louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00174239: Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.
Official title: A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.

Detailed description: The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson Disease
* Must be experiencing sleep akinesia

Exclusion Criteria:

* Current treatment with other dopamine agonists
* Nocturnal hallucinations
* Dementia

Primary outcomes:
measure: PDSS, UPDRS
Secondary outcomes:
measure: CGI, PGI, Epworth Sleepiness Scale, PDQ-39
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Loc. Camerelle - Pozzilli
country: Italy
facility: Pfizer Investigational Site
state: IS
city: Vittoria
country: Italy
facility: Pfizer Investigational Site
state: Ragusa
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Bolzano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03094039: Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia
Official title: Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 0
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants.

Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation.

With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.


Eligibility criteria: Inclusion Criteria:

* Newborn infants with an antenatal diagnosed CDH.

Exclusion Criteria:

* Severe antepartum or postpartum hemorrhage.
* Any obstetrical concern.
* Lack of parental consent.

Primary outcomes:
measure: Proportion of infants with hypotension requiring inotropes
timeFrame: first 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004639: Cleft Palate Surgery and Speech Development
Official title: Velopharyngeal Function for Speech After Palatal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cleft Lip
Cleft Palate
Keywords: cleft lip and palate
children
speech
velopharyngeal function
congenital facial malformation
von Langenbeck procedure
Furlow procedure
cleft lip and palate repair
Unilateral cleft lip and palate
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 1999-09-20
Enrollment: 475
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.

Detailed description: This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

Eligibility criteria: Inclusion Criteria:

* Unrepaired unilateral cleft lip and palate
* Lip repair surgery to be accomplished by 3-6 months of age
* Able to return to research site at least once a year for follow-up

Exclusion Criteria:

* Patients with concomitant conditions (ie. mental retardation, deafness)
* Patients with Simonart Band of the cleft
* Patients who could not return to research site on a yearly basis

Primary outcomes:
measure: Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Bauru
country: Brazil
facility: Hospital for Rehabilitation of Craniofacial Anomalies (USP-HRAC)
state: Sao Paulo
Study officials:
affiliation: Univerisity of Florida
name: William N Williams, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00358839: Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Official title: Calcitonin Gene Related Peptide-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hemiplegic Migraine
Keywords: Familial hemiplegic migraine type 1 and 2
CGRP
middle cerebral artery
superficial temporal artery
headache
genotype
Healthy Volunteers
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
Collaborators: name: EUROHEAD
First posted: 2006-08-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to Calcitonin Gene Related Peptide (CGRP)infusion.

Detailed description: Calcitonin Gene Related Peptide (CGRP) induces migraine attacks indistinguishable from spontaneous attacks in approximately 50% of migraine sufferers. Treatment of spontaneous migraine attacks with an antagonist to CGRP is effective in many patients. These data show that CGRP is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to CGRP infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria: Inclusion Criteria:

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: Healthy volunteers

Exclusion Criteria:

Controls: No primary headache in their own history 2) Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours

Primary outcomes:
measure: headache and associated symptoms
measure: blood flow velocity of the middle cerebral artery
measure: diameter of the superficial temporal artery
Secondary outcomes:
measure: MAP
measure: HR
Other outcomes:
Locations:
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Jakob Møller Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000339: Infusion Laboratory: Protocol 3 (Risperidone) - 4
Official title: Infusion Laboratory: Protocol 3 (Risperidone)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies the subjective as well as physiological effects of cocaine.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Evidence of change in neurotoxicity based on chore
measure: Degree of drug craving
measure: History, incidence and amount of drug use
measure: Type and severity of stimulant withdrawal symptoms
measure: Characterization of study population
measure: Population incidence of symptoms of depression, po
measure: Frequency and intensity of drug use and sexual beh
measure: Evidence of change in subjective responses to coca
measure: Clinical physiological response to cocaine challen
measure: Degree to which study medication influences change
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370339: Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes
Official title: Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Insufficient Sleep
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with type 1 diabetes

Brief summary: The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with T1D at least 3 months
* Receive clinical care at the Barbara Davis Center

Exclusion Criteria:

* Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
* Participation in an interventional research protocol
* Unable to complete study procedures

Primary outcomes:
measure: Number of nocturnal awakenings per week
timeFrame: One week per participant
measure: Assessment of facilitators and barriers to good sleep quality and duration
timeFrame: One week per participant
Secondary outcomes:
measure: Identification of common causes of sleep disruptors in adolescents with type 1 diabetes
timeFrame: One week per participant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Barbara Davis Center
state: Colorado
Study officials:
References:
Clinical trial NCT01899339: Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis
Official title: Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Submassive Pulmonary Embolism
Keywords: submassive pulmonary embolism
Ultrasonic energy
Ekosonic Endovascular Device
RV:LV function after Pulmonary Embolism
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: EKOS Corporation
First posted: 2013-07-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient presenting to the Emergency Department with submassive pulmonary hypertension over the age of 18.

Brief summary: Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with acute (\< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio \> 0.9

Exclusion Criteria:

* age \> 80
* Recent thrombolytic therapy (with in 4 days)
* Active bleeding or know bleeding diathesis
* Known coagulopathy (including treatment with vitamin K antagonists) INR \> 3 and/or PTT \> 50
* Thrombocytopenia (PLT cound \< 100,000)
* History of any intracranial or intraspinal surgery, trauma or bleed
* Intracranial neoplasms, AVM, or aneurysm
* Recent (\< 1 month) GI bleed
* Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy
* Recent (\< 7 days) major surgery, trauma, or obstetrical delivery
* Renal insufficiency with eGFR \< 45 ml/min
* Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
* Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP \> 90 mm Hg for \> 15 min or need for pressor agents to maintain BP \> 90.
* Severe Hypertension (sustained systolic \> 180 mm Hg or diastolic \> 90 mm Hg.
* Pregnant patients
* known right to left shunt
* Large (\>10 mm)intracardiac thrombus
* Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
* Life expectancy \< 30 days

Primary outcomes:
measure: Change in Right Ventricular:Left Ventricular ratio
timeFrame: baseline to 72 hours post
Secondary outcomes:
measure: recurrent pulmonary embolism
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
Study officials:
affiliation: Spectrum Health Hosptials and ARS
name: Michael Knox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03989739: A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
Official title: A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Cost-effectiveness
Pancreatectomy
Willingness to pay
Robotic
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was carried out at the General Surgery Department of Sanchinarro University Hospital of Madrid.

Details of the procedure have been described in a previous report and standardized in both groups. RDP was performed using a da Vinci Robotic Surgical System model Si and Xi (Intuitive Surgical, Sunnyvale, CA, USA) (8). All consecutive cases were conducted by the same group of 6 surgeons all with considerable experience in both laparoscopic and robotic approaches.

Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included and assigned either to RDP or LDP, depending on the availability of the robot. The indication for resection was given in the context of a multidisciplinary institutional committee.

Brief summary: This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.


Eligibility criteria: Inclusion Criteria:

* Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included.
* The indication for resection was given in the context of a multidisciplinary institutional committee

Exclusion Criteria:

-

Primary outcomes:
measure: Quality-adjusted life years
timeFrame: 2014-2018
measure: ICER
timeFrame: 2014-2018
measure: Costs
timeFrame: 2014-2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04622839: Post-Operative Pain Control Following Shoulder Surgery
Official title: Post-Operative Pain Control Following Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Shoulder and Elbow Surgeons
First posted: 2020-11-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants undergoing shoulder surgery will be randomized into one of the three study arms.
Primary purpose: TREATMENT

Brief summary: This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

Detailed description: There is currently very limited information in the literature regarding postoperative pain medication consumption following orthopedic shoulder surgery. To fill this knowledge gap, this study will evaluate overall opioid consumption in morphine milligram equivalents following surgical treatment for shoulder pathology.

Eligibility criteria: Inclusion Criteria:

* Opioid-naive adults age 18-90 years old planning to undergo surgical treatment for shoulder pathology with the PI at Johns Hopkins Shoulder Service (Columbia, Odenton clinic sites; Howard County General Hospital/Johns Hopkins Hospital operative sites) will be included.

Exclusion Criteria:

* Patients with prior history of opioid misuse, addiction, or chronic pain
* Patients taking chronic pain medication or have taken opioid medication in the past 3 months will be excluded due to risk of developing drug tolerances that could affect the amount of pain medication consumed after surgery An exception will be made for those who have used narcotic medication for fracture-related events, and expect to undergo surgical treatment for fracture repair (ORIF or arthroplasty)
* Patients with BMI \< 18.5 or \> 39.9
* Patients with a history of adverse reaction and/or allergy to oxycodone
* Patients lacking the ability to consent will also be excluded.
* Patients whose primary residence is outside the United States will be excluded.
* Patients who are unable to complete questionnaires due to medical condition, psychiatric illness, or significant language barrier will also be excluded.

Primary outcomes:
measure: Morphine milligram equivalents (MMEs) consumed
timeFrame: 2 weeks postop
measure: Opioid Prescription Refills
timeFrame: 2 weeks postop
measure: Office Contacts
timeFrame: 2 weeks postop
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) score
timeFrame: 2-4 months postop
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Howard County General Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Orthopedics
name: Umasuthan Srikumaran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: