louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02089516: Activity Monitoring in Frail Elderly Patients
Official title: Activity Monitoring in Frail Elderly Patients. A Methods Comparison Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Keywords: Frailty
Accelerometry
Physical activity
validity
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Home-dwelling frail elderly (GFI score ≥ 4) of 75 years and older.

Brief summary: The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod in measuring movement / physical activity in frail elderly.

Detailed description: Elderly subjects will be recruited from a residential-care complex in Zwolle, the Netherlands. All subjects will be asked to fill in the Groningen Frailty Index. We aim to select patients with varying GFI scores to ensure that we include patients with different degrees of frailty. The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. The participant will be instructed to act like it is a normal/usual day. Every 5 minutes the type of activity at that moment and movement intensity of the last 5 minutes (METs scale) is manually entered onto a case report form (CRF) by the two employees. The timing has to be exact in order to compare the data to the data of the DynaPort MicroMod. Type of activity is described as well as categorised into lying, sitting, standing or walking. Movement intensity is categorised according to a MET-value (Metabolic Equivalent of Task).

Sensitivity, specificity, and percentage of overall agreement will be calculated for each type of activity (standing, sitting, lying, walking) and for intensity. The primary analysis will be the comparison between walking and not walking (lying, sitting or standing). An overall agreement/sensitivity/specificity of 90% or higher is considered as sufficient agreement. The Bland and Altman method will also be used as multiple observations are recorded per patient, the limits of agreement will also be calculated with the Bland and Altman method for repeated measures.

Eligibility criteria: Inclusion Criteria:

* Age: 75 years and older
* Frailty: GFI (Groningen Frailty Index) score ≥ 4

Exclusion Criteria:

* Living in a nursing-home

Primary outcomes:
measure: Type of movement: lying, sitting/standing or walking
timeFrame: up to six hours
Secondary outcomes:
measure: Movement intensity (METs)
timeFrame: up to six hours
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Woonzorgcentrum De Wissel
state: Overijssel
city: Zwolle
country: Netherlands
facility: Woonzorgcentrum Westenhage
state: Overijssel
Study officials:
affiliation: Isala, diabetes centre
name: Kornelis van Hateren, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004316: Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Interstitial Cystitis
Vulvar Diseases
Keywords: interstitial cystitis
rare disease
renal and genitourinary disorders
vulvar vestibulitis
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 1999-10-19
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis.

II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis.

III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin.

IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies.

The first group is treated with capsaicin. A second group is given individually titrated doses of capsaicin: the dose is increased as tolerated or until symptomatic response is acceptable. A control group receives a placebo. Therapy for all groups is administered intravesically every week for 5 weeks.

Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies. One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks. The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule. The control group applies a placebo.

Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Women with interstitial cystitis by National Institute of Diabetes and Digestive and Kidney Diseases criteria Vulvar vestibulitis by International Society for the Study of Vulvar Disease, i.e.: Severe pain on touch or attempted entry of vagina Tenderness to pressure within the vulvar vestibule Vulvar erythema Duration of symptoms at least 6 months Absence of vulvovaginal infection, i.e.: No fungus No trichomonas No chlamydia No gonorrhea No "clue cells" in vaginal discharge

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittspurgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Hugh Flood
role: STUDY_CHAIR
References:
Clinical trial NCT03877016: Pilot Study in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
Official title: Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: neuropathic pain
electrical nerve stimulation therapy
patient report outcomes
non-pharmalogical treatment
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.

The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Adult
* Patient covered by national health insurance
* Patient able to express consent
* Patient with neuropathic pain with DN4 (Douleur Neuropathique 4 Questions) \> or = 4/10.
* Actual or potential neurologic lesion
* Patient still using a TENS device

Exclusion Criteria:

* Planned surgery in the next two months
* Modification of the reatment in the next two motnhs
* Other study ongoing for the patient
* Medical contraindication for TENS

Primary outcomes:
measure: Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
timeFrame: day7 after patient inclusion
measure: Disconfort of using TENS (Electrical Nerve Stimulation Therapy) Eco2 versus actiTENS
timeFrame: day 35 after patient inclusion
Secondary outcomes:
measure: length of TENS daily use
timeFrame: day7 after patient inclusion
measure: length of TENS daily use
timeFrame: day 35 after patient inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: La Roche-sur-Yon
country: France
facility: CHD La Roche Sur Yon
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: APHP - Hopital Saint Antoine
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU Amiens
name: Eric SERRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628016: The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms
Official title: A Randomized, Double-blind, Placebo-Controlled Evaluation of the Efficacy of Attentional Bias Modification Training in the Treatment of Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
attention
training
modification
Lead sponsor: Hunan Normal University
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 77
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether attention bias modification training is an effective neurobehavioral therapy to improve depressive symptoms.That is whether attention bias modification training is superior to placebo in reducing depressive symptoms over 1 year after training.

Detailed description: Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Eligibility criteria: Inclusion Criteria:

* A score of 14 or higher on the Beck Depression Inventory-II

Exclusion criteria :

1. a current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
2. any concurrent psychotherapy;
3. any concurrent psychotropic medication.

Primary outcomes:
measure: Depressive Symptoms Measured by Beck Depression Inventory-II
timeFrame: From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training
Secondary outcomes:
measure: Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）
timeFrame: From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Psychology, Hunan Normal University
state: Hunan
Study officials:
affiliation: Department of Psychology, Hunan Normal University
name: Wenhui Yang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang W, Ding Z, Dai T, Peng F, Zhang JX. Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):101-11. doi: 10.1016/j.jbtep.2014.08.005. Epub 2014 Sep 8.
Clinical trial NCT01960816: InFlux System for Nasal Breathing Improvement
Official title: Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Airway Obstruction
Keywords: nasal obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2013-10-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing

Detailed description: This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.

Eligibility criteria: Inclusion Criteria:

* Patients with history of Chronic nasal obstruction and Poor nasal breathing

Exclusion Criteria:

* Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study

Primary outcomes:
measure: Incidence of Unanticipated Serious Adverse Device Effects
timeFrame: 90 Days
measure: Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
timeFrame: Procedure, up to 1 hour (average, 16 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Ocean Springs
country: United States
facility: Bay Area ENT
state: Mississippi
Study officials:
affiliation: Steward Hospital
name: Peter Catalano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930316: Validation of a Portable Sleep Device in Patients With Co-existing Medical Illnesses
Official title: Using a Portable Monitoring Device for Diagnosing Obstructive Sleep Apnea in Patients With Multiple Co-existing Medical Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 80
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: DIAGNOSTIC

Brief summary: The standard sleep study for diagnosing obstructive sleep apnea (OSA) in patients with co-existing illness is by conducting an attended polysomnography (PSG) with more than 7 channels for recording physiological parameters in the sleep center, as recommended by international guidelines. However the guidelines are more than 10 year old without update. With the growing and aging of the population, there is a need to explore if portable monitoring devices could be used in this group of population, so this group of patients can be managed in a timely manner. Portable monitoring devices have been used widely in patients without significant co-existing illness. These devices record at least 4 physiological parameters for diagnosing OSA and can be performed in an unattended setting e.g. at home because of the simplicity. This can shorten the waiting time for making a diagnosis using PSG.

Eighty patients suspected of OSA, with stable co-existing illnesses, will be recruited for the study. Informed consent will be signed before participation. They will be offered a standard attended PSG in the sleep center. A portable monitoring device "Nox T3" will be hooked up to the patients concurrently during the PSG.


Eligibility criteria: Inclusion Criteria:

* Adult patients suspect of OSA (with or without symptoms) of age between 18 to 80 years old, with or without significant comorbidities.
* Patients consent of concurrent use of both type I and or type III devices at the same time in hospital setting.

Exclusion Criteria:

* Pregnant patients.
* Patients refuse to have both type I and type III devices used concurrently.
* Patients with any co-existing medical illnesses which are unstable. "Unstable" is defined as:
* Any recent hospital admission within 1 month before the schedule of sleep study
* Any recent change of medication within 1 month before the schedule of sleep study
* Any change in patient conditions requiring medical attention within 1 month before the schedule of sleep study.

Primary outcomes:
measure: To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT01131416: The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
Official title: The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Paralytic Ileus
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.


Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing cesarean delivery

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy
* Concurrent bowel surgery
* Previous bowel surgery
* Concurrent bowel obstruction
* History of inflammatory bowel diseases
* Previous abdominal/pelvic radiation
* Postoperative placement of endotracheal tube/nasogastric tube
* Postoperative admission to intensive care unit

Primary outcomes:
measure: Postoperative interval until the first flatus
timeFrame: Up to 7 days after delivery
Secondary outcomes:
measure: Postoperative interval until the first passage of stool
timeFrame: Up to 7 days after delivery
measure: Clinically significant postoperative ileus
timeFrame: Up to 7 days after delivery
measure: Postoperative hospital stay
timeFrame: Up to 7 days after delivery
measure: Related complications
timeFrame: Up to 7 days after delivery
measure: Patients' satisfaction
timeFrame: Up to 7 days after delivery
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Kittipat Charoenkwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056716: Silastic Versus Conventional Drain in Thoracic Surgery
Official title: Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Air Leak From Lung
Post Procedural Persistent Drain Fluid
Keywords: thoracic surgery
silastic drains
conventional drains
Lead sponsor: T.C. Dumlupınar Üniversitesi
Sponsor class: OTHER
Collaborators: name: Bursa Yüksek İhtisas Education and Research Hospital
First posted: 2017-02-17
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.

Detailed description: Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.

Eligibility criteria: Inclusion Criteria:

* Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.

Exclusion Criteria:

* Pneumonectomy, diaphragm plication, and decortication candidates

Primary outcomes:
measure: Duration of hospital stay
timeFrame: 3 years
Secondary outcomes:
measure: Daily amount of fluid drainage
timeFrame: 3 years
measure: Duration of fluid drainage
timeFrame: 3 years
measure: Duration of air leak
timeFrame: 3 years
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Research and Education Hospital
state: Yildirim
Study officials:
References: