louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04367285: Sensor-based Technology for Upper Limb Rehabilitation
Official title: Sensor-based Technology for Upper Limb Rehabilitation in Subject With Multiple Sclerosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database in order to quantitatively monitoring measures and therapy progress. The aim of this study is to evaluate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limbs functions of MS patients. The training consisting of twelve sessions of upper limb training, was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. All patients were evaluated at baseline (T0) and after 4 weeks of training (T1)


Eligibility criteria: Inclusion Criteria:

* diagnosis of Multiple Sclerosis
* upper limb deficits,
* disability between 5 and 8.5 on the Expanded Disability Status Scale (EDSS).

Exclusion Criteria:

* Modified Ashworth Scale (MAS) \< 3 at the upper limb;
* cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \< 24
* Medical Research Council (MRC) scale with score 0 or 5;
* presence of clinically evaluated severe comorbidities; pregnancy;
* subjects with artificial pacemaker;
* subjects involved in other studies.

Primary outcomes:
measure: Changes in functionality of the upper limb measured in 9 Hole Peg Test (9HPT) at 1 months
timeFrame: 1 month
Secondary outcomes:
measure: Fatigue Level at 1 month
timeFrame: 1 month
measure: Modified Barthel Index (MBI) at 1 month
timeFrame: 1 month
measure: Changes in Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54)at 1 month
timeFrame: 1 month
measure: Changes of Medical Research Council scale (MRC) at 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tramontano
Study officials:
affiliation: SANTA LUCIA FOUNDATION
name: Marco Tramontano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053685: Metanephrines in Obstructive Sleep Apnoea
Official title: Utility of Plasma and Urine Metanephrines in the Diagnosis of Phaeochromocytoma in Patients With Obstructive Sleep Apnoea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Obstructive Sleep Apnea
Catecholamine; Secretion
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending for sleep studies for evaluation of OSA

Brief summary: Although most patients have essential (unexplained) hypertension, some patients have a treatable underlying condition. One such condition is phaeochromocytoma, a tumour that produces excessive stress hormones. Left undiagnosed, patients may develop a hypertensive crisis that can be fatal. Measurements of stress hormones (both 24-hour urine collection and morning blood tests) are highly sensitive for detecting these tumours. However, these stress hormones may also be elevated in obstructive sleep apnoea (OSA) which affects 1 in 5 adults.

The investigators hypothesize that in patients with OSA, blood tests will be better than 24-hr urine tests at ruling out a tumour. If this is confirmed, then OSA patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test, reducing unnecessary additional tests and patient anxiety.

In this single site study, the investigators plan to recruit 70 patients undergoing polysomnography. 24hr urine and bloods will be measured. Patients with elevated hormone levels will undergo imaging to rule out a tumour.

The primary outcome will be the accuracy of each test in ruling out a tumour. The secondary outcomes will be the relationship between stress hormone level and severity of OSA, which may help to explain the increased cardiovascular risk in patients with OSA, and the change in stress hormone level with treatment for OSA


Eligibility criteria: Inclusion Criteria:

* Patients aged 21-70 years attending for a sleep study to evaluate for OSA

Exclusion Criteria:

* Medications that can cause changes in metanephrine levels
* Other factors that can cause changes in metanephrine levels
* Renal impairment (eGFR \< 60ml/min)
* Other serious medical conditions

Primary outcomes:
measure: Urine and plasma metanephrines
timeFrame: 1 year
measure: Urine and plasma metanephrines
timeFrame: 1 year
Secondary outcomes:
measure: Relationship between metanephrine level and severity of OSA
timeFrame: 1 year
measure: Change in metanephrine levels with treatment for OSA
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
Clinical trial NCT03627585: Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
Official title: Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Dysfunction
Heart Failure, Systolic
Left Ventricular Failure
Pacemaker; Complication, Mechanical
Keywords: pacemaker
heart failure
left ventricular dysfunction
bradycardia
remodelling
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 91
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: The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.

This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

Detailed description: Patients (n=70) with long-term (\>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.

Eligibility criteria: Inclusion Criteria:

* Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
* Willing and able to give informed consent for the intervention

Exclusion Criteria:

* Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
* Patients with complete heart block and no reprogramming options

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: LV remodelling parameters
timeFrame: 6 months
measure: Quality of Life Measures
timeFrame: 6 months
measure: Battery Longevity
timeFrame: 6 months
Other outcomes:
Locations:
city: Harrogate
country: United Kingdom
facility: Harrogate District Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: University of Leeds
name: Klaus Witte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paton MF, Gierula J, Lowry JE, Cairns DA, Bose Rosling K, Cole CA, McGinlay M, Straw S, Byrom R, Cubbon RM, Kearney MT, Witte KK. Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial. PLoS One. 2021 Dec 13;16(12):e0259450. doi: 10.1371/journal.pone.0259450. eCollection 2021.
Clinical trial NCT02088385: Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers : A Pilot Study
Official title: Pilot Study of a Randomized Controlled Trial Comparing Hemospray Versus the Combined Conventional Technique for Endoscopic Hemostasis of Bleeding Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Peptic Ulcers
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemospray (TC-325, Cook Medical Inc, Winston-Salem, NC, USA), a new adsorptive nanopowder hemostatic agent for endoscopic treatment of high-risk bleeding peptic ulcers, provides significant ease of administration compared to the combined conventional technique of saline-adrenaline injection with mechanical clip or heater probe applications. The Hemospray powder is easily applied on ulcers at difficult endoscopic positions and ulcers with fibrotic bases, where the combined conventional technique has limited efficacy. Building up on preliminary work from small single-arm studies, the investigators aim to establish the efficacy and safety of Hemospray in treating bleeding peptic ulcers in comparison with the combined conventional technique. The investigators propose a pilot study to establish our centre's feasibility of performing a prospective, randomized, parallel group trial, which compares the efficacy of Hemospray with the combined conventional technique, in the endoscopic treatment of high-risk bleeding peptic ulcers. Patients with high-risk bleeding peptic ulcers will be treated with Hemospray to determine its initial hemostasis rate (defined as endoscopically verified cessation of bleeding for at least 5 minutes after endoscopic treatment), rebleeding rate (recurrent hemorrhage during a 4-week period following the initial hemostasis) and its safety profile.


Eligibility criteria: Inclusion Criteria:

* Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

* Patients younger than 21 years of age
* Refusal to participate in study
* Contraindicated for endoscopy
* Pregnant or lactating patients
* Bleeding secondary to non-peptic ulcer source
* Patients requiring mechanical ventilation
* Patients with acute coronary syndrome

Primary outcomes:
measure: Re-bleeding Within 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Initial Hemostasis Rate
timeFrame: Within first endoscopy session
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Andrew Kwek, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449485: Bariatric Surgery and Pharmacokinetics of Chlorprothixene
Official title: Bariatric Surgery and Pharmacokinetics of Chlorprothixene: BAR-MEDS Chlorprothixene
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Chlorprothixene
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on chlorprothixene.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Chlorprothixene concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06660485: Establishment of a Cohort for Continuous Coronary Artery CTA Scanning and Predictive Analysis of Plaque Progression
Official title: Establishment of a Cohort for ConTinuous COronary CTA SCanning And PredicTive Analysis of Plaque Progression (TOCCATA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CAD - Coronary Artery Disease
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone multiple consecutive CCTA examinations.

Brief summary: This research develops risk prediction models for coronary artery stenosis and vulnerable plaques. The coronary artery stenosis model aims to predict stenosis using multimodal deep learning by integrating text, structured numerical data, and imaging features, focusing on metrics like maximum and cumulative stenosis. The vulnerable plaque model seeks to identify early formation indicators, allowing for timely interventions to prevent plaque rupture, using similar data integration techniques. Additionally, a decision support system is created, comprising a patient database, risk prediction models, and a high-risk alert module. This system facilitates real-time notifications to healthcare providers when risk thresholds are exceeded, enabling personalized treatment planning and improved patient outcomes.


Eligibility criteria: Inclusion Criteria:

Patients who have undergone multiple consecutive CCTA examinations.

Exclusion Criteria:

Patients who have undergone only a single CCTA examination. Patients whose CCTA image quality is poor and cannot be analyzed.

Primary outcomes:
measure: Maximum Coronary Stenosis (MAXS)
timeFrame: 2 year
Secondary outcomes:
measure: Cumulative Coronary Stenosis (SIS):
timeFrame: 2 year
measure: Segment Involvement Score (SSS):
timeFrame: 2 year
Other outcomes:
Locations:
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
state: Chengdu
Study officials:
References:
Clinical trial NCT03341585: Influence of Expiration Lente Prolongée on Gastro-oesophageal Reflux
Official title: Influence of Expiration Lente Prolongée on Gastro-oesopageal Reflux in Infants Under the Age of 1 Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-esophageal Reflux
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a specific airway clearance technique, l'Expiration Lente Prolongée (ELPr), induces or aggravates gastro-oesophageal reflux in infants under the age of one year. Infants referred to hospital for a multichannel intraluminal impedance pH (pH-MII) monitoring are included in this study. Participation is only possible after signing the informal consent by one of the parents.


Eligibility criteria: Inclusion Criteria:

* Infants under the age of one year and on suspicion of GOR who were referred for 24h impedance-pH monitoring are included in this study.

Exclusion Criteria:

* prematurity (gestational age less than 37 weeks),
* the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Primary outcomes:
measure: number of refluxes
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
affiliation: Vrije Universiteit Brussel
name: filip van ginderdeuren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lievens L, Vandenplas Y, Vanlaethem S, Van Ginderdeuren F. Prolonged Slow Expiration Technique and Gastroesophageal Reflux in Infants Under the Age of 1 Year. Front Pediatr. 2021 Sep 8;9:722452. doi: 10.3389/fped.2021.722452. eCollection 2021.
Clinical trial NCT00001885: Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis
Official title: Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Identification of Genetic Polymorphisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Pulmonary Fibrosis
Rheumatoid Arthritis
Keywords: Interstitial Lung Disease
Inherited Disease
Genetic Markers
Alpha 1 Protease Inhibitor
DNA Mutations
Rheumatoid Arthritis
Pulmonary Fibrosis
Normal Volunteer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.

Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified.

The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.

Detailed description: Pulmonary fibrosis that develops within a subpopulation of patients with rheumatoid arthritis is a disorder of unknown etiology. Although previous reports suggest that some individuals with rheumatoid arthritis have a genetic predisposition to the development of fibrotic lung disease, genetic factors have not been clearly identified. It is the intent of this clinical protocol to identify genetic polymorphisms in individuals with pulmonary fibrosis and rheumatoid arthritis.

Eligibility criteria: * INCLUSION CRITERIA:

Individuals 21 years of age or older with any of the following:

RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or

RA-only, or

Biopsy-proven idiopathic PF-only, or

Healthy research volunteers.

EXCLUSION CRITERIA:

Individuals with any of the following:

Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).

Chronic pulmonary disorders other than pulmonary fibrosis.

Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).

Non-rheumatoid arthritis.

Viral infections associated with PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).

Pregnancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
citation: Hakala M. Poor prognosis in patients with rheumatoid arthritis hospitalized for interstitial lung fibrosis. Chest. 1988 Jan;93(1):114-8. doi: 10.1378/chest.93.1.114.
Clinical trial NCT00163085: The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

* 30- 80-year-old PD patients (UK Parkinson's Disease Brain Bank criteria) with a Hoehn \& Yahr stage score of 2-5 in the "off" state.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Dyskinesia Rating Scale
Secondary outcomes:
measure: Fingertapping
Other outcomes:
Locations:
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: