louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03956043: Diagnostic Accuracy in Sepsis
Official title: Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 1989
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: Oslo University Hospital is a secondary and tertiary Hospital in Norway's largest city Oslo. The Emergency Department treats about 30 000 patient per year, including approximately 500 with suspected sepsis.

Brief summary: The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo

Exclusion Criteria:

* Non

Primary outcomes:
measure: Diagnostic accuracy in sepsis
timeFrame: within 90 days after inclusion
measure: Prognostic accuracy in sepsis
timeFrame: 90 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Aleksander R Holten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen EE, Binde C, Leegaard M, Tonby K, Dyrhol-Riise AM, Kvale D, Amundsen EK, Holten AR. DIAGNOSTIC ACCURACY AND ADDED VALUE OF INFECTION BIOMARKERS IN PATIENTS WITH POSSIBLE SEPSIS IN THE EMERGENCY DEPARTMENT. Shock. 2022 Oct 1;58(4):251-259. doi: 10.1097/SHK.0000000000001981. Epub 2022 Sep 6.
Clinical trial NCT04470843: Impact of Acetazolamide in Reducing Referred Postoperative Pain
Official title: Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Men
Keywords: Prostatectomy
Acetazolamide
Postoperative Pain
Prostate Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves removing a man's prostate using a minimally invasive robotic approach under the guidance of a surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic procedures because it is cost-effective, noncombustible and readily excreted via the respiratory system in healthy patients.

Insufflation with CO2, however, has been linked to post-operative referred pain secondary to peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred pain, may not be adequately treated with the current standard pain control regimen.


Eligibility criteria: Inclusion Criteria:

• Male patients ≥18 years of age undergoing robotic-assisted prostatectomy

Exclusion Criteria:

* Patients with renal insufficiency with serum creatinine \>2.0 mg/dl
* Patients with renal transplant
* Patients with pre-existing metabolic acidosis
* Patients with chronic obstructive pulmonary disease
* Patients with hepatic disease
* Patients with central nervous system disorders
* Patients with hematological disease history
* Patients with pre-existing electrolyte abnormalities
* Patients with hypovolemia
* Patients with lithium or diuretic usage
* Patients with sulfonamides allergy
* Patients with American Society of Anesthesiologists physical status 4 or 5

Primary outcomes:
measure: Visual Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Scott Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06212843: Effect of 8 Week Plyometric Training on Injury Prevention in Domestic Cricket Players
Official title: Effect of 8 Week Plyometric Training on Injury Prevention in Domestic Cricket Players
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Injury Prevention
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to find the effectiveness of plyometric training on injury prevention of domestic cricket players. Players will be taken from Chakwal and a well designed plyometric plan will be implied on them for 8 weeks. After that the results will be compared with the other group who did not get any plyometric training to see the effectiveness of the treatment plan.


Eligibility criteria: Inclusion Criteria:

* domestic cricket players between 18-25 years.
* actively engaged for more than 1 year

Exclusion Criteria:

* history of trauma/injury in last month

Primary outcomes:
measure: Deep squat Test
timeFrame: 8 weeks
measure: One legged squat
timeFrame: 8 weeks
measure: Inline lunges
timeFrame: 8 weeks
measure: active hip flexion test
timeFrame: 8 weeks
measure: straight leg raise test
timeFrame: 8 weeks
measure: Push-up
timeFrame: 8 weeks
measure: Diagonal lift
timeFrame: 8 weeks
measure: Seated rotation test
timeFrame: 8 weeks
measure: functional shoulder mobility
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University Islamabad
name: Aqsa safdar, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746443: Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey
Official title: Impact of Covid-19 Affliction on Psychological and Mental Health of the College Students: Cross-Sectional Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: college students
CORONA
COVID-19
Graduates
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: College going students

Brief summary: The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).

Detailed description: Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students

Methodology:

Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests

Eligibility criteria: Inclusion Criteria: Students positive for COVID-19 test -

Exclusion Criteria: Students negative for COVID-19 test

-

Primary outcomes:
measure: EVENT IMPACT SCALE - REVISED
timeFrame: Within 1 month of the impact of COVID-19
Secondary outcomes:
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: King Khalid University
state: Aseer
Study officials:
affiliation: King Khalid University
name: SNEHIL DIXIT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05981443: An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Official title: Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brow Ptosis
Surgical Wound
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are:

* if Dermabond provides equivalent wound healing compared to conventional non-absorbable skin suture techniques
* if Dermabond provides equivalent scar appearance compared to conventional non-absorbable suture techniques
* if Dermabond results in equivalent complication rates compared to conventional non-absorbable suture techniques Participants will have be randomly selected to have either Dermabond or non-absorbable suture closure methods. Scar analysis and both participant and provider surveys will be performed to assess the differences between groups, if any.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing bilateral direct excision brow lift for brow ptosis at the University of Kentucky Medical Center.
* Patients \> 18 years of age.
* Patients must be able to follow up at the specified intervals.
* Patients who are able to give their own informed consent.
* Health Status: Variable health status reflective of general population of Kentucky. Patients will be healthy enough to be seen in an office setting.
* All patients will need to be proficient in the English language to understand the scale used for scar assessment

Exclusion Criteria:

* Patients \<18 years of age or \>100
* Allergy to Dermabond
* Adults with impaired consent capacity
* Incarcerated individuals

Primary outcomes:
measure: Scar Appearance
timeFrame: 10 days
measure: Scar Appearance
timeFrame: 6 weeks
measure: Number of Participants With Complications
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Peter Timoney, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00239343: Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer
Official title: Randomised Placebo-controlled Phase II Trial of Preoperative Therapy With Gefitinib (Iressa®/ZD1839) and Epirubicin-Cyclophosphamide in Patients With Primary Operable (T2-T3) Oestrogen Receptor Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 160
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: The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.

Exclusion Criteria:

* any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding

Primary outcomes:
measure: the complete pathological response rate in the two study groups at trial closure
Secondary outcomes:
measure: complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Research Stie
city: København N
country: Denmark
facility: Research Site
city: København Ø
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Århus C
country: Denmark
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05669443: Effect of Optimized PEEP on Mechanical Ventilation During Robot Assisted Laparoscopic Prostatectomy
Official title: Application of Individualized Positive End-expiratory Pressure Using Electrical Impedance Tomography (EIT) in Patients Undergoing Robot Assisted Laparoscopic Prostatectomy : a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.


Eligibility criteria: Inclusion Criteria:

1. 20 - 70 years of age who are scheduled for robotic assisted laparoscopic prostatectomy at the Department of Urology, Gangnam Severance Hospital,
2. ASA-PS (American Society of Anesthesiology Body Rating) I-IlI,
3. Patients with a BMI of 35 kg/m2 or less

Exclusion Criteria:

1. Patients with lung disease
2. BMI \>35kg/m2
3. Patients for whom positive end-tidal pressure cannot be applied (large bullae, severe cardiac disease)
4. patient refusal

Primary outcomes:
measure: PaO2/FiO2
timeFrame: end of surgery (before extubation)
Secondary outcomes:
measure: PaO2/FiO2
timeFrame: 15 minutes after intubation, 1 hour after pnemoperitoneum
measure: ROI (region of interests)
timeFrame: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
measure: inhomogeneity index
timeFrame: 15 minutes after intubation, 1 hour after pnemoperitoneum, end of surgery (before extubation)
measure: total amount of fluid administered during surgery
timeFrame: end or surgery
measure: total dose of vasopressor administered during surgery
timeFrame: end of surgery
measure: length of hospitalization after surgery
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severacne Hospital Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02146443: Validation and Test-retest Study of the Star-shaped Manual Dexterity Test.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Dexterity
Keywords: Manual dexterity
hand to eye coordination
stress
fatigue
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure test-retest reliability and validate the star shaped test of manual dexterity. The purpose of this is to see if there is any significant learning effect, and if the test can discriminate between individuals who are at their normal skill level, and when they are stressed and/or fatigued. The test is designed to test hand to eye coordination and precision control. This is done by following a star shaped track with a pair of a surgical scissors. this is done 10 times, 5 times clockwise and 5 times counter clockwise. Each time the scissors come into contact with the border of the track, an error is counted. Overall completion time is recorded. As a randomized crossover study, we will have 20 test subjects complete the test 4 times. Each test will be conducted with a pause of two breaks between the tests. Before each test, the test subjects are randomized to: no intervention, physical fatigue prior to testing, distractions during the test or both physical fatigue prior to testing and distractions during the test. All participants will complete a test with all four interventions. Furthermore, a test-retest trial will be conducted on 4 test-subjects. Each subject will complete the test two times with no interventions, with two days apart.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 55 years

Exclusion Criteria:

* Diagnosed heart disease
* Diagnosed endocrinological disease
* Diagnosed Neurological or autoimmune disease
* Diagnosed Sleep disorder
* Diagnosed orthopedic diseases or former orthopedic surgery (e.g. arthrosis, rotator cuff syndrome)

Primary outcomes:
measure: Completion time of the star shaped manual dexterity test.
timeFrame: up to day 10
Secondary outcomes:
measure: Number of errors during the completion of the star shaped manual dexterity test.
timeFrame: Test completion period at day 1, 4, 7 and 10
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital, Copenhagen University
name: Niels Kildebro, BSc.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930043: A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
Official title: A Metagenome-wide Association Study of Gut Microbiota in Gastrointestinal Non-Hodgkin's Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The non-Hodgekin lymphoma patients with gastrointestinal involvement.

Brief summary: This is a observational study on the fecal microbiota in primary/secondary gastrointestinal lymphoma patients.

Detailed description: This observation study is aimed at investigating the gut microbiota alteration in gastrointestinal lymphoma (GIL) patients by performing metagenomic shotgun sequencing on GIL patients' fecal specimen. Before immuno-chemotherapy, the feces specimen of GIL would be collected and stored for further laboratory examination. This study would NOT alter the subsequential treatment of the patients.

Eligibility criteria: Inclusion Criteria:

* Gastrointestinal lymphoma with a clarified pathological diagnosis
* De novo gastrointestinal lymphoma patients who haven't received chemotherapy
* BMI in normal range

Exclusion Criteria:

* Antibiotics or probiotics application within a month
* Overweight (BMI≥25) or malnourished (BMI\<18.5) patients
* Patients who have been accepted gastrointestinal fistulation
* Gastrointestinal patients with inflammatory bowel disease (IBD), colorectal carcinoma (CRC) or any other chronic intestinal disease
* Patients infected by HIV

Primary outcomes:
measure: Metagenomic Linkage Groups (MLGs)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao, MD. PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT03330743: Parent Mentor Interventions for Early Childhood Obesity
Official title: Parent Mentor Interventions for Early Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 188
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to identify the most effective strategy for intervention to change behaviors and affect weight status in obese children 2-5 years of age within the context of early childhood education centers.

Detailed description: The primary aim is to test an intervention to disseminate and promote the adoption of positive deviance behaviors among parents of obese Hispanic children using peer mentors. This trial will evaluate the efficacy and feasibility of this approach in reducing adiposity among a high-risk population of children.

Our central hypothesis is that children randomized to the intervention with a parent mentor using positive deviance methods with have a greater reduction in adiposity as measured by body mass index (BMI) compared with a parent mentor using traditional education or a control receiving usual education.

Eligibility criteria: Inclusion Criteria:

* 2-5 years of age child, Hispanic ethnicity, attends the Head Start facility

Exclusion Criteria:

* any major medical disorder impairing growth or development

Primary outcomes:
measure: BMIz
timeFrame: 6 months post-enrollment
Secondary outcomes:
measure: Self-efficacy
timeFrame: 6 months post-enrollment
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Byron Foster, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foster BA, Alvarez HO, Padilla T, Meyer JS. Longitudinal Examination of Hair Cortisol Concentrations and Weight Changes in Preschool-Aged Children of Latino Farmworkers. Child Obes. 2023 Sep;19(6):399-407. doi: 10.1089/chi.2022.0103. Epub 2022 Aug 24.
citation: Foster BA, Weinstein K, Padilla T, Martinez C, Angeles-Ramos D. Growing Healthy Together: A Randomized Clinical Trial Using Parent Mentors for Early Childhood Obesity in Low-Income, Latino Families. Child Obes. 2022 Apr;18(3):168-177. doi: 10.1089/chi.2021.0165. Epub 2021 Oct 5.
citation: Foster BA, Weinstein K, Shannon J. Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community. Trials. 2019 Apr 25;20(1):235. doi: 10.1186/s13063-019-3342-3.