louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06174636: Lung Overdistension and Abdominal Pressure Rise
Official title: Lung Overdistension and Abdominal Pressure Rise: an EIT Based Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Respiratory Distress Syndrome, Adult
Keywords: Abdominal pressure
Overdistension
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-12-18
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: DIAGNOSTIC

Brief summary: The goal of this pilot interventional no-profit study is to evaluate airway pressure, esophageal pressure and variations in lung volume distribution with EIT in mechanically ventilated patients admitted to our UTI with respiratory failure after the application of an abdominal weight and resulting increase of intra-abdominal pressure.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation in acute respiratory failure (PaO2/FiO2 \<300 mmHg)
* Need of PEEP trial
* Need of urinary catheter (used to measure IAP)

Exclusion Criteria:

* Contraindication to EIT use
* Pacemaker or other metal device in thoracic region
* Contraindication to abdominal weight placement
* Surgical or traumatic incision on the abdomen
* Severe abdominal hypertension
* Esophageal diseases that counterindicate naso-gastric tube placement
* Severe hemodynamic instability (norepinephrine \> 0.1 mcg/kg/min; dobutamine or dopamine \> 5 mcg/kg/min; epinephrine every dosage)
* Severe obesity (BMI \> 35 kg/m2)
* Need of \> 7 kg weight to reach 5 mmHg IAP increase

Primary outcomes:
measure: Variation of lung volume distribution
timeFrame: through study completion, an average of 1 year
measure: Variation of airway pressure
timeFrame: through study completion, an average of 1 year
measure: Variation of esophageal pressure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera Università di Padova
Study officials:
References:
Clinical trial NCT02075736: KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients
Official title: The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BPH (Benign Prostatic Hyperplasia)
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients


Eligibility criteria: Inclusion Criteria:

* Men with anticoagulant medication undergoing surgery for BPH

Exclusion Criteria:

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma

Primary outcomes:
measure: Re-bleeding rate requiring hospitalization
timeFrame: two months postoperatively
Secondary outcomes:
measure: IPSS (International Prostate Symptom Score)
timeFrame: 0, 3, 6 and 12 months
measure: DAN-PSS (Danish Prostate Symptom Score)
timeFrame: 0, 3, 6 and 12 months
measure: Maximum flow rate (Qmax)
timeFrame: 0, 3, 6 and 12 months
measure: Residual urine
timeFrame: 0, 3, 6 and 12 months
measure: Length of catheterization
timeFrame: Participants will be followed for the duration of hospital stay, an expected maximum of one week
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected maximum of one week
measure: Perioperative bleeding
timeFrame: Time of operation
measure: IIEF (International Index of Erectile Function) questionnaire
timeFrame: 0,12 months
measure: TRUS (transrectal ultrasound)
timeFrame: 0, 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
References:
Clinical trial NCT00063336: Treatment Response to Rehabilitation in Patients With Schizophrenia
Official title: Treatment Response to Rehabilitation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-06-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

Detailed description: Patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. This study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit.

Two studies will be conducted. The first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. The second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment.

Both the cognitive remediation and computer skills training programs will last 4 to 6 months. Participants will be assessed pre- and post-treatment. Neuropsychological, psychosocial and vocational status will be measured.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* In need of intensive outpatient care
* Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

Exclusion Criteria:

* Auditory or visual impairment
* Mental retardation (IQ less than 70)
* Traumatic brain injury with loss of consciousness
* Presence or history of any neurological illness that may affect brain physiology
* Lack of proficiency in English
* Concurrent substance abuse and/or dependence

Primary outcomes:
measure: Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities
timeFrame: Measured pre- and post-treatment
measure: Schizophrenia symptoms
timeFrame: Measured pre- and post-treament
measure: UCSD Performance-Based Skills Assessment
timeFrame: Measured pre- and post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Schizophrenia Rehabilitation Program, Institutes of Living
state: Connecticut
Study officials:
affiliation: Schizophrenia Rehabilitation Program, Institutes of Living
name: Matthew M. Kurtz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001336: Thyroid Function and Diabetes Complications
Official title: Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Thyroid Disease
Keywords: Thyroid
Diabetes Mellitus
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 260
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012 were enrolled in this study.

Brief summary: The purpose of this study is to investigate the potential association between thyroid function and diabetes complications in the elderly subjects with type 2 diabetes mellitus (T2DM).

Detailed description: Aims: We investigated the potential association between thyroid parameters and microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).

Subjects: Elderly inhospital patients with T2DM who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.

Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine albuminuria and fluorescence fundus angiography are conducted.

The relationships levels of thyroid function and diabetic complications are analysed.

Eligibility criteria: Inclusion Criteria:

1. Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is according to the World Health Organization in 1999.
2. Patients have normal thyroid function and negative for thyroid autoantibodies, such as thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).

Exclusion Criteria:

1. Patients with a history of thyroid disease or chronic liver disease or nondiabetic renal problems or cancer.
2. Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs, glucocorticoids and oral contraceptives.
3. Patients are pregnant or lactating women.
4. Patients with acute intercurrent illness of diabetes.
5. Patients with an acute infection.
6. Patients with a history of drug abuse alcohol dependence in the past 5 years.

Primary outcomes:
measure: Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.)
timeFrame: Day One
Secondary outcomes:
measure: 24h-albuminuria
timeFrame: Day One
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00814736: A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate The Safety And Toleration Of Single Dose Sildenafil In Subjects Receiving Chronic UK-369,003.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Hyperplasia
Urinary Bladder, Overactive
Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 22
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil


Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Healthy male subjects between the ages of 40 and 55 years, inclusive
* Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.

Primary outcomes:
measure: Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
timeFrame: hours
Secondary outcomes:
measure: Incidence of postural hypotension.
timeFrame: hours
measure: Standing and supine pulse rate (PR) at each postdose time.
timeFrame: hours
measure: Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
timeFrame: hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03929536: Treatment of Acetabular Fractures in Elderly Patients
Official title: Treatment of Acetabular Fractures in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Keywords: hip joint replacement
hip joint preserving surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 211
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acetabular fracture between 2009 and 2018 treated at the Department of Orthopedic and Trauma Surgery of University Hospital Basel

Brief summary: This retrospective study investigates surgical treatment of acetabular fractures in elderly patients (\>60 years of age), either undergoing joint-preserving surgery or joint- replacement. 1 year- outcome with regard to mobility and autonomy is assessed.


Eligibility criteria: Inclusion Criteria:

* surgical treatment of acetabular fracture between 2009 and 2018

Exclusion Criteria:

* pathological fractures due to neoplasm or metastasis
* status after implantation of an endoprosthesis

Primary outcomes:
measure: Change in living arrangements
timeFrame: at baseline (right after surgery) and 1 year after surgery
Secondary outcomes:
measure: number of rehospitalisations
timeFrame: single time point assessment 1 year after surgery
measure: number of re-surgeries
timeFrame: single time point assessment 1 year after surgery
measure: mortality
timeFrame: single time point assessment 1 year after surgery
measure: infections
timeFrame: single time point assessment 1 year after surgery
measure: Change in leg length difference
timeFrame: at baseline (right after surgery) and 1 year after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Franziska Saxer, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04419636: Binding of Lu AG06466 in the Brain in Healthy Men
Official title: Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Detailed description: The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group

PET scans will be used to quantify MAGL occupancy

Eligibility criteria: Inclusion Criteria:

* body weight ≥60 kg.
* body mass index ≥18.5 and ≤27 kg/m2.
* waist circumference ≤94 cm.
* The subject has a normal sMRI performed during the screening period.
* The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
* Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
* The subject must make use of contraception.

Exclusion Criteria:

* The subject is left handed.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: Central monoacylglycerol lipase (MAGL) occupancy
timeFrame: From dosing to 8 hours post-dose
Secondary outcomes:
measure: C(PET)
timeFrame: From zero to Day 10
measure: AUC (0-24)
timeFrame: From zero to 24 hours post-dose
measure: Cmax
timeFrame: From zero to 24 hours post-dose
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven campus Gasthuisberg
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT05505136: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes
Official title: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects who completed the MAPS study with a reported medication change based wholly or in part on biometric information.

Brief summary: To determine the associations among biometric data and previously reported medication changes in the original MAPS study

Detailed description: 1. Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision.
2. Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Eligibility criteria: Inclusion Criteria:

* those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.

Exclusion Criteria:

* Those patients from the MAPS study that did not have medication changes.

Primary outcomes:
measure: Association Between Arrhythmia Biometric and Medication Change
timeFrame: 1 Day
measure: Association Between Subject-Reported Symptom Biometric and Medication Change
timeFrame: 1 Day
measure: Association Between Subject Wellness Biometric and Medication Change
timeFrame: 1 Day
measure: Association Between Subject Adverse Event and Medication Change
timeFrame: 1 Day
measure: Association Between Subject Status and Medication Change
timeFrame: 1 Day
measure: Association Between Subject Hospital Events and Medication Change
timeFrame: 1 Day
measure: Association Between Subject Clinical Events and Medication Change
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Cardiovascular Institute of Central Florida
state: Florida
city: Saint Augustine
country: United States
facility: First Coast Heart & Vascular Center
state: Florida
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Amarillo
country: United States
facility: PharmaTex Research
state: Texas
city: Kingwood
country: United States
facility: Texas Cardiology Associates of Houston
state: Texas
city: McKinney
country: United States
facility: CardioVoyage
state: Texas
city: Burien
country: United States
facility: Dr. Daniel W. Gottlieb
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center EP
state: West Virginia
Study officials:
affiliation: Zoll Services LLC
name: Steven Ringquist
role: STUDY_CHAIR
References:
Clinical trial NCT02515136: Stimulus-response and Parkinson's Disease (SRlearning)
Official title: Stimulus-response Associations in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. They will respond to each image by acting on the keyboard in a specific manner. Each participant will repeat that task 384 times per session. A break will be inserted every 12 tests so that participants can rest.

The experiment consists of three sessions. Each image will be presented three times. For the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. In the third presentation, the same task and the same action will be maintained or will be swapped. In this way, It can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.


Eligibility criteria: Inclusion Criteria:

* Patient : Parkinson's disease Controls: healthy volunteers paired to patients on sex and age group

Exclusion Criteria:

* Other neurological condition
* Known pregnancy or breastfeeding woman
* No medical insurance coverage
* Person under legal protection

Primary outcomes:
measure: Reaction time (second)
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT00259636: Zonisamide for Fibromyalgia & Migraine
Official title: Zonisamide for Fibromyalgia & Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Fibromyalgia
Migraine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2005-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with fibromyalgia \& migraine are randomized to receive zonisamide or placebo.

Detailed description: Study was not conducted due to logistical problems

Eligibility criteria: Inclusion Criteria:

* 18-65 with fibromyalgia \& migraine

Exclusion Criteria:

* allergy sulfa, liver or kidney disease, pregnant or not using contraception

Primary outcomes:
measure: Visual analogue score
timeFrame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
measure: Tender point count
timeFrame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
measure: Headache index
timeFrame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Secondary outcomes:
measure: Sleep efficiency
timeFrame: assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dawn Marcus, MD
role: PRINCIPAL_INVESTIGATOR
References: