louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00177385: Aging Well, Sleeping Efficiently: Protecting Health In Later Life
Official title: AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Health Promotion
Keywords: Sleep
Sleep Hygiene
Modest sleep deprivation
Healthy Aging and sleep
Health Promotion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2005-09-15
Enrollment: 66
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

Detailed description: The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.

Eligibility criteria: Inclusion Criteria:

* age 75 or older
* without sleep disorders
* without psychiatric disorders
* Folstein MMSE of 24 or greater

Exclusion Criteria:

* Apnea-hypopnea index greater than 30
* Mean sleep latency less than 6
* Psychotropic medications present

Primary outcomes:
measure: Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.
Secondary outcomes:
measure: Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons.
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Charles F. Reynolds lll, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03377985: Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
Official title: Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention. The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks. Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain. 80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively. The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.


Eligibility criteria: Inclusion Criteria:

* patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery

Exclusion Criteria:

* Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway disease

Primary outcomes:
measure: block related complications
timeFrame: 24 hours after the block
Secondary outcomes:
measure: number of first needle pass
timeFrame: 10-20 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00225485: Study Evaluating Effexor XR in Elderly Patients With Major Depression.
Official title: Phase III Study of Effexor XR for the Treatment of Elderly Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Phase III study evaluating Effexor XR in elderly patients with major depression.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with major depression based on DSM-IV-TR
* Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" of HAM-D at baseline

Exclusion Criteria:

* Patients with schizophrenia or any other psychotic disorder
* Patients with history or presence of bipolar disorder

Primary outcomes:
measure: Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy
Secondary outcomes:
measure: Difference of total score of HAM-D17 between baseline and final-on-therapy
measure: Remission rate of HAM-D17 at the final-on-therapy
Other outcomes:
Locations:
city: Ichikawa
country: Japan
state: Chiba
city: Ichikawa
country: Japan
state: Chiba
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Ohnojo
country: Japan
state: Fukuoka
city: Otaru
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tsukuba
country: Japan
state: Ibaragi
city: Hanamaki
country: Japan
state: Iwate
city: Kawasaki
country: Japan
state: Kanagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Moriguchi
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Adachi-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Higashimurayama
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Nakano-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Tachikawa
country: Japan
state: Tokyo
city: Hiroshima
country: Japan
city: Okayama
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02146885: The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention
Official title: The Use of Diffuse Optical Spectroscopy to Characterize Adipose Tissue Oxygenation and Vascular Reactivity in Response to Weight-Loss Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-05-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine Medical Center Department of Cardiology, preventive cardiology intervention program.

Brief summary: The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.

Detailed description: Optical technologies under development at the Beckman Laser Institute.

Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. The researcher use Diffuse Optical Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index greater than 25, overweight
* Participation in Weight Loss program

Exclusion Criteria:

* A medical history of myocardial infarction or cerebrovascular stroke
* Pregnancy or planned pregnancy during the course of the study period

Primary outcomes:
measure: Weight Control
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Shaista Malik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00623285: The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting
Official title: The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain.
Keywords: Pain.
Postoperative.
CABG.
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 40
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: TREATMENT

Brief summary: We hypothesize that the perioperative administration of pregabalin will significantly decrease pain scores and post-operative opioid requirements for patients undergoing coronary artery bypass grafting, and reduces the incidence of opioid-induced side effects such as respiratory depression. This may reduce ICU admission and possibly abbreviate length of hospital stay.


Eligibility criteria: Inclusion Criteria

* Patients whom are able and willing to provide written informed consent.
* Male and female 18-70 years of age.
* Patients whom are undergoing isolated coronary artery bypass grafting through a midline sternotomy for the treatment of ischemic heart disease.

Exclusion criteria

* Patients undergoing cardiac surgery for valvular or pericardial surgery.
* Patients with a documented ejection fraction of less than 50%.
* Patients with known chronic renal insufficiency and a calculated creatinine clearance of \< 60mL/min.
* Patients with known sensitivity to the study drugs.
* Patients with documented pre-existing chronic pain.
* Patients with seizure disorders.
* Patients whom are taking pregabalin or gabapentin
* Patients on chronic neuroleptic medications for control of psychiatric disorders as to avoid possible drug interactions and to avoid modulation of any pain states by such medications.
* Patients whom are taking tricyclic antidepressants or serotonin and norepinephrine re-uptake inhibitors(SNRI) will be excluded because of the effect of these drugs on neuropathic pain.
* Patients greater than 70 years of age will also be excluded because of their increased risk of side-effects and perioperative confusion.
* Pregnant or breast feeding females

Primary outcomes:
measure: Pain scores and morphine consumption post surgery
timeFrame: 6 months
Secondary outcomes:
measure: To determine the occurrence of opioid-related side effects such as nausea, vomiting, and respiratory depression in patients receiving pregabalin compared to those receiving placebo.
timeFrame: 6 days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: St. Boniface General Hospital and U of M
name: Joel A Loieselle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05162885: Effect of Sodium Alendronate on the Final Implant Stability.
Official title: Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anterior Labial Wall Defect
Keywords: Stability, Sodium Alendronate, Implant, Sticky bone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials

Detailed description: compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique

Eligibility criteria: Inclusion Criteria:

* Patients with seeking implant drive prosthesis after socket has been preserved by either technique.
* Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to implant surgery.
* Patient seeking immediate implant placement.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly
* followed. Referred only for implant placement or unable to attend a 5-year follow-up

Primary outcomes:
measure: Implant stability
timeFrame: 3-4 months after Dental implant placement
Secondary outcomes:
measure: marginal bone
timeFrame: 3-4 months after Dental implant placement
Other outcomes:
measure: Bone Density
timeFrame: 3-4 months after Dental implant placement
Locations:
city: Cairo
country: Egypt
facility: Hossam Abdallah Mohammed Ghazally
state: Manial
Study officials:
References:
Clinical trial NCT01273285: Reproducibility of Nerve Fiber Layer Thickness Measurements in Patients With Glaucoma and Healthy Controls Using Spectral-Domain and Time-Domain OCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma Patients and Healthy Controls
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess the reproducibility of Spectral-Domain-OCT (SD-OCT) retinal nerve fiber layer thickness (RNFL) thickness measurements in healthy volunteers and patients with glaucoma and to compare these results to conventional Time-Domain-OCT (TD-OCT).

* Trial with medical device


Eligibility criteria: Inclusion criteria: control group:

age 18yo or older, healthy

glaucom group: age 18yo or older, diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria: Exclusion criteria in the control group were history of glaucoma, history of any other ocular disease, or intraocular pressure greater than 21mmHg. Exclusion criteria in the glaucoma group were history of other optic neuropathies.

or severe optic media opacities.

Primary outcomes:
measure: reproducibility of retinal nerve fiber layer thickness measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Toteberg-Harms M, Sturm V, Knecht PB, Funk J, Menke MN. Repeatability of nerve fiber layer thickness measurements in patients with glaucoma and without glaucoma using spectral-domain and time-domain OCT. Graefes Arch Clin Exp Ophthalmol. 2012 Feb;250(2):279-87. doi: 10.1007/s00417-011-1811-9. Epub 2011 Sep 10.
Clinical trial NCT03056885: Inflammatory Local Response During OLV: Protective vs Conventional Ventilation Strategy
Official title: Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-Induced Lung Injury
Inflammatory Response
Respiratory Complication
Keywords: one-lung ventilation
broncho-alveolar lavage
protective ventilation
cytokines
thoracic surgery
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.

Detailed description: One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective lobectomy and wedge resection

Exclusion Criteria:

* emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV

Primary outcomes:
measure: local cytokine inflammatory response in the two study groups
timeFrame: Change from Baseline cytokines level and the end of surgery (about 60 minutes)
Secondary outcomes:
measure: incidence of postoperative respiratory in the two study groups
timeFrame: within 48 hours of the operation
measure: lenght of stay in the two study groups
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03384485: Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients With Antiphospholipid Syndrome.
Official title: Prevalence of Lysosomal Hydrolase Alpha-glagtosidase Deficiency in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antiphospholipid Syndrome
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fabry disease, an X-linked disorder of glycosphingolipids that is caused by mutations of the GLA gene that codes for α-galactosidase A, leads to dysfunction of many cell types and includes a systemic vasculopathy. As a result, patients have a markedly increased risk of developing ischemic stroke, small-fiber peripheral neuropathy, cardiac dysfunction and chronic kidney disease. Because this disease is a rare disease most of the time it is misdiagnosed, so in this study we will check out the Prevalence of lysosomal hydrolase alpha-glagtosidase deficiency ( Fabry disease) in patients with Antiphospholipid Syndrome.

Detailed description: the investigators would like to assess the prevalence of Fabry in men and women aged 18-100 who were diagnosed with antiphospholipid syndrome in our departmental clinic in 2000-2017 It is very important to diagnose Fabri that then the treatment of patients can vary dramatically.

The study will include 100 adult patients (18-100) men and women. Testing for the Fabri test in men is an enzyme test and will be performed subject to their consent to sign informed consent. In the women, an enzyme test will be carried out, and the plasma Lys-3-3 plasma storage, as recommended in the recently published diagnostic algorithms, is examined. If diagnosed, a patient will be referred to a genetic institute for further genetic counseling

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Antiphospholipid syndrome.
* able to read and sign inform concent

Exclusion Criteria:

• Fabry disease.

Primary outcomes:
measure: Lys-3-3 plasma
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: head of department internal medicin E
name: Yair Levy
role: PRINCIPAL_INVESTIGATOR
References: