louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01657916: 5-Year Objective and Subjective Results of a Mid-Urethral Sling
Official title: 5-Year Objective and Subjective Results of a Mid-Urethral Sling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: mid-urethral sling
Align urethral support system
tension free vaginal tape
cough stress test
pelvic exam
PFDI-20
PFIQ
SSQ
Urinary retention
mesh erosion
urodynamics
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 90
Sex: FEMALE
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: women who suffered from stress urinary incontinence (leakage of urine will laughing/coughing/sneezing/exercising)

Brief summary: Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.

Detailed description: Between June 2007 and December 2008, the investigators performed 155 Align mid-urethral slings in patients who were only receiving this operation. Very few studies have outcomes at 5 years of greater. The aim of this prospective cohort study is to evaluate five-year objective and subjective cure rates. Secondary endpoints will assess failure risk factors and describe any complications of the retropublic Align Urethral Support System five years postoperatively.

Eligibility criteria: Inclusion Criteria:

* women
* complaint of stress urinary incontinence
* underwent Align urethral support system from June 2007-December 2008

Exclusion Criteria:

* concommitant procedures

Primary outcomes:
measure: Cough stress test
timeFrame: 5 year follow up appt
Secondary outcomes:
measure: Pelvic exam
timeFrame: 5 year follow up appt
measure: Stress urinary incontinence related symptoms
timeFrame: 5 year follow up appointment
measure: Urgency incontinence related symptoms
timeFrame: 5 year follow up appointment
measure: Quality of life and self-reported data
timeFrame: 5 year follow up appointment
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
References:
Clinical trial NCT00044616: Relapse Prevention for Bipolar Type-II Disorder
Official title: Relapse Prevention of Bipolar Type-II Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-09-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.

Detailed description: Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE.

BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00602537

Eligibility criteria: Inclusion Criteria:

* Bipolar II Depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Depression Research Unit, Univ Penn
state: Pennsylvania
Study officials:
References:
citation: Amsterdam JD, Luo L, Shults J. Efficacy and mood conversion rate during long-term fluoxetine v. lithium monotherapy in rapid- and non-rapid-cycling bipolar II disorder. Br J Psychiatry. 2013 Apr;202(4):301-6. doi: 10.1192/bjp.bp.111.104711. Epub 2012 Oct 25.
citation: Amsterdam JD, Shults J. Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry. 2010 Jul;167(7):792-800. doi: 10.1176/appi.ajp.2009.09020284. Epub 2010 Apr 1.
Clinical trial NCT04952116: Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors
Official title: Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eyelid Defects
Periocular Tumors
Keywords: Eyelid
Reconstruction
periocular tumors
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects.
* To determine the complications of eyelid reconstruction and how to prevent them

Detailed description: Patients will undergo the following :

Direct eyelid closure will be done in small defects with or without canthyolysis Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps

Patients will be followed up as regard

* The stability of flap or graft
* The vertical and horizontal measurements of palbepral fissure
* Detection of any complications
* Donor site follow up
* Patient degree of satisfaction

Eligibility criteria: Inclusion Criteria:

* Patients with periocular tumors and candidate for excision

Exclusion Criteria:

* patients with history of radiotherapy or chemotherapy

Primary outcomes:
measure: Stability of graft or flap
timeFrame: 9 months
measure: Measurement of vertical and horizontal diameters of the palbepral fissure
timeFrame: 9 months
Secondary outcomes:
measure: Donor site
timeFrame: 9 months
measure: complications
timeFrame: 9 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Professor
name: Ali Ismail, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02855216: Effects of Two Sub-occipital Techniques on Limited Mobility According to the Flexion-rotation Test
Official title: Comparative Study of the Effects of Two Sub-occipital Techniques on Healthy Subjects With Limited Mobility According to the Flexion-rotation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Cervical Spine Rotational Hypomobility
Keywords: Physiotherapy
Range of motion
Inhibition sub-occipital techniques
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The cervical spine should work as a functional unit. If hypomobility should exist in any of the segments it would limit the mobility of the spine as a whole. Although it is frequent that certain cervical segments present hypomobility, they are not always related to symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have not been evaluated.

The objetive of this trials is to assess and compare the effects on cervical mobility, of the manual technique of sub-occipital inhibition by applying pressure and self-treatment by way of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility assessed by the flexion-rotation test.


Eligibility criteria: Inclusion Criteria:

* Flexion rotation test with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
* Sing the informed consent form.

Exclusion Criteria:

* Inability to tolerate FRT
* Contraindication to manual therapy.
* Cervical treatment during the study.
* Poor language and communication skills making difficult to undertand the informed consent.

Primary outcomes:
measure: Change in baseline in Range of movement in Upper Cervical Spine
timeFrame: 15 minutes after intervention
Secondary outcomes:
measure: Change in baseline in Range of motion of cervical spine
timeFrame: 15 minutes after intervention
measure: Change in baseline in Upper cervical spine range of motion
timeFrame: 15 minutes after intervention
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Unidad de Investgación en Fisioterapia. Universidad de Zaragoza
Study officials:
References:
Clinical trial NCT06249516: Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
Official title: A Randomized Controlled Trial to Explore Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Rhythm Disorder
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 80
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: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Detailed description: A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: The Penetration-Aspiration Scale
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 15
measure: Yale Pharyngeal Residue Severity Rating Scale
timeFrame: day 1 and day 15
measure: Fiberoptic Endoscopic Dysphagia Severity Scale
timeFrame: day 1 and day 15
measure: Murray Secretion Scale
timeFrame: day 1 and day 15
measure: Swallowing Quality of Life
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Xinzhu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01457716: Pharmacokinetic Pilot Study on Budesonide/Formoterol
Official title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females, 18-55 years of age.
* Normal weight at least 50 kg.

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
* Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
* Pregnant or lactating females.

Primary outcomes:
measure: Cmax of Budesonide and Formoterol
timeFrame: 24 hours
measure: AUCt of Budesonide and Formoterol
timeFrame: 24 hours
Secondary outcomes:
measure: AUCinf of Budesonide and Formoterol
timeFrame: 24 hours
measure: tmax of Budesonide and Formoterol
timeFrame: 24 hours
measure: t1/2 of Budesonide and Formoterol
timeFrame: 24 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Johanna Hietamäki, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06776016: Dietary Supplements to Treat Radiation-Induced Rectal Injury
Official title: A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Radiotherapy
Radiation Proctitis
Keywords: radiotherapy
radiation proctitis
tributyrin
rectal bleeding
butyrate
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 33
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: This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* At least 3 months since the completion of pelvic radiotherapy
* No evidence of tumor recurrence or metastasis
* Rectal bleeding with grade 1-2 by LENT-SOMA scales

Exclusion Criteria:

* Acute or chronic infectious diseases
* Serious systemic diseases
* Known allergies to any components of the study medication
* Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
* Late complications related to pelvic radiation injury
* Other hemorrhagic or coagulation disorders
* Previous rectal resection
* Bowel obstruction or perforation that require surgery
* Cognitive or psychological disorder

Primary outcomes:
measure: Number of participants with alleviated rectal bleeding (degraded by 1 or more)
timeFrame: At the time of 12 weeks since the start of treatment
Secondary outcomes:
measure: Number of participants with mild rectal bleeding (grade 0-1)
timeFrame: At the time of 24 weeks since the start of treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01578616: Endothelial Dysfunction and Plaque Vulnerability
Official title: Association of Endothelial Function With Plaque Vulnerability Assessed by Optical Coherence Tomography in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Coronary artery disease
Endothelial function
Optical coherence tomography
Thin cap fibroatheroma
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Yokohama City University Medical Center

Brief summary: Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability. The high resolution of optical coherence tomography (OCT) provides an accurate measurement of fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic and quantitative method to evaluate endothelial function. The investigators will investigate the association between endothelial function assessed by RH-PAT and plaque vulnerability determined by OCT-derived thin-cap fibroatheroma (TCFA).

Detailed description: Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT before discharge.

Eligibility criteria: Inclusion Criteria:

* patients with angiographically proven ACS (luminal stenosis of at least 50%) who undergo both OCT examination before coronary stent implantation and RH-PAT examination before discharge.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Division of Cardiology, Yokohama City University Medical Center
Study officials:
affiliation: Division of Cardiology, Yokohama City University Medical Center
name: Kiyoshi Hibi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02098616: Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
Official title: RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Antiviral Agents
Drug Resistance, Viral
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: VA Long Beach Healthcare System
name: National Cancer Institute (NCI)
name: Bristol-Myers Squibb
First posted: 2014-03-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1a
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion Criteria:

* Evidence of cirrhosis
* Liver or any other organ transplant
* Current or known history of cancer within 5 years prior to enrollment
* Documented or suspected hepatocellular carcinoma (HCC)
* Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy

Primary outcomes:
measure: Sustained Virologic Response
timeFrame: Post treatment week 12
Secondary outcomes:
measure: Safety
timeFrame: Up to end of treatment (+7 days)
measure: Sustained virologic response
timeFrame: 2, 4 and 24 weeks post-treatment
measure: Post treatment virologic response
timeFrame: post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
measure: On treatment virologic response
timeFrame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
measure: Virologic failure
timeFrame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
measure: Day 2 positive predictive value
timeFrame: Post treatment Week 12
measure: Interferon lambda genotype and virologic response
timeFrame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System/Southern California Institute for Research and Education
name: Timothy R. Morgan, MD
role: PRINCIPAL_INVESTIGATOR
References: