louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02361619: Dabigatran in an Interaction Probe Drug Cocktail
Official title: An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-02-12
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Weight at least 50 kg and body mass index 19 - 30 kg m-2
* Normal clinical laboratory profiles
* No childbearing potential or use of adequate contraceptive measures

Exclusion Criteria:

* Blood loss \>300 ml within 2 months prior to the first dosing day
* Pregnancy, breastfeeding
* Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
* Infection with HIV, HBV or HCV
* Participation in the preceding 3 months or concomitantly in any clinical drug study
* Suspected current drug or alcohol abuse
* History of drug or alcohol abuse.
* Concomitant medication with the exception of hormonal contraception.
* Positive result in urine test for drug abuse.
* Nicotine consumption equivalent to \>5 cigarettes per day

Primary outcomes:
measure: AUC of dabigatran in plasma
timeFrame: 24 h
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 23 days
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Teutori CPRU
Study officials:
affiliation: Turku University Hospital
name: Petri Vainio, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05239819: The Cardiopulmonary Effects and Diaphragm Function of Complete Inspiratory Muscle Training in Patients With Upper Abdominal Surgery
Official title: The Fully Engaged Inspiratory Muscle Training Reduces Postoperative Pulmonary Complications Rate and Increased Respiratory Muscle Function in Patients With Upper Abdominal Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Muscle Training
Postoperative Pulmonary Complications
Respiratory Muscle Function
Abdominal Surgery
Keywords: inspiratory muscle training
postoperative pulmonary complications
respiratory muscle function
abdominal surgery
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population will be randomized and separated in two groups, Intervention and Usual care group.
Primary purpose: PREVENTION

Brief summary: Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). The threshold inspiratory muscle training (IMT) may serve as an effective modality to improve respiratory muscle strength and endurance in patients. However, whether this training could help patients with upper abdominal surgery remain to be determined.


Eligibility criteria: Inclusion Criteria:

1. ≧20 years old with upper abdominal surgery,
2. American Society of Anesthesiologists; ASA) I-IV
3. body Mass Index; BMI≥ 18
4. able to follow exercise protocol. T

Exclusion Criteria:

1. history of prior abdominal surgery
2. high risk of exercise contraindications (e.g. severe cardiac or cardiovascular disease), 3) American Society of Anesthesiologists; ASA) V-IV

4) unable to follow exercise protocol 5) severe organ failure

Primary outcomes:
measure: Postoperative Pulmonary complications rate
timeFrame: Change from baseline (0 week) to follow up (4 weeks)
measure: Respiratory muscles strength
timeFrame: Change from baseline (0 week) to follow up (4 weeks)
measure: Diaphragm mobilit
timeFrame: Change from baseline (0 week) to follow up (4 weeks)
Secondary outcomes:
measure: Quality of life score
timeFrame: Change from baseline (0 week) to follow up (4 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
citation: Huang YT, Lin YJ, Hung CH, Cheng HC, Yang HL, Kuo YL, Chu PM, Tsai YF, Tsai KL. The fully engaged inspiratory muscle training reduces postoperative pulmonary complications rate and increased respiratory muscle function in patients with upper abdominal surgery: a randomized controlled trial. Ann Med. 2022 Dec;54(1):2222-2232. doi: 10.1080/07853890.2022.2106511.
Clinical trial NCT02984319: Effect of Cherry Concentrate on Vascular Function
Official title: Effect of Cherry Concentrate on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young men


Eligibility criteria: Inclusion Criteria:

* no prescription medications

Exclusion Criteria:

* prescription medications

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: Change from baseline to 3 hours post dietary supplementation
Secondary outcomes:
measure: Microvascular function (laser doppler flowmetry)
timeFrame: Change from baseline to 3 hours post dietary supplementation
measure: Plasma nitrite concentration
timeFrame: Change from baseline to 3 hours post dietary supplementation
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences
state: Devon
Study officials:
References:
Clinical trial NCT05523219: Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Official title: Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 81
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: Due to its non-comparative design, no patient was randomized. Every patient who respected the selection criteria were included to create an exhaustive and consecutive cohort

Brief summary: This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:

* To assess functional clinical score's evolution,
* To evaluate patient's satisfaction
* To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021.

Patients were implanted and followed as per standard of care led in the investigational site.

The following regulation and guidelines were followed for this investigation:

* Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable;
* Regulation (UE) 2016/679 (RGPD) ;
* Regulation (UE) 2017/745 (MDR) ;
* MEDDEV 2.12.1;
* Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Major patient on the date of surgery
* Patient with foot pathology requiring Akin osteotomy
* Patient not opposed to the collection of data

Exclusion Criteria:

* Patient unable to understand and follow the postoperative instructions
* Patient with a contraindication to the use of the implant
* Non-implanted patient with a varisation staple

Primary outcomes:
measure: AOFAS Score
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 3 and 12 months
measure: Number of Complications Observed During the Clinical Investigation
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Victor Hugo Clinical
state: Ile De France
Study officials:
References:
Clinical trial NCT03500419: Penile Length Maintenance Post-Prostatectomy
Official title: Penile Length Maintenance Post-Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Penile Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 82
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: The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

Detailed description: The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene.

Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length.

To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.

Eligibility criteria: Inclusion Criteria:

* Undergoing robotic prostatectomy
* Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit

Primary outcomes:
measure: Change in Penile Length
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Erectogenic Therapy Use
timeFrame: 6 months
measure: Intracavernosal Injections
timeFrame: 6 months
measure: Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
timeFrame: baseline, 6 months
measure: Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
timeFrame: Baseline, 6 months
measure: Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Ziegelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03292419: Topography-guided LASIK Surgery
Official title: A Prospective Evaluation of Topography-guided LASIK Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Topography guided
Primary purpose: TREATMENT

Brief summary: The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism

Detailed description: The investigators are analyzing outcomes of topography-guided LASIK surgery in participants with myopia and myopic astigmatism. The investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. The investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. In addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why UDVA and CDVA improves over time

Eligibility criteria: Inclusion Criteria:

* Subjects age 18 and older with healthy eyes. Nearsightedness between -0.50 diopters and -8.00 diopters.
* Subjects with up to 3.00 diopters of astigmatism.
* Subjects with a spherical equivalent of up to -9.00 diopters.

Exclusion Criteria:

* Subjects under the age of 18.
* Subjects with excessively thin corneas.
* Subjects with topographic evidence of keratoconus.
* Subjects with ectatic eye disorders.
* Subjects with autoimmune diseases.
* Subjects who are pregnant or nursing.
* Subjects with more than 3.00 diopters of astigmatism

Primary outcomes:
measure: Epithelial thickness maps
timeFrame: 12 months
Secondary outcomes:
measure: Changes in corrected visual acuity
timeFrame: 12 months
measure: Uncorrected distance visual acuity
timeFrame: 12 months
measure: Quality of Vision
timeFrame: 12 months
measure: Predictability
timeFrame: 12 months
measure: Contrast visual acuity
timeFrame: 12 months
measure: Residual astigmatism levels after surgery
timeFrame: 12 months
measure: Change in refraction over time
timeFrame: 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Edward E Manche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252419: Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat
Official title: Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharyngitis
Keywords: Postoperative Period
Anesthesia, General
Intubation, Intratracheal
Dexamethasone
Acetaminophen
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 242
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Detailed description: The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for urologic surgery under general anesthesia
* ASA I-III

Exclusion Criteria:

* Patients with recent sore throat
* Patients with neck surgery
* Patients with anticipated difficult airway
* Patients with Mallampati grade 3
* Patients with severe cardiovascular or pulmonary disease
* Patients with allergic history to dexamethasone or paracetamol
* Patients with liver function disorder
* Patients with liver disease

Primary outcomes:
measure: Postoperative sore throat
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Postoperative sore throat degree
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Postoperative pain
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Nausea
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Vomiting
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Somnolence
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Shivering
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Headache
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Hoarseness
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Dysphagia
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Analgesics
timeFrame: 0, 1, 6, 24 hour postoperatively
measure: Postoperative sore throat
timeFrame: 0, 6, 24 hour postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seolu National University of Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyoung Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776619: Safety and Tolerability Study of Multiple Doses of PF-06305591
Official title: A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
tolerability
PK
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 14 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 14 days
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 14 days
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05150119: Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty
Official title: Correlation Between Altered Glycometabolic Status and Joint Inflammation in Diabetic Patients With Osteoarthritis Undergoing Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic Patients
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is made up of diabetic patients, of age, undergoing knee replacement surgery for osteoarthritis

Brief summary: Evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery


Eligibility criteria: Inclusion Criteria:

* Diabetic patients
* Patients with osteoarthritis awaiting knee replacement surgery
* Patients awaiting knee replacement surgery
* Patients who agree to sign informed consent

Exclusion Criteria:

* Patients less than 55 years of age.
* Patients over 85 years of age.
* Patients who are unable to understand and want.
* Patients with severe neurological disorders or with severe disabilities.
* Rheumatoid arthritis patients
* Cancer patients
* Patients suffering from chronic inflammatory bowel syndromes (RCU and Crohn's disease)
* Patients on immunosuppressive therapy

Primary outcomes:
measure: To evaluate if there is a linear positive correlation between plasma glycated hemoglobin concentration HbA1c and synovial IL-6 in diabetic patient
timeFrame: 2 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References: