louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04637633: Topical Cyclosporine-A for Management of Epiphora
Official title: Topical Cyclosporine-A for Management of Epiphora in Eyes With Acquired Punctal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Epiphora
Keywords: cyclosporine A
Epiphora
punctal stenosis
Lead sponsor: Farwaniya Hospital
Sponsor class: OTHER_GOV
First posted: 2020-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to investigate the clinical outcomes and tolerances of Cyclosporine A (CsA) in treating epiphora in eyes with acquired punctum stenosis

Detailed description: a prospective study included patients who were referred to our outpatient clinics in Farwanyia hospital, Kuwait during the period between July 2019 and January 2020, having symptomatic epiphora associated with severe acquired lower punctal stenosis. Patients were treated with topical 0.05% CsA on twice daily dose with topical preservative free artificial tears Q.I. D. Patients were followed up monthly for at least 3 months by epiphora grading, Fluorescein dye disappearance test (FDT) and evaluating the patient satisfaction

Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex
* had a diagnosis of epiphora that persisted more than three months both indoors and outdoors
* grade 0 punctal stenosis
* did not adequately respond to artificial tears, topical corticosteroids and topical antibiotics or in whom corticosteroids were discontinued due to their side effects.

Exclusion Criteria:

* congenital punctal obstruction
* edematous puncti
* allergic conjunctivitis
* history of dacryocystitis,
* inflammatory systemic diseases
* any previous chemotherapy treatment, and local irradiation.
* other causes of epiphora, lid laxity, entropion, and ectropion
* lid malposition, canalicular or nasolacrimal sac or duct obstruction
* previous eyelid or lacrimal drainage surgery
* untreated conjunctivitis or blepharitis

Primary outcomes:
measure: Epiphora grading
timeFrame: 3 months
Secondary outcomes:
measure: Fluorescein dye disappearance test (FDT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Farwanyia Hospital
state: Farwanyia
Study officials:
References:
Clinical trial NCT02353533: Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoma
Keywords: adenoma
EMR
FTRD
non- lifting
colon
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 40
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: Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.

Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.

In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).


Eligibility criteria: Inclusion Criteria:

* patients ≥ 18 years
* adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")

Exclusion Criteria:

* patients \< 18 years
* lesions \> 20 mm in size
* high risk carcinomas ("deep submucosal carcinoma")
* American Society of Anesthesiologists (ASA) class IV and higher

Primary outcomes:
measure: Success of resection
timeFrame: 3 month
Secondary outcomes:
measure: Duration of procedure
timeFrame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Study officials:
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
name: Stefan von Delius, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00061633: Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Official title: A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Gram-Positive Bacterial
Abscess
Burns
Cellulitis
Ulcer
Wound Infections
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-06-02
Enrollment: 169
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: Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:

  * major abscess requiring surgical incision and drainage
  * infected burn (see exclusion criteria for important qualifications)
  * deep/extensive cellulitis
  * infected ulcer (see exclusion criteria for important qualifications)
  * wound infections
* Patients must be expected to require at least 4 days of intravenous antibiotic treatment

Exclusion Criteria:

* Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days).
* Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Primary outcomes:
measure: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
timeFrame: 7-14 days following end of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: eStudy Site, 3450 Bonita Road, Ste 201
state: California
Study officials:
affiliation: Duke University
name: G. Ralph Corey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02939833: Effects of Scalp Nerve Blocks on Systemic Inflammation
Official title: Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meningiomas
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 160
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: Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

* previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial

Primary outcomes:
measure: serum TNF-α level
timeFrame: 24 hour after surgery
measure: serum IL-6 level
timeFrame: 24 hour after surgery
measure: serum IL-1β level
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: serum TNF-α level
timeFrame: 1 hour after surgery
measure: serum IL-6 level
timeFrame: 1 hour after surgery
measure: serum IL-1β level
timeFrame: 1 hour after surgery
measure: serum TNF-α level
timeFrame: 72 hour after surgery
measure: serum IL-6 level
timeFrame: 72 hour after surgery
measure: serum IL-1β level
timeFrame: 72 hour after surgery
measure: VAS score
timeFrame: 24 hour after surgery
measure: VAS score
timeFrame: 48 hour after surgery
measure: VAS score
timeFrame: 72 hour after surgery
measure: dosage of pain-control medicine
timeFrame: within 72 hour after surgery
measure: NRS score
timeFrame: 24 hour after surgery
measure: NRS score
timeFrame: 48 hour after surgery
measure: NRS score
timeFrame: 72 hour after surgery
measure: incidence of intracranial infection
timeFrame: within 30 days after surgery
measure: Hospitalization Days
timeFrame: up to 30 days
measure: out of pocket expenditure for hospitalisation
timeFrame: hospital discharge/up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04316533: Work Stress and Impact of Pruritus on Quality of Life
Official title: Study of the Association Between Work Stress and the Impact of Pruritus on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Occupational stress
Pruritus
Quality of life
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 30
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: Active and employed population, suffering from psoriasis, presenting for consultation or hospitalization of dermatology at the CHRU of Brest

Brief summary: Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis.

Detailed description: Background. Stress increases the likelihood of psoriasis flare-up episodes and itching. Few studies have focused on work-related stress on such skin symptoms.

Objective. To study the association between work-related stress, pruritus and quality of life among workers suffering from psoriasis.

Methods. Investigators will conduct a monocentric non-interventional prospective study. Patients suffering from psoriasis will be recruited in both the Dermatology inpatient ward and outpatient clinic of Brest University Hospital . Included patients will be workers. Work-related stress will be assessed using the Effort-Reward Imbalance (ERI) model. The impact of pruritus on quality of life will be assessed with the Itchy Quality of Life (ItchyQoL) self-administered questionnaire. The collected data will include age, sex, body mass index, ordered medication to treat psoriasis, weekly working hours. The association between ERI and ItchyQoL scores will be studied using a univariate logistic regression.

Eligibility criteria: Inclusion Criteria:

* Major patients
* Active busy patients with psoriasis presenting for a dermatology consultation or hospitalization at the Brest CHRU
* Participation agreement

Exclusion Criteria:

* Presence of another potentially pruritic pathology
* No command of the French language
* Patient under legal protection (guardianship, curatorship, etc.)
* Refusal to participate

Primary outcomes:
measure: Pruritus' impact on quality of life
timeFrame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
Secondary outcomes:
measure: Occupational stress
timeFrame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
Other outcomes:
Locations:
city: Brest
country: France
facility: Chru Brest
state: Finistère
Study officials:
References:
Clinical trial NCT05992987: Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria
Official title: Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Spontaneous Urticaria
Keywords: chronic spontaneous urticaria
adenosine deaminase
immunoglobulin E
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Settings: Dermatology outpatient clinics and Central Research Lab at Sohag University.

Study population: The study will include adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).

Brief summary: adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .


Eligibility criteria: Inclusion Criteria:

* adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).

Exclusion Criteria:

* Pregnancy and lactation.
* Patients with systemic diseases, especially those with autoimmune diseases and infections.
* Patients with skin diseases.
* Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.

Primary outcomes:
measure: Serum level of adenosine deaminase
timeFrame: 3 months
measure: Serum level of IgE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02264587: Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
Official title: Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Gastroparesis
Lead sponsor: Qingdao University
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma (Suzhou) Co., Ltd.
First posted: 2014-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.

Detailed description: To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test.

IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at 15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer, then can calculate the gastric emptying rate.

Eligibility criteria: Inclusion Criteria:

1. 18≤ age ≤ 75
2. Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels tendency for 11.1 / L）
3. fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L
4. Be diagnosed diabetes more than 5 years, blood sugar steady in one month.
5. have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation.
6. Be diagnosed as Delayed Gastric Emptying by C13 breath test.
7. Signed informed consent.

Exclusion Criteria:

1. take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease.
2. All patients will be administrated gastroscope in order to exclude stomach or duodenum disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen, nephridium by Ultrasound examination .
3. Serious ketoacidosis.
4. History of abdominal operation.
5. Thyroid hypofunction or hyperthyroidism.
6. nervous system disease or autoimmune diseases.

Primary outcomes:
measure: The improvement of gastric emptying time after taking the medicine
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03413787: The Türkish Version of the Freezing of Gait Questionnaire
Official title: The Türkish Version of the Freezing of Gait Questionnaire in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Motor Disorder
Gait Disorders, Neurologic
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be selected from neurologic clinic.

Brief summary: The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q) and assess the validity and reliability of this Türkish version.

The researchers firstly communicated with the developers of the FOG-Q. The permission for Turkish version was received by Giladi. Then, the FOG-Q will be adapted into Türkish using forward-backward translation by three native Türkish-speaking forward translators and one native English-speaking backward translator. The internal reliability of the FOG-Q Türkish version will be assessed using Cronbach's alpha, and item analyses will be conducted by examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items individually. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC).

Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs). In this section will be determined the correlation between the FOG-Q scores and scores of the UPDRS motor section , Berg Balance Scale, Timed up and go test, Falls Efficacy Scale and Hoehn and Yahr stages.


Eligibility criteria: Inclusion Criteria:

* a clinical diagnosis of idiopathic PD
* able to walk with or without a walking device

Exclusion Criteria:

* a diagnosis of other neurological disorders
* any other medical conditions
* not able to take commands.

Primary outcomes:
measure: Türkish version of the Freezing of Gait Questionnaire
timeFrame: 5 minutes
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale-part III
timeFrame: 5 minutes
measure: Berg Balance Scale
timeFrame: 10 minutes
measure: Timed up and go test
timeFrame: 2 minutes
measure: Fall Efficacy Scale
timeFrame: 5 minutes
measure: Hoehn and Yahr Scale
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Sevim ACARÖZ CANDAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714687: Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
Official title: Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Acute Rhinosinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2012-10-26
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.


Eligibility criteria: Inclusion Criteria:

* 19 years of age or greater
* diagnosis of recurrent acute rhinosinusitis
* suitable candidate for office-based procedure
* willing and able to read and sign informed consent and remain compliant with protocol and study procedures
* able to read and understand English

Exclusion Criteria:

* diagnosis of chronic rhinosinusitis
* prior sinus surgery
* physician determined need for ancillary procedures
* known immune deficiency, ciliary dysfunction and/or autoimmune disease
* clinically significant illness that may interfere with evaluation of the study
* participation in clinical studies 6 months prior to study participation
* pregnant or lactating females

Primary outcomes:
measure: CSS Total Score Change From Baseline to 24 Week Visit
timeFrame: 24 Week Visit
Secondary outcomes:
measure: CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks
timeFrame: 8, 16, 24, 32, 40, and 48 Weeks
measure: RSDI Total and Sub-score Changes From Baseline Over 48 Weeks
timeFrame: 8, 24, and 48 Weeks
measure: Medication Usage at 24 and 48 Weeks
timeFrame: 24 Weeks and 48 Weeks
measure: Unscheduled Medical Care Visits Due to Sinusitis
timeFrame: 24 Weeks and 48 Weeks
measure: Sinus Infections and Sinus Severity - Part 1
timeFrame: 24 Weeks and 48 Weeks
measure: Sinus Infections and Sinus Severity - Part 2
timeFrame: 24 Weeks
measure: Frequency of Second Procedure
timeFrame: Up to 24 weeks
measure: Return to Normal Activity
timeFrame: 2 week
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Atlanta
country: United States
state: Georgia
city: Las Vegas
country: United States
state: Nevada
city: Dallas
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
Study officials:
affiliation: Ear Nose and Throat Consultants of Nevada
name: Ashley Sikand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Institute for Sinus & Respiratory Disease
name: Ford Albritton, MD
role: PRINCIPAL_INVESTIGATOR
References: