louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05002335: Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Official title: Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Rotator Cuff Tear Arthropathy
Rheumatoid Arthritis Shoulder
Avascular Necrosis
Fracture
Revision of Shoulder Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 200
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: Patients requiring Total Shoulder Arthroplasty (anatomic/reverse) and who are suitable to receive Medacta Shoulder System will be proposed to take part to the current post-market surveillance study during their pre-operative visit.

Brief summary: This is a post-market surveillance study on Medacta Shoulder System


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patient with one of the following diagnosis:

  1. Primary osteoarthritis
  2. Secondary osteoarthritis
  3. Cuff tear arthropathy; insufficient rotator cuff
  4. Acute fracture (\<21d)
  5. Rheumatoid or inflammatory arthritis
  6. Avascular necrosis
  7. Other posttraumatic condition
  8. Revision of shoulder arthroplasty

Exclusion Criteria:

* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspect infections (at the time of surgery)
* Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)

Primary outcomes:
measure: Survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Clinical outcome; Constant and Murley score
timeFrame: 1, 2, and 5 years
measure: Functional outcome: Oxford Shoulder Score
timeFrame: 1, 2, and 5 years
measure: Radiographic performance of the implants: Presence of radiolucencies
timeFrame: 3 months, 1, 2, and 5 years
measure: Quality of life assesed by EQ-5D-5L score
timeFrame: 1, 2, and 5 years
measure: Number of Intraoperative and postoperative Adverse events
timeFrame: intraop, 3 months, 1, 2, and 5 years
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Namur
country: Belgium
facility: Clinique St-Luc Bouge
Study officials:
affiliation: AZ Sint-Jan (Brugge, Belgium)
name: Bart Berghs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05634135: Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation
Official title: The Difference and Prognostic Significance of Lung Ventilation and Perfusion in Different Phenotypes of Chronic Critical Illness With Prolonged Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prolonged Mechanical Ventilation
Keywords: Ventilation
mechanical ventilation
weaning
oxygen uptake
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic critically ill patients receiving prolonged mechanical ventilation

Brief summary: This project will conduct a series of analysis of physiological and clinical data on tracheostomy patients who receive prolonged mechanical ventilation, hoping to find out the different manifestations of patients through the investigation by a variety of physiologic measurements, so as to understand whether different types of patients phenotype to derive different clinical strategies for liberation of the mechanical ventilator.


Eligibility criteria: Inclusion Criteria:

* Patients with at least 10 days of mechanical ventilation at the intensive care unit of National Taiwan University Hospital and transferred to the Respiratory Care Center of National Taiwan University Hospital for weaning training
* Patients who have undergone tracheostomy and still have a tracheotomy tube
* Are at least 20 years old
* Stable respiratory condition with inspired oxygen fraction not exceeding 50%

Exclusion Criteria:

* Hemodynamic instability or continuous use of vasopressors
* Pregnancy

Primary outcomes:
measure: Liberation from mechanical ventilation at discharge from the weaning unit
timeFrame: Five days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jih-Shuin Jerng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06698835: Turnip Consumption and Qigong Exercise Program on Weight Loss
Official title: The Effect of Turnip Consumption and Qigong Exercise Program on Weight Loss Among Female Students: Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Keywords: obesity
qigong exercise
turnip consumption
weight loss
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: King Faisal University
First posted: 2024-11-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study design indicates two arms (e.g., experimental and control) which will divide the group into small groups (5 in each) for experimental. and 10 students as a control group
Primary purpose: PREVENTION

Brief summary: Obesity and weight-related issues are prevalent concerns affecting individuals worldwide, with particular significance among the younger demographic, such as female students. As lifestyles evolve and dietary habits play a pivotal role in overall well-being, exploring innovative approaches to weight management becomes imperative. Thus, obesity is a huge public health importance with economic emotional and social consequences.

Detailed description: Obesity is an epidemic causing serious health consequences, including diabetes, dyslipidemia, and hypertension. Obesity in adolescents can cause chronic brain hypoxia and affect learning. Weight loss occurs when energy intake is less than energy expenditure, and achieving an energy deficit remains the main dietary target. The evidence for the specific impact of vegetables is qualified. Recently, there has been much scientific interest and debate on the potential link between dairy consumption and body weight regulation. The idea of turnip consumption and qigong exercise includes a broad variety of subjects. vegetables are high in water and fiber and low in energy density, so their consumption is suggested to prevent obesity. Moreover, Traditional Chinese exercises are an ancient way of exercise and fitness, which have been reported to have unique advantages in the treatment of obesity.

Eligibility criteria: Inclusion Criteria:

* aged from 10 to 12 years
* free from any chronic diseases
* accept to participate

Exclusion Criteria:

* have any digestive problems
* unable to communicate or participate

Primary outcomes:
measure: change fat mass index
timeFrame: 3 months
measure: weight loss
timeFrame: 3 months
Secondary outcomes:
measure: assess their endurance
timeFrame: 3 months
measure: pulse Rate
timeFrame: 2 weeks
measure: respiration rate
timeFrame: 2 weeks
measure: heart rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Egypt- faculty of nursing
name: Safaa Osman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06447935: Acute Eosinophilic Myocarditis International Registry
Official title: Acute Eosinophilic Myocarditis International Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Keywords: Eosinophilic Myocarditis
Endomyocardial Biopsy
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective observational cohort of eosinophilic myocarditis patients

Brief summary: Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.

Detailed description: Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.

Eligibility criteria: Patients with histological diagnosis gained during an hospitalization within 30 days from symptoms onset.

Primary outcomes:
measure: Natural History of Eosinophilic Myocarditis
timeFrame: 3 year
Secondary outcomes:
measure: Natural History of Eosinophilic Myocarditis subgroups based on etiology
timeFrame: 3 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
Study officials:
References:
Clinical trial NCT06914635: Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Official title: Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SARS CoV-2
Liver Tumours
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Line 1: Recovered subjects from SAS-CoV-2 infection. Line 2: Patients with primary liver tumor

Brief summary: The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.


Eligibility criteria: Inclusion Criteria:

Line 1: - Age \>18 at time of signing informed consent form

* Signed informed consent form Line 2: - Primery liver tumor
* Age \>18 at time of signing informed consent form
* Signed informed consent form

Exclusion Criteria:

Line 1: - Active or history of neoplastic malignancy

* Active autoimmune disease ongoing treatment with immunosuppressive therapy
* Evidence of positive HIV, HCV, HBV test
* Diabetes
* Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
* Chronic autoimmune or inflammatory diseases
* Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
* Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for \>3 years prior to signing informed consent and considered low risk of relapse
* HIV infection
* Failure to sign informed consent form

Primary outcomes:
measure: The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.
timeFrame: From enrollement to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References:
Clinical trial NCT03274635: Penn State Hershey Sitting and Health Study
Official title: Desk-Compatible Elliptical Device: Feasibility Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help employees to increase their daily physical activity without compromising work productivity; and (b) evaluate the effects of different types of incentives for pedaling the desk-based elliptical device on employees' pedaling quantity over a one-month intervention period. The study will involve placing a compact elliptical device (provided at no cost by the research team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data evaluating the effects of the elliptical device on work productivity will be obtained from both employees and the employees' supervisors.


Eligibility criteria: Inclusion Criteria:

* Full time employee, employed at least 35 hours per week at Penn State Hershey
* Able to provide documented approval from supervisor to participate
* Age 18-70 years
* Overweight or obese (BMI between 25-55)
* Sit at desk at least 5 hours per day
* Have regular working hours between 6 am and 6 pm on weekdays
* Ability to understand written and spoken English
* Own a smartphone (Android or iPhone) with Internet access
* Willing to download cycling app on smartphone during one month study period

Exclusion Criteria:

* Not present in Penn State Hershey office during study period due to personal circumstances such as travel/extended vacation or leave, relocation, or health-related circumstances
* Advised to only do physical activity recommended by a physician
* Chest pain during physical activity or during prior month
* Currently has a desk-based pedaling device or treadmill workstation already installed at desk

Primary outcomes:
measure: Change in Worker Productivity
timeFrame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
measure: Elliptical Device Pedaling Quantity
timeFrame: 1 month (4 weeks) during pedaling program
Secondary outcomes:
measure: User satisfaction, process evaluations
timeFrame: Post-program (immediately after program ends)
measure: General (non-desk pedaling) physical activity
timeFrame: Baseline (1 month period prior to program start) and post-program (immediately after program ends)
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03899935: Laparoscopy for Endometriosis in Obese Patients
Official title: Feasibility and Safety of Endometriosis Laparoscopic Removal in Obese Patients: a Propensity Score Method Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Obesity
Keywords: Endometriosis
Obesity
Laparoscopy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 1230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients affected by endometriosis undergoing to laparoscopic endometriosis removal.

Brief summary: Evaluation of surgical outcomes of endometriosis laparoscopic surgery in obese patients.

Detailed description: Obesity may influence surgical variables such as operative time, laparotomic conversion rate and intraoperative and postoperative complication rate. Moreover, it might influence the hospital length of stay. For that reason, the study aims to compare a group of obese patients with a non-obese group of patients about these topics.

Eligibility criteria: Inclusion Criteria:

* Obese patients undergoing endometriosis laparoscopic treatment
* Obteined Informed Consensus

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative: from the skin incision to the skin suture
Secondary outcomes:
measure: Laparotomic conversion rate
timeFrame: Intraoperative
measure: Hospital length of stay
timeFrame: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
measure: Intraoperative complication rate
timeFrame: Intraoperative
measure: Postoperative complication rate
timeFrame: Postoperative: from surgery to hospitalization discharge, assessed up to 30 days after surgery.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Diego Raimondo
state: BO
Study officials:
References:
Clinical trial NCT05134935: Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.
Official title: Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) Versus Orthokerathology Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years. The Noninferiority NISDO Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in Danish myopic children aged 6-12 years. It is a clinical randomized non-inferiority trial, where the participants are randomly assigned to either OKL or DIMS spectacles. The participants are followed during 18 months of therapy. The hypotheses:

* There is no statistically significant difference between the myopia control efficacy between OKL and DIMS spectacles.
* Larger pupil size is positively correlated to treatment efficacy for both devises.
* Increasing choroidal thickness during early treatment is positively correlated to treatment efficacy for both devises.
* There is no difference in vision related quality of life between the two groups.


Eligibility criteria: Inclusion Criteria:

* Myopic children aged 6 to 12 years. Myopia of the 6 to 8-year-olds: -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism. Myopia of the 9 to 12-year-olds: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism.
* Anisometropia \< 1,5 D cycloplegic spherical equivalent refractive error.
* Best corrected visual acuity: Age 6 to 8 (inclusive) years: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters). Age 9 to 12 years: 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)

Exclusion Criteria:

* Manifest or latent squint.
* Contraindications to the use of OKL comprising keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca.
* Previous eye surgery.
* Chronic eye disease demanding daily use of eye drops.
* Non-compliance to eye examinations

Primary outcomes:
measure: Axial length growth of the eye
timeFrame: During 18 months of therapy
Secondary outcomes:
measure: Overall eye length growth, defined as the sum of axial length and choroidal thickness
timeFrame: During 18 months of therapy
measure: Pupil size
timeFrame: During 6 months of therapy
measure: Choroidal thickness
timeFrame: During 18 months of therapy
measure: Vision related quality of life using the questionnaire PREP2
timeFrame: Prior to and 9 months after treatment initiation
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: The Ophthalmic department, Vejle Hospital
state: Southern Denmark
Study officials:
affiliation: Vejle Hospital
name: Lou-Ann Andersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01427335: Calcium for Prevention of Ovarian Hyperstimulation Syndrome
Official title: Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS
ICSI
calcium injection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \& the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect \& the real mechanism for its action.

Detailed description: The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.

Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.

Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes

Eligibility criteria: Inclusion Criteria:

* infertile women aged 20 to 38 years.
* BMI ranged from 18 to 40.
* serum FSH within normal limits( 1-12IU /l)
* presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion Criteria:

* endocrinopathies.
* a systemic disease.
* using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
* patients need coasting for high risk of OHSS.
* patients need cycle cancellation.
* severe male infertility requiring testicular sperm extraction.

Primary outcomes:
measure: OHSS rate
timeFrame: 2 years
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr elini hospital
state: Cario
Study officials:
affiliation: Cairo University
name: Waleed M El-Khayat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046.