louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01462747: Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
Official title: An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perianal Fistulas
Lead sponsor: Nordic Drugs AB
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.

Detailed description: Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.

Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.

Eligibility criteria: Inclusion Criteria:

1. Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
2. Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
3. Superficial fistula involving a part of the external sphincter muscle
4. Age: ≥18 years and ≤ 75 years
5. Informed consent and/or Letter of Authority (as applicable) obtained

   Exclusion Criteria
6. Inflammatory Bowel Disease (IBD)
7. Rectovaginal fistulas
8. Rectourethral fistulas
9. Rectovesical fistulas
10. Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
11. Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
12. Any surgical treatment for perianal fistulas
13. Colorectal and/or anal malignancy
14. Other malignancy requiring active treatment
15. Subcutaneous fistulas not involving any part of the external sphincter
16. Other diseases which as per the investigator's opinion should be contraindicated
17. Subjects who are not able to complete study procedures as per the investigator's opinion

Primary outcomes:
measure: Clinical evaluation of fistula healing, change from baseline
timeFrame: week 8 and 24
Secondary outcomes:
measure: Anal ultrasonography, change from baseline
timeFrame: week 8 and 24
measure: Patient assessment of Symptoms and Impact on Daily Function, change from baseline
timeFrame: week 8 and 24
measure: Safety, change from baseline
timeFrame: week 2, 8, 24
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö University Hospital Dept of Surgery
city: Stockholm
country: Sweden
facility: Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Study officials:
affiliation: Skane University Hospital
name: Måns Bohe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091947: Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Official title: Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Incontinence
Keywords: FMS
Urine incontinence
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2014-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.

Detailed description: 5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

Eligibility criteria: Inclusion Criteria:

* Urine incontinence refractory to traditional treatment

Exclusion Criteria:

* Arrhythmia, pacemaker implantation

Primary outcomes:
measure: Symptom scoring on Urge-Urinary Distress Inventory questionnaire
timeFrame: up to 5 months
Secondary outcomes:
measure: Cystometry and stress urethral pressure profile as measures of objective incontinence improvement
timeFrame: up to 5 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Dep of PMR, Taipei VGH
name: Po-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai PY, Wang CP, Hsieh CY, Tsai YA, Yeh SC, Chuang TY. Long-term sacral magnetic stimulation for refractory stress urinary incontinence. Arch Phys Med Rehabil. 2014 Dec;95(12):2231-8. doi: 10.1016/j.apmr.2014.07.010. Epub 2014 Jul 27.
Clinical trial NCT03397147: Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
Official title: Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial with 2 conditions (intervention and usual care).
Primary purpose: TREATMENT

Brief summary: Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.


Eligibility criteria: Inclusion Criteria:

* child between 5-9 years of age
* child have been diagnosed with type 1 diabetes for at least 12 months
* caregiver lives with child
* caregiver can read/speak English

Exclusion Criteria:

* child has other major health problems or sleep disorders other than insufficient sleep or insomnia
* participating in other intervention studies

Primary outcomes:
measure: Child Sleep Duration
timeFrame: 3 months
measure: Child Sleep Quality
timeFrame: 3 months
Secondary outcomes:
measure: Glycemic Control
timeFrame: 3 months
measure: Parent Sleep Duration
timeFrame: 3 months
measure: Parental Well-being
timeFrame: 3 months
measure: Child Behavior Problems
timeFrame: 3 months
measure: Parent Sleep Quality
timeFrame: 3 months
measure: Parental Fear of Hypoglycemia
timeFrame: 3 months
measure: Parental Diabetes Distress
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01023347: A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 276
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: This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
* At least one measurable lesion(s) by RECIST criteria
* No previous palliative chemotherapy
* Age 18 or higher.
* ECOG PS 0-2
* Life expectancy of at least 3 months.
* Adequate hematologic, hepatic, renal function
* Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)
* Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)
* Adequate renal function (≤ serum creatinine 1.5 mg/dl)
* Written informed consent

Exclusion Criteria:

* No prior chemotherapy for NSCLC
* Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
* Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
* Clinically significant cardiac disease (medically uncontrollable heart disease)
* Active infection or other serious medical illness
* Contraindication to any drug contained in the chemotherapy regimen
* Pregnant or lactating women were excluded.

Primary outcomes:
measure: response rate
timeFrame: up to 6 cycles
Secondary outcomes:
measure: overall survival
timeFrame: up to 3 years
measure: progression-free survival
timeFrame: up to 3 years
measure: toxicity profiles
timeFrame: up to 6 cycles
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
Study officials:
affiliation: Chungnam National University Hospital
name: Sun Young Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596747: A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
* Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Have received a stable daily dose of basal insulin at screening
* Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
* Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.

Exclusion Criteria:

* Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
* Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
* Are receiving insulin other than once daily basal insulin
* Have any active infectious or serious disease or major organs insufficiency
* Women who are pregnant or lactating

Primary outcomes:
measure: Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 12
measure: Incidence and Severity of Hypoglycemia
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
timeFrame: Baseline through Week 6
measure: PD: Change from Baseline in 7-Point Glucose
timeFrame: Baseline through Week 6
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02617147: Choroidal Thickness Vitrectomy
Official title: Influence of Vitrectomy and Membrane Peeling on Choroidal Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with epiretinal membrane scheduled to undergo vitrectomy

Brief summary: The purpose of this study is to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

Detailed description: Since the development of new OCT modalities, like enhanced depth or swept-source OCT imaging, a better visualization and evaluation of retinal structures and the choroidea became possible. 23G Vitrectomy and membrane peeling seem to have an influence on posterior segment structures of the eye but data show no clear evidence evaluating those changes after surgery. Only little information is currently available on the influence or the changes resulting from vitreous surgery on the central choroidea. Hence, the aim of this study is to evaluate those influences resulting on choroidea using two different OCT devices.

To assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices.

This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna.

40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

The measuring procedures used in this study are well tolerated and used in routine clinical practice and are non-invasive.

Eligibility criteria: Inclusion Criteria:

* Patients with epiretinal membrane scheduled to undergo vitrectomy without endotamponade
* Male or female, at least 18 years of age
* Written informed consent has been obtained
* Visual acuity ≥0.4

Exclusion Criteria:

* Any abnormalities preventing reliable measurements as judged by the investigator
* Participation in a clinical trial in the 3 weeks preceding the study

Primary outcomes:
measure: choroidal thickness using 2 different OCT devices
timeFrame: 3 months
Secondary outcomes:
measure: Visual Acuity using Snellen charts
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology, Medical University of Vienna, Austria
Study officials:
References:
Clinical trial NCT01906047: Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis
Official title: Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Keywords: Non-cystic fibrosis bronchiectasis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a HRCT diagnosis of bronchiectasis and do not have a diagnosis of cystic fibrosis. They also need to have typical bronchiectatic disease (recurrent infections and sputum).

Brief summary: We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis bronchiectasis outcome.

Detailed description: * Patient files will be search for time of death and cause of death.
* Other variables will be collected: bacterial culture results, therapy, gender, age, etc.
* These data will be linked with pollution data: trafic load, distance to major road, etc.

Eligibility criteria: Inclusion Criteria:

* HRCT diagnosis of bronchiectasis
* recurrent infections or chronic sputum production
* patients between 18 and 65 years old.

Exclusion Criteria:

* Cystic Fibrosis
* Tumoral disease
* Traction bronchiectasis due to interstitial lung disease
* patients older than 65 years or younger than 18 years at recruitment
* COPD

Primary outcomes:
measure: Death
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Lieven J Dupont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Pieter C Goeminne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goeminne PC, Bijnens E, Nemery B, Nawrot TS, Dupont LJ. Impact of traffic related air pollution indicators on non-cystic fibrosis bronchiectasis mortality: a cohort analysis. Respir Res. 2014 Sep 3;15(1):108. doi: 10.1186/s12931-014-0108-z.
Clinical trial NCT04513847: PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis
Official title: PsoVac: A Psoriatic Patient-based Survey on the Understanding of the Use of Vaccines While on Biologics During the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Covid19
Keywords: Education
Vaccine
Biologic
Lead sponsor: Dermatrials Research
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 661
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dermatology Clinic

Brief summary: To determine if there is a need for further education on vaccines with psoriasis patients who are on a biologic. In regards to the COVID-19, it is important that psoriasis patients - whether on a biologic or not - understand whether they can have certain vaccines. That will depend on the type of vaccine that becomes available.


Eligibility criteria: Inclusion Criteria:

* psoriasis patient

Exclusion Criteria:

* no exclusions

Primary outcomes:
measure: Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey.
timeFrame: Data will be collected over a span of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
Study officials:
References:
Clinical trial NCT01291147: Local Anaesthetic Infusion For Laparoscopic Hysterectomy
Official title: Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: pain
anaesthetic
Lead sponsor: Ashford and St. Peter's Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.


Eligibility criteria: Inclusion Criteria:

All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy

Exclusion Criteria:

Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.

Primary outcomes:
measure: • Need for 'rescue' analgesia
timeFrame: 48 hours
Secondary outcomes:
measure: • Pain intensity
timeFrame: 48 hours
measure: Side effects from rescue analgesia
timeFrame: 48 hours
measure: Amount of patient controlled analgesia needed
timeFrame: 48 hours
measure: Hospital length of stay
timeFrame: 48 hours
measure: Patient satisfaction with pain relief
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Ashford and St Peter's Hospitals NHS Foundation Trust
name: Jeremy T Wright, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrews V, Wright JT, Zakaria F, Banerjee S, Ballard K. Continuous infusion of local anaesthetic following laparoscopic hysterectomy--a randomised controlled trial. BJOG. 2014 May;121(6):754-60; discussion 761. doi: 10.1111/1471-0528.12610. Epub 2014 Feb 19.