louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00761839: Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?
Official title: Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wounds
Keywords: wound healing
self-management
patient education
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-09-30
Enrollment: 0
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: The purpose of this research study is to evaluate a patient education program for chronic wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound self-management "after-care summary" with approximately half of her patients. This study will examine whether using this patient education tool for self-management of wound care results in improved patient outcomes.


Eligibility criteria: Inclusion Criteria:

All patients presenting for outpatient wound care at the Ann Arbor VA Medical Center NP wound care clinic, who meet the following inclusion criteria for chronic wounds: stage II, III, IV pressure ulcers; venous stasis ulcers, and diabetic ulcers.

Exclusion Criteria:

Cognitively impaired patients who cannot give informed consent.

Primary outcomes:
measure: patient satisfaction, frequency of self-management activities, time to healing
timeFrame: Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Julie C Lowery, PhD MHSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526539: Is There Increased Polyethylene Wear and Increased Periprosthetic Bone Loss in Femur in Reverse Hybrid Technique Compared With Conventional Cemented Technique in Total Hip Replacement?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: THR
reversed hybrid
wear
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-09-10
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Total hip replacement is a very cost effective procedure to enhance life quality in a group of patients. In the period 2000-2004 7-8000 procedures were preformed, 13% were revisions (1). Historically, many different principles have been used from the first resurfacings to cemented and uncemented total hip replacements as we know them today. In 2000, 28 different femoral stems and 26 different acetabular components were in regular use in Norway. There are several well-documented cemented acetabular components, but no such uncemented cup. On the femoral side there are several well-documented stems both cemented and uncemented. (2).

From the late 1990's a reverse hybrid (uncemented stem and cemented cup) is being more frequently used. In 2004 a total of 276 reverse hybrid hips were done and the trend is increasing. (1). This technique is solely based on experience and the fact that one combines the better of two principles (cemented and uncemented). There is no scientific evidence that this technique is as good or better than a cemented THR.

One of the potential problems with hydroxyapatite coated components is that it is suspected that it may increase wear due to the particle theory. (3,4). There are no prospective randomised controlled RSA and DXA studies that conclude on this matter. This is such a study and our hypothesis is that there is no difference in wear or osteolysis between the methods.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis
* Indication for THR

Exclusion Criteria:

* Significant anatomical abnormalities
* Rheumatoid artheritis, dysplasia, fracture sequela

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ullevål University Hospital, N-0407 Oslo
name: Lars Nordsletten, professor, MD, Ph.D
role: STUDY_CHAIR
affiliation: Lovisenberg Hospital, N- 0440 Oslo
name: Einar Lindalen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05639439: Comparative Evaluation of Periglottic Airway Devices With Performed Shape
Official title: Comparative Evaluation of Periglottic Airway Devices With Performed Shape
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Management
Keywords: ventilation
airway management
periglottic airway device
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
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 four, most popular periglottic airway devices as regards to ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

Detailed description: After being informed about the study and potential risks, all patients (\>18 years old scheduled for elective surgery under general anesthesia) giving written informed consent will undergo preoperative screening examination to determine eligibility for study entry. A randomization process has been previously done, according to which the participants have been classified into one of the four groups of the study. Each study group is scheduled to receive one of the four periglottic devices (LM FastrachTM, LM ProsealTM, LM I-GelTM, LM ProtectorTM) while evaluating the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old, undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Patients \< 18 years old
* Patients undergoing emergency surgery or trauma patients
* Obstetric population
* Patients receiving regional anesthesia
* Patients to whom the use of periglottic airway device is contraindicated
* Patients with RODS score ≥ 1 (score to predict difficult laryngeal mask placement 1-4)
* Patients with anticipated difficult airway, planned for awake intubation
* Patients' refusal to participate in the trial

Primary outcomes:
measure: Ventilation sufficiency
timeFrame: Up to study completion, an average of 2 years
measure: Time required for successful periglottic airway device placement
timeFrame: Up to study completion, an average of 2 years
measure: Perfection of installation/ anatomical application to the larynx
timeFrame: Up to study completion, an average of 2 years
Secondary outcomes:
measure: Leak pressure
timeFrame: Up to study completion, an average of 2 years
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Ahaia
Study officials:
affiliation: University Hospital of Patras
name: Evanthia Dimitriou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00451139: Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Jimma University
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2007-03-23
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Detailed description: Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.

Eligibility criteria: Inclusion Criteria:

* Patients aged above 5 years
* Uncomplicated falciparum malaria
* Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
* Ability to tolerate oral therapy
* Informed consent by the patient or by parent/guardian for children
* Residence in study area

Exclusion Criteria:

* Known or suspected hearing deficits
* Adequate anti-malarial treatment within the previous 7 days
* Mixed infection
* Danger signs and signs of severe malaria as defined by the WHO
* Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response
* History of allergy or intolerance against study medications
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University Hospital
Study officials:
affiliation: Facuty of Medical Sciences Jimma University
name: Nebreed Fesseaha, MD, Dean
role: STUDY_CHAIR
References:
Clinical trial NCT06359639: Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults
Official title: Randomised Controlled Trial of Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breakup Distress
Posttraumatic Growth
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling.


Eligibility criteria: Inclusion Criteria:

* Malaysian young adults.
* Proficient in English.
* Basic technological skill and resources.
* Reported ongoing distress due to a breakup that occurred within the past 6 months.
* Current single relationship status.

Exclusion Criteria:

* Consumption of psychiatric medications within past 8 weeks.
* Currently receiving other psychological interventions.
* Presence of significant psychotic or manic symptoms.
* Severe suicide risk.

Primary outcomes:
measure: Breakup distress
timeFrame: BDS will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
measure: Posttraumatic growth
timeFrame: PTGI will be administered: 1) before the start of intervention sessions, 2) after 5 weeks of intervention sessions, and 3) 1 month after the participant's 5th (final) intervention session.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06086639: A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
Official title: A PILOT TRIAL OF A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders
Child Behavior Problem
Feeding Behavior
Online Intervention
Occupational Therapy
Keywords: feeding and eating disorders
mother-child relations
online group intervention
occupational therapy
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Feeding problems such as selective eating, loss of appetite, and mealtime behavior problems are common in childhood. Parents play a primary role in learning about feeding, and difficulties experienced in this process may cause the parent to experience stress, despair and exhibit incorrect attitudes. The aim of this study is to examine the effect of online occupational therapy group training for mothers on mothers' attitudes and stress levels, and children's eating behaviors. Mothers of children aged 3-6 years with feeding problems (n=29) were randomly divided into groups. Early Childhood Adaptive Eating Behavior Scale, Feeding Process Mother Attitudes Scale and State-Trait Anxiety Inventory scales were used for evaluation. The mothers in the research group participated in the 4-week training. As a result of the research, positive effects were found on mothers' attitudes and children's eating behaviors (p\<0.05). There was no change in mothers' state and trait anxiety levels (p\>0.05). This study shows that online group training to mothers can support existing therapies and guides clinicians working in the field.


Eligibility criteria: Inclusion Criteria:

* Being a mother with a child between 37-72 months of age,
* Experiencing feeding problems with their child,
* Having the ability to understand the training and comprehend the scale items,
* Volunteering to participate,
* Having the competence to use online platforms, tools, and the internet connection.

Exclusion Criteria:

* Receiving special education and/or occupational therapy sessions due to any risk,
* Having any chronic disease or disability in their child.

Primary outcomes:
measure: Early Childhood Adaptive Eating Behavior Scale
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Feeding Process Mother Attitudes Scale
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
state: Ankara/ Altındağ
Study officials:
References:
Clinical trial NCT03854539: Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation
Official title: Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Condition Salivary Alpha Amylase
Lead sponsor: Arkansas Tech University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.

Detailed description: The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* NA

Primary outcomes:
measure: Change in Salivary Alpha Amylase concentration.
timeFrame: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation
Secondary outcomes:
measure: Change in Heart Rate Variability.
timeFrame: Within single one hour session change in heart rate variability immediately prior to and following stimulation period.
Other outcomes:
Locations:
city: Russellville
country: United States
facility: Arkansas Tech University
state: Arkansas
Study officials:
References:
Clinical trial NCT04959539: Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Official title: Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesteatoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the main objective of the study is to compare endoscopic transcanal tympanoplasty with attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of limited attic cholesteatoma.


Eligibility criteria: Inclusion Criteria:

* Cases of cholesteatoma limited to the middle ear and/or attic but not extending beyond the posterior end of the lateral semicircular canal (LSCC) proved radiologically with computed tomography (CT) scan

Exclusion Criteria:

* Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach

Primary outcomes:
measure: eradication of attic cholesteatoma
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
state: ElDakahlia
Study officials:
References:
citation: Moneir W, Hemdan A, El-Kholy NA, El-Kotb M, El-Okda M. Endoscopic transcanal attico-antrostomy versus endoscopic-assisted canal wall up mastoidectomy in management of localized cholesteatoma: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4371-4378. doi: 10.1007/s00405-021-07200-x. Epub 2021 Dec 1.
Clinical trial NCT01717339: Sleep Apnea and Vascular Function
Official title: Sleep Apnea and Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part of these studies we will look at NO signaling pathways in adipose tissue and microvessels from normal and OSA subjects.


Eligibility criteria: Inclusion Criteria:

* Non OSA, and newly diagnosed OSA subjects, naïve to CPAP treatment, aged 18-65 years, with BMI less than or equal to 55 kg/m2, who are free of all chronic diseases including diabetes, and cardiovascular diseases, will be recruited for our study. Subjects with dyslipidemia and hypertension will be allowed to participate in the study. Subjects taking anti-depressents, and anithypertensives will be allowed to participate in the study. Also, subjects taking beta blockers and beta agonists will be allowed to participate in the study.

If a subject is on aspirin or any other anti-inflammatory medication but free of known vascular disease and depending on the indication, the study doctor may ask the subject to suspend aspirin or anti-inflammatory therapy for 7 days prior to participation in the study. In the event that the subjects does not stop the aspirin or other anti-inflammatory medication, they will not be able to participate in the study because of the risk of bleeding during the fat biopsy.

Exclusion Criteria:

* Body weight \>450 pounds (204.5kg)
* Pregnancy.
* Anemic (hemoglobin \<13.5 g/dL for men and \<12.0 g/dL for women.
* Postmenopausal
* Smoking
* Use of chronic Medications (aspirin, statins, anti-inflammatory drugs)

Primary outcomes:
measure: Change in Brachial artery diameter in response to hyperemia.
timeFrame: Baseline and 15 min after hyperemia
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend K Somers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: