louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00538148: Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
Official title: A Multicenter, Multinational, Randomized, DB Controlled Study of the Efficacy & Safety of Oral Telithromycin 800 mg Once QD for 5 Days vs Azithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchitis, Chronic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 668
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-inferiority efficacy of telithromycin versus azithromycin


Eligibility criteria: Inclusion Criteria:

* Adult outpatients, either sex, aged 45 years or older.
* Patients with a documented history of chronic bronchitis with a basal FEV1 \<70% and \>35% made in the previous 12 months and who had had at least one or more AEBC in the previous year and with FEV1/FVC \<70% (lung function tests made in the previous 12 months).
* Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis presumably due to bacterial infection based on all of the following signs and symptoms of AECB: increased sputum purulence, and at least 1 of the 2 following signs and symptoms (increased dyspnea, increased sputum volume).
* Patients with negative chest radiography (posterior/anterior and lateral views) to rule out a pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication (it was necessary to not include patients with pneumonia associated with AECB).
* Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture.

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

Primary outcomes:
measure: Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.
timeFrame: At TOC visit (Day 17-Day 21).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01777048: Omega-3 Fatty Acids Supplementation in ADHD
Official title: Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: ADHD
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Universitäre Psychiatrische Kliniken (UPK) Basel
First posted: 2013-01-28
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.


Eligibility criteria: Inclusion Criteria:

Participants between ages 6 and 12 years who:

1. have been clinically diagnosed with ADHD by a physician
2. meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
3. are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
4. are on stable dosage of methylphenidate treatment before the start of the study
5. are able to speak English or German

Exclusion Criteria:

1. Participants who are younger than 6 years old or older than 12 years old
2. Those who have not been clinically diagnosed with ADHD by a physician
3. Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
4. Those without written parental consent
5. Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ \< 70)
6. Those with titrated dosage of methylphenidate before the start of the study
7. Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
8. Those with known hypersensitivity to the IMP under investigation
9. Those who are unable to read and understand the parent/participant information
10. Those receiving medications other than methylphenidate

Primary outcomes:
measure: Change in ADHD Rating Scale-IV total score
timeFrame: Baseline, Week 6, and Week 12
Secondary outcomes:
measure: Change in Child Behaviour Checklist total score
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken (UPK) Basel
Study officials:
affiliation: University of Basel
name: Yoon Phaik Ooi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01851148: Clinical Effectiveness of Osteopathic Manipulative Treatment in Chronic Migraine
Official title: Clinical Effectiveness of Osteopathic Manipulative Treatment Versus Sham Therapy and Usual Care in Chronic Migraine: 3 Armed RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: osteopathic manipulative treatment
migraine
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to determine the extend to which OMT is effective on a sample of subjects affected by migraine evaluated using the headache impact test (HIT-6) questionnaire.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 60 years old
* chronic migraine

Exclusion Criteria:

* secondary forms of headache,
* chronic illness,
* psychiatric illness,
* post-menopausal women

Primary outcomes:
measure: difference in HIT-6 score
timeFrame: at entry and after 26 weeks
Secondary outcomes:
measure: number of migraine attacks
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ancona's Hospital, division of neurology
Study officials:
affiliation: European Institute for Evidence Based Osteopathic Medicine
name: Francesco Cerritelli, MS, DO
role: STUDY_CHAIR
References:
citation: Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.
citation: Schabert E, Crow WT. Impact of osteopathic manipulative treatment on cost of care for patients with migraine headache: a retrospective review of patient records. J Am Osteopath Assoc. 2009 Aug;109(8):403-7.
citation: Cerritelli F, Ginevri L, Messi G, Caprari E, Di Vincenzo M, Renzetti C, Cozzolino V, Barlafante G, Foschi N, Provinciali L. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complement Ther Med. 2015 Apr;23(2):149-56. doi: 10.1016/j.ctim.2015.01.011. Epub 2015 Jan 21.
Clinical trial NCT01202448: Prospective Cohort Study With Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
Official title: Prospective Cohort Study With Risk-adapted Central Nervous System Evaluation in Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B cell lymphoma
central nervous system
prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Yonsei University
name: National Cancer Center, Korea
name: Korea Cancer Center Hospital
name: Korea University
First posted: 2010-09-15
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate the incidence of central nervous system (CNS) relapse or metastasis in patients with diffuse large B-cell lymphoma.

Detailed description: We dichotomize patients according to the risk of CNS involvement. Then, we perform CNS evaluation in patients at risk of CNS involvement. We prospectively monitor whether CNS relapse or metastasis occurs in patients with diffuse large B-cell lymphoma

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed patients with diffuse large B cell lymphoma
2. \> 20 years
3. life expectancy more than 6 months
4. Written informed consent

Exclusion Criteria:

1. Refusal to informed consent
2. Lymphomas other than diffuse large B cell lymphoma
3. Primary CNS lymphoma

Primary outcomes:
measure: CNS relapse/involvement
timeFrame: Up to 2 years after participants are enrolled.
Secondary outcomes:
measure: survival
timeFrame: Up to 2 years after participants are enrolled
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Consortium for Improving Survival of Lymphoma
name: Cheolwon Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205348: Swallowing Function Before and After Surgery for Thyroid Goiter
Official title: Swallowing Function Before and After Surgery for Thyroid Goiter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing thyroid surgery

Brief summary: To date, there have been no comprehensive studies on swallowing function in patients undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has significant effect on swallowing function in symptomatic and asymptomatic patients, which can be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2. Surgery will improve swallowing function as measured post-operatively by these same parameters. Patients with multinodular goiter will be asked to fill out a validated survey (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).

Detailed description: Detailed description not desired.

Eligibility criteria: Inclusion Criteria:

* thyroidectomy

Exclusion Criteria:

* na

Primary outcomes:
measure: Swallowing Quality of Life
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin Medical School
name: Herbert Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03404648: Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
Official title: Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Adenocarcinoma
Keywords: high risk
prostate cancer
C11-choline
PET/MR
mpMRI
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Detailed description: High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

Eligibility criteria: Inclusion Criteria:

1. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.

Exclusion Criteria:

1. Patients who already received primary treatment or neo-adjuvant therapy.
2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.
3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement \[e.g., tremor, dystonia\]).
4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.
5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.
6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.

Primary outcomes:
measure: Uptake Value of C11-choline
timeFrame: Baseline
measure: Number of Lesions Showing C11-Choline Uptake
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Ming Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564248: Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.
Official title: Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paediatric Surgery
Analgesics Prescriptions
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 340
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Patient with a Physical status score equal or II
* Ages 2-12
* Receiving outpatient surgery according to the eligibility criteria established in the latest expert recommendations in 2009 and in accordance with the service's practices

Exclusion Criteria:

* Lack of access to internet
* Cognitive dysfunction in children that interfere with understanding instructions
* Patient already receiving a analgesic treatment

Primary outcomes:
measure: Number of analgesic treatment taken
timeFrame: day 1 after surgery
Secondary outcomes:
measure: Number of analgesic treatment taken
timeFrame: day 2 after surgery
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Pascal DELMON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105648: Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm
Official title: Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Computerized Cytomorphometry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who previously had received thyroid fine needle aspiration cytology examination

Brief summary: The prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Nowadays, the gold standard is fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity is fair (\~90%), but still has its limitation that some results are indeterminate in about 15% of the nodules. These obstacles are especially troublesome for papillary and follicular thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation. Preoperative evaluation of the prognosis is extraordinary important for cancer management. However, current prognostic scoring systems is only applicable after surgery. Hence, we urgently need a better risk-stratification system for individual-tailored treatment, and genetic-based computerized morphometry study seems to be the most realistic and promising one. The goal of this study is to propose a reliable method for diagnosis and prognosis of papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic characteristics.


Eligibility criteria: Inclusion Criteria:

* patients who previously had received thyroid fine needle aspiration cytology examination

Exclusion Criteria:

* patients who are younger than 20 years old

Primary outcomes:
measure: cytomorphometry of the cells
timeFrame: 2016/4/20-2026/4/20
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospita
name: Shyang-Rong Shih, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03181048: Clinical Trial of Concomitant Hip Arthroscopy During PAO
Official title: Single-Blind Randomized Clinical Trial of Concomitant Hip Arthroscopy During Periacetabular Osteotomy for the Management of Hip Dysplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Dysplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 106
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.

Detailed description: There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
* Skeletally mature
* Age 15 - 55
* Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
* Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip

Exclusion Criteria:

* Pregnant women
* Previous surgery about the hip
* Patients receiving PAO for acetabular retroversion in the absence of DDH
* Previous hip arthroscopy to address intra-articular pathology

Primary outcomes:
measure: Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)
timeFrame: 1 year follow-up time point
measure: Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 1 year follow-up time point
measure: Mean score of University California Los Angeles (UCLA) activity assessment
timeFrame: 1 year follow-up time point
measure: Mean score of the Marx Activity Scale (MARX)
timeFrame: 1 year follow-up time point
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rafael Sierra, MD
role: PRINCIPAL_INVESTIGATOR
References: