louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03373084: Imaging Location of Hamstring Muscle Lesions in Sport and Relationships With Injury Mechanism.
Official title: Imaging Location of Hamstring Muscle Lesions in Sport and Relationships With Injury Mechanism.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sport Injury
Hamstring Muscle Lesions
Keywords: Magnetic Resonance Imaging (MRI)
Ultrasound
Sport
Hamstring muscle
Injury
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletics with thigh injury will be included.

Brief summary: Hamstring muscle injuries are a common pathology in sports mainly present in sprint and acceleration sports, accounting for about 12% of all football injuries. Because of their frequency, risk of reinjury and financial cost, they can be considered as a public health problem. Improving knowledge of the pathophysiology of hamstring muscle injury appears to be a relevant research focus for prevention purposes.

Detailed description: This study is a cohort of athletes in the context of suspicion of hamstring muscle injuries.

Eligibility criteria: Inclusion Criteria:

* To be recreational sportsmen, competitions, amateurs, high-level or professional
* Aged 18 to 50 years
* Perform an Magnetic Resonance Imaging (MRI) or an ultrasound of the thigh in the context of the suspicion of an acute hamstring muscle injury
* Injury during sport since less 21 days old.

Exclusion Criteria:

* a history of surgery of the anterior cruciate ligament with removal of the transplant in the posterior compartment of the thigh
* an antecedent of surgery of the thigh.
* inability to understand the French language for completing the self-questionnaire

Primary outcomes:
measure: location of the lesion of injury
timeFrame: at inclusion
measure: mechanism of onset of injury
timeFrame: at inclusion
Secondary outcomes:
measure: mapping of hamstring lesions
timeFrame: at inclusion
measure: volumetric analysis of the hamstrings
timeFrame: at inclusion
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal EDOUARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05718284: High Flow Nasal Cannula After Esophagectomy
Official title: High Flow Nasal Cannula Oxygen Administration Versus Standard Care After Esophagectomy for Cancer: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Postoperative Pulmonary Atelectasis
Postoperative Pneumonia
Postoperative Pneumothorax
Postoperative Infection of Incision
Postoperative Acute Myocardial Infarction
Keywords: esophageal cancer
anesthesia
high flow nasal cannula
pneumonia
esophagectomy
acute myocardial infarction
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effect of HFNC versus standard oxygen administration after elective esophagectomy for cancer.


Eligibility criteria: Inclusion Criteria:

* elective esophagectomy for cancer
* METS≥4
* AGE 18-85
* Written informed consent

Exclusion Criteria:

* ASA\>3
* COPD≥ III stage according to GOLD criteria
* FEV1\<50%
* EF\<30%
* NYHA\>2
* BMI\<17 or \>35 Kg/m2
* CKD with eGFR\<60 mL/min

Primary outcomes:
measure: POST-OPERATIVE PULMONARY COMPLICATIONS
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: CARDIO-VASCULAR COMPLICATIONS
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
Study officials:
References:
citation: Deana C, Vetrugno L, Stefani F, Basso A, Matellon C, Barbariol F, Vecchiato M, Ziccarelli A, Valent F, Bove T, Bassi F, Petri R, De Monte A. Postoperative complications after minimally invasive esophagectomy in the prone position: any anesthesia-related factor? Tumori. 2021 Dec;107(6):525-535. doi: 10.1177/0300891620979358. Epub 2020 Dec 15.
citation: Xia M, Li W, Yao J, Jin Y, Du G, Xu Q, Yi X, Nv X, Wu Y, He P, Wu W. A postoperative comparison of high-flow nasal cannula therapy and conventional oxygen therapy for esophageal cancer patients. Ann Palliat Med. 2021 Mar;10(3):2530-2539. doi: 10.21037/apm-20-1539. Epub 2021 Jan 21.
Clinical trial NCT01923584: A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Official title: A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Edison Pharmaceuticals Inc
First posted: 2013-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Age 40 - 75
3. Ambulatory with or without assistance
4. Hoehn and Yahr Scale score of 1 - 3
5. Patient able to consent and comply with protocol requirements
6. Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil
2. Allergy to vitamin E
3. Clinical history of bleeding or abnormal baseline PT/PTT
4. Diagnosis of any other neurologic disease
5. Malignancy within past two years
6. Pregnant or plans to become pregnant
7. Concomitant ophthalmologic disease
8. History of stroke
9. History of brain surgery
10. Inability to undergo MRI scan or MRS
11. Hepatic insufficiency with LFTs greater than two times upper limit of normal
12. Renal insufficiency requiring dialysis
13. End stage cardiac failure
14. Fat malabsorption syndromes precluding drug absorption
15. Use of anticoagulant medications, azilect

Primary outcomes:
measure: Visual function
timeFrame: 3 months
Secondary outcomes:
measure: Neurologic function
timeFrame: 3 months
measure: Motor function
timeFrame: 3 months
measure: Brain metabolites
timeFrame: 3 months
measure: Cognitive function
timeFrame: 3 months
measure: Mood
timeFrame: 3 months
measure: Disease biomarkers
timeFrame: 3 months
measure: Safety
timeFrame: 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Theresa Zesiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074684: Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer
Official title: Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: diagnosis
nodules
fine needle aspiration
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 959
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: Consecutive patients with palpable thyroid nodules with indication for surgery (positive cytology, 2 consecutive inconclusive cytologies, or negative cytology with at least 2 of the following: previous exposure to neck radiation, calcitonin greater than twice normal values, positive pentagastrin test, or irregular margins or hypoechogenicity on ultrasound.

Brief summary: The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients presenting for thyroid disease (palpable nodules)
* Indication for surgery
* Age \> 18 years
* Signed informed consent for surgery
* Signed informed consent for data collection

Exclusion Criteria:

* Concurrent condition that contraindicates surgery
* Clinical or radiologic evidence of locally advanced tumor
* Clinical or radiologic evidence of metastatic lymph nodes or distant metastases
* Nonpalpable nodes

Primary outcomes:
measure: positive predictive value of preoperative suspicious clinical, laboratory and imaging findings
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Università di Cagliari
city: Firenze
country: Italy
facility: Azienda Ospedaliera Unviersitaria Careggi - Firenze
city: Ivrea
country: Italy
facility: ASL TO/4 Ospedale di Ivrea
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore di Roma Policlinico Gemelli
city: Taormina
country: Italy
facility: Ospedale di Taormina
city: Terni
country: Italy
facility: Università degli studi di Perugia - Sede di Terni
Study officials:
affiliation: National Cancer Institute, Naples
name: Luciano Pezzulo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Maria Grazia Chiofalo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Massimo Di Maio, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651884: Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation
Official title: High Definition-transcranial Direct Current Stimulation (HD-tDCS) for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Aphasia
Keywords: Stroke
Anomia
Lead sponsor: Soterix Medical
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2012-07-27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the changes in language processing of patients with chronic aphasia after receiving non-invasive brain stimulation.Previous research using traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has shown that persons with aphasia show more improvement after treatment when that treatment is accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver current to more specific locations in the brain. This new delivery method is called high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse current delivery) or HD-tDCS (more focal current delivery) will be the better approach for enhancing treatment outcomes. To answer this question, computerized speech-language treatment will be administered during the application of the different forms of brain stimulation.


Eligibility criteria: Inclusion Criteria:

1. one-time ischemic stroke in the left hemisphere
2. greater than 6-months post-stroke onset
3. between 25 and 80 years of age
4. aphasia diagnosis (as determined by pre-treatment language-based testing)
5. right-handed (before the stroke)
6. native speaker of English
7. ability to provide informed written or verbal consent

Exclusion Criteria:

1. clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
2. factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
3. prior history of epileptic or unprovoked seizures occurring during the previous 12 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of South Carolina
name: Julius Fridriksson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164084: A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris
Official title: A Phase 1, Single-center, Double-blind, Randomized, Cross-over, Pharmacokinetics, Safety and Tolerability Study of SB204 8% (NVN1000 Gel) and Vehicle Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will identify how much (if any) drug is absorbed from the skin of subjects with acne vulgaris after topical application of SB204.

Detailed description: This is a single-center, double-blind, randomized, 2 period cross-over study to be conducted in 18 subjects (18 years of age and above) each of whom will receive SB204 8% and Vehicle Gel. Subjects who satisfy the entry criteria will be randomized to SB204 8% or Vehicle Gel in a 1:1 ratio for the first treatment period. Study drug will be applied to the face, upper chest, upper back and shoulders (approximately 17% BSA) twice daily on Days 1- 4 approximately 12 hours apart. On Day 5, the study drug will be applied to the same areas only once, in the morning. Pharmacokinetic (PK) profiling will be performed on Day 1 and Day 5. After a wash out period, subjects will be treated with the alternate product and undergo similar treatment and assessments. The primary assessment is the pharmacokinetic profile of nitrate and silicon as markers for systemic exposure to nitric oxide (nitrate) and NVN1000 (silicon) after topical application of SB204 8% to approximately 17% of the total body surface area.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects with an acne severity of moderate or severe and a minimum of 20 inflammatory and 20 non-inflammatory lesions on the face, trunk and shoulders
* 18 years of age and older

Exclusion Criteria:

* Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
* Subjects who smoke or use tobacco products
* Subjects with methemoglobin level greater than 2% at Screening or Baseline by pulse co-oximeter.
* Subjects with a previous history of methemoglobinemia
* Subjects being treated with nitrates or any drug associated with methemoglobinemia
* Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens.

Primary outcomes:
measure: Pharmacokinetics of nitrate and silicon
timeFrame: After single dose and multiple dose (Day 5) application
Secondary outcomes:
measure: Safety
timeFrame: Safety will be assessed throughout the study duration (up to 7 weeks).
Other outcomes:
measure: Tolerability
timeFrame: During both treatment periods, through last day of treatment.
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research, LLC
state: Wisconsin
Study officials:
affiliation: Spaulding Clinical Research LLC
name: Carlos Sanabria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238184: Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: Postmarketing Surveillance Study (as Per §67(6 )AMG [German Drug Law]) of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 105
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive airways disease recruited by registered pneumologists

Brief summary: To obtain further information on the prescribing pattern and therapeutic long term value in patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease
* Only patients who showed following diagnosis parameters were to be considered for inclusion

  * FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) \<70%
  * Reversibility FEV1 \<12% in the last 6 months
  * Smoker or Ex-smoker (\>10 Pack years)
  * Asthma to be excluded

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics

Primary outcomes:
measure: Change in overall severity of the clinical picture rated on a 4-point scale
timeFrame: Up to 6 months after first study drug administration
measure: Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile
timeFrame: Up to 6 months after first study drug administration
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: Up to 6 months after first study drug administration
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: Up to 6 months after first study drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Up to 6 months after first study drug administration
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: Up to 6 months after first study drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 6 months after first study drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02255084: Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women
Official title: Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Cervix
Keywords: Cervical cancer screening
High Risk Human papillomavirus Infection
vaginal self-sampling
pap smear
general practitioner
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 3612
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.


Eligibility criteria: Inclusion Criteria:

* women from 30 to 65 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")

Exclusion Criteria:

* pap smear made in the three last years

Primary outcomes:
measure: Participation / no participation to complete cervical cancer screening
timeFrame: 9 months after postal mail
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: UH Tours
state: Indre et Loire
Study officials:
affiliation: Centre de coordination des dépistages des cancers, Tours, France
name: Ken HAGUENOER, MD-PHD
role: STUDY_DIRECTOR
affiliation: Centre de coordination des dépistages des cancers, Tours, France
name: Somany SENGCHANH, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13.