louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01901640: Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction
Official title: Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 302
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

Detailed description: Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Eligibility criteria: Inclusion Criteria:

* Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)

Exclusion Criteria:

* Had uncontrolled blood pressure
* Had hepatic or renal dysfunction
* Had significant psychiatric disorders or drug abuses
* Was currently under anticancer chemotherapy
* Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors

Primary outcomes:
measure: Safety
timeFrame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Secondary outcomes:
measure: International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal
timeFrame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)
Other outcomes:
Locations:
Study officials:
affiliation: the Catholic University of Korea St. Mary's Hospital
name: S W Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: D G Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: J J Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: N C Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: S W Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: J S Paick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: T Y Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: K H Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Hospital
name: W S Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: K S Min, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: J K Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: D Y Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670940: Bronchiectasis Effect in COPD Patients
Official title: Effect of Bronchiectasis on Respiratory Functions, Exercise Capacity, Dyspnea Perception and Quality of Life in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Copd
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with and without bronchiectasis.

Brief summary: The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.

Detailed description: The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.

Torax CTs of patients with COPD who are admitted to the outpatient clinic will be examined. There will be two groups, group 1 in patients with COPD accompanied by bronchiectasis and group 2 in COPD patients without bronchiectasis. In both groups, respiratory function tests, exercise capacities, dyspnea perceptions and quality of life will be evaluated. The data will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* above 18 years old
* clinically stable

Exclusion Criteria:

* other respiratory disease

Primary outcomes:
measure: Exercise capacity
timeFrame: 15 minutes
Secondary outcomes:
measure: Dyspnea Severity
timeFrame: 5 minutes
measure: Lung Function
timeFrame: 20 minutes
measure: Health Related Quality of Life
timeFrame: 25 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01576640: Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
Official title: An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nicotine Dependence
Schizophrenia
Keywords: Nicotine Dependence
Smoking Cessation
Relapse Prevention
Cognitive Behavioral Therapy
Schizophrenia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
* Reported smoking 10 or more cigarettes per day for at least the prior year
* Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
* Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
* Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment

Exclusion Criteria:

* Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.

Primary outcomes:
measure: 7-Day Point Prevalence Abstinence at Month 15
Secondary outcomes:
measure: 4-Week Continuous Abstinence at Month 15
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street
state: Massachusetts
Study officials:
References:
Clinical trial NCT00810940: Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Official title: Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Severe Head Trauma
Keywords: TBI
closed head injury
severe head trauma
traumatic brain injury
Lead sponsor: Abela Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
name: University of California, Irvine
name: Dr. Mahajan's Hospital & Industrial Trauma Centre
First posted: 2008-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis TBI
* GCS 4-8
* Age 16-70

Exclusion Criteria:

* Multiple trauma resulting in shock
* Bilateral absent pupil response
* Time from injury \> 6 hours
* Brain tumor or mass effect secondary to hemorrhage or brain surgery
* Pregnancy
* Confounding condition or injury
* Spinal cord injury
* Sustained high blood pressure or arterial oxygen saturation

Primary outcomes:
measure: reduction in intracranial pressure
timeFrame: 24 hours, 5 days
Secondary outcomes:
measure: mortality
timeFrame: 3 months
measure: Glasgow Outcome Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT03139240: Opioid Analgesia for MAB
Official title: Opioid Analgesia for MAB: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: MAB
Pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2017-05-03
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.

Detailed description: This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (\<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Seeking elective medical abortion
* In good health
* Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
* Able and willing to receive text messages via phone
* Literate in English
* Able and willing to give informed consent and agree to the study terms
* Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

* Lack of access to cell phone and texting capabilities
* Early pregnancy failure
* Contraindications to the study medications: Oxycodone, Ibuprofen
* Contraindications to medical abortion with Mifepristone or Misoprostol
* History of methadone or heroin use
* Used alcohol in the past 24 hours
* Used marijuana \>4 times per week
* Any opioid in the past 30 days
* Using additional pain medications

Primary outcomes:
measure: Overall Maximum Self-reported Pain Score
timeFrame: 24 hours after misoprostol administration
measure: <7 Weeks of Gestation - Maximum Self-reported Pain Score
timeFrame: 24 hours after misoprostol administration
measure: 7-10 Weeks Gestation - Maximum Self-reported Pain Score
timeFrame: 24 hours after misoprostol administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beaverton
country: United States
facility: Site 1
state: Oregon
Study officials:
References:
citation: Colwill AC, Bayer LL, Bednarek P, Garg B, Jensen JT, Edelman AB. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1163-1170. doi: 10.1097/AOG.0000000000003576.
Clinical trial NCT03600740: Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus
Official title: Advancing Pre-operative Targeting for Deep Brain Stimulation in the Globus Pallidus Internus: Functional Segmentation Based on Probabilistic Tractography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Deep Brain Stimulation
Diffusion Tensor Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 1
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: In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.


Eligibility criteria: Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erik H Middlebrooks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05565040: Concealed Penis in Pediatric Age Group
Official title: Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Surgery
Urologic Diseases
Keywords: Concealed
phallopexy
dartos excision
degloving
penile re-retraction
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2022-10-04
Enrollment: 150
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by both phallopexy and dartos excision.

Detailed description: Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 \& 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia \& group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.

Eligibility criteria: Inclusion Criteria:

* patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature

Exclusion Criteria:

* Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.

Primary outcomes:
measure: Post-operative appearance of penile skin congestion and/or necrosis
timeFrame: 6 months
measure: Wound infection
timeFrame: 6 months
measure: Penile edema
timeFrame: 6 months
measure: Penile re-retraction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faulty of Medicine
Study officials:
affiliation: University of Alexandria
name: Ahmed EZ Elrouby, A.Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00860340: Hemodynamic Effects of Spironolactone in Patients With Heart Failure
Official title: Hemodynamic Effects of Spironolactone in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Hemodynamics
Echocardiographs
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action.

Randomized, two group placebo controlled, single blind study.


Eligibility criteria: Inclusion Criteria:

* CHF
* 21 - 80 years
* Serum creatinine \< 2 mg/dL
* Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks

Exclusion Criteria:

* Less than 21 years
* Pregnancy

Primary outcomes:
measure: Echocardiogram
timeFrame: 3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
measure: Measure of Kidney function and potassium levels
timeFrame: This will be taken before drug, two hours after and the following day
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
Study officials:
References:
Clinical trial NCT02292940: Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
Official title: Consumer Health IT Tools: Impact on Patient Experience, Access, and Health Outcomes for Patients With Complex Chronic Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Patient Outcome Assessment
Electronic Health Records
Keywords: patient outcome assessment
electronic health records
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-18
Enrollment: 168477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a chronic disease

Brief summary: Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic conditions
* Patient had at least 10-month membership in 2005

Exclusion Criteria:

* Patients less than age 18

Primary outcomes:
measure: Number of Ambulatory Care Sensitive Conditions (ACSC) Hospitalizations. Portal Users vs Those Who Are Not Portal Users
timeFrame: Data from 2006-2007
measure: Patient Self-report Survey Data
timeFrame: March 2015-April 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Mary E Reed, DrPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844740: Calcimimetics in Hypophosphatemic Rickets
Official title: Effect of Cinacalcet on the Long-term Treatment of Familial Hypophosphatemic Rickets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Familial Hypophosphatemic Rickets
Keywords: Familial hypophosphatemic rickets
Cinacalcet
hyperparathyroidism
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, large oral doses of phosphate and 1,25(OH)2D (calcitriol) are the standard treatment of patients with familial hypophosphatemic rickets (XLH). While this therapy is effective in healing the rickets, it is often limited by development of complications due to the high dose of medications required to achieve cure. Among them are the development of calcifications in the kidneys and secondary hyperparathyroidism (HPT) which in some patients may cause complications like high blood calcium level, high blood pressure and damage to the kidney. A drug to treat secondary hyperparathyroidism was just developed. In a short term study we found that it might help the treatment of XLH, by allowing the use of lower doses of the both phosphate and calcitriol. In the present study we will learn if indeed the addition of this new medicine (Cinacalcet) to the long-term treatment will allow the use of lower doses of both phosphate and calcitriol and consequently lower the risk of complications.


Eligibility criteria: Inclusion Criteria:

1. Patients with XLH
2. Age 5-21 years old
3. From the Renal and Endocrinology Clinics who have been in a stable clinical, biochemical and radiological condition for the preceding 9 months
4. Who have not received Cinacalcet before

Exclusion Criteria:

1. Treatment with growth hormone
2. Inability to swallow pills.
3. An orthopedic surgery or braces in the past 9 months, or scheduled within 9 months of start.
4. Pregnancy
5. History of seizure disorder
6. Abnormal liver functions (which may change the drug's AUC)

Primary outcomes:
measure: doses of phosphate and calcitriol required to sustain goals of blood and urine chemistries
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References: