louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966589: Surgical or Conservative Treatment of Sportsman Hernia
Official title: Chronic Groin Pain and Sportsman Hernia of Athletes: Randomized Study Between Conservative Treatment and Laparoscopic Hernioplasty (TEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Groin Pain
Keywords: groin pain
sportsman hernia
osteitis pubis
laparoscopic surgery
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Five to ten percent of athletes and physical active adults are suffering chronic groin pain. The most common diagnoses are adductor tendinitis, sportsman hernia and osteitis pubis. Sportsman hernia is not a real hernia in the groin, but overuse injury of the groin muscles and tendons. No evidence-based treatment of this disabling condition has been found so far. Experimental surgical treatments are based on various hernioplasties. Laparoscopic extraperitoneal hernioplasty (TEP) is a mini-invasive and effective method to heal sportsman hernia in non-randomized cohorts.

Detailed description: This prospective randomized study investigates the effect of active conservative treatment (rest, physical treatment, corticosteroid injections, anti-inflammatory analgesics) versus surgery (laparoscopic TEP) on the healing of sportsman hernia. Diagnosis of sportsman hernia is always based on careful clinical examination and magnetic resonance imaging. 25 patients with sportsman hernia are randomized into conservative treatment and 25 patients in surgery. The duration of follow-up is 1 year. The main end-point of treatments is disappearing of chronic groin pain (visual analogue scale, entering to sports).

Eligibility criteria: Inclusion Criteria:

* severe groin pain lasting \> 6 months
* sportsman hernia

Exclusion Criteria:

* other diagnosis ruled out by MRI and clinical examination

Primary outcomes:
measure: Decrease of groin pain measured by visual analogue scale (VAS)
timeFrame: 1 year
Secondary outcomes:
measure: Return to sport activities
timeFrame: 1 year
Other outcomes:
Locations:
city: Mikkeli
country: Finland
facility: Hannu Paajanen
Study officials:
affiliation: Central Hospital of Mikkeli, Finland
name: Hannu EK Paajanen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kuikka L, Hermunen H, Paajanen H. Effect of pubic bone marrow edema on recovery from endoscopic surgery for athletic pubalgia. Scand J Med Sci Sports. 2015 Feb;25(1):98-103. doi: 10.1111/sms.12158. Epub 2013 Dec 18.
Clinical trial NCT02256189: Sitagliptin and Glucagon Counterregulation
Official title: The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

Detailed description: The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.

Eligibility criteria: Inclusion Criteria:

1. Written consent has been given.
2. Patients with metformin treated T2DM (metformin dose \>0,5 g/day and stable during the preceding 3 months)
3. Age \>65 years.
4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
5. Ability to complete the study

Exclusion Criteria:

1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
2. Type 2 diabetes, positive GAD antibodies
3. eGFR \<60 ml/min
4. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
5. Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes.
6. Liver disease such as cirrhosis or chronic active hepatitis
7. History of coronary heart disease or heart failure class III or IV
8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study

Primary outcomes:
measure: Glucagon Counterregulation to Hypoglycemia
timeFrame: Four weeks treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital Malmö
Study officials:
affiliation: Lund University
name: Bo Ahrén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288689: Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term
Official title: Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients 20-44 years old at term

Brief summary: In this study the investigators aim to compare the cervical dilation time in pregnant patients at term who had clinical evaluation of the cervical consistency with patients who had also quantitative measurement of the cervical elasticity in .

Detailed description: Softening of the uterine cervix in pregnant patients at term is usually evaluated clinically by subjective vaginal manual examination (Bishop's score).One of the variables of the score is cervical consistency which is considered important factor.The cervical consistency is described as soft,medium or stiff.However, the digital assessment of consistency is subjective and less reproducible.The Bishop's score also gives information about expected duration of labor after induction. The consistency of the uterine cervix can also be evaluated objectively sonoelastographically by measuring the cervical elasticity.This is illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.In this study we aim to compare the cervical dilation time between the clinical evaluation of the cervical consistency and the quantitative measurement of the cervical elasticity in pregnant patients at term.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients at term

Exclusion Criteria:

* Various pregnancy complications

Primary outcomes:
measure: Assess elasticity of uterine cervix through comparison of sonoelastographic evaluation and manual vaginal examination [Bishop Score] in pregnant patients at term
timeFrame: at time of the manual vaginal examination and participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Rami Aviram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04866589: COVID-19: The Effectiveness of Free Face Mask Distribution
Official title: The Effectiveness of Distributing Free Face Masks to Increase Use of Face Masks During the COVID-19 Pandemic. A Randomised Experiment in Stovner District, Oslo, Norway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Face masks
Infection control
Behavioral intervention
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Stovner District, City of Oslo, Norway
First posted: 2021-04-30
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The team members from the Stovner district-administration will send a numbered list to Norwegian Institute of Public Health-team, with the names of the stores. The ordering of the stores will define the numbers used to represent each store in the randomisation process. Using Stata software, we will carry out 13 separate and independent randomisations, each assigning the intervention to half the included stores. An additional randomisation to the treatment or control group will be carried out for a marginal store each day in the event of an odd number of stores.

Unless it proves too logistically cumbersome, we will also randomise the corona hosts, i.e. the store they are allocated to will be decided through randomisation.
Primary purpose: PREVENTION

Brief summary: The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. The investigators will compare the proportion of customers who wear face masks as they enter the store in stores with or without face mask distribution.


Eligibility criteria: All grocery stores in the Stovner district are eligible as long as they have not, or only sporadically, had free distribution of face masks previously.

At the customer level, we will only include those 12 years or older (age based on the outcome assessor's judgement).

Primary outcomes:
measure: Face mask use
timeFrame: Through study completion, 3 weeks.
Secondary outcomes:
measure: Correct use of face masks
timeFrame: Through study completion, 3 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Stover District
Study officials:
affiliation: Norwegian Institute of Public Health
name: Atle Fretheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elgersma IH, Fretheim A, Indseth T, Munch AT, Johannessen LB, Hansen CE. The Evaluation of a Social Media Campaign to Increase COVID-19 Testing in Migrant Groups: Cluster Randomized Trial. J Med Internet Res. 2022 Mar 24;24(3):e34544. doi: 10.2196/34544.
Clinical trial NCT05958589: Caudal Block for Inguinal Hernioplasty in Children
Official title: Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: general anesthesia
caudal block
pain
hemodynamic parameters
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 70
Sex: MALE
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.

Detailed description: This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.

Eligibility criteria: Inclusion Criteria:

* boys between 3 to 5 years old
* scheduled for elective inguinal hernioplasty
* without comorbidities and chronic therapy, ASA class I
* body mass and growth normal for the given age
* no allergies
* no congenital anomalies and birth complications

Exclusion Criteria:

* emergency surgeries
* surgeries longer than 60 minutes
* acute infections with leucocytosis/leucopenia
* acute or chronic diseases
* deformities and disorders of spine and nervous system
* allergies
* pilonidal cyst and/or inflammation in sacral region

Primary outcomes:
measure: Postoperative pain
timeFrame: 5 hours
measure: Postoperative pain
timeFrame: 5 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: 5 hours
measure: Heart rate
timeFrame: 5 hours
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Institute for health care of children and youth of Vojvodina
state: Vojvodina
Study officials:
References:
Clinical trial NCT01682889: The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
Official title: The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation: a Randomized, Controlled Clinical Trial in Patients Receiving Peripheral Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Medical Scientific Fund of the Mayor of Vienna
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on hemodynamic and on parameters of microcirculation in patients with peripheral arterial occlusive disease (PAOD).


Eligibility criteria: Inclusion Criteria:

* female or male patients receiving peripheral bypass surgery
* age between 55 and 75 years

Exclusion Criteria:

* metabolic acidosis

Primary outcomes:
measure: Change from baseline in temperature gradient at 3h post-surgery
timeFrame: baseline and 3h post-surgery
Secondary outcomes:
measure: Change from baseline in Laser Doppler blood perfusion imaging at 1h
timeFrame: baseline & 1h post-surgery
measure: Change from baseline in Laser Doppler blood perfusion imaging at 2h
timeFrame: baseline & 2h post-surgery
measure: Change from baseline in Laser Doppler blood perfusion imaging at 3h
timeFrame: baseline & 3h post-surgery
measure: Change from baseline in Laser Doppler blood perfusion imaging at 24h
timeFrame: baseline & 24h post-surgery
measure: Change from baseline in Laser Doppler blood perfusion imaging at 48h
timeFrame: baseline & 48h post-surgery
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
timeFrame: baseline & 3h post-surgery
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
timeFrame: baseline & 24h post-surgery
measure: Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
timeFrame: baseline & 48h post-surgery
measure: Change from baseline in plasma arginine concentration at 3h
timeFrame: baseline & 3h post-surgery
measure: Change from baseline in plasma arginine concentration at 24h
timeFrame: baseline & 24h post-surgery
measure: Change from baseline in plasma arginine concentration at 48h
timeFrame: baseline & 48h post-surgery
measure: Change from baseline in temperature gradient at 1h
timeFrame: baseline & 1h post-surgery
measure: Change from baseline in temperature gradient at 2h
timeFrame: baseline & 2h post-surgery
measure: Change from baseline in temperature gradient at 24h
timeFrame: baseline & 24h post-surgery
measure: Change from baseline in temperature gradient at 48h
timeFrame: baseline & 48h post-surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Jörg Michael Hiesmayr, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02115789: Perceptions of Aesthetic Outcomes of Zigzag and Linear Scars
Official title: Perceptions of Aesthetic Outcomes of Zigzag and Linear Scars
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Linear Scar
Zigzag Scar
Keywords: cicatrix
Demonstrate
that there
is no perception of superiority
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the dermatology clinic at UC Davis Medical Center.

Brief summary: Surgical wounds can be closed in several manners. Some physicians believe that closure in a straight line produces a scar that is more visible and slightly raised when compared to closure in a zigzagging fashion. The researchers of this study believe that there is no difference in the cosmetic appearance of one type of wound closure over the other. To evaluate this, they will provide a survey with visual aids to volunteers to rate the appearance of a straight line scar versus a zigzag scar.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years or older

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Subjects will review examples of both linear and zigzag scars and rate the aesthetic appearance of both configurations of scars on a scale of 1 through 10, with 1 being "normal skin" and 10 being "the worst scar imaginable".
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232189: Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
Official title: Serum Concentrations of Pregnancy-associated Proteins for Assessment of Gestational Age Before Abortion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Keywords: placental protein
gestational age
abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Family Planning Associates Medical Group, LTD
name: Planned Parenthood of Greater New York
name: Presidential Women's Center
First posted: 2020-01-18
Enrollment: 275
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant people seeking abortion at multiple clinics that provide abortion through at least 18 weeks of gestation.

Brief summary: This will be a case-series multicenter study enrolling 800 pregnant people. Serum will be collected from people seeking abortion and assayed at a qualified laboratory.

Detailed description: Knowledge of gestational age (GA) is essential for guiding abortion care. In 2016, Gynuity Health Projects (GHP) launched a portfolio of research that aims to explore the possibility of developing a blood or urine test for this purpose.The goal of the present study is to validate initial study findings (protocol 8000) in a larger population of people seeking abortion.

Staff will obtain a serum specimen from each participant before any cervical manipulation is performed and before any abortifacient drug is administered. The site will send the specimens to a central facility for storage until assay. Serum assays for PAPP-A and possibly other proteins will be performed at a selected laboratory by qualified experts.

Eligibility criteria: Inclusion Criteria:

* Pregnant and seeking medical or surgical abortion
* Has had or will have an ultrasound on the day of study enrollment or earlier during the current pregnancy
* Able to provide blood and urine specimens before any trans-cervical procedure or mifepristone ingestion
* Not previously enrolled in this study

Exclusion Criteria:

* Does not meet Inclusion Criteria

Primary outcomes:
measure: Negative Predictive Value 70 days
timeFrame: 1 day
measure: Negative Predictive Value 105 days
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Presidential Women's Center
state: Florida
city: Chicago
country: United States
facility: Family Planning Associates
state: Illinois
city: New York
country: United States
facility: Planned Parenthood of New York City
state: New York
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth G Raymond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418989: A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers
Official title: An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, age 18 to 65 years inclusive
* Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
* A body mass index (BMI) between 18 to 32 kg/m2 inclusive

Exclusion Criteria:

* Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra
timeFrame: 21 days
measure: Peak plasma concentration of RoActemra/Actemra
timeFrame: 21 days
Secondary outcomes:
measure: Safety (Incidence of adverse events)
timeFrame: 28 days
Other outcomes:
Locations:
city: Montpellier
country: France
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: