louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01127399: Bariatric and Obstructive Lung Disease Study II
Official title: Effects of Obesity on Airway Caliber and Airway Smooth Muscle Tone
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Asthma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric Center at The Johns Hopkins University (Bariatric participants only), local community (Baltimore and Central Maryland area; control participants only)

Brief summary: The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning.

The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control)
* Physician diagnosis of asthma and on active asthma medication (if asthmatic)

Exclusion Criteria:

* Weight greater than 450 lbs
* Unstable cardiovascular disease
* Uncontrolled hypertension
* Renal failure on dialysis
* Cirrhosis
* Pregnant or lactating
* Bleeding disorders or Coumadin use
* Recent hospitalization for asthma in the past 3 months
* Active smoking or more than 10 pack year smoking history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University, The Johns Hopkins Bayview Medical Campus
state: Maryland
Study officials:
affiliation: The Johns Hopkins University
name: Emmanuelle Clerisme-Beaty, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018499: Genotype Influence on Recovery After Traumatic Brain Injury
Official title: The Influence of APOE Genotype on Recovery After Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Keywords: Traumatic Brain Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: Genetic differences in response to brain injury may reasonably be expected to play a role in the initial consequences of traumatic brain injury and in the rate of recovery from such injury.

Detailed description: Polymorphisms in the Apolipoprotein E gene encode functional variants which differentially determine the rate at which neuronal repair can occur, and are associated with differences in expression of neurodegenerative processes, including traumatic brain injury. It is proposed that the accuracy of prediction of outcome after head injury will be significantly increased by inclusion of APOE genotype alone, or in combination with other variables such as severity of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment strategies.

Eligibility criteria: Patients enrolled in the DVHIP are subject to the following recruitment criteria:

1. Mild, moderate or severe closed head injury, where the cut off between mild and moderate is defined by GCS\<12. PTA\>24 hrs or - foca cerebral contusion on CT/MRI or Loss of Consciousness (LOC) \> 12 hours.

   Note: the definition of mild, moderate or severe head injury differs widely between centers and is absolutely not critical for the work proposed as we will use continuous measures of severity throughout.
2. Within three months of first assessment. (In practice, patients may be recruited after 3 months. We will deal with this issue by covarying the time from injury to first assessment in our analyses).
3. Rancho Los Amigos cognitive level of 5-7 at first assessment.
4. Volunteer informed consent signed by patient of family.
5. Military or veterans health care beneficiary.
6. Age 17-55

Exclusion Criteria:

1. Unwillingness to participate in rehabilitation program or cooperate with investigators.
2. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital
state: Florida
Study officials:
name: Fiona Crawford, Ph.D.
name: Rodney Vanderploeg, Ph.D.
name: Robert Thatcher, Ph.D.
name: Andres Salazar, M.D.
References:
Clinical trial NCT03393299: Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric.
Official title: Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Drug Use
Keywords: elderly people
geriatric short-stay
STOPP/START criteria
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 65
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.


Eligibility criteria: Inclusion Criteria:

* Patient with more than 75 years old
* Hospitalized in geriatrics short-stay
* Patient with a written informed consent
* Patient with a social security scheme

Exclusion Criteria:

* Severe dementia
* Not able to respond to SF-12
* Disease at final stage
* Patient under legal protection (maintenance of justice, tutelage, legal guardianship)

Primary outcomes:
measure: SF-12 Quality of life scale
timeFrame: at inclusion and at 2 months
Secondary outcomes:
measure: Number of falls
timeFrame: at 2 months
measure: Proportion of patients rehospitalized
timeFrame: at 2 months
measure: Mortality
timeFrame: at 2 months
Other outcomes:
Locations:
city: Versailles
country: France
facility: Hôpital La Porte Verte
Study officials:
References:
Clinical trial NCT04093999: Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction
Official title: Nerve Coaptation Improves the Sensory Recovery of the Breast in DIEP Flap Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast reconstruction
DIEP flap
Sensory recovery
Breast sensation
Nerve coaptation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 126
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: In this prospective study, patients who underwent an innervated or noninnervated DIEP flap breast reconstruction between August 2016 and August 2018 at Maastricht University Medical Center in the Netherlands were included if they returned for follow-up between August 2016 and August 2019.

Brief summary: Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.


Eligibility criteria: Inclusion Criteria:

* Female patients 18 years or older
* Unilateral or bilateral DIEP flap breast reconstruction
* Returned for follow-up between August 2016 and August 2019
* Informed consent

Exclusion Criteria:

* Total flap loss complication
* Flaps that required a take-back
* Follow-up less than six months postoperatively
* Only one postoperative measurement at less than 12 months follow-up
* Mixed reconstructions: an innervated breast reconstruction on one side and a noninnervated breast reconstruction on the other side

Primary outcomes:
measure: Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
timeFrame: Through study completion up to 36 months postoperatively
Secondary outcomes:
measure: Mean monofilament value as a measure for the sensory recovery of the reconstructed breast
timeFrame: Through study completion up to 36 months postoperatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: René van der Hulst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04545099: Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
Official title: Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supraglottic Airway Device Insertion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex.


Eligibility criteria: Inclusion Criteria:

1. Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.

Exclusion Criteria:

1. Patients under 20 years old
2. Pregnant women
3. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
4. Patients who refused the clinical trial
5. Patients with dementia or cognitive impairment
6. Patients with neuromuscular disorders impairing neuromuscular blockade
7. Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
8. Past history of allergic reactions to neostigmine or sugammadex
9. Patients with ASA class IV or higher
10. Robotic surgery, adenoid or tonsillectomy
11. Patients with moderate or severe asthma, pulmonary function tests with forced expiratory volume for 1second of 1 liter or less, patients with upper respiratory infection symptoms within 2 weeks before surgery, current smokers (within 1 month of smoking cessation is included.)

Primary outcomes:
measure: Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
timeFrame: 1-2 minutes after drug administration (inhalation, exhalation)
measure: Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
timeFrame: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)
Secondary outcomes:
measure: Time to recover from spontaneous breathing
timeFrame: immediately after drug(sugammadex or neostigmine) administration
measure: Time to extubation
timeFrame: immediately after drug(sugammadex or neostigmine) administration
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Jeong-Rim Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03414099: Ketum and Pain Tolerence
Official title: Ketum and Pain Tolerence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain
Kratom
Ketum
mitragynine
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2018-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subject, repeated measures
Primary purpose: OTHER

Brief summary: The study aim is to evaluate potential analgesic properties of ketum using the cold pressor task.

Detailed description: Participants in the proposed study will be individuals who report consuming ketum more than once a day, daily for the past 12 months. The study is a placebo-controlled, double-blind within-subject repeated mesaures design. Participants will ingest a sequence of ketum and placebo drinks prepared by pharmacologists at USM Centre for Drug Research and their pain tolerance will be measured by the cold pressor task after ingesting ketum or placebo.

Eligibility criteria: Inclusion Criteria: Individuals who report drinking ketum decoction more than once a day, daily for the past 12 months.

-

Exclusion Criteria: (1) tested positive for illicit drug use including morphine, cannabis, methamphetamine, amphetamine, methadone, benzodiazepine and ketamine; (2) have current or previous history of psychological or neurological problems (self-report); (3) have current or previous alcohol use history (self-report); (4) HIV infections; (5) history of chronic liver disease (e.g. cirrhosis, hepatitis A, B, C, etc.) 6) non-alcoholic fatty liver disease; (7) history of coronary heart disease and diabetes; (8) existing chronic pain condition and (9) history of psychiatric disorders. Exclusion criteria for female particiapns: (1) pregnancy, (2) nursing.

-

Primary outcomes:
measure: Pain tolerance
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Centre for Drug Research, Univerisiti Sains Malaysia
state: Penang
Study officials:
affiliation: Director
name: Vicknasingam Kasinather, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004399: Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-eclampsia
Keywords: cardiovascular and respiratory diseases
hypertensive disorder
pre-eclampsia
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: University of Utah
First posted: 1999-10-19
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: OBJECTIVES:

I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

Detailed description: PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.

Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.

Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
* Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
* Proteinuria greater than 5 g/24 hr
* Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
* Severe headache and/or scotomata
* Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
* Pulmonary edema

--Prior/Concurrent Therapy--

* No prior/concurrent magnesium sulfate or dihydropyridine agents
* No other concurrent antiseizure medications

--Patient Characteristics--

* Age: Not specified
* Performance status: Not specified
* Hematopoietic: See Disease Characteristics
* Hepatic: See Disease Characteristics
* Renal: No severe renal failure See Disease Characteristics
* Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
* Pulmonary: See Disease Characteristics

--Other:--

* No severe mental or physical disorder that may affect therapy
* Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
* No evidence of fetal distress or fetal anomalies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Michael Anthony Belfort
role: STUDY_CHAIR
References:
Clinical trial NCT06666699: RIVOS Feasibility (MBO)
Official title: Design Optimization of RIVOS EUS Access Device - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Biliary Obstruction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:

* Can the device be used to gain and maintain access to target anatomy?
* Does the device have a clinically acceptable safety profile?
* How does the device perform overall?

All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.


Eligibility criteria: Inclusion Criteria:

* Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
* Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
* 18 years of age or older
* Patient willing and able to provide written informed consent and comply with specified study visits

Exclusion Criteria:

* Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure
* Abnormal coagulopathy:

  * INR \&gt;1.5 and not correctable
  * presence of bleeding disorder
  * platelets \&lt;50,000 mm3
* Patient with contraindication to use of electrical devices
* Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
* Patient from a vulnerable population
* Current participation in another investigational drug or device study that could interfere with the endpoints of this study

Primary outcomes:
measure: Technical Success
timeFrame: Day 0 Study Procedure
measure: Safety
timeFrame: Day 0 Study Procedure through Day 7 Post-Study Procedure
measure: Device Performance
timeFrame: Day 0 Study Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Sundeep Lakhtakia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00082199: Study of Aripiprazole in Subjects With Alcoholism
Official title: A Randomized, Multicenter, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Aripiprazole in the Maintenance of Abstinence From Alcohol in Subjects With Alcoholism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-05-04
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied.


Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.

Primary outcomes:
measure: Assessment of abstinence from the consumption of alcohol during the study
Secondary outcomes:
measure: Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Local Institution
state: Connecticut
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: New York
country: United States
facility: Local Institution
state: New York
city: Rochester
country: United States
facility: Local Institution
state: New York
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Houston
country: United States
facility: Local Institution
state: Texas
city: Charlottesville
country: United States
facility: Local Institution
state: Virginia
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Anton RF, Kranzler H, Breder C, Marcus RN, Carson WH, Han J. A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence. J Clin Psychopharmacol. 2008 Feb;28(1):5-12. doi: 10.1097/jcp.0b013e3181602fd4.