louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00412100: Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation
Official title: A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: A randomised
double-blind
double-dummy
parallel-group multicentre study to demonstrate improvement in symptoms of constipation
Moderate to severe, chronic non-malignant pain
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2006-12-15
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 primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Detailed description: Patients with a documented history of moderate to severe non-malignant pain that require around-the-clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm. The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 18 years or older with moderate to severe pain that requires around the clock opioid therapy. Subjects must report constipation caused or aggravated by opioids.

Exclusion Criteria:

* Females who are pregnant or lactating.
* Subjects with evidence of any clinically unstable disease or subjects with evidence of impaired liver/kidney function upon entry into the study.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.

Primary outcomes:
measure: To demonstrate that subjects with moderate to severe non malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.
timeFrame: 12 weeks with a 6 month open label extension
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Private Practice
name: Oliver Lowenstein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lowenstein O, Leyendecker P, Lux EA, Blagden M, Simpson KH, Hopp M, Bosse B, Reimer K. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010 Sep 29;10:12. doi: 10.1186/1472-6904-10-12.
Clinical trial NCT06851000: The Effects of Ultrasound-guided PRF Versus DN in Myofascial Pain Patients
Official title: The Effects of Ultrasound-guided Pulsed Radiofrequemcy Versus Dry Needling in Myofascial Pain Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myofascial Pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old, gender unlimited.
* Myofascial pain diagnosed according to the "Simons and Travell" criteria.
* Able to complete treatment and follow-up.
* Signed inform consent form.

Exclusion Criteria:

* History of surgery, trauma, or infection in the pain area.
* Severe systemic disease, e.g. malignant tumor; severe hepatic, renal, or coagulation disorder; etc.
* Pregnancy, needle phobia, unable to cooperate.
* Concurrently receiving pain treatment in other institutions.

Primary outcomes:
measure: Change of mechanical pain threshold (△MPT)
timeFrame: week 0 to week 4
Secondary outcomes:
measure: Severity of pain
timeFrame: week 0 to week 12
measure: Sleep
timeFrame: week 0 to week 12
measure: Depression and anxiety
timeFrame: week 0 to week 12
measure: Life quality
timeFrame: week 0 to week 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05727800: A Phase 1, First-in-human Study of VX-668
Official title: A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-668
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alpha-1 Antitrypsin Deficiency
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-668 at various doses.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Participants of age between 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>)50 kg
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Females of childbearing potential

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 20
Secondary outcomes:
measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-668
timeFrame: Day 1 up to Day 20
measure: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of VX-668
timeFrame: Day 1 up to Day 20
measure: Part A and B: Urine Concentration of VX-668
timeFrame: Part A Cohort A3: Days 1 and 5; Part B Cohort B3: Days 1, 10, and 11
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A.
state: Florida
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT00603200: Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
Official title: The Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ascites
Fatigue
Cirrhosis
Keywords: Quality of Life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 0
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 with cirrhosis and refractory ascites.

Brief summary: The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).


Eligibility criteria: Inclusion Criteria:

* ambulatory patient with cirrhosis
* baseline Cr \<2
* ability to complete psychometric testing
* refractory ascites

Exclusion Criteria:

* Cr \>2
* history of Gastrointestinal bleed
* history of infection
* history of renal failure

Primary outcomes:
measure: Improvement in Fatigue symptomatology, as defined by fatigue questionnairre
timeFrame: instantly
Secondary outcomes:
measure: Improvement in sleep
timeFrame: post paracentesis
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterial, Weill Cornell medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Samual Sigal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Hospital-Cornell/Columbia
name: Reem Sharaiha, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06295900: The Effect of Aromatherapy Massage on Sleep Quality
Official title: The Effect of Aromatherapy Massage Applied to Intensive Care Patients on Sleep Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Respiratory Failure
Pneumonia
Respiratory Disease
Stroke, Ischemic
Keywords: intensive care
sleep quality
aromatherapy massage
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be conducted as a randomized controlled single-blind study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and over,
* Conscious patients,
* Staying in intensive care for 24 hours or more,
* Those with stable hemodynamic status,
* Receiving O2 therapy,
* Intubated patients, patients who have passed 24 hours after being extubated,
* Those whose saturation level is 85 and above

Exclusion Criteria:

* Patients with peripheral neuropathy or quadriplegia,
* Patients with open wounds on their body,
* Patients receiving analgesia and sedation infusion,
* Patients who are sedated,
* Patients in delirium,
* Patients with allergies detected before starting the application

Primary outcomes:
measure: Patient Introduction Form
timeFrame: 1 year
Secondary outcomes:
measure: Patient Follow-up Form
timeFrame: 1 year
Other outcomes:
measure: Visual Comparison Sleep Scale
timeFrame: 1 year
Locations:
city: Nigde
country: Turkey
facility: Ömer Halisdemir University Training and Research Hospital
Study officials:
References:
Clinical trial NCT01335100: Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Keywords: Functional outcome
Quality of life
Global Positioning System (GPS)
Advanced tracking technologies
Time-space activity.
walking speed
distances
number of walking events and destinations
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ambulatory children with CP following BTX injection to the lower limbs

Brief summary: Background:

Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population.

Objective:

To examine outdoor activity as a functional outcome following lower limb BTX in children with CP.

Methods:

In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires.

Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.


Eligibility criteria: Inclusion Criteria:

* ambulatory children with CP following BTX injection to the lower limbs

Exclusion Criteria:

* significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces

Primary outcomes:
measure: outdoor activity
timeFrame: 9 months
Secondary outcomes:
measure: leisure activity preferences and quality of life
timeFrame: 9 months for the pilot
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT04936100: Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
Official title: Assessment of the Validity, Reliability, and Feasibility of Two Smartphone Applications for Testing the Visual Acuity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Impairment
Blindness
Keywords: Visual acuity
Smartphone
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Visual acuity (VA) is the most common measure of visual function globally. In clinical settings and during screening events, VA is an important measure to quantify changes in vision over time. Additionally, in the context of epidemiological studies and population-based surveys, VA is a critical measure to determine the presence and degree of vision impairment and to report on the indicators of effective eye care service coverage (i.e. refractive error and cataract surgery), that are currently considered by World Health Organization (WHO) for monitoring progress towards the Universal Health Coverage.

There are numerous applications for assessing VA; however, the number of validated applications is limited. In this study, the investigators aim to evaluate the external validity, intra- and inter-observer reliability, and feasibility of two applications ("Easy Vision" and "Peek Acuity") for testing the visual acuity.


Eligibility criteria: Inclusion criteria:

• Age ≥10 years old

Exclusion criteria:

• Subjects who are not able to respond to the examiner

Primary outcomes:
measure: Distance visual acuity assessment with Easy Vision versus Peek Acuity versus conventional distance visual acuity chart
timeFrame: Through study completion [an average of 6 months]
measure: Near visual acuity assessment with Easy Vision versus Peek Acuity versus conventional near visual acuity chart
timeFrame: Through study completion [an average of 6 months]
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Study officials:
References:
Clinical trial NCT03779100: Lenvatinib Plus PD-1 Antibody for Unresectable ICC
Official title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Unresectable Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
Lenvatinib
PD-1 Antibody
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of ICC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* Chemotherapy resistance or patient refuse chemotherapy
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* Without distant metastasis, but intrahepatic lymph node metastasis is allowed
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 12 months
measure: Objective Response Rate (ORR)
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06244875: Biological Collection of Neurocognitive Disorders
Official title: Collection Biologique Des Atteintes Neurocognitives
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neurocognitive Disorders
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed in the memory clinic at the Center for Cognitive Neurology of Lariboisière Hospital (APHP) or at the memory clinic of Bretonneau Hospital (APHP), with a clinical indication for the measurement of blood and cerebrospinal fluid (CSF) biomarkers (day hospital for the diagnosis of a neurocognitive disorder).

Brief summary: The development of biological biomarkers reflecting neuropathology has enhanced the diagnostic precision of Alzheimer's disease over the past decade, compared to the clinical diagnosis that suffers from low specificity. Patients undergoing evaluation in specialized memory clinics suspected of major or minor neurocognitive disorder are notably examined through a lumbar puncture to measure beta-amyloid 42, beta-amyloid 40, total tau, and phosphorylated tau in the cerebrospinal fluid (CSF). The purpose of this clinico-biological collection is to better characterize the existing biomarkers used in clinical practice, as well as the development of new diagnostic or prognostic biomarkers for neurodegenerative diseases causing neurocognitive disorder (Alzheimer's disease, Lewy body disease, frontotemporal lobar degeneration, in particular).

The primary objective is to gain a better understanding of conventional biomarkers and to develop new diagnostic and prognostic biomarkers for neurocognitive diseases: establishing a prospective clinico-biological collection of patients evaluated in clinical practice for a neurocognitive disorder.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Not under legal guardianship
* Clinical indication for blood and cerebrospinal fluid (CSF) biomarkers measurement during a day hospital stay for Alzheimer's disease (beta-amyloid peptide, tau protein).
* Signature of the research consent form.

Exclusion Criteria:

* Not affiliated with a social security scheme.
* Patient under State Medical Aid (AME).

Primary outcomes:
measure: Identification of new biomarkers for neurodegenerative diseases
timeFrame: Up to 10 years
Secondary outcomes:
measure: Description of the level of usual biomarkers by type of dementia
timeFrame: Up to 10 years
measure: Evaluation of the relationship between biomarker levels and cognitive evolution measured in routine care
timeFrame: Up to 10 years
measure: Comparison of biomarker levels in neurodegenerative pathologies and psychiatric pathologies with cognitive expression
timeFrame: Up to 10 years
Other outcomes:
Locations:
Study officials:
References: