louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02920879: Airway Effects of PEEP During Anesthesia Induction.
Official title: Airway Effects of PEEP During Anesthesia Induction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Management
Positive End Expiratory Pressure
Mask-ventilation
Anesthesia Induction
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates airway effects of PEEP during maskventilation at anesthesia induction. Four patient groups will be ventilated with different PEEP and driving pressures to evaluate time to open airway after start of positive pressure maskventilation during anesthesia induction.

Detailed description: The use of continuous positive pressure (CPAP/PEEP) during pre-oxygenation and mask-ventilation in patients undergoing anesthesia induction is increasing. Continuous positive pressures have several respiratory benefits with well-documented data on both spontaneously breathing patients and intubated patients. However the effects of PEEP on anesthetized patients during mask-ventilation is poorly investigated. In a previous trial the that the investigators conducted, a PEEP-level of 10 cmH2O during mask ventilation after anesthesia induction surprisingly delayed time to alveolar ventilation compared to ZEEP. In order to investigate this phenomenon, four groups of patients will be compared during preoxygenation and mask ventilation after anesthesia induction.

Each group consisting of 30 patients will be pre-oxygenated and mask ventilated with different CPAP/PEEP levels and different driving pressures. Time to open airway is measured as number of respiratory cycles until detection of CO2 on the capnograph.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18- ≤ 65 years male or female.
2. Elective surgery under general anesthesia
3. ASA-classification 1-3
4. Signed and dated informed consent

Exclusion Criteria:

1. BMI \> 30
2. Predicted difficult mask-ventilation
3. Known hiatus hernia or GERD

Primary outcomes:
measure: Time to open airway
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00501579: Study of Difluprednate in the Treatment of Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-16
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of endogenous anterior uveitis in at least 1 eye

Exclusion Criteria:

* Presence of intermediate uveitis, posterior uveitis or panuveitis
* Corneal abrasion
* Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
* Allergy to similar drugs, such as other corticosteroids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel, MD
role: STUDY_CHAIR
References:
citation: Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.
Clinical trial NCT00790179: Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
Official title: Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Continuous lumbar plexus,Femoral,hydromorphone
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty.

Detailed description: above may be applied

Eligibility criteria: Inclusion Criteria:

* 18-80 years old
* primary diagnosis of osteoarthritis

Exclusion Criteria:

* allergy to local anesthetics
* peripheral neuropathy
* opioid dependency
* dementia
* coagulopathy

Primary outcomes:
measure: VAS pain scores
timeFrame: at 24 and 48 hours
Secondary outcomes:
measure: hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects
timeFrame: at 24 and 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Huntington Hospital
name: Joseph Marino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493579: Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain Activity
Official title: "Impact of Mandibular Implant Supported Overdenture on Changes of Electromyographic Activity, Brain Activity, Cognitive Function, Nutrition and Depression Status."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Supported Overdenture
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Maximum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the effects of a mandibular implant-supported overdenture with a mandibular complete denture on electromyographic activity, brain activity, and cognitive performance in edentulous patients. Ten patients who are entirely edentulous and did not wear dentures will be chosen. To assess brain activity and cognitive function, electroencephalograms, the Mini-Mental State Examination (MMSE), and electromyographic examinations of the temporalis and masseter muscles will be performed prior to complete denture construction, one and three months after complete denture construction, and one and three months after implant supported overdenture insertion, respectively.


Eligibility criteria: Inclusion Criteria:

* All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
* Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
* All patients must have sufficient inter arch space.

Exclusion Criteria:

* Patients with oral or systemic diseases.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits (bruxism or clenching).
* Heavy smoker or alcoholic patients.
* Patients with history of temporo-mandibular dysfunction.
* Patients with neurological or psychiatric disorders.

Primary outcomes:
measure: Brain Activity (EEG)
timeFrame: 3 months
Secondary outcomes:
measure: Cognitive Function (MMSE)
timeFrame: 3 months
Other outcomes:
measure: Muscle Activity (EMG)
timeFrame: 3 months
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry. AL Azhar University for Girls, Cairo, Egypt.
Study officials:
References:
Clinical trial NCT02331979: Improving Bladder Function in SCI by Neuromodulation
Official title: Improving Bladder Function in SCI by Neuromodulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.

Detailed description: This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury. Neuromodulation will be in the form of transcutaneous electrical stimulation and/or magnetic stimulation.

Eligibility criteria: Inclusion Criteria:

1. Male 18-45 years;
2. At least 1 year post-injury;
3. Non-progressive SCI at C2-T8 (non-conus injury);
4. Motor Complete ASIA (A or B);
5. Neurogenic bladder requiring clean intermittent straight catheterization;
6. Able to attend twice weekly testing sessions for 6 months.
7. Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping.

Exclusion Criteria:

1. History of autonomic dysreflexia;
2. Ventilator dependency;
3. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection;
4. Clinically significant depression or ongoing drug abuse;
5. Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.); 6. Prostatic hypertrophy or bladder outlet disorder;

7. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.

Primary outcomes:
measure: Urine flow and volume
timeFrame: Months 1-48
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
Clinical trial NCT02155179: Sperm Pathology Samples and Morphokinetics
Official title: Embryo Kinetics and Sperm Quality. Depends on the Sperm Quality the Embryo Cleavage Rate?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cylinical Embryo
Oligospermia
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 112
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sperms samples of assisted reproduction treatments

Brief summary: The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of semen quality in the embryo kinetic.

In this study The investigators propose that the sperm quality may has influence in the embryo division.


Eligibility criteria: Inclusion Criteria:

* Sperm samples with more than 15 mill/ml of sperms, more than 40% of mobile sperms
* Sperm samples with less than 5 mill/ml of sperms, less than 10% of mobile sperms

Exclusion Criteria:

* sperm samples between 5 to 15 mil/ml of sperms and between 10% to 40% of mobile sperms

Primary outcomes:
measure: embryo division in 2, 3, 4, 5, 6, 7, 8, cells and blastocyst formation
timeFrame: between day 0 and day 5 of development
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI MAdrid
city: Madrid
country: Spain
Study officials:
affiliation: lab coordinator
name: david agudo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06783179: Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Official title: Postoperative Outcomes and Patient Satisfaction for Patients Admitted to the Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis.

Brief summary: This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement. At Mayo Clinic Florida, patients receiving low risk surgeries are often admitted to the hospital overnight for observation. A new model of delivering patient care was created at the Mayo Clinic Florida coined the "Care Hotel." This is a temporal, voluntary accommodation that offers patients a comfortable environment to receive nursing care before or after hospital treatment with in-person daytime monitoring and 24-hour virtual tele-monitoring in a hotel setting. This study evaluates post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

Detailed description: PRIMARY OBJECTIVE:

I. To investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home.

OUTLINE: This is an observational study.

Patients have their medical records reviewed and may complete a survey on study.

Eligibility criteria: Inclusion Criteria:

* Women who underwent mastectomy followed by tissue expander reconstruction for breast cancer or high-risk gene mutation prophylaxis followed by immediate tissue expander reconstruction who are either admitted to the Care Hotel post operatively, discharge home or admitted to the hospital.

Exclusion Criteria:

* Younger than 18 years old.

Primary outcomes:
measure: Complications
timeFrame: Up to 30 days
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian D. Rinker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00257179: The Serum Tissue Factor Level in Lung Cancer Patients as a Prognostic Factor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Tissue factor
Lung cancer
Tissue factor protein inhibitor
Factor VII
Factor X
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status with clinical staging and prognosis.

Detailed description: The staging of lung cancer was according to tumor size, involvement of lymph node and metastatic status. But there is a different prognosis in cancer patients of the same stage. The coagulation status of cancer patients was considered as an important possible prognostic factor. So in this study, we want to evaluate patients' coagulation status and find the relation of coagulation status and cancer status.

We thus propose a prospective study using coagulation factors in order to search for the relationship between cancer stage and pre-coagulation status in Taiwanese lung cancer patients. We will also evaluate the potential use of tissue factor as a prognosis predictor in lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Patients with newly-diagnosed lung cancer
* Serum from cancer-free healthy volunteers

Exclusion Criteria:

* Chronic renal failure or end-stage renal disease \[ESRD\] (creatinine \[Cr\] \> 2 )
* Hyperlipidemia on statin therapy
* Acute myocardial infarction
* Tapal or Plavix use
* Active thromboembolic event
* Severe liver disease (\> child B)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chong-Jen Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02463279: SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Official title: SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Lead sponsor: SinuSys Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-04
Enrollment: 30
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: The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

Detailed description: A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CRS
* Subject in in need of frontal recess and/or sphenoid sinus dilation

Exclusion Criteria:

* Pregnant or breastfeeding females
* Previous treatment site intervention
* Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation

Primary outcomes:
measure: Patency of treated target site
timeFrame: Patency immediately post device expansion and removal
Secondary outcomes:
measure: Patency of treated target site
timeFrame: 1 month and 3 months
measure: Reports of sinus related adverse events during the 3 months follow-up period
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Upland
country: United States
facility: Upland ENT
state: California
city: Denver
country: United States
facility: Colorado ENT
state: Colorado
city: Brighton
country: United States
facility: St. Elizabeth Medical Center
state: Massachusetts
Study officials:
affiliation: SinuSys Chief Medical Officer
name: Jerome Hester, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02088879: Physical Workload Identify in Chest Compression Position Using Surface Electromyogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Cardiac Arrest
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The chest compression depth decreases over time after starting continuous chest compression due to the rescuers' fatigue.

The investigators hypothesized that the frequency parameters from surface electromyogram from each muscle during chest compression may reflect the muscle fatigue of the rescuers.

Then investigators can identify which of the body are mainly used and get tired by continuous chest compression using surface electromyogram.


Eligibility criteria: Inclusion Criteria:

* doctors with American Heart Association Basic Life Support (AHA BLS) provider certification
* healthy, experienced health-care providers

Exclusion Criteria:

* physical pain (ex. low back, wrist)
* heart disease

Primary outcomes:
measure: median frequency of electromyogram
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Department of emergency medicine, college of medicine, Hanyang university
name: Wonhee Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho Y, Lee Y, Lim TH, Chee Y, Oh J, Kim W, Jang SH, Kim SM. What muscles need to be trained for high-quality chest compression? Australas Emerg Care. 2020 Dec;23(4):272-280. doi: 10.1016/j.auec.2020.06.002. Epub 2020 Jul 7.
Clinical trial NCT01056679: Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients
Official title: Phase I Trial of AVD Plus Lenalidomide (Revlimid) in Elderly Intermediate or Advanced Stage Hodgkin Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be.


Eligibility criteria: Inclusion Criteria:

* Hodgkin Lymphoma, intermediate or advanced stage
* Age \>60 and \<75 years
* ECOG 2 or better
* No major organ dysfunction
* Ability to take aspirin or LMW Heparin

Exclusion Criteria:

* HL as composite lymphoma
* Prior use of lenalidomide
* Prior use of chemo- or radiotherapy

Primary outcomes:
measure: Dose limiting toxicities (DLT)
Secondary outcomes:
measure: Overall response rate (ORR)
measure: Progression free survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
state: NRW
Study officials:
affiliation: University of Cologne
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: