louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01476033: Strong Women Study
Official title: Impact of Encapsulated Fruit, Berry and Vegetable Juice Powder Concentrate on Oxidative Stress, Inflammation and Blood Flow Before and Post Exercise in Overweight, Middle-aged, Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Keywords: Oxidative stress
inflammation
blood flow
Lead sponsor: Green Beat
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 44
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice powder concentrate on oxidative stress, inflammation and blood flow before and post exercise in overweight, middle-aged, women.

Main hypotheses (H1):

* The nutraceutical has an impact on oxidative stress reduction.
* The nutraceutical has an impact on inflammation.
* The nutraceutical has an impact on blood flow and microcirculation.
* Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers.
* Walking exercise for 30 minutes has an impact on blood flow and microcirculation
* The combination of nutraceutical supplementation + walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers, and on blood flow/microcirculation.


Eligibility criteria: Inclusion Criteria:

* women
* BMI \> 27
* praemenopausal
* non smokers
* eligibility for exercise
* 4wk wash out

Exclusion Criteria:

* male
* all people not matching this age group
* BMI \> 40 and \< 27
* peri- or postmenopausal women
* smokers
* all women taking dietary supplements
* all women that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure \> 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..)
* Diabetics
* osteoporosis or osteopenia

Primary outcomes:
measure: Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Manfred Lamprecht, PhD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122533: Reliability of Clinical Limb-length Measurements Methods
Official title: Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leg Length Inequality
Keywords: leg length inequality
leg length discrepancy
EOS 2D/3D
physical examination
length measurement
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young, healthy volunteers

Brief summary: There are numerous ways to measure limb length discrepancy in the clinical practice, although their reliability and accuracy are not well known. In our prospective diagnostic study we aimed to test the most popular methods and compare their results to EOS 3D reconstructions data.


Eligibility criteria: Inclusion Criteria:

* Age: 18-30 years
* BMI: \< 30
* Without orthopaedic complaint

Exclusion Criteria:

* Previous surgery on lower limb or spine
* Developmental disorder in the patients history

Primary outcomes:
measure: Radiological limb length
timeFrame: 6 months
measure: Intra- and interobserver reliability of the clinical lower limb measurements methods
timeFrame: 6 months
measure: Accuracy of the clinical lower limb measurements methods
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Universtify of Pecs, Department of Orthopaedics
state: Baranya
Study officials:
affiliation: University of Pecs Medical School, Department of Orthopaedics
name: Adam T Schlegl, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01078233: Observational Data Analysis in EuroSIDA (MK-0518-058)
Official title: Observational Safety Data Analysis From Routine Follow-up in the EuroSIDA Study of Patients Treated With Raltegravir in a Five-Year Post Authorization Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infections
Keywords: HIV
antiretroviral treatment
HIV Cohort
Treatment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: EuroSIDA Coordinating Centre, Copenhagen HIV Programme (CHIP)
First posted: 2010-03-02
Enrollment: 6617
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 16 years old and older in the EuroSIDA database

Brief summary: The main objective of the study is to monitor health outcomes associated with antiretroviral drugs in a population of HIV-infected patients.

Detailed description: Time Perspective: Retrospective and Prospective

Eligibility criteria: Inclusion Criteria:

* Adults 16 years old and older with HIV-1

Exclusion Criteria:

* Subjects will be excluded if they have no prospective follow up

Primary outcomes:
measure: Incidence of Malignancy
timeFrame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
measure: Incidence of Clinically Important Hepatic Events
timeFrame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
measure: Incidence of Lipodystrophy
timeFrame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
measure: Incidence of All-Cause Mortality
timeFrame: Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cozzi-Lepri A, Zangerle R, Machala L, Zilmer K, Ristola M, Pradier C, Kirk O, Sambatakou H, Fatkenheuer G, Yust I, Schmid P, Gottfredsson M, Khromova I, Jilich D, Flisiak R, Smidt J, Rozentale B, Radoi R, Losso MH, Lundgren JD, Mocroft A; EuroSIDA Study Group. Incidence of cancer and overall risk of mortality in individuals treated with raltegravir-based and non-raltegravir-based combination antiretroviral therapy regimens. HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.
Clinical trial NCT05829733: 6-month Efficacy and Safety of Synolis VA 80/160 in Hip Osteoarthritis
Official title: 6-month Evaluation of the Efficacy and Safety of Synolis VA 80/160 in the Treatment of Symptomatic Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis
Hip osteoarthritis
Hyaluronic acid
Lead sponsor: Aptissen SA
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, independent study of Synolis VA 80/160 over a period of 6 months


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age,
* Patient with osteoarthritis of the hip. The diagnosis is based on the following criteria:
* Treated hip pain: Oxford score ≥ 21/60,
* Kellgren-Lawrence positive X-ray stage: II - III (inclusion radiograph dated no more than 6 months before the inclusion visit),
* Symptoms related to osteoarthritis of the hip for at least 2 months,
* Failure of treatments (i.e., inadequate or ineffective response to analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids (leaving an OXFORD score ≥ 21/60),
* Informed consent form signed by the patient,
* The patient has never had a visco supplement injection or corticosteroid injection in the hip to be treated (or more than 6 months old).

Exclusion Criteria:

* Pregnancy,
* Participation in another clinical trial,
* Skin lesion near the injection site,
* Recent or old infection of the affected joint,
* Patient with a programmed arthroplasty,
* Patient with a pathology that makes decision-making impossible,
* The patient must not have undergone non-prosthetic hip-conserving surgery such as osteotomy or arthroscopy less than 12 months old.

Primary outcomes:
measure: Evolution of the Oxford Hip Score (OXFORD 12)
timeFrame: 6 months (M6)
Secondary outcomes:
measure: Evolution of the Oxford Hip Score (OXFORD 12)
timeFrame: Month 3, Month 3 to Month 6
measure: Self-assessment symptoms evolution
timeFrame: Month 3, Month 3 to Month 6
measure: MCID Oxford Hip Score (OXFORD 12)
timeFrame: Month 3, Month 3 to Month 6
measure: Hip prosthesis placement after the injection
timeFrame: Month 6
Other outcomes:
measure: Safety and tolerability of SYNOLIS VA 80/160
timeFrame: Month 6
Locations:
city: Belfort
country: France
facility: Service de Rhumatologie, Hôpital Nord Franche-Comté
city: Dunkerque
country: France
facility: Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD
city: Lille
country: France
facility: Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille
Study officials:
References:
Clinical trial NCT05404633: Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
Official title: Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End-stage Renal Disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce functional independence, increase post-discharge institutionalization and death among frail older adults. It is known that patients receiving early physical evaluation and rehabilitation (in the 24 hours following admission) improves post-discharge orientation, decreases delirium and the need of acute care. The rehabilitation often involves ergocycles, but commercially available devices are expensive and often hard to move, to set up in hospital bed and lack connectivity.

In this context, a connected ergocycle prototype which has a number of desired characteristics, including low production cost, relatively light and easy to move and with internet connectivity. The goal of this study is thereby to assess the usefulness and acceptability of the prototype with health professionals involved in physical rehabilitation and patients receiving said rehabilitation.


Eligibility criteria: Inclusion Criteria :

* \> 55 years old
* receiving treatments for terminal renal insufficiency at least 3 times a week, for at least 3 months (hemodialysis; HD) or under mechanical ventilation for less than 72 hours, and that should last for at least 24 more hours (intensive unit care; ICU)
* Physically independent outside HD or before admission (ICU) (≥ 70 on the Barthel index)
* with medical clearance (HD : nephrologist; ICU : intensivist)

Exclusion Criteria:

* unable to walk without assistance (before ICU admission)
* diagnosed neurocognitive decline
* recent hemiarthroplasty for a hip fracture that causes a limitation in the flexion of the hip during pedaling
* already involved in another study

Exclusion Criteria Specific for ICU Patients :

* neuromuscular disorder affecting the weaning from mechanical ventilator support
* pathologic fracture or unstable cervical spine fracture
* hospitalized for more than 7 days
* COVID-19 positive
* reported as moribund by the intensivist

Primary outcomes:
measure: Acceptability of the device
timeFrame: up to 1 hour after the exercise session for both the patients and professionals
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
References:
Clinical trial NCT00569933: Audio Recording for Improved Surgical Outcome (ARISO)
Official title: Audio Recording for Improved Surgical Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Hip Surgery
Perioperative
suggestions/imagery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Detailed description: Pt undergoing orthopedic surgery are randomized into 3 groups. These interventionals will be listening to CD recording just prior to and during orthopedic surgery. The 2nd group will be listening to a recording before and during surgery without any positive suggestions. The 3rd group will be receiving usual care. Prior to hospital discharge patients will fill out a questionaire assessing their perception of their surgery and hospital stay. Pt. charts will be reviewed for use of pain, sleep, anesthesia and nausea medication and for the number of units of blood transfused. Pt. outcomes will be asssessed with this data.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl.
* Willingness to sign consent.
* Age 18 or greater.

Primary outcomes:
measure: Post Op pain
timeFrame: Day 1 to 3
Secondary outcomes:
measure: Blood Loss, Nausea, sleep
timeFrame: Day 1 to Day 3
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: James H. Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906633: Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers
Official title: Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Keywords: antifungal therapies
Lead sponsor: University Hospital, Udine, Italy
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2009-05-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Haematologic patients with proven or probable invasive fungal infectious

Brief summary: This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).


Eligibility criteria: Inclusion Criteria:

* Haematologic patients with proven or probable IFI
* Therapy with a combination of antifungal drugs

Exclusion Criteria:

* Haematologic patients with possible IFI

Primary outcomes:
measure: safety, efficacy and duration of therapy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Udine
country: Italy
facility: University Hospital, Udine
Study officials:
affiliation: University Hospital, Udine, Italy
name: ANNA CANDONI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Candoni A, Caira M, Cesaro S, Busca A, Giacchino M, Fanci R, Delia M, Nosari A, Bonini A, Cattaneo C, Melillo L, Caramatti C, Milone G, Scime' R, Picardi M, Fanin R, Pagano L; SEIFEM GROUP (Sorveglianza Epidemiologica Infezioni Fungine nelle Emopatie Maligne). Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: the SEIFEM real-life combo study. Mycoses. 2014 Jun;57(6):342-50. doi: 10.1111/myc.12161. Epub 2013 Dec 23.
Clinical trial NCT01919333: Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Reserve
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery

Brief summary: This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.


Eligibility criteria: Inclusion Criteria:

* • Participants must be between the ages of 18 - 45 during enter the study .

  * Every participants have to completely understand the process of this study and have written informed consent .
  * Having regular menstrual cycles (21-35 days) at the time of operation
  * no evidence of any other endocrine disorders such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or adrenal insufficiency.
  * undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery for benign pelvic disease
  * No previous history of adnexal surgery
  * No any suspicious findings of malignant ovarian diseases
  * Never taking any medication such as oral pill and hormonal drugs within 3 months before the enrollment.
  * pathological diagnosis of excised ovarian tissue confirm as endometriotic cyst in study group and other benign pelvic disease in control group

Exclusion Criteria:

* polycystic ovarian syndrome according to the Rotterdam criteria

  * pathological report as the malignant diseases
  * have operation conversion to open-laparotomy

Primary outcomes:
measure: Serum AMH levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rangsit
country: Thailand
facility: Faculty of medicine , Thammasat university
state: Pathumthanee
Study officials:
References:
Clinical trial NCT03242733: Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip Fracture
Official title: Ultrasound Assessment of Gastric Contents in Fasted Elderly Patients With Hip
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fractures
Keywords: Gastroparesis
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Who has hip fracture and agrees with the purpose of the study

Brief summary: Evaluation of gastric contents in fasted elderly patients with hip fracture. The gastric contents will be examined by using ultrasonography in fasted elderly patients scheduled for hip fracture surgery. The primary outcome is the number of patients with stomach contents, and the secondary outcome is the component of residual gastric contents.

Detailed description: In the patients who has femur fracture, they are immobilized because of the pain. This condition makes the gastric movement slow, and the pain also contributes to delayed digestion.

In the present study, the gastric content is assessed by using ultrasonography in fasted elderly patients for hip fracture surgery. Ultrasound assessment is performed in the supine position. All patients scheduled elective surgery for hip fracture over 65 years old are objects. The primary outcome is the number of patients with not empty stomach and full stomach, and the secondary outcome is the component of residual gastric contents.

Eligibility criteria: Inclusion Criteria:

* Who has hip fracture and agrees with the purpose of the study

Exclusion Criteria:

* gastrointestinal pathology
* history of any type of gastrectomy
* gastrointestinal anomaly

Primary outcomes:
measure: Ultrasound assessment of the presence of gastric contents.
timeFrame: Before the induction of anesthesia (Baseline)
Secondary outcomes:
measure: Ultrasound assessment of the component of residual gastric contents
timeFrame: Before the induction of anesthesia (Baseline)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Jin-Young Hwang, MD,phD
role: STUDY_CHAIR
References:
citation: Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
citation: Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
citation: Landreau B, Odin I, Nathan N. [Pulmonary aspiration: epidemiology and risk factors]. Ann Fr Anesth Reanim. 2009 Mar;28(3):206-10. doi: 10.1016/j.annfar.2009.01.020. Epub 2009 Mar 21. French.