louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06247462: Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
Official title: Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Kidney Injury
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.


Eligibility criteria: Inclusion Criteria:

Participants will be physically active males and females between the ages of 18 and 45. Participants will be able to run continuously for at least 60 minutes. All will be able to speak and read English.

Exclusion Criteria:

1. non-English speakers, prisoners, pregnant women, or persons requiring a LAR will not be included
2. previous history of heat stroke or heat illness
3. currently experiencing a sunburn or other burn injury
4. have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
5. has resided in a hot climate within 2 months prior to the trial
6. answered "yes" to at least one question on the physical activity readiness questionnaire,
7. show signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
8. are a current smoker,
9. history of regular gastrointestinal distress,
10. known history of stomach ulcers or taking blood thinning medication,
11. known allergy to caffeine
12. have a resting blood pressure greater than 140 systolic or 90 diastolic, and
13. do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.

Primary outcomes:
measure: Biomarkers of Acute Kidney Injury from Ibuprofen Ingestion Prior to Exercise in the Heat
timeFrame: Change in urinary IFGBP7 multiplied by urinary TIMP2, urinary NGAL, and serum Cystatin C pre-exercise, immediately post-exercise and 1-hour post-exercise.
Secondary outcomes:
measure: Circulating Markers of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat
timeFrame: Change in plasma LBP and I-FABP from pre- to immediately post-exercise.
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Exercise Physiology Lab
state: New Mexico
Study officials:
References:
Clinical trial NCT00466362: Lifestyle Intervention in Obesity, Effect on Diabetes
Official title: One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 2 Diabetes
Keywords: Obesity
Diabetes
Weight
Lifestyle
Follow up
Lead sponsor: Evjeklinikken
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Morbidly obese patients

Brief summary: There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the "Evje-model" on type 2 diabetes.

The "Evje-model" is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients' local physician.

Detailed description: There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.

Eligibility criteria: Inclusion Criteria:

* All patients with BMI \> 35 with diagnosed type 2 diabetes
* Referred to Lifestyle Intervention from a public hospital

Exclusion Criteria:

* Pregnancy
* Active major psychiatric disease(s)
* Active and serious eating disorder
* Drug- and/or alcohol dependency

Primary outcomes:
measure: Health related quality of life
timeFrame: 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Evje Og Hornnes
country: Norway
facility: Evjeklinikken AS
state: Evjemoen
Study officials:
affiliation: Evjeklinikken
name: Tom B Schulz, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02277262: PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Incisional Hernia
Keywords: peritonitis patients
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.


Eligibility criteria: Inclusion Criteria:

* • Patients aged \> 18 years old

  * Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin (peritoneal reactivity, positive Blumberg sign, fever, free air/fluid in abdominal cavity, leucocytosis, increased CRP (C-reactive protein, lactic dehydrogenase (LDH), tachycardia, tachypnea, clinical or radiological evidence/suspect of bowel ischemia)
  * Eventual strong suspect of possible bacterial translocation (reduction of the natural intestinal barrier against bacterial translocation, i.e. bowel ischemia, bowel overdistension, intestinal occlusion, etc.)
  * Surgical indication for midline laparotomy independently from eventual previous laparotomies
  * Informed consent

Exclusion Criteria:

* • Patients aged \< 18 years old

  * Informed consent refusal
  * No Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin.
  * Surgical indication for laparotomies other than midline one
  * Pregnancy

Primary outcomes:
measure: Incisional hernia rate
timeFrame: 3 months
measure: Incisional hernia rate
timeFrame: 6 months
measure: Incisional hernia rate
timeFrame: 12 months
measure: Incisional hernia rate
timeFrame: 24 months
Secondary outcomes:
measure: Morbidity
timeFrame: 0 months
measure: Morbidity
timeFrame: 3 months
measure: Morbidity
timeFrame: 6 months
measure: Morbidity
timeFrame: 12 months
measure: Morbidity
timeFrame: 24 months
measure: Length of surgery
timeFrame: Day 0
measure: Time to drain removal
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
measure: Length of stay in hospital
timeFrame: At the discharge, an expected average of 1-2 weeks after the intervention
measure: Mortality
timeFrame: 0 months
measure: Mortality
timeFrame: 3 months
measure: Mortality
timeFrame: 6 months
measure: Mortality
timeFrame: 12 months
measure: Mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII hospital
Study officials:
References:
Clinical trial NCT02983162: Is wGRS Associated With DD Recurrence?
Official title: Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren Contracture
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are selected among those who participated in a previous study on the genetic basis of Dupuytren disease (GODDAF). In this study, patients with Dupuytren disease, Peyronie disease or Ledderhose disease and their family members were included. To answer the current research question, only the DD patients are required. The GODDAF study was a multi-center study. For practical reasons, we only want to include patients who were admitted to the UMCG.

1098 participants were included in the GODDAF study in the Netherlands. Of them 797 were DD patients. Of these 797 patients, we estimate that approximately 85% (677) were admitted to the UMCG. These patients will be approached for participation.

Brief summary: Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease.

Objective: We aim to determine whether the wGRS is associated with recurrent DD.

Study design: An observational study, in which the participants of the GODDAF study are followed up.

Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease.

Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.


Eligibility criteria: Inclusion Criteria:

* DD patient
* participant in the GODDAF study
* genetic data passed the quality control
* surgical treatment of DD
* written informed consent

Exclusion Criteria:

* Decisionally incapacitated
* Patients treated for DD with collagenase or radiotherapy

Primary outcomes:
measure: Presence of recurrent Dupuytren disease
timeFrame: 1 day
Secondary outcomes:
measure: Severity of Dupuytren recurrence
timeFrame: 1 day
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, dept Plastic Surgery
Study officials:
affiliation: University Medical Center Groningen
name: P. MN Werker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449462: Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function
Official title: The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CLA
liver
kidney
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2007-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.

The CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.

Detailed description: Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.

Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* serum total cholesterol \< 8.0 mmol/L
* serum triglycerides \< 3.0 mmol/L
* ALAT \< 45 IU/L
* ASAT \< 41 IU/L
* amylase 35-130 U/L
* alkaline phosphatase 40-125 U/L
* bilirubin \< 17 µmol/L
* gamma-glutamyltranspeptidase \> 75 U/L (men) and \< 40 U/L (women)
* lactate dehydrogenase 230-485 U/L
* creatinine clearance \>= 90 mL/min
* fasting glucose levels 70-115 mg/dL
* fasting insulin levels 5-30 mU/L

Exclusion Criteria:

* use of cholesterol lowering medication
* high alcohol intake
* BMI \> 30
* chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
* pregnancy

Primary outcomes:
measure: ALAT
measure: ASAT
measure: amylase
measure: bilirubin
measure: alkaline phosphatase
measure: gamma-glutamyltranspeptidase
measure: lactate dehydrogenase
measure: creatinine clearance
Secondary outcomes:
measure: total cholesterol
measure: HDL cholesterol
measure: LDL cholesterol
measure: triglycerides
measure: fatty acids
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Amsterdam, Institute for Health Sciences
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: VU University of Amsterdam
name: Ingeborg A Brouwer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University of Amsterdam
name: Martijn B Katan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wanders AJ, Leder L, Banga JD, Katan MB, Brouwer IA. A high intake of conjugated linoleic acid does not affect liver and kidney function tests in healthy human subjects. Food Chem Toxicol. 2010 Feb;48(2):587-90. doi: 10.1016/j.fct.2009.11.036. Epub 2009 Nov 22.
Clinical trial NCT00415662: Effect of Biomagnetic Therapy on Gonarthrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2006-12-25
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: In order to assess the effectiveness of biomagnetic therapy (PST) in the treatment of gonarthrosis, we conducted a randomized, double blind controlled clinical trial comparing one group of patients treated with PST and a second group of patients treated with conventional physical therapy.


Eligibility criteria: Inclusion Criteria:

* at least 35 years old
* local symptoms over a period of at least one-year
* persistent symptoms despite non steroidal anti-inflammatory drugs
* informed consent

Exclusion Criteria:

* operative treatment in the last six months
* intra-articular injection in the last four months
* rheumatic disease
* homolateral coxarthrosis
* malignant disorder
* body mass index greater than 33%
* pregnancy
* inability to understand the visual analog scale

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: HOSR
Study officials:
affiliation: HOSR
name: G Gremion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06983262: Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile
Official title: Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gummy Smile
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile


Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals
* Chiefs complain gummy smile
* Gummy smile due to short hypermobile upper lip
* Gingival Display not more than 5 mm

Exclusion Criteria:

* Pregnancy
* Lactation
* History of smoking more than 10 cigarettes per day
* Systemic conditions or intake of medications that could affect soft and hard tissue healing
* Use of orthodontic appliances
* Gingival display above 5mm

Primary outcomes:
measure: Postoperative pain assessment
timeFrame: up to one week
measure: Facial Edema (Swelling)
timeFrame: up to one week
measure: Healing Quality
timeFrame: up to 3 weeks
measure: Gingival display
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05017662: A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072
Official title: A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neuroendocrine Tumors
Lead sponsor: Ariceum Therapeutics GmbH
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

Detailed description: The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.

Eligibility criteria: Inclusion Criteria:

* Participant is capable of giving signed informed consent
* Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001

Exclusion Criteria:

- There are no exclusion criteria in this safety surveillance study.

Primary outcomes:
measure: Proportion of participants with second primary haematological and non-haematological malignancies.
timeFrame: During the whole study period (approximately 5 years).
Secondary outcomes:
measure: Proportion of treatment-related adverse events of any grade.
timeFrame: During the whole study period (approximately 5 years).
measure: Changes over time in laboratory tests (haematology)
timeFrame: During the whole study period (approximately 5 years).
measure: Changes over time in laboratory tests (biochemistry)
timeFrame: During the whole study period (approximately 5 years).
measure: Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause.
timeFrame: During the whole study period (approximately 5 years).
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Center
city: Perth
country: Australia
facility: Ramsay Hollywood Private Hospital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Nantes
country: France
facility: Hôtel Dieu de Nantes
city: Basel
country: Switzerland
facility: University Hospital Basel
city: London
country: United Kingdom
facility: Royal Free Hospital London
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00934362: Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Official title: A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: Windtree Therapeutics
First posted: 2009-07-08
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.

Detailed description: This single-center pilot study is designed as a double-blind, randomized, cross-over clinical trial to evaluate the effects of inhaled lucinactant, an investigational peptide-containing synthetic surfactant (6 ml of 20 mg total phospholipid (TPL)/mL solution x 5 doses) in patients with mild to moderate CF lung disease. Lucinactant and vehicle will be delivered via a 510k approved vibrating mesh nebulizer, the Pari eFlowTM. The study duration corresponds to a 2-10 day screening phase, followed by a 20 day post-randomization phase that consists of two treatment periods (3 days each) and a washout period (14 days). A total of 16 patients will be enrolled and randomly assigned to one of two treatment sequences (Lucinactant followed by vehicle or vehicle followed by lucinactant). The primary outcome will be the rate of MC, as assessed via gamma scintigraphy, post-lucinactant and post vehicle. Secondary outcomes will include the rate of cough clearance (CC), lung clearance index (LCI), absolute change from baseline in FEV1 after 5 doses of study medication, CF-specific quality of life score (via CFQ-R instrument), in vitro assessments of sputum rheology, and various safety parameters.

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis
* FEV1\>40%

Exclusion Criteria:

* Unstable lung disease
* Unable or unwilling to stop hypertonic saline and dornase alfa for 3 days prior to each study period
* Relevant drug allergy or intolerance
* Recent investigational drug use (30 days)

Primary outcomes:
measure: Change in Mucociliary Clearance
timeFrame: 1 hour after final treatment (5th dose) minus baseline
Secondary outcomes:
measure: Spirometry
timeFrame: after 5 doses
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Scott H Donaldson, MD
role: PRINCIPAL_INVESTIGATOR
References: