louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05963178: Speech Therapy and Functional Dysphonia After Thyroidectomy
Official title: Effects of an Early Logopedic Management and Speech Therapy in Post-Thyroidectomy Central Compartment Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Dysphonia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Following a thyroidectomy, voice and swallowing alterations, which more frequently would appear to be caused by lesions of the laryngeal nerve, may occur. But, voice and swallowing changes can also occur in the absence of lesions of the inferior laryngeal nerve or the external branch of the superior laryngeal nerve, defining a condition called central compartment syndrome or functional post-thyroidectomy syndrome. It has been demonstrated that, in the presence of the aforementioned syndrome, the quality of the voice undergoes a deterioration immediately after thyroidectomy surgery with a lowering of pitch.

The purpose of this study will be to verify the effects of early speech therapy, including pre-operative speech therapy counseling (during which the patient will be provided with indications to be implemented in the immediate post-operative period).


Eligibility criteria: Inclusion Criteria:

* awaiting Total Thyroidectomy surgery
* able to sign a written consent

Exclusion Criteria:

* Under the age of 21 or over the age of 65
* Previous vocal cord paralysis
* History of vocal or laryngeal pathologies that have required therapy
* Presence of speech disorders or lung pathologies
* Previous neck surgery
* Presence of malignant diseases

Primary outcomes:
measure: Acoustic analysis (f0)
timeFrame: 3 months
measure: Acoustic analysis (NHR)
timeFrame: 3 months
measure: Acoustic analysis (Jitter%)
timeFrame: 3 months
measure: Acoustic analysis (Shimmer%)
timeFrame: 3 months
measure: Voice Range Profile (Flow)
timeFrame: 3 months
measure: Voice Range Profile (Fhigh)
timeFrame: 3 months
measure: Voice function
timeFrame: 3 months
measure: Swallowing function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS
Study officials:
References:
Clinical trial NCT06338878: PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes
Official title: PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for cardiac decompensation in the cardiology department of CHRU of Nancy,

Brief summary: This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome.


Eligibility criteria: Inclusion Criteria:

* Man or women ≥ 18 years
* Patients hospitalized for cardiac decompensation (ESC 2016 and 2021 criteria)

Exclusion Criteria:

* Patient expressing refusal to participate in research
* Patient who is a minor or under administrative protection
* Pregnant women
* Patient with ventricular assistance
* Patient with congenital heart disease

Primary outcomes:
measure: All-cause post-hospitalization mortality
timeFrame: Within 1 year following hospital discharge
measure: Rehospitalization for heart failure
timeFrame: Within 1 year following hospital discharge
Secondary outcomes:
measure: Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations
timeFrame: Within 1 year following hospital discharge
measure: Influenza and pneumococcal vaccination status
timeFrame: Within 1 year following hospital discharge
measure: Evolution of renal function
timeFrame: During hospitalization for up to 2 months and within 1 year after discharge.
measure: All-cause Rehospitalization
timeFrame: Within 1 year following hospital discharge
measure: All-cause mortality
timeFrame: Within 1 year following hospital discharge
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU de Nancy
name: Nicolas GIRERD
role: STUDY_CHAIR
affiliation: CHRU de Nancy
name: Olivier HUTTIN
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Nancy
name: Laura FILIPPETTI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830178: A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
Official title: Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage, Gastrointestinal
Myocardial Infarction
Stroke
Kidney Diseases
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 144337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is a cohort of participants 18 and over who received a first prescription of single-ingredient paracetamol or ibuprofen in 2012.

Brief summary: The Purpose of this study is to examine whether evidence of channeling exists by analyzing within a cohort of participants with first prescriptions of single-ingredient paracetamol or ibuprofen (or both) whether participants with paracetamol were more likely to have an ibuprofen-related contraindication.


Eligibility criteria: Inclusion Criteria:

* Enrolled in up-to-standard practices (practices that have been qualified for research purposes by the Clinical Practice Research Datalink \[CPRD\] administrators) in the CPRD
* Received a first prescription for paracetamol or a first prescription for ibuprofen in 2012
* Were age 18 or older in the date of their qualifying prescription in 2012

Exclusion Criteria:

* Who received a prescription for paracetamol or ibuprofen in the 6 months prior to their qualifying prescription in 2012
* Who received a prescription for any acetaminophen- or ibuprofen-containing combination products in the 6 months prior to the qualifying prescription in 2012

Primary outcomes:
measure: Evidence of Channeling as Measured by an Odds-ratio Different From 1.0 for Contraindications to Ibuprofen Comparing Paracetamol and Ibuprofen Groups
timeFrame: up to 7 months
Secondary outcomes:
measure: Propensity Score Model
timeFrame: up to 7 months
measure: Extent of Bias as Measured by an Odds-ratio Different From 1.0 for the Covariate Indicating Exposure to Paracetamol or Ibuprofen in the Negative Control Outcome Models
timeFrame: up to 7 months
Other outcomes:
Locations:
city: Raritan
country: United States
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Weinstein RB, Ryan P, Berlin JA, Matcho A, Schuemie M, Swerdel J, Patel K, Fife D. Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications. Drug Saf. 2017 Dec;40(12):1279-1292. doi: 10.1007/s40264-017-0581-7.
Clinical trial NCT00876278: Night Driving Pilot
Official title: Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Intraocular Lens (IOL)
Mesotest II
Evaluation of usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL \*AT.Smart 46LC.

Target Criterion:

Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).


Eligibility criteria: Inclusion Criteria:

* Healthy eyes with cataract
* Patient age 50-75 years
* Written Patient Informed Consent
* Assured follow-up examination

Exclusion Criteria:

* Any kind of macula degeneration and impairment of retina (clinical diagnosis)
* Amblyopia
* Intraoperative complications; damaged posterior bag; intraocular haemorrhage
* Astigmatism \> 1.5 D (objective, preoperative)
* Pregnancy or lactation period for female patients

Primary outcomes:
measure: Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg, Klinik für Augenheilkunde
Study officials:
affiliation: Klinikum Augsburg, Klinik für Augenheilkunde
name: Arthur J. Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173978: Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance
Official title: Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Deteriorated Glucose Homeostasis
Inactivity
Keywords: Incretin hormones
Glucagon
Insulin/c-peptide
Plasma glucose
Insulin resistance
Deteriorated glucose homeostasis
Inactivity
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: European Foundation for the Study of Diabetes
First posted: 2010-08-03
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

Detailed description: The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

Eligibility criteria: Inclusion Criteria:

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g of glucose) according to WHO's criteria
* BMI 20-30
* Hemoglobin \> 8.0 mmol/l
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT \> 2 x normal level)
* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents/siblings) with T2DM
* Medical treatment witch cannot be stopped for 12 hours

Primary outcomes:
measure: Insulinotropic effect of incretin hormones
timeFrame: 12 days
Secondary outcomes:
measure: Plasma concentration of glucagon
timeFrame: 12 days
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Clinical Physiology
Study officials:
affiliation: Glostrup University Hospital
name: Katrine B Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gentofte University Hospital
name: Filip K Knop, MD,PhD
role: STUDY_CHAIR
affiliation: Gentofte University Hospital
name: Tina Vilsbøll, MD,DmSc
role: STUDY_CHAIR
affiliation: University of Copenhagen
name: Jens J Holst, MD, DmSc
role: STUDY_CHAIR
References:
Clinical trial NCT00005378: Impact of Sleep Disordered Breathing in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Depression
Sleep Apnea Syndromes
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.

Detailed description: BACKGROUND:

The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention.

DESIGN NARRATIVE:

The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01985178: Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
Official title: Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 21
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Eating Disorder, less than 18 years of age

Exclusion Criteria:

* unable to read and understand English

Primary outcomes:
measure: Dropout rate
timeFrame: 2 months
Secondary outcomes:
measure: Rate of patients reporting side effects
timeFrame: 2 months
measure: Change in weight
timeFrame: 2 months
Other outcomes:
measure: Severity of depressive symptoms
timeFrame: 2 months
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Jennifer Couturier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06102278: ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture
Official title: Machine Learning Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Metastasis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 522 rHCC patients who underwent radical hepatectomy

Brief summary: This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis. Clinical data from 522 patients with ruptured HCC who underwent surgery at seven different medical centers were collected and analyzed. Machine learning models were employed for analysis and prediction.


Eligibility criteria: Inclusion Criteria:(1) HCC confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) R0 resection (4) first tumor detection -

Exclusion Criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data

-

Primary outcomes:
measure: overall survival
timeFrame: 2018-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00956878: Cancer Pain Single Nucleotide Polymorphisms (SNPs)
Official title: Storage and Analysis of Patient Blood-samples for Cancer Pain Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Pain
Keywords: Cancer
Pain
SNP
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer pain patients in a large university hospital

Brief summary: Cancer pain is common in advanced cancer patients. Opioids are the mainstay of treatment in cancer pain. Responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human DNA. Using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (SNPs) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.


Eligibility criteria: Inclusion Criteria:

* Cancer pain patients

Exclusion Criteria:

* Patients not able to provide informed consent

Primary outcomes:
measure: correlation between pain SNPs and equianalgesic opioid requirement
timeFrame: timepoint at blood sample
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Centrumlocatie en Daniel den Hoed
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Joost L Jongen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331278: A Comparative Study of Knee Systems
Official title: A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: total joint replacement
knee
Lead sponsor: Foundation for Southwest Orthopedic Research
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 60
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 custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
* must be 18 years of age or older
* must be capable and willing to provide informed consent
* must have flexion contracture less than 15 degrees.
* must have ligament stability no more than 2 degrees instability in varus/valgus extension stress

Exclusion Criteria:

* medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
* currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
* known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
* Knee alignment deformities greater than 7 degrees varus or valgus
* known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
* known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee

Primary outcomes:
measure: mean intraoperative time
timeFrame: measured during surgery (day 1)
Secondary outcomes:
measure: alignment accuracy
timeFrame: 3 weeks post-op
Other outcomes:
Locations:
city: Houston
country: United States
facility: Southwest Orthopedic Group, LLP
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
References:
citation: Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. 2014 Sep;29(9):1699-704. doi: 10.1016/j.arth.2014.03.019. Epub 2014 Mar 28.