States
facility: Charite Site 07
state: Ohio
city: Plano
country: United States
facility: Charite Site 01
state: Texas
Study officials:
affiliation: DePuy Spine
name: Daniel H Stoutenburgh
role: STUDY_DIRECTOR
References:
Clinical trial NCT06740032: Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise
Official title: Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise on the Autonomic Nervous System Activity and Biomechanical Properties of the Muscle in Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Stimulations
Keywords: Auricular vagus nerve stimulation
deep breathing exercises
Lead sponsor: Istanbul Gelisim University
Sponsor class: OTHER
Collaborators: name: Bahçeşehir University
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.

Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.


Eligibility criteria: Inclusion Criteria:

* could read and write Turkish

Exclusion Criteria:

* being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation

Primary outcomes:
measure: HRV results
timeFrame: 5 minutes
measure: Muscle Natural Oscillation Frequency
timeFrame: 5 minutes
measure: Muscle Dynamic Stiffness [N/m]
timeFrame: 5 minutes
measure: Mechanical Stress Relaxation Time [ms]
timeFrame: 5 minutes
Secondary outcomes:
measure: Perceived stress scale
timeFrame: 5 minutes
measure: Pulse rate
timeFrame: 5 minutes
measure: blood pressure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Gelisim University
state: Avcılar
Study officials:
References:
Clinical trial NCT06101732: LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
Official title: Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Keywords: lipodelling
breast reconstruction
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap)

Brief summary: The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.


Eligibility criteria: Inclusion Criteria:

* Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.

Patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.

Exclusion Criteria:

* Patient under 18 at first consultation
* Opposition of the patient to the collection of her data

Primary outcomes:
measure: number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap
timeFrame: Between october 2017 and 2022
Secondary outcomes:
measure: description of patients' age
timeFrame: at inclusion
measure: description of patients' Body Mass Index
timeFrame: at inclusion
measure: description of patients' menopause status
timeFrame: at the time of data collection
measure: description of patients' smoking status
timeFrame: at inclusion
measure: description of patients' diabetes or other medical condition
timeFrame: at inclusion
measure: description of patients' relevant medical history
timeFrame: at inclusion
measure: description of patients' History of breast surgery
timeFrame: at inclusion
measure: description of patients' type of cancer
timeFrame: at inclusion
measure: description of patients' type of surgical treatment
timeFrame: at inclusion
measure: description of patients' Type of treatment associated with surgery
timeFrame: at inclusion
measure: description of Time elapsed between mastectomy and reconstruction
timeFrame: at inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de besancon
Study officials:
References:
Clinical trial NCT02119832: A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
Official title: A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease (CKD)
Keywords: Chronic kidney disease
Arteriovenous fistula
Hemodialysis
Vascular access
Lead sponsor: TVA Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
* Written informed consent obtained

Primary outcomes:
measure: Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Access Functionality
timeFrame: 6 months
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Italian Hospital
Study officials:
affiliation: Italian Hosptial, Asuncion, Paraguay
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: