louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01559909: Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
Official title: Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amputation
Keywords: Lower limb loss
Leg amputation
walking study
socket technology
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Otto Bock Healthcare Products GmbH
First posted: 2012-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.


Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 21 and 75 with a transfemoral amputation.
* Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
* People who are comfortably fitted with a prosthesis for at least 6 months.

Exclusion Criteria:

* People with severe cardiac or pulmonary disease that limits ability to walk.
* People with too much discomfort and/or pain.
* People with active wounds on their residual limb or other foot.

Primary outcomes:
measure: Gait changes
timeFrame: 1 day
Secondary outcomes:
measure: Comfort
timeFrame: 1 day
measure: Balance
timeFrame: 1 day
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: West Babylon
country: United States
facility: Long Island Orthotics and Prosthetics
state: New York
Study officials:
affiliation: Stony Brook University
name: Eric M Lamberg, EdD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04344509: Microbial Etiology of Ventilator-associated Pneumonia in COVID-19 Infected Patients
Official title: Microbial Etiology of Ventilator-associated Pneumonia (VAP) in COVID-19 Infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Brief summary: National multicentric observational retrospective case-control study comparing the relative frequency of the various microorganisms responsible for VAP in patients infected or not by SARS-CoV-2 and their resistance to antibiotics.


Eligibility criteria: Inclusion Criteria:

* All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Exclusion Criteria:

* All patients with microbiologically confirmed VAP with pulmonary samples collected from March 15 to April 15 in France.

Primary outcomes:
measure: Prevalence of the microorganisms responsible for VAP among patients infected or not by the SARS-CoV-2
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence of multi-drug resistant bacteria responsible for VAP among patients infected or not by the SARS-CoV-2
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03295409: Testing Familial Self-affirmation for Smoking Cessation
Official title: Testing Familial Self-affirmation for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evidence suggests that affirming the self can help people to make changes in their health behavior. Typically, people affirm a personally-important value, but evidence suggests that affirming the values of family ("familial self-affirmation") might exert stronger effects. The aim of the present study is to examine the effects of familial self-affirmation versus standard self-affirmation versus a control group on smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Smoker

Exclusion Criteria:

* Non-smoker
* Unable or unwilling to complete questionnaire

Primary outcomes:
measure: Smoking cessation
timeFrame: 1 month
measure: Quit attempts
timeFrame: 1 month
measure: Nicotine dependence
timeFrame: 1 month
measure: Craving
timeFrame: 1 month
Secondary outcomes:
measure: Habit
timeFrame: 1 month
measure: Self-regulation
timeFrame: 1 month
measure: Subjective well-being
timeFrame: 1 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: HC Engineering Company
city: Hong Kong
country: Hong Kong
facility: Perfect Match Wedding Service
Study officials:
References:
Clinical trial NCT01509209: Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Official title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Rhinitis
Keywords: vasomotor
pseudoephedrine
levocetirizine
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 137
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
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 evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

Detailed description: randomized, double-blind, placebo-controlled, phase 3

Eligibility criteria: Inclusion Criteria:

* Diagnosis of vasomotor rhinitis

Exclusion Criteria:

* Significant concomitant medical condition
* Use corticosteroids or other allergy medications during the study
* Considered by investigator as not appropriate to participate in the clinical study with othe reason

Primary outcomes:
measure: TVRSS(Total Vasomotor Rhinitis Symptom Score)
timeFrame: 2week
Secondary outcomes:
measure: TVRSS, VRSS
timeFrame: 1week or 2 week
Other outcomes:
Locations:
city: Dongjak
country: Korea, Republic of
facility: ear, nose and throat, Boramae Hospital
state: Seoul
Study officials:
affiliation: Hanmi Pharmaceutical Company Limited
name: Kyungmi Park, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03363009: Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program
Official title: Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Keywords: prehabilitation
connected devices
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery.

A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18
* Patients scheduled for a surgical procedure 4 weeks later (more or less 1 week) after initial assessment
* Patients having consented to participate
* Patients benefiting from a social security system.

Exclusion Criteria:

* Pregnant or lactating women
* Inability to perform physical assessment
* Dependant patients
* Inability to complete questionnaires

Primary outcomes:
measure: Functional capacity
timeFrame: 2 months
measure: Functional capacity
timeFrame: 2 months
Secondary outcomes:
measure: Critical events
timeFrame: 2 months
measure: Postoperative complications
timeFrame: 2 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch hospital
Study officials:
affiliation: Hopital Foch
name: Barizien Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch
name: Marc Fischler
role: STUDY_CHAIR
References:
Clinical trial NCT00189709: Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia
Official title: A Single Center, Open, Parallel, Comparative, Randomized Study of Micafungin (FK463) vs Fluconazole (Diflucan) in the Treatment of Invasive Candidiasis and Candidaemia (Protocol No: MCFGCAN-0301F-TW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Invasive Candidiasis
Candidemia
Keywords: micafungin
fluconazole
invasive candidiasis
candidemia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2005-09-19
Enrollment: 24
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: To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Detailed description: Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of candidemia and invasive candidiasis
* Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
* Inpatients aged 16 and above

Exclusion Criteria:

* Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
* Patients with severe complications in the liver
* Pregnant or lactating women
* Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
* Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.

Primary outcomes:
measure: Response rate
timeFrame: 2-8 Weeks
Secondary outcomes:
measure: Clinical response, mycological response
timeFrame: 2-8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
state: Republic of China
Study officials:
affiliation: National Taiwan University Hospital
name: Shan-Chwen Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06273709: Remote Assessment of OCT Scans for BCC Detection
Official title: The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans: a Diagnostic Case-control Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Basal Cell Carcinoma
Keywords: Basal cell carcinoma
Optical coherence tomography
Imaging
Non-melanoma skin cancer
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included cases contain OCT scans of patients with lesions suspect for BCC. Three OCT assessors will be included in this study to assess the OCT scans with and without clinical and dermoscopic photographs.

Brief summary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).


Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* Underwent OCT scan and punch biopsy for lesions suspect for BCC

Exclusion Criteria:

* Unable to sign informed consent

Primary outcomes:
measure: Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs
timeFrame: Measured before December 31st 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02107209: Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema
Official title: Evaluation of Bronchoscopic Biological Lung Volume Reduction Therapy in Pulmonary Emphysema Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Emphysema
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.

Detailed description: Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.

Eligibility criteria: Inclusion Criteria:

1. Emphysema determined by HRCT of the chest with:

   * .Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of \>2 despite medical therapy).
   * FEV1 /FVC \< 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013).
   * Hyperinflation (total lung capacity (TLC) \> 110% pred and residual volume/total lung capacity (RV/TLC) \> 120% pred.
2. Patients not candidate for or had refused lung volume reduction surgery.
3. Age \> 40 yrs.

Exclusion Criteria:

1. Airflow limitation with FEV1 \< 20%.
2. DLCO \< 20%.
3. Current smoker.
4. Patients not candidate for FOB.

Primary outcomes:
measure: Post-procedure lung volume reduction
timeFrame: 12 week
Secondary outcomes:
measure: Post-procedure Improvement in dyspnea and exercise capacity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Chest Medicine Department, Faculty Of Medicine, Mansoura University
state: Al-dakahliya
Study officials:
affiliation: Chest Medicine Department, Faculty of Medicine, Mansoura University
name: Ahmad Saad El-Morsi, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03669809: The Biological Rhythm of Human Metabolite
Official title: Association Between Serum Metabolism Markers and Biological Rhythm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhythm Nodal
Metabolism and Nutrition Disorder
Metabolism Disorder, Lipid
Keywords: biological rhythm
metabolism
hormone
lipid
bile acids
obesity
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged of 18 to 30 years old.

Brief summary: The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.


Eligibility criteria: Inclusion Criteria:

* Male or female；
* Aged of 18 to 30 years old;

Exclusion Criteria:

* Presence of pituitary/hypothalamic disorders, polycystic ovarian syndrome， thyroid disorders, hypertension, malignant tumor, cardiac insufficiency，hepatic or renal insufficiency, gastrointestinal disorders and acute infection;
* Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;
* Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;
* Pregnancy or lactation women;
* Obviously poor compliance.

Primary outcomes:
measure: circadian rhythms of serum lipid levels （the change of serum lipid levels within 24 hours）
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
Secondary outcomes:
measure: circadian rhythms of gonadal hormone and gonadotropin（the change of gonadal hormone and gonadotropin within 24 hours）
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
measure: circadian rhythms of serum total bile acids（the change of serum total bile acids within 24 hours）
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
measure: change in urine metabolite
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
measure: change in intestinal flora
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
measure: change in sperm quality
timeFrame: Measured at baseline, and every 10 years during the 40-year follow-up period
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao
role: STUDY_CHAIR
References:
Clinical trial NCT00731809: Evaluation of PET CT in the Management of Patients With Crohn's Disease.
Official title: Evaluation of PET CT in the Management of Patients With Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-08-11
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: 18F-FDG PET/CT (2-\[fluorine-18\] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.


Eligibility criteria: Inclusion Criteria:

* Patients suspicious for active disease:

  * Patients with suspected but undiagnosed Crohn's disease
  * Patients with serological markers of inflammation (elevated ESR, CRP or thrombocytosis) but clinically in remission
  * Patients with a stricture which might be fibrous in which case surgery is indicated or inflammatory for which medical management is indicated
  * Able to sign a consent form

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Infectious colitis determined at the initial checkup
* Allergy to iodine contrast

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References: