louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01531660: Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+
Official title: Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+: Feasability, Role of Motivation and Sustained Benefit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 68
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Background: Inactive individuals face motivational obstacles for becoming and staying physically active. Therefore, sustainable physical activity promotion programs tailored to reach inactive individuals are needed.

Purpose: to test the effect (long and short-term) and feasibility of a training program and to evaluate the association between the baseline motivation to become physical activity and the change in physical activity and performance.

Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main outcome measures: physical performance and level of physical activity


Eligibility criteria: Inclusion criteria:

* female hospital stuff
* no regular physical activity
* older than 45 years

Exclusion criteria:

* osteoporotic fracture in the last three month
* significant musculoskeletal, cardiac or respiratory disorder

Primary outcomes:
measure: physical activity
timeFrame: 3 and 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Rheumatology
name: Daniel Uebelhart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04053660: Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
Official title: Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Gingival Crevicular Fluid
Lipid Mediator
Periodontal Treatment
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. In addition, the investigators evaluated the levels of these mediators after non-surgical periodontal treatment in patients with chronic periodontitis. A total of 20 subjects, 10 patients with chronic periodontitis (CP) and 10 periodontally healthy individuals were included in the study. Clinical parameters including plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment levels (CAL) were recorded. GCF and saliva samples were obtained at the beginning of the study from all individuals. GCF and saliva samples were re-collected from patients with CP at 1 month after non surgical periodontal therapy.


Eligibility criteria: Inclusion Criteria:

* Have at least 20 natural teeth, excluding third molars.
* Chronic periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.
* Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss.

Exclusion Criteria:

* History of systemic disease.
* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
* Periodontal treatment during last 6 months that could affect periodontal status.
* Smoking.
* History of radiotherapy or chemotherapy.
* Ongoing orthodontic treatment.
* Aggressive periodontitis.
* Current pregnancy, lactation or menopause.

Primary outcomes:
measure: Lipoxin A4 levels
timeFrame: 1st month
Secondary outcomes:
measure: Prostaglandin E2 levels
timeFrame: 1st month
measure: Leukotriene B4
timeFrame: 1st month
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
affiliation: Ordu University Faculty of Dentistry
name: Ceren Gokmenoglu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06222060: Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards
Official title: Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shaken Baby Syndrome
Keywords: Shaken Baby Syndrome
Child abuse
Parental knowledge
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of newborns in maternity wards

Brief summary: As part of everyday clinical practice, messages about preventing Shaken Baby Syndrome are delivered to young parents in maternity wards. The modality of these messages changes regularly. For example, in the near future, the messages will be delivered by video in addition to the usual practice. The investigators are setting up a prospective observational cohort study in order to evaluate and then monitor the state of knowledge of young parents on shaken baby syndrome.


Eligibility criteria: Inclusion Criteria:

* Parents of newborns in maternity wards

Exclusion Criteria:

* Single parent

Primary outcomes:
measure: Shaken Baby Syndrome Knowledge
timeFrame: Week 1, 6
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Aymeric CANTAIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01605760: House Dust Mite SLIT in Elderly Patients
Official title: House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: immunotherapy
elderly
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 111
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.


Eligibility criteria: Inclusion Criteria:

* Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study

Exclusion Criteria:

* Patients with any of the following characteristics were excluded:

  * hypersensitivity to other allergens,
  * non-allergic rhinitis (especially senile or vasomotor rhinitis) or
  * severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.

Primary outcomes:
measure: Number of participants with adverse event during immunotherapy
timeFrame: three year
Secondary outcomes:
measure: Change from baseline of nasal symptoms after immunotherapy
timeFrame: three year
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Allergology Outpatient Clinic
Study officials:
References:
citation: Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012.
citation: Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.
Clinical trial NCT02697760: The CZT Dynamic Myocardial Perfusion Imaging
Official title: The Quantification, Clinical Application of Dynamic Imaging Using Cadmium-zinc-telluride (CZT) Cameras to Assess Myocardial Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: cadmium-zinc-telluride，CZT cameras
myocardial blood flow，MBF
myocardial flow reserve，MFR
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 234
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with clinically suspected coronary artery disease, heart failure, or intermediate and high cardiovascular risks

Brief summary: To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease.

Detailed description: Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations.

The present project aims to develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications.

Eligibility criteria: Inclusion Criteria:

1. Coronary heart disease
2. Clinical diagnosis of heart failure
3. Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons.

Exclusion Criteria:

Significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.

Primary outcomes:
measure: Coronary artery disease (CAD) diagnosis
timeFrame: 12 months after the index MPI
Secondary outcomes:
measure: MACE (major adverse cardiac events)
timeFrame: 5 years after the index MPI
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yen-Wen Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02247960: Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Official title: Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Urinary Tract Infection
Clostridium Difficile
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 175
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 aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.

Exclusion Criteria:

* Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.

Primary outcomes:
measure: Number of Participants With a Positive Urinary Tract Infection
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Positive for Clostridium Difficile
timeFrame: 3 months
measure: Number of Participants With Bacteria in Urine
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Jean V Joseph, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570060: Stepwise Screening for Silent Atrial Fibrillation After Stroke
Official title: Stepwise Screening for Silent Atrial Fibrillation After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Cerebrovascular Accident
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 264
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: Hospitalized patients

Brief summary: The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.


Eligibility criteria: Inclusion Criteria:

* Patient who had an ischemic stroke defined according to WHO criteria and hospitalized in the Stroke Unit at the Dijon University Hospital.
* Patient 18 years of age and older
* Patient who has given oral consent

Exclusion Criteria:

* Person not affiliated to a national health insurance scheme
* Protected adult
* Pregnant or breastfeeding woman
* Patient refusing to participate in the study
* Transfer planned after the stay in the Stroke Unit to a department outside the Dijon University Hospital, not allowing for the long term screening with an external ECG monitor
* History of atrial fibrillation or atrial flutter
* Patient wearing a pacemaker or defibrillator with an atrial lead

Primary outcomes:
measure: Diagnosis of atrial fibrillation during continuous monitoring in a Stroke unit within six months of stroke.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
citation: Garnier L, Duloquin G, Meloux A, Benali K, Sagnard A, Graber M, Dogon G, Didier R, Pommier T, Vergely C, Bejot Y, Guenancia C. Multimodal Approach for the Prediction of Atrial Fibrillation Detected After Stroke: SAFAS Study. Front Cardiovasc Med. 2022 Jul 13;9:949213. doi: 10.3389/fcvm.2022.949213. eCollection 2022.
Clinical trial NCT05156060: Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
Official title: Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Locally Advanced Head and Neck Carcinoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.

Detailed description: Objectives:

* To establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day.
* To evaluate feasibility and tolerability

Exploratory:

- To assess pain, symptom burden, functionality, and quality of life

Eligibility criteria: Inclusion Criteria:

* Histologically proven cancer of the head and neck cancer
* Locally advanced non-metastatic disease (T3N0M0, T4N0M0, T1-4N1-3M0)
* Planned primary or adjuvant radiation or chemoradiation therapy
* Willing and able to provide informed consent
* ECOG PS 0-2
* Age ≥ 21 years
* English speaking

Exclusion Criteria:

* Currently on gabapentin or ketamine
* Prior non-tolerance of gabapentin or ketamine
* Unable to administer ketamine intranasally due to anatomical restrictions
* History of seizure disorder
* History of schizophrenia
* History of increased intracranial pressure
* Glomerular filtration rate \<30 mL/min/1.73 m2

Primary outcomes:
measure: Establish the maximum tolerated dose of ketamine in combination with gabapentin (per Common Terminology Criteria for Adverse Events Criteria 4.0)
timeFrame: Approximately 28 days (Phase I)
measure: Count of participants with adverse events (Common Terminology Criteria for Adverse Events Criteria 4.0)
timeFrame: Up to 30 post-treatment (Phase II)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Natalie Lockney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06032260: The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite
Official title: The Effects of a Fiber-enriched Bakery Product on Glucose, Insulin Values and Appetite. A Pilot Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Arabinoxylan
fiber-enriched product
glycemia
insulin
appetite
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover randomized double-blind trial
Primary purpose: PREVENTION

Brief summary: The aim of the present pilot randomized controlled trial is to compare the effects of the following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy volunteers.

Detailed description: This is a crossover, randomized double-blind trial. A product enriched with arabinoxylan extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic index) was developed to assess the impact on metabolic responses and satiety when compared to the standard product (p-standard) .

Ten Caucasian non-smoker healthy adult volunteers were enrolled starting from January 2023.

Participants were randomized to receive either the p-rich or p-standard. The order of administration of each product was randomized using a computer-generated sequence. The day of each test, fasting individuals underwent a blood sample collection, and weight and height measurements. Then, participants consumed 100 grams of the product within 20 minutes, while sitting. Blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the consumption of each food.

Eligibility criteria: Inclusion Criteria:

* non-smokers healthy adults;
* age 20-65 years;
* ability to provide informed written consent

Exclusion Criteria:

* obesity;
* chronic diseases or pharmacological therapies;
* dietary restrictions;
* allergy or intolerance to the tested food

Primary outcomes:
measure: Changes in circulating concentrations of glucose
timeFrame: 15, 30, 45, 60, 90, 120 minutes after the consumption of each food
Secondary outcomes:
measure: Changes in circulating concentrations of insulin
timeFrame: 15, 30, 45, 60, 90, 120 minutes after the consumption of each food
measure: Changes in subjective appetite score (VAS)
timeFrame: 60, 120, 180, and 240 minutes after the consumption of each food
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
state: AT
Study officials:
References: