louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004670: Phase II Study of Pallidotomy for Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson disease
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Emory University
First posted: 2000-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus.

The other group receives standard medical care for 6 months followed by a pallidotomy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during "off" periods

Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry

No atypical or secondary disease, e.g.:

* No history of cerebrovascular accident
* No cerebellar involvement
* No severe brain atrophy on magnetic resonance imaging

No Mattis Dementia Rating Scale score less than 116

No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria

No Hamilton Depression Rating Scale score greater than 10

No Hamilton Anxiety Scale score greater than 14

--Patient Characteristics--

Other: No medical contraindication to surgery, e.g.:

* Diabetes
* Cardiopulmonary disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Mahlon R. DeLong
role: STUDY_CHAIR
References:
Clinical trial NCT02801370: Phase 3 Study of OTO-201 in Acute Otitis Externa
Official title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Swimmer's Ear
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 262
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).


Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female age 6 months or older
* Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
* Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has tympanic membrane perforation
* Subject has eczematoid otitis externa
* Subject has diabetes mellitus

Primary outcomes:
measure: Number of Subjects Considered a Clinical Cure at Day 8
timeFrame: At Day 8 (1 week after dosing)
Secondary outcomes:
measure: Number of Subjects Considered a Clinical Cure at Day 15
timeFrame: At Day 15 (2 weeks after dosing)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Call Otonomy call center for trial locations
state: California
city: Saskatoon
country: Canada
facility: Call Otonomy call center for trial locations
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01845870: Serum 1,25-dihydroxyvitamin D Levels in Type 2 Diabetes Mellitus Patients With Different Levels of Albuminuria
Official title: Study Whether Serum 1,25-dihydroxyvitamin D Levels Could be an Indicator for Dysfunction of Renal Tubules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2DM were recruited from the general hospital of Tianjin Medical University in China .

Brief summary: Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be presented with the characteristics of albuminuria, and its main pathological change is glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1 and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular injury may be the primary pathological change in diabetic renal injury not only the secondary change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM patients, the tubular injury may be severe already. An index which is predominant, sensitive and convenient to be measured should be purposed.It is predicted that insufficient renal 1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators present the presumption that the activity of renal 1-alpha hydroxylase could reflect the degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.


Eligibility criteria: Inclusion Criteria:

* age \>18 years, DM duration \>1 year, all of the patients were predialysis

Exclusion Criteria:

* history of liver or kidney disease, malignancy, current pregnancy, extensive dermatologic disease, evidence of metabolic bone disease and hyper-/hypo- thyroidism that would affect mineral metabolism. Patients who were taking native or active vitamin D, steroids, phosphate binders, or medications that affect vitamin D metabolism were also excluded.

Primary outcomes:
measure: determination of urinary albumin
timeFrame: 8 weeks
Secondary outcomes:
measure: determination of serum vitamin D metabolites
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Chenlin Dai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06781242: Genotype-phenotype Relationship Between Cryptogenic Cholestasis and Familial Intrahepatic Cholestasis
Official title: Genotype-phenotype Relationship Between Adult Cryptogenic Cholestasis and Mutations in Genes Responsible for Progressive Familial Intrahepatic Cholestasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholestatic Liver Disease
Intrahepatic Cholestasis
Progressive Familial Intrahepatic Cholestasis
Hepatobiliary Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 300
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: Data from all patients with PFIC/CCLDs/HBCs will be collected and retrospectively evaluated relating to the centers participating in the study from May 2013 until the start date of the study.

Brief summary: Genotype-phenotype relationship between adult cryptogenic cholestasis and mutations in genes responsible for progressive familial intrahepatic cholestasis

Detailed description: Due to the high number of unsolved cases of adults with cholestatic liver disease, it is crucial to determine the prevalence of PFIC gene mutations and gather information on various clinical presentations that often coexist. This will help identify risk factors related to the disease and its progression, ultimately allowing for personalized treatment options for affected patients.

This multicenter, retrospective observational study will collect data on patients with cholestatic liver diseases (CCLDs) from May 2013 until the study begins. Diagnoses of PFIC/CCLD/HBC will be confirmed through imaging studies, excluding other liver disease causes.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* diagnosis of PFIC/CCLDs/HBCs
* obtaining informed consent

Exclusion Criteria:

* Another documented cause of chronic liver disease capable of justifying the clinical phenotype

Primary outcomes:
measure: Mutation classification in PFIC genes in patients with CCLDs
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Outcomes in PFIC Gene Mutation Carriers
timeFrame: 12 months
measure: Histological Patterns of Familial Intrahepatic Cholestasis in PFIC Gene Mutation Carriers
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Azienda Ospedaliero-Universitaria di Bologna
city: Modena
country: Italy
facility: Ospedale Civile Sant'Agostino Estense Baggiovara
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giovanni Vitale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595842: Artificial Root-End Barriers
Official title: Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Cements
Tooth Abnormalities
Keywords: Mineral trioxide aggregate
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: 59th Medical Wing
First posted: 2008-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 5-40 years old who have been treated with MTA

Brief summary: This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.

Detailed description: The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. The purpose of this retrospective study was to determine the clinical success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. Patients were recalled and evaluated for clinical signs and symptoms and osseous healing. Immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the Periapical Index (PAI).

Eligibility criteria: Inclusion Criteria:

* a tooth with a single canal and presence of an open apex by radiograph
* Ca(OH)2 treatment for at least one week prior to obturation
* use of MTA to produce an artificial apical barrier
* placement of a final restoration
* radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth
* patients ages 5-40 years old

Exclusion Criteria:

* patients younger than 5 and greater than 40 years old
* patients unable to be contacted for recall during the study
* patients with a medical condition whose health would be jeopardized by participation in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: David Holden, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489642: Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Official title: Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Association for Respiratory Care
First posted: 2018-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers want to learn more about telehealth pulmonary rehabilitation programs that help people with Chronic obstructive pulmonary disease (COPD) improve physical activity and quality of life.


Eligibility criteria: Inclusion Criteria:

* Hospital discharge diagnosis of COPD
* Spirometry-confirmed evidence of COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages I to IV
* Access to internet connection and knowledge on use of web-based programs

Exclusion Criteria:

* Persons with additional significant comorbidities including cancer, cardiac disease and physical impairments
* Non-English speaking persons
* The inability to provide an informed consent

Primary outcomes:
measure: Measure of physical activity
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: Quality of Life
timeFrame: Change from Baseline to Week 12
measure: Adherence to physical activity requirements
timeFrame: Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Cheryl Skinner, RRT, CPFT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Dave Burnett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Clinical trial NCT05820542: Glottic Opening Percentage (POGO) With Miller and McGrath MAC Videoingoscopes
Official title: Comparison of Glottic Opening Percentage (POGO) With Miller and McGrath MAC Videoingoscopes According to Direct Epiglottis Lifting Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal intübation
Keywords: percentage of glottic opening
laryngoscopy
direct epiglottis lifting method
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 85 patients 18-65 years both genders in all surgeries requiring intubation

Brief summary: The aim of this study is to compare the percentage of glottic opening (POGO) with Miller and McGrath MAC Videoingoscopes compared to the direct epiglottis lifting method.

Detailed description: The aim of this study is to compare the percentage of glottic opening (POGO) with Miller and McGrath MAC Videoingoscopes compared to the direct epiglottis lifting method.

Eligibility criteria: Inclusion Criteria:

* Those who agreed to participate in the study
* He will undergo elective surgery
* Endotracheal intubation required
* 18-65 years old
* ASA 1-2 risk
* Body mass index\<30
* No risk of difficult intubation

Exclusion Criteria:

* Those who do not want to participate in the study,
* Allergic to study drugs,
* Pregnant women
* Those with a history of difficult intubation
* They will be applied rapid-serial intubation
* Emergency

Primary outcomes:
measure: Comparison of Glottic Opening Percentage (POGO) With Miller and McGrath MAC Videolaryngoscopes According to Direct Epiglottis Lifting Method
timeFrame: during laryngoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT03797742: A Clinical Follow-up Study of Heart Failure Patients.
Official title: A Clinical Follow-up Study of Heart Failure Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.

Brief summary: Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.


Eligibility criteria: Inclusion Criteria:

* LVEF≤ 55%
* enlarged left ventricular end-diastolic dimension
* ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
* symptomatic heart failure

Exclusion Criteria:

* Known malignant tumour diseases
* Pregnancy or lactation period；
* Investigators think not suitable to participate in this trial.

Primary outcomes:
measure: NYHA functional class
timeFrame: one year after enrolled
measure: All-cause mortality
timeFrame: one year after enrolled
Secondary outcomes:
measure: hospitalization for cardiac causes
timeFrame: one year after enrolled
measure: left ventricular end-diastolic dimension(LVEDD) dilates.
timeFrame: one year after enrolled
measure: left ventricular ejection fraction reduces
timeFrame: one year after enrolled
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
References:
Clinical trial NCT06995742: Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity
Official title: Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vital Sign Evaluation
Vital Sign Monitoring
Sleep Quality
Provider Behavior
Patient Satisfaction
Keywords: time motion study
vital signs
sleep quality
inpatient sleep
wireless device
patient satisfaction
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Minnesota Medical School/University of Minnesota Foundation
name: Sibel Health Inc.
First posted: 2025-05-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.


Eligibility criteria: Inclusion Criteria:

* Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.

Exclusion Criteria:

* Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.

Primary outcomes:
measure: Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs
timeFrame: Number of seconds spent obtaining and charting vital signs is obtained at 8a daily, for maximum of three days for each study participant, and are added together to equal the total time spent on vital sign assessment.
Secondary outcomes:
measure: Sleep Quality of Inpatient Study Participants
timeFrame: Survey conducted 24-72 hours after enrolment.
measure: Patient Satisfaction with Inpatient Sleep Quality
timeFrame: Survey sent within a week of hospital discharge and collected within the subsequent thirty days.
measure: Healthcare Provider Experience with the Vital Sign Device Array
timeFrame: The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Feinberg 16 West, Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Gregory (Randy) R Smith Jr, MD MS
role: PRINCIPAL_INVESTIGATOR
References: