louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05894759: The Impact of Different Relaxation Techniques on Psoriasis Patients With an Elevated Psychological Stress Level
Official title: Psychodermatological Approaches of Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Stress, Psychological
Depression
Anxiety
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of psoriasis
* adequate psychological stress profile
* access to a personal computer/ laptop/ smartphone with internet connection
* agreement to the informed consent form

Exclusion Criteria:

* other dermatological conditions which impair the life quality
* psychological disorders under psychiatric treatment
* hearing impairment
* other on-going medical studies
* pregnancy
* aliteracy

Primary outcomes:
measure: Dermatological Life Quality Index
timeFrame: 6 months
measure: Psychological stress
timeFrame: 6 months
measure: General Anxiety Disorder-7
timeFrame: 6 months
measure: Patient Health Questionnaire-9
timeFrame: 6 months
Secondary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: 6 months
measure: Self Administered Psoriasis Area and Severity Index
timeFrame: 6 months
measure: The Revised Illness Perception Questionnaire
timeFrame: 6 months
measure: Dermatological treatment compliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Saint Spiridon Emergency Clinical County Hospital- Dermatology department
Study officials:
affiliation: Grigore T. Popa University of Medicine and Pharmacy Iasi
name: Laura Gheuca Solovastru, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05733559: QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study
Official title: An Observational Prospective Clinical Study to Assess Clinical Performance of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 Target in the Intended Use Population and Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Keywords: Respiratory Virus
SARS-CoV-2 coronavirus
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 565
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptoms of respiratory infection

Brief summary: This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

Detailed description: This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

Eligibility criteria: Inclusion Criteria:

* Presenting with signs and symptoms of a respiratory infection.
* Consent or assent to be obtained
* Able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents.
* Willing and able to provide Nasopharyngeal Swab (NPS) Specimen collected per manufacturer's instructions.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.

Primary outcomes:
measure: PPA
timeFrame: 8 weeks
measure: NPA
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT06455800: Severe Lung Disease in Childhood
Official title: Long Term Outcome of Severe Lung Disease in Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Disease Chronic
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe chronic lung desease

Brief summary: Only little information exists about the long term consequences of having severe lung disease in childhood. The patient population is heterogenous and the prognostic markers are few.

This observational study will investigate which parameters that can be used to predict the outcome of having severe lung disease in childhood.

Detailed description: All patients aged 0-18 years at the HCA Childrens Hospital with a severe lung disease will prospectively be registered in a database.

At a yearly follow up, data from the patient record will be registered. Informed consent from the patients and/or their parents will be obtained. Registered data will include height, weight, results of lung function tests and imaging diagnostics.

The study will provide knowledge of the prognosis of different lung diseases and how to monitor lung function in children.

Eligibility criteria: Inclusion Criteria: severe lung disease -

Exclusion Criteria: no informed consent

-

Primary outcomes:
measure: FEV1
timeFrame: 18 years
measure: FVC
timeFrame: 18 years
measure: Lung Clearance Index (LCI)
timeFrame: 18 years
Secondary outcomes:
measure: height
timeFrame: 18 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Hans Christian Andersen Children's Hospital
Study officials:
affiliation: Odense University Hospital
name: Josefine Gradman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967600: Clinical and Biological Characteristics of Hidradenitis Suppurativa
Official title: Clinical and Biological Characteristics of Hidradenitis Suppurativa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hidradenitis Suppurativa

Brief summary: Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.


Eligibility criteria: Hidradenitis Suppurativa Patients

Inclusion Criteria:

1. Age 13 years or older
2. Diagnosis of HS clinically-confirmed by a physician

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

Healthy Volunteer

Inclusion Criteria:

1. No history of chronic skin conditions
2. No recent history of antibiotic use

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

Primary outcomes:
measure: The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa.
timeFrame: 2016-2026
Secondary outcomes:
measure: Secondary aims include correlating alterations in clinical and biological characteristics with disease status, and identifying genetic variants that predict disease progression or response to therapy.
timeFrame: 2016-2026
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Haley B Naik, MD, MHSc, FAAD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02525900: ssTAP vs TAP Catheters in TAH
Official title: Comparing the Efficacy of Transversus Abdominis Plane Block, Both Single Injection and Continuous Block Technique, to Wound Infiltration for Total Abdominal Hysterectomy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo total abdominal hysterectomy
* Age ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status ≤ 3

Exclusion Criteria:

* Known coagulopathy
* Known allergy to Bupivacaine or morphine
* Contraindication to Tylenol usage
* Medical conditions contraindicated to bupivacaine use
* Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.

Primary outcomes:
measure: Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale.
timeFrame: Up to 48 hours post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Sarah Tingle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562900: Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
Official title: Robotic Assisted Versus Laparoscopic Cholecystectomy -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystolithiasis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience.

* Trial with surgical intervention

Detailed description: Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery.

The study is designed to assess the potential benefits of robotic-assisted cholecystectomy. To achieve a high level of evidence we chose a prospective case matched controlled methodology. Three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. Each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy.

The robotic assisted operations are performed with the 3- arm Da Vinci robot system (Da Vinci Robot, Intuitive Surgical). Similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.

Eligibility criteria: Inclusion criteria:

* Cholecystectomy due to symptomatic cholecystolithiasis
* Acute or chronic cholecystitis

Exclusion criteria:

* Patients \< 18 years
* Primary open cholecystectomy

Primary outcomes:
measure: complications
timeFrame: Dec 04 - Feb 06
Secondary outcomes:
measure: Conversion rates, operative time, hospital-costs
timeFrame: Dec 2004 - Feb 2006
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: stefan breitenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breitenstein S, Nocito A, Puhan M, Held U, Weber M, Clavien PA. Robotic-assisted versus laparoscopic cholecystectomy: outcome and cost analyses of a case-matched control study. Ann Surg. 2008 Jun;247(6):987-93. doi: 10.1097/SLA.0b013e318172501f.
Clinical trial NCT04049500: Adapt and Incorporate dDPP Into Clinical Workflows
Official title: An Observational Study to Adapt a Digital Diabetes Prevention Program (dDPP) and Incorporate it Into the Clinical Workflows.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Physician-Patient Relations
Nurse-Patient Relations
Keywords: Physicians
Nurses
Practice assistants
Health coaches
Population health managers
Patient navigators
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Five practices will be selected from NYULH ambulatory practice sites to represent the spectrum of provider settings within the system. These sites will be the clinical partners for the adaptation of the dDPP tool suite.

Brief summary: This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data elements (e.g. weight and daily step count) directly into EHR workflows of primary care to enhance patient engagement. It seeks to determine the impact of combining adapted visualizations and summaries of key dDPP data elements directly into the EHR with automated notifications and messaging designed to enhance patient engagement in the dDPP. The study will involve provider workflow analysis based on observation and facilitated group tool adaptation sessions.

Detailed description: Primary objective: to examine the impact of the dDPP tool suite on the EHR and clinical workflows, and identify optimization opportunities.

Secondary objective: to assess the "usability" of the proposed dDPP tool suite in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Physicians
* Nurses
* Practice assistants
* Health coaches
* Population health managers
* Patient navigators

Exclusion Criteria:

* Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.

Primary outcomes:
measure: Usability will be assessed using a 5-point Likert scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone
name: Devin Mann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawrence K, Rodriguez DV, Feldthouse DM, Shelley D, Yu JL, Belli HM, Gonzalez J, Tasneem S, Fontaine J, Groom LL, Luu S, Wu Y, McTigue KM, Rockette-Wagner B, Mann DM. Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 9;10(2):e26750. doi: 10.2196/26750.
Clinical trial NCT03517800: Surgical Management of Postpartum Haemorrhage Without Embolization
Official title: Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Second Line Management
Uterine Arteries Embolization
Surgical Management of Haemorrhage
Keywords: Embolization
surgery
hysterectomy
arterial ligation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 716
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with postpartum haemorrhage with a surgical management in a type III universitary maternity.

Brief summary: Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.


Eligibility criteria: Inclusion criteria:

* Age over 18
* Postpartum haemorrhage
* Necessity of second line management
* No embolization performed
* Necessity of surgical management after embolization

Exclusion criteria:

* Unnecessity of second line management
* Management by only embolization
* Incomplete medical files

Primary outcomes:
measure: Frequency of each type of surgical management
timeFrame: at delivery
Secondary outcomes:
measure: Number of surgical interventions
timeFrame: at delivery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pierre BOULOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044600: Gene Expression in Hyperparathyroidism
Official title: Gene Expression in Hyperparathyroidism: Identifying Molecular Differences in MEN1 Patients Versus Young MEN1 Negative Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parathyroid Disease
Hyperparathyroidism
Keywords: Parathyroid disease
Hyperparathyroidism
Chart review
MEN1-negative
HRPT2 mutations
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 22
Sex: ALL
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: Participants with parathyroid tumors at MD Anderson Cancer Center

Brief summary: Objectives:

1. To better define the differences in molecular genetics of parathyroid tumors in patients with MEN1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old.
2. To better define the incidence of HRPT2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.

Detailed description: Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports. Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients will be stained for parafibromin to evaluate for HRPT2 mutations.

Eligibility criteria: Inclusion Criteria:

1. All patients previously enrolled in parathyroid tissue banking under protocol Lab08-0034.
2. For the subgroup designated for HRPT2 mutation testing:

Patients with primary hyperparathyroidism who are younger than 50 years of age and have tested negative for MEN1, between January 1, 1980 and the present.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Molecular Genetics of Parathyroid Tumors
timeFrame: 10 years
Secondary outcomes:
measure: HRPT2 Mutations
timeFrame: 10 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nancy D. Perrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01735500: hsTnT After Elective Coronary Angiography
Official title: Rise of hscTnT After Elective Coronary Angiography Without Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Prei-procedural
Elevation
cardia Troponin T
in stable
unknown
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 545
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: Consecutive patients with stable or unknown CAD undergoing CAG with/or without PCI. Patients receiving additional examination, such as biopsy, Ablation or any other procedure that could lead to myocardial injury resulting in elevation of the cardiac Troponin are being excluded, as well as Patients with acute coronary syndrome.

Brief summary: A prospective Study, aiming to understand and analyse the key role of the novel High Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated coronary angiography without receiving any additional intervention. The peri-procedural elevation of the hsTnT indicates some other factors being responsible for the elevation of the hsTnT in absence of an acute coronary syndrome, such as physiological components or micro-injuries. A one year follow-up has been collected.


Eligibility criteria: Inclusion Criteria:

- Stable or unknown CAD

Exclusion Criteria:

- Acute Coronary Syndrome

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: Up to 12 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Cardiology - University Hospital of Heidelberg
Study officials:
affiliation: Department of Cardiology, University Hospital of Heidelberg
name: Evangelos Giannitsis, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: