louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050972: Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population
Official title: Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Population of an Extensive Territory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Migraine
Tension Type Headache
Cervical Pain
Keywords: Headache
Cervical Pain
Cognitive treatment
Relaxation
Exercise
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Fondazione CRT, Torino
name: Turin, Italy
name: Regione Piemonte
First posted: 2010-01-18
Enrollment: 15000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an interventional trial to evaluate the effectiveness of a cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in the population of an extensive territory of Italy.

Detailed description: In a previous non-randomized-controlled study in which the cognitive and physical programme was applied to a consistent number of office workers, a significant reduction of frequency of pain in the head and neck areas and of analgesic drug consumption was obtained. The results were stable at a 12 month follow up. More recently a controlled, cluster randomised, interventional trial was conducted on 1930 local government employees of the Municipality of Turin. The data obtained confirm those of the previous studies.

The present study was designed to confirm the data in a much more extensive population , that is, residents of the Italian Region Piemonte (Piedmont) who will apply to participate.

Primary objective is to confirm the effectiveness of the cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large population of a territory.

Secondary objective is to confirm the effectiveness of the Intervention, in reducing analgesic drugs consumption after the Intervention in the same population.

Eligibility criteria: Inclusion Criteria:

* All residents of the Region Piemonte (Italy) may apply for recruitment

Exclusion Criteria:

* Because of the pragmatic design, no exclusion criteria are required for this study

Primary outcomes:
measure: Reduction in number of days per month with headache and shoulders pain after 12 months.
timeFrame: 24 months
Secondary outcomes:
measure: Reduction in number of days per month of drug intake after 12 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Headache and Facial Pain Unit University of Turin
Study officials:
affiliation: Headache and Facial Pain Unit Dept. Clinical Pathophysiology University of Turin
name: Franco Mongini, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03801772: Effects of a Metronome on Functional Outcomes in Aquatic Therapy
Official title: Effects of a Metronome on Functional Outcomes in Aquatic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Keywords: Aquatic Therapy
Hydrotherapy
Pool Therapy
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the use of a pacing device, a metronome, improves functional outcome measures in aquatic therapy when compared to a control group.


Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18 assigned to aquatic therapy

Exclusion Criteria:

* Women who identify themselves as pregnant on the clinics intake sheet.
* Anyone unable to hear the beats of the metronome.

Primary outcomes:
measure: Change between initial 30 second sit to stand measure and final measurement
timeFrame: Initial evaluation and up to 8 weeks
Secondary outcomes:
measure: Change from the initial level reported on the Numerical Pain Rating Scale and the final reported level.
timeFrame: Initial evaluation and up to 8 weeks
measure: Global Rating of Change
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Tusc Therapy
state: Ohio
Study officials:
References:
Clinical trial NCT02878772: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients
Official title: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Immunoregulation
Inflammation
Vinpocetine
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion
* measurable neurological deficit (NIHSS \> 5)
* interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy

Exclusion Criteria:

* hemorrhagic stroke and severe hemorrhage in other organs
* other diseases of the central nervous system (CNS)
* diabetes mellitus
* tumor or hematological systemic diseases
* any infection before acute ischemic stroke
* concomitant use of antineoplastic or immune modulating therapies
* contraindication to MRI

Primary outcomes:
measure: changes in lesion volume
timeFrame: lesion volume from baseline to day 7
measure: brain inflammatory level
timeFrame: day 7
measure: extent of clinical improvement
timeFrame: from baseline to day 7 and 14
Secondary outcomes:
measure: probability of excellent recovery
timeFrame: at day 90
measure: cytotoxic edema
timeFrame: day 3
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang F, Yan C, Wei C, Yao Y, Ma X, Gong Z, Liu S, Zang D, Chen J, Shi FD, Hao J. Vinpocetine Inhibits NF-kappaB-Dependent Inflammation in Acute Ischemic Stroke Patients. Transl Stroke Res. 2018 Apr;9(2):174-184. doi: 10.1007/s12975-017-0549-z. Epub 2017 Jul 9.
Clinical trial NCT00478972: Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Diabetes Mellitus Type 2
Keywords: obese
diabetes
cannabinoid-1 receptor
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 321
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

* To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
* To evaluate the safety and tolerability of Rimonabant compared to placebo;
* To evaluate the pharmacokinetics of Rimonabant.

Detailed description: The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
* HbA1C ≥ 7.0 % and ≤ 10.0 %
* Body Mass Index ≥ 25 kg/m²

Exclusion Criteria:

* Type 1 diabetes
* Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
* Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
* Secondary obesity
* Primary hyperlipidemia
* Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Absolute change from baseline in HbA1C
timeFrame: Baseline to Week 36
measure: Relative change from baseline in body weight
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Absolute change from baseline in Fasting Plasma Glucose
timeFrame: Baseline to Week 36
measure: Absolute change from baseline in waist circumference
timeFrame: Baseline to Week 36
measure: Relative change from baseline in Triglycerides and HDL-cholesterol
timeFrame: Baseline to Week 36
measure: Safety: Overview of adverse events
timeFrame: Baseline to Week 47
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06156072: Ultrasound-guided Blood Sampling Drawing for Microbiological Analysis in the Critically Ill
Official title: Use of Ultrasound for Blood Sample Drawing for Microbiological Analysis in Critically Ill Patients:he ECOVEN Feasibility Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Septic Shock
Infections
Diagnosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alla adult patients admitted to ICU with a suspected sepsis will be enrolled, when treating physician will prescribe blood culture for microbiological analysis

Brief summary: This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 year-old)
* admitted to intensive care unit
* suspected sepsis requiring blood cultrure

Exclusion Criteria:

* pregnancy
* infections requiring respiratory isolation
* burns or skin disease involving arms and/or more than 60% of body surface

Primary outcomes:
measure: Number of attempted venipunctures
timeFrame: One hour after clinical decision of blood culture execution
Secondary outcomes:
measure: Incidence of possible complications (accidental arterial puncture, visible ematoma)
timeFrame: One hour after clinical decision of blood culture execution
measure: Incidence of contamination of ultrasound-guided venipuncture
timeFrame: One hour after clinical decision of blood culture execution
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Antonio M Dell'Anna, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04287972: A Study to Reduce the Reflux After a Sleeve Gastrectomy in Obese Patients
Official title: A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroesophageal Reflux
Obesity
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.

At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
* Patients with no preoperative gastroesophageal reflux disease symptoms
* Hill 2-3 or 4 (with HH \<2 cm) hypogastric valve diagnosed preoperatively

Exclusion Criteria:

* Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
* Hiatal Hernia \>2cm and/or esophagitis and/or Barrett metaplasia
* Previous bariatric and/or gastric surgery
* Normal gastroesophageal valve (Hill 1)
* Motility disorders of the esophagus (documented on manometry)
* PH-study positive for gastro-oesophageal reflux disease (DeMeester Score \>14.1)
* Contraindications to gastroscopy or manometry or ph-study
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Patient not legally competent
* Pregnancy

Primary outcomes:
measure: De novo GastroEsophageal Reflux Disease (GERD) onset
timeFrame: 6 months post surgery
Secondary outcomes:
measure: hiatal hernia appearance
timeFrame: 6 months post surgery
measure: change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
timeFrame: baseline and 6 months post surgery
measure: change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire
timeFrame: baseline and 6 months post surgery
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months post surgery
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Civico e Italiano
Study officials:
affiliation: EOC
name: Fabio Garofalo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022372: Endometrial Biopsy as Diagnostic Method for Endometriosis and Endometrioma
Official title: The Evaluation of Endometrial Biopsy in the Diagnosis of Endometriosis and Endometrioma: a Double Blind Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Women in the Reproductive Age Group
Undergoing Laparoscopy for Pelvic Pain and/or Infertility
Not Currently Receiving Hormonal Treatment for at Least 3 Months Prior to Laparoscopy.
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study.

Brief summary: Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison with diagnostic laparoscopy.


Eligibility criteria: Inclusion Criteria:

* Women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study

Primary outcomes:
measure: The density of nerve fibers in the endometrial biopsy sample.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: The hospital of Meram medical Faculty
Study officials:
References:
Clinical trial NCT02534272: Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota
Official title: Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diarrhea
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 27
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: Symptomatic subjects will be recruited during their visit to hospital for intestinal symptoms. Asymptomatic subjects will be recruited in the general population.

Brief summary: D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.


Eligibility criteria: Inclusion Criteria for symptomatic group:

* male/female aged at least of 18 years
* subject with abdominal pain, diarrhea, bloating
* no other known intestinal disease

Inclusion Criteria for asymptomatic group:

* male/female aged at least of 18 years
* no known intestinal disease

Exclusion Criteria of symptomatic and asymptomatic groups:

* chronic intestinal diseases such as IBD, IBS ...
* intake of antibiotic or probiotic within the 2 last months
* subject in exclusion period
* subject unable to understand information for a free consent to the study
* subject in safeguarding justice or guardianship

Primary outcomes:
measure: 16SrRNA copy numbers
timeFrame: Within the 2 days following inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Médecine interne, maladies tropicales et infectieuses Hôpital Civil
city: Strasbourg
country: France
facility: Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil
city: Strasbourg
country: France
facility: Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: CANDOLFI Ermanno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346372: Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ocular Melanoma
Keywords: Ocular Melanoma
Optical Coherence Tomography
Eye Tumor
Choroidal Melanoma
Uveal Melanoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2006-06-29
Enrollment: 5
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 who meet the following Eligibility Criteria

Brief summary: During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years or older) with:

  * choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to 1.25 mm in apical height or:
  * choroidal melanoma located in the posterior pole (4mm or less from the center of fovea or the border of the optic nerve head)

Exclusion Criteria:

* Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
Study officials:
affiliation: Jules Stein Eye Institute, UCLA
name: Bradley R Straatsma, MD, JD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03240172: Assessment of DNA Damage Due to Ionizing Radiation
Official title: Assessment of DNA Damage and Capacity of DNA Repair System Among Nuclear Medicine and Clinical Oncology Workers Exposing to Ionizing Radiation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Exposure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Case control study that will include 100 participants (50 radiation exposed workers will be compared with 50 healthy age and sex-matched control group not exposed to radiation.

G power program was used to calculate the sample size for two independent groups. power calculation estimated to detect an effect size of 0.88 of difference between means of two independent groups, with a p value \< 0.05 and 80% power,.

Brief summary: detection of DNA damage due to occupational exposure to low dose ionizing radiation using comet assay technique and genotyping of certain DNA repair genes to detect inherited polymorphism.


Eligibility criteria: Inclusion Criteria:

* • The radiation exposed workers will include nurses, technicians and physicians.

These persons will be occupationally exposed to different radiation sources.

Exclusion Criteria:

* History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to sampling.

Primary outcomes:
measure: detection of DNA damage due to occupational exposure to ionizing radiation
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: asmaa HA mohamed, PHD
role: PRINCIPAL_INVESTIGATOR
References: