louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03508596: STRAIN - Work-related Stress Among Health Professionals in Switzerland
Official title: STRAIN - Work-related Stress Among Health Professionals in Switzerland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Health Care Professionals
Work-Related Condition
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences and Arts of Southern Switzerland
name: University of Applied Sciences of Western Switzerland
First posted: 2018-04-26
Enrollment: 8112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors.

Detailed description: Methods: This study is a cross-sectional design and randomly selected hospitals, nursing homes and home care organizations. The study sample included nursing staff and midwives, physicians, medical-technical and medical-therapeutic professionals at all hierarchical levels. Data were collected using self-report questionnaires and analysed using multiple regression models.

Eligibility criteria: Inclusion Criteria:

* Employee within a participating health organization in Switzerland
* Health care professional (nurse, medical-technical medical-therapeutical profession, physician)

Exclusion Criteria:

* Health professionals without an fixed employment contract

Primary outcomes:
measure: effort reward imbalance model (ERI)
timeFrame: Changes in self reported results of the ERI from t1 to t2 (1 year)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bern University of Applied Sciences Switzerland
name: Sabine Hahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT02129296: Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Official title: Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Morbid Obesity
Weight Loss
Tolerance
Keywords: Morbid obesity
Gastric balloon
Weight loss
Tolerance
Safety
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric balloons are an evolving way of reducing weight. There are two types on the market, up to date. Air filled balloons seem to be more safe, and more tolerable.

Detailed description: Morbidly obese patients are categorized into two groups: the 1st group to whom intragastric air filled balloon and the 2nd group to whom saline filled balloon is applied for treatment of their morbid obesity. The aim of study is to compare both types of balloons regarding safety, efficacy and tolerance.

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patients

Exclusion Criteria:

* Patient refused
* Non compliant patients
* Psychological patients
* Oesophageal varices, big hiatus hernia, ulcers
* Gastric vascular malformations

Primary outcomes:
measure: Tolerance
timeFrame: 6 months
Secondary outcomes:
measure: Weight loss
timeFrame: 6 months
measure: Rate of deflation or puncture
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Mansoura University
country: Egypt
facility: Hafr Albatin Central hospital
Study officials:
affiliation: Mansoura University
name: Mohamed E Abd Ellatif, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06375096: Bone Mineral Density in Children With Graves' Disease
Official title: Bone Mineral Density in Children With Graves' Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Density, Low
Bone Mineral Density in Children With Graves' Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children diagnosed with graves' disease, more than 2 years and less than 18 years

Brief summary: to evaluate bone mineral density in children with graves' disease


Eligibility criteria: Inclusion Criteria:

* age at enrollment ≥2 years to \< 18 years
* both sexes
* the patients should be diagnosed with graves'

Exclusion Criteria:

* patients less than 2 years
* patients more than 18 years
* Controlled GD patients on antithyroid
* patients with other endocrine diseases

Primary outcomes:
measure: bone mineral density
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06042296: Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
Official title: Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pterygium
Keywords: PCNA,
cd44
e-cadherin
immunohistochemistry
pterygium
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patient with primary and recurrent pterygium

Brief summary: Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular processes, for instance, cell adhesion, division, and migration, by binding with its main ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a significant role in the protection of tissue integrity and cell-to-cell adhesion. This study aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and E-cadherin in pterygium formation and recurrence.

Detailed description: Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin expressions in surgically removed pterygium will be compared with tissue samples from normal control group.

IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.

Eligibility criteria: Inclusion Criteria: patient with pterygium -

Exclusion Criteria: patient with pseudopterygium

-

Primary outcomes:
measure: Immunohistochemistry
timeFrame: up to three weeks after pterygium surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Hümeyra Yildirim
Study officials:
affiliation: Balıkesir Medical Faculty
name: HÜMEYRA YILDIRIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770796: Statins for Prevention of Contrast Induced Nephropathy
Official title: Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Induced Nephropathy
Keywords: Contrast induced nephropathy
Lead sponsor: Ospedale Misericordia e Dolce
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.


Eligibility criteria: Inclusion Criteria:

* patients with pre-angiographic estimated creatinine clearance \< 60 ml/min

Exclusion Criteria:

* contrast medium administration within the previous 10 days
* end-stage renal failure requiring dialysis
* refusal to give informed consent
* previous therapy with statin

Primary outcomes:
measure: Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards
timeFrame: within 5 days after contrast exposure
Secondary outcomes:
measure: Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
timeFrame: within 5 days after contrast agent administration
measure: Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale Misericordia e Dolce, Prato
name: Mauro Maioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706896: Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Official title: Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Age-related Macular Degeneration
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will take place by eye, each patient will have one eye treated and the contralateral subjected to sham. The treated eye will receive CB-PRP injections modulated differently over time in each of the sub-studies, i.e. monthly, bimonthly or quarterly, while the contralateral eye will receive a SHAM injection.
Primary purpose: TREATMENT

Brief summary: The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD)


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Bilateral dry-AMD
* ETDRS-corrected visual acuity between (or equal to) 1/10 and 4/10
* No concomitant ocular pathology (e.g., Glaucoma, amblyopia) or systemic pathology that would result in a BIAS for primary goal assessment
* Signature of informed consent

Exclusion Criteria:

* Age \< 65 years
* Pregnancy
* Previous inflammatory/infectious events involving the eyes
* Eye trauma, diabetes, or disease potentially damaging to the visual system, even in the absence of impairment at the time of intake
* Previous intravitreal treatments.
* Refusal to sign informed consent.

Primary outcomes:
measure: Autofluorescence atrophy area changes in treated eyes compared with sham group
timeFrame: 1 year
measure: Autofluorescence atrophy area changes in treated eyes compared with sham group (1)
timeFrame: 1 year
Secondary outcomes:
measure: ETDRS visual acuity
timeFrame: 1 year
measure: Mean increase in ONL thickness and retinal volumetrics
timeFrame: 1 year
measure: Mean increase in retinal volumetrics
timeFrame: 1 year
measure: Stabilization of the atrophy region of the EPR
timeFrame: 1 year
measure: Retinography of the ocular fundus
timeFrame: 1 year
measure: Incomplete retinal pigment epithelial (RPE) and outer retinal atrophy (iRORA)
timeFrame: 1 year
measure: Outer retinal atrophy (iRORA)
timeFrame: 1 year
Other outcomes:
measure: Evaluation of therapy safety
timeFrame: 1 year
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02082496: GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations
Official title: Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Obesity Genetics
GLP-1
GLP-1 Receptor Agonists
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The obesity epidemic is attributable to dietary and behavioral trends acting on a person's genetic makeup to determine body mass and susceptibility to obesity-related diseases. Furthermore, common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the appetite center in the hypothalamus. Today, GLP-1 receptor agonists are available for the treatment of type 2 diabetes, and their treatment potential in obesity is an area of active research.

The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in people diagnosed with obesity causing genetic disorders and to investigate the physiological role of GLP-1 on food intake and appetite regulation in this group.

Detailed description: * Exploration of the physiological role of GLP-1 concerning food intake and appetite regulation in obese adults diagnosed with obesity related genetic disorders.
* Assessment of the effect of GLP-1 on body composition, bone mineral density, energy expenditure, cardiac function, glucose tolerance, insulin sensitivity, lipid concentrations and neuroendocrine function.
* Assessment of the impact of the leptin induced adaptive thermogenesis response in the weight reduced study participants.
* Investigating the alteration of the composition of gut bacteria as well as subjective ratings of satiety and hunger before after supplement with GLP-1.

Eligibility criteria: Inclusion Criteria:

* BMI above 28 (kg/m2)
* age 18-65 years
* otherwise healthy

Exclusion Criteria:

* pregnancy or breastfeeding
* Type 2 Diabetes
* suffering from severe medical conditions

Recruitment for this study finished November 2015

Primary outcomes:
measure: Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls
timeFrame: 4 months intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Biomedical Sciences
Study officials:
affiliation: University of Copenhagen
name: Jens J Holst, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00003016: Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
Official title: Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Detailed description: OBJECTIVES:

* Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.

OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.

Patients are followed annually.

PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Curatively treated carcinoma of the breast
* Currently taking adjuvant tamoxifen

  * Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* No contraindications to receiving tamoxifen
* No other serious medical problems

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy allowed

Chemotherapy:

* Prior chemotherapy allowed

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Prior surgery allowed

Primary outcomes:
measure: Overall survival (i.e., all-cause mortality)
Secondary outcomes:
measure: Specific-cause mortality
measure: Incidence of second primary tumors
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Atlas Trial Office
state: England
Study officials:
affiliation: Karolinska Institutet
name: Rodrigo Arriagada, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05221216: Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
Official title: Single-center Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: cotrimoxazole
Acute Kidney Injury
renal replacement therapy
pharmacodynamic
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole will be included.

Brief summary: Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.

Detailed description: The objective is to compare the plasma concentrations of patients with acute renal failure (ARF) or requiring extra renal replacement therapy (RRT) with those of patients without these characteristics to look for differences in concentration.

Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in Intensive Care Units between October 2020 and July 2021 with infection treated with cotrimoxazole

Exclusion Criteria:

* None

Primary outcomes:
measure: plasma concentrations of cotrimoxazole (mg/l)
timeFrame: From the antibiotic initiation until the patient is discharged from the ICU with a maximal time frame of 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Sophie PERINEL RAGEY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04701216: A Trial of SHR8735 in Healthy Subjects
Official title: A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 open-label study.

Detailed description: This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects

Eligibility criteria: Inclusion Criteria:

* Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
* Be able to comply with all the requirements and able to complete the study.
* Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
* No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
* Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion Criteria:

* Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
* History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
* Severe, active psychiatric conditions that require ongoing treatment.

Primary outcomes:
measure: Adverse events
timeFrame: Start of Treatment to end of study (approximately 28 days)
Secondary outcomes:
measure: Pharmacokinetics-AUC0-last
timeFrame: Start of Treatment to end of study (approximately 15 days)
measure: Pharmacokinetics-AUC0-inf
timeFrame: Start of Treatment to end of study (approximately 15 days)
measure: Pharmacokinetics-Tmax
timeFrame: Up to 15 days
measure: Pharmacokinetics-Cmax
timeFrame: Up to 15 days
measure: Pharmacokinetics-CL/F
timeFrame: Up to 15 days
measure: Pharmacokinetics-Vz/F
timeFrame: Up to 15 days
measure: Pharmacokinetics-t1/2
timeFrame: Up to 15 days
measure: Change from baseline to end of treatment for platelet count
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical research
state: Western Australia
Study officials:
affiliation: Study Principal Investigator
name: Ana Sun, Dr
role: PRINCIPAL_INVESTIGATOR
References: