louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01865825: Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
Official title: PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erosive Esophagitis
Keywords: Erosive Esophagitis
Gastroesophageal reflux disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with GERD that have been currently diagnosed with erosive esophagitis at endoscopy, at Mayo Clinic Rochester, Minnesota

Brief summary: The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.

If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.


Eligibility criteria: Inclusion criteria:

* Age 18 or older
* Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
* Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.

Exclusion criteria:

* Neoplasm of the esophagus or stomach
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

Primary outcomes:
measure: Abnormal esophageal distensibility in patients with PPI responsive Eosinophilic Infiltrates to patients with Eosionophilic esophagitis and Gastroesophageal Reflux Disease.
timeFrame: 1 year
Secondary outcomes:
measure: The relationship of abnormal esophageal distensibility to other endoscopic findings of EoE (furrows, rings, fragility, stricture)
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeffrey Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05986825: Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)
Official title: Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Verneuil disease

Brief summary: Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa. The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first time, and a second time 1 week later.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Patient with Verneuil disease
* Beneficiary of or affiliated to a social security insurance
* Participation agreement

Exclusion Criteria:

* Patients physically or mentally unable to complete questionnaires.
* Refusal to participate
* Patient under legal protection (guardianship, curatorship) or deprived of liberty

Primary outcomes:
measure: Validation of the questionnaire
timeFrame: During the visit and 1 week later
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
References:
Clinical trial NCT04279925: A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
Official title: A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Maxillofacial Injuries
Maxillofacial Prosthesis Implantation
Fracture Fixation, Internal
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital. The subject is the fracture line who met the inclusion criteria and randomly allocated into the study (locally-made miniplate and screw) and control (BIOMET® miniplate and screw) group through a predetermined randomization list. The healing process is follow up using non-contrast head computed tomography immediately after surgery as a baseline, and 3 months post-op. Afterward, a radiologist consultant as a blinded evaluator will evaluate the score of bone density, and screw loosening, while local tissue reaction after fixation evaluates during the patient's visit outpatient clinic. All scores from points of the evaluation group will be collected and going to statistically evaluated using independent t-test or Mann Whitney test depending on the distribution of the data


Eligibility criteria: Inclusion Criteria:

* Midface fracture with the indication of surgery
* Midface fracture sustained within 2 weeks

Exclusion Criteria:

* Comminuted and defect fracture
* Midface fracture on patients with systemic diseases affecting bone healing.
* Midface fracture in children
* Midface fracture in multiple trauma patients with neurological deterioration

Primary outcomes:
measure: Bone Density
timeFrame: 3 months
Secondary outcomes:
measure: Screw Loosening (Yes/No)
timeFrame: 3 months
measure: Tissue Reaction (Yes/No)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto mangunkusumo National Hospital
state: Central
Study officials:
References:
Clinical trial NCT00758225: Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)
Official title: A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne Muscular Dystrophy
DMD
Duchenne
Idebenone
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 21
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The scientific aim of the present extension study is to monitor long-term safety and tolerability of idebenone in patients with DMD. Furthermore, the long-term effect on respiratory, cardiac and motor functions, and skeletal muscle strength/function will be assessed.


Eligibility criteria: Inclusion Criteria:

* Completion of study SNT-II-001
* Body weight ≥ 25 kg
* Glucocorticosteroids and ACE-inhibitors are allowed, if on stable dosage within 2 months prior to inclusion
* Eligibility to participate in the present extension study as confirmed by the investigator

Exclusion Criteria:

* Safety or tolerability issues arising during the course of SNT-II-001 which in the opinion of the investigator preclude further treatment with idebenone
* Clinically significant abnormalities of haematology or biochemistry
* Abuse of drugs or alcohol
* Use of coenzyme Q10 or idebenone within 30 days prior to inclusion
* Intake of any investigational drug within 30 days prior to inclusion
* Symptomatic heart failure
* Previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at baseline
* Known individual hypersensitivity to idebenone or to any of the excipients

Primary outcomes:
measure: Measures of safety and tolerability of idebenone: - Nature and frequency of AEs - Laboratory parameters (haematology, biochemistry and urinalysis) - Physical examinations and vital signs - ECGs
timeFrame: Month 0, 3, 6, 12, 18, 24, FU
Secondary outcomes:
measure: Measures of efficacy of idebenone: - Respiratory Function Testing - Motor Function Measure - Quantitative Muscle Testing - Hand-Held Myometry - Echocardiography and Color Doppler Myocardial Imaging - Cardiac biomarkers
timeFrame: Month 0, 6, 12, 18, 24
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Prof Gunnar Buyse, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618225: Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
Official title: Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-thoracotomy Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 60
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: A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung cancer, will be randomized by the use of a computer-generated table of random numbers to receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure or a placebo pill following the same time schedule.


Eligibility criteria: Inclusion criteria

* ASA I, II, and III patients scheduled for thoracotomy for pleural or lung cancer resection.
* Age above 18 years \& less than 65 years.
* Adequate coagulation function within 30 days of surgery, defined as platelet count 100,000/mL or more, INR≤ 1.5, and partial thromboplastin time ≤40 seconds.

Exclusion criteria:

* Allergy to duloxetine or to local anesthetics.
* Patients with educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barriers that would prevent understanding of the informed consent \& preclude accurate assessment of postoperative pain and/or ability to answer questions about pain.
* Patients with severe renal and/or liver disease.
* History of chronic pain, long term narcotic use and/or antidepressants.
* Reasons for exclusion after randomization will be protocol violations or patient request.
* Fever, evidence of infection, or other coexisting medical conditions that would preclude epidural placement.

Primary outcomes:
measure: Total dose of morphine needed to treat postoperative pain
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute, Cairo University
Study officials:
References:
Clinical trial NCT01201525: Pulsed Dye Laser Treatment of Recent Surgical Scars
Official title: Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Scars
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.

Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
* Age at least 18 years old.
* Patient able and willing to give written informed consent

Exclusion Criteria:

* Patients with planned surgical intervention on hands, feet and genital area
* Patients with a history of photodermatoses
* Patients with a history of keloids
* Patients with a history of adverse outcomes related to PDL

Primary outcomes:
measure: Physician global assessment for the treated and control region (PhGA)
timeFrame: Before start of the study, 1 and 6 months after treatment
measure: Patient global assessment for the treated and control region (PGA)
timeFrame: Before start of the study, 1 and 6 months after treatment
Secondary outcomes:
measure: Assessment of scar color by colorimetry
timeFrame: Before start of the study, 1 and 6 months after treatment.
measure: Assessment of scar tickness by ultrasound measurements
timeFrame: Before start of the study, 1 and 6 months after treatment.
measure: Assessment of viscoelasticity by Cutometer measurements
timeFrame: Before start of the study, 1 and 6 months after treatment.
measure: Clinical scar assessment by the Vancouver Scar scale and POSAS scale.
timeFrame: Before the start of the PDL treatment, and 1 and 6 months after the last treatment.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Evelien Verhaeghe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06716125: Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus
Official title: Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Tinnitus, Subjective
Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 40
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: obese male usually complain subjective tinnitus that may affect their sexual function.

Detailed description: this study will enroll forty obese males with subjective tinnitus (bilateral complaint) and sexual dysfunction (erectile dysfunction) who will be divided to group I and group II with an equal number of males within each group (n =20 for the group). all male in both groups will administer low calorie diet for 12 weeks but Group I will additionally administer supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks).

Eligibility criteria: Inclusion Criteria:

* obese person
* body mass index less than 40 kg/m2 and more than 30 kg/m2
* males with subjective tinnitus (bilateral presentation from at least 24 weeks).
* males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

Exclusion Criteria:

* cardiac diseased males
* respiratory diseased males
* hepatic, musculoskeletal, and hepatic diseased males
* diabetic males

Primary outcomes:
measure: international index of erectile function
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: body mass index
timeFrame: it will be assessed after 12 weeks
measure: waist circumference
timeFrame: it will be assessed after 12 weeks
measure: visual analogue scale of severity of tinnitus
timeFrame: it will be assessed after 12 weeks
measure: visual analogue scale of discomfort induced by tinnitus
timeFrame: it will be assessed after 12 weeks
measure: tinnitus handicap inventory
timeFrame: it will be assessed after 12 weeks
measure: triglycerides
timeFrame: it will be measured after 12 weeks
measure: high density lipoprotein
timeFrame: it will be measured after 12 weeks
measure: atherogenic index
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223625: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Official title: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endothelial Dysfunction
Atherosclerosis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.


Eligibility criteria: Inclusion Criteria:

1. STEMI
2. no prior treatment with statins

Exclusion Criteria:

1. age below 18 or above 81 years
2. unconscious patients
3. serum creatinine \> 176μmol/L
4. total-cholesterol \> 7.0 mmol/l
5. hypothyreoidism ((TSH \> 1.5 x ULN (upper limit of normal))
6. current liver disease (ALAT \> 2 x ULN)
7. unexplained creatine kinase \> 3 x ULN
8. alcohol or drug abuse within the last five years
9. prior myopathy or serious hypersensitivity reaction caused by statins
10. women with childbearing potential who were not using chemical or mechanical contraception
11. pregnant or breastfeeding women
12. history of malignancy unless a disease-free period of more than five years was present
13. patients with abnormal lung function test (LFT)
14. participation in another investigational drug study less than four weeks before enrolment in the present study
15. treatment with cyclosporine or fibrates.

Primary outcomes:
measure: The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
timeFrame: One year
Secondary outcomes:
measure: The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery
timeFrame: One Year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardiology, Odense University Hospital
state: Fuenen
Study officials:
affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
name: Rasmus Egede, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egede R, Jensen LO, Hansen HS, Antonsen L, Hansen KN, Junker A, Thayssen P. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients. Int J Cardiol. 2012 Jul 26;158(3):376-9. doi: 10.1016/j.ijcard.2011.01.071. Epub 2011 Feb 23.
Clinical trial NCT01553825: Assessment of Patient Experience During Treatment for Cancer
Official title: Assessment of Patient Experience During Treatment for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathologically diagnosed carcinoma patients at Stanford cancer center who signed the informed consent form.

Brief summary: Assessing the mindset of cancer patients will help us better understand which patients are having difficulty dealing with the diagnosis and treatment that may not otherwise be fully appreciated by their physicians. By identifying such patients, we may then be able to design and implement strategies that can help improve their coping skills both during the treatment as well as after the completion of treatment. In addition to addressing physical concerns and symptoms, this approach will help address the overall emotional impact of a cancer diagnosis as more patients are living as cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed carcinoma patients at Stanford cancer center who signed the informed consent form.

Exclusion Criteria:

* Patients with a prognosis of \< 6 months life expectancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kathleen Horst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922025: Multicentre Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Male Patients
Official title: A Multi-centre, Naturalistic Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of EGFR TKI in Male Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer of Adeno Histology Failed 1st Line Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Male
Smoking Pattern
Efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 186
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The objective is to investigate the correlation between smoking pattern and clinical efficacy of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage, quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current practice of EGFR mutation testing in Taiwan will be surveyed.


Eligibility criteria: Inclusion Criteria:

* Male patients age 20 years or older
* Histological or cytological confirmation of NSCLC of adeno histology. If sputum is the only available sample, a second positive test is necessary for cytological confirmation
* Locally advanced or metastatic on or after first-line chemotherapy. Imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acceptable

Primary outcomes:
measure: Correlation between smoking patterns and best objective tumor response rate
timeFrame: 6 Months
Secondary outcomes:
measure: correlation between smoking patterns and progression free survival (PFS)
timeFrame: 9 months
measure: correlation between smoking patterns and overall survival (OS)
timeFrame: 9 Months
measure: changes from baseline in quality of life questionnaires (EQ-5D) after EGFR-TKI therapy
timeFrame: 3 Months
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Research Site
city: Chiayi
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipe
country: Taiwan
facility: Research Site
Study officials:
affiliation: Taipei Ventrans General Hospital
name: Chun-Ming Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: