louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01259960: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation
Official title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Disease
Lead sponsor: General Hospital Amstetten
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will undergo minimal access surgical technige for degenerative lumbar disease fusion

Brief summary: Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.


Eligibility criteria: * All patients who will undergo minimally access surgical technique for degenerative lumbar disease fusion surger
* Patient willing to participate in observational study and who signs patient information and patient consent form
* patient older that 18 years
* all products will be used within intended use

Primary outcomes:
measure: Operation related complications
timeFrame: between operation and hospital discharge of patient
measure: Post operative fever
timeFrame: between operation and hospital discharge of patient
measure: Liquor leakage
timeFrame: between operation and hosital discharge of patient
Secondary outcomes:
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: General Hospital
Study officials:
affiliation: General Hospital Amstetten
name: Wolfgang Senker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05601960: A Combination Treatment Reduces Acne Severity and PIHP
Official title: A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Postinflammatory Hyperpigmentation
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 1785
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.

Brief summary: Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.\[1\] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.\[2, 3\] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.


Eligibility criteria: Inclusion Criteria:

* adult
* mild to moderate acne
* presence of postinflammatory hyperpigmentation lesions
* phototype IV to VI

Exclusion Criteria:

* less than 18 years
* severe acne

Primary outcomes:
measure: seborrhoea level
timeFrame: baseline
measure: seborrhoea level
timeFrame: Month 2
measure: acne severity
timeFrame: baseline
measure: acne severity
timeFrame: Month 2
measure: PAHPI: post-acne hyperpigmentation index
timeFrame: baseline
measure: PAHPI: post-acne hyperpigmentation index
timeFrame: Month 2
measure: inflammatory lesions
timeFrame: baseline
measure: inflammatory lesions
timeFrame: Month 2
measure: non-inflammatory lesions
timeFrame: baseline
measure: non-inflammatory lesions
timeFrame: Month 2
Secondary outcomes:
measure: Investigator satisfaction acne
timeFrame: Month 2
measure: Investigator satisfaction
timeFrame: Month 2
measure: Patient satisfaction acne
timeFrame: Month 2
measure: Patient satisfaction PAHPI
timeFrame: Month 2
measure: Patient: Skin quality
timeFrame: Month 2
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: L'Oreal
Study officials:
affiliation: Dermatique Skin Care, Khobar, KSA
name: Rana Shabab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03398460: Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)
Official title: Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU) health care providers face, this study will evaluate burnout rates in intensive care unit (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a bereavement card on these burnout rates

Detailed description: This study will evaluate:

1. Burnout rates among nurses and ancillary staff with the Abbreviated Maslach burnout inventory. This is a well validated tool that is used to evaluate symptoms of burnout such as denationalization, emotional exhaustion and lack of personal accomplishment.
2. Burnout rates at the beginning of and at the end of the house staff's ICU rotation to gauge the effect of an ICU rotation on burnout rates amon medical trainees.
3. Determine whether the introduction of a bereavement card will improve symptoms of burnout as gauged by the abbreviated maslach burnout inventory
4. Staff perceptions and response to the introduction of a bereavement

Eligibility criteria: Inclusion Criteria:

* Health care providers who work in the Bellevue Hospital Medical ICU

Exclusion Criteria:

* NA

Primary outcomes:
measure: Burnout rate before introduction of bereavement card
timeFrame: 1 Year
measure: Burnout rate after introduction after introduction of bereavement card
timeFrame: 1 Year
measure: Burnout rates before ICU rotation for physicians
timeFrame: 1 Year
measure: Burnout rates after an ICU rotation for physicians
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Vikramjit Mukherjee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05488860: Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases
Official title: Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Diseases
Hypertrophic Scar
Keloid
Plantar Wart
Warts
Skin Tumor
Keywords: Microneedling
Ultrasound
Refractory skin diseases
Piezoelectric drived
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison is designed in each participant. For each individual, two similar hypertrophic scar/keloid or a single hypertrophic scar/keloid is randomly assigned into traditional injection group or piezoelectric divied microneedling group.
Primary purpose: TREATMENT

Brief summary: Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.

Detailed description: Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.

Eligibility criteria: Inclusion Criteria:

* Age over 16 years
* Diagnosed by 2 or more professional dermatologists
* Willing to underwent a new treatment modality
* Follow up is easy to conduct

Exclusion Criteria:

* Poor general condition
* Bleeding tendency
* Allergy to drug

Primary outcomes:
measure: Short-term response
timeFrame: 1 week after treatment
measure: Long-term response
timeFrame: 1 month after treatment
Secondary outcomes:
measure: Pain score during treatment
timeFrame: Immediately
measure: POSAS(The Patient and Observer Scar Assessment Scale) score
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
Study officials:
References:
Clinical trial NCT04418960: Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease
Official title: Physiological Changes of the Mitral Annulus After Annuloplasty in Barlow Disease: an MRI-focused Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barlow Disease (BD)
Mitral Insufficiency
Keywords: mitral annuloplasty
mitral valve repair
mitral annulus
coaptation of mitral leaflets
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to cardiac surgery clinic (University Hospital Basel) through cardiologist meeting the inclusion criteria based on the medical history, clinical and echocardiographic findings.

Brief summary: Barlow disease (BD) is a common cause of mitral insufficiency. In 2012 the University Hospital of Basel started to perform a simplified mitral valve repair technique in BD just by implanting an annuloplasty-ring. It is hypothesized that the major mechanism of the valvular insufficiency in Barlow disease is a deformation of the left ventricle and the posterior mitral annulus, causing its aberrant displacement during the systole towards posterior and basal and thus impairing the coaptation of the leaflets. This prospective individual MRI study is to investigate the ventricle and the mitral annulus pre- and postoperatively for detailed analysis.


Eligibility criteria: Inclusion Criteria:

* identified Barlow disease suffering from significant mitral insufficiency with indication to surgery

Exclusion Criteria:

* Active endocarditis or any other etiology of mitral insufficiency else than Barlow disease
* Inability to perform a cardiac MRI (e.g., metallic implants, claustrophobia)
* Pregnancy
* Inability to give consent

Primary outcomes:
measure: Change in anatomical structures by MRI
timeFrame: The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation.
Secondary outcomes:
measure: function of the mitral valve by echocardiography
timeFrame: during the hospital stay, between 3 and 7 days after the operation and at cardiological follow-up over the first 3 months.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Cardiac Surgery, University Hospital Basel
Study officials:
affiliation: HerzZentrum Hirslanden, Zurich
name: Martin Grapow, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01544660: Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Official title: Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Mineral Density
Keywords: spine and hip scan
BMD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2012-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women aged 65-80

Brief summary: Our overarching aim is to set up a procedural, analytic and developmental framework to establish CT of the central and peripheral skeleton as a clinically useful biomarker for skeletal strength in the clinical research and ultimately in the clinical setting. To accomplish this, the investigators will develop and validate phantoms and scanning procedures to standardize strength and structure measurements between different vQCT scanners and develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with an emphasis on optimization for multi-center studies.

Detailed description: The investigators will develop new calibration phantoms to address inter and intra scanner variability in vQCT and HRpQCT. Phantom sets to evaluate inter-scanner disparity and determine corrections to apply to in vivo scan data in the multi-center settings. These methods will be validated in a multi-center phantom study and in a 120 patients

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* must be able to lie down on bed

Exclusion Criteria:

* on wheel chair
* age above 80 years 0r less than 65 years

Primary outcomes:
measure: Develop and Validate phantoms and scanning procedures to standardize strength and structure measurements between different scanners.
timeFrame: one visit lasting 3 hours for each subject.
Secondary outcomes:
measure: Development of open-source image analysis metric for vQCT
timeFrame: Time frame will be 3 hours for a visit
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Department of Radiology, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Lang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583348: Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy
Official title: An Open Case Series About Technical Feasibility of Routine Intraoperative Cholangiography (IOC) During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy (tvNCC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone Disease
Keywords: transvaginal
NOTES
cholecystectomy
cholangiography
symptomatic gallstone disease
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with symptomatic gallstone disease with an indication for elective cholecystectomy

Brief summary: While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* symptomatic gallstone disease
* age \> 18 years
* written informed consent

Exclusion Criteria:

* age \< 18 years
* not able to understand informed consent
* pregnancy
* vaginal atresia
* florid vaginal infection
* gynecological neoplasia
* allergy to Iod
* missing informed consents
* emergency procedure

Primary outcomes:
measure: Number of patients with successful introduction of cholangiography catheter into cystic duct (yes/no)
timeFrame: intraoperative
Secondary outcomes:
measure: Time required for cholangiography
timeFrame: intraoperative
measure: Intraoperative complications
timeFrame: intraoperative
measure: postoperative complications
timeFrame: within 6 weeks from surgery
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Cantonal Hospital Baselland, Bruderholz, Department of Surgery
state: Baselland
Study officials:
affiliation: Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
name: Andreas Zerz, MD
role: STUDY_CHAIR
affiliation: Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
name: Daniel C Steinemann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cantonal Hospital Baselland, Department of Surgery, Bruderholz, Switzerland
name: Önder Ögredici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02612948: Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Official title: Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psychomotor Agitation
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.

Detailed description: Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model.

Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse).

Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit.

Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* Trauma/surgical patients admitted to the trauma/surgical ICU

Exclusion Criteria:

* sustained RASS of -4/-5 during the complete ICU admission
* presence of a condition preventing delirium assessment
* anticipated or known ICU length of stay of less than 48 hours
* taking antipsychotics prior to admission
* history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment
* primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU
* current treatment with a continuous infusion neuromuscular blocking agent
* pregnancy
* screened positive for delirium upon admission to the ICU.

Primary outcomes:
measure: Incidence of delerium
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: University General Surgeons, P.C.
name: Brian Daley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04730648: Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
Official title: Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lipid Metabolism
Cardiovascular Diseases
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that PCSK9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.


Eligibility criteria: Inclusion Criteria:

* New diagnosis ACS patient by serum biomarker and coronary arteriography.

Exclusion Criteria:

* Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer

Primary outcomes:
measure: cardiovascular prognosis
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Tangzhiming Li
state: Guangdong
Study officials:
affiliation: Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China
name: Tangzhiming Li, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ou Z, Yu Z, Liang B, Zhao L, Li J, Pang X, Liu Q, Xu C, Dong S, Sun X, Li T. Evolocumab enables rapid LDL-C reduction and inflammatory modulation during in-hospital stage of acute coronary syndrome: A pilot study on Chinese patients. Front Cardiovasc Med. 2022 Aug 9;9:939791. doi: 10.3389/fcvm.2022.939791. eCollection 2022.