louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03466307: Ultrasonographic Parameters and Life Quality in Nocturnal Shoulder Pain
Official title: Comparison of Clinical and Ultrasonographic Parameters of Rotator Cuff Tendinopathy Patients With and Without Nocturnal Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Keywords: Nocturnal pain
shoulder pain
ultrasonography
resistive index
quality of life
anterior circumflex humeral artery
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged over 18 years diagnosed with rotator cuff tendinopathy attending our physical medicine and rehabilitation outpatient clinic and healthy volunteers

Brief summary: This study aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy.

Detailed description: Thirty patients with nocturnal pain, 30 patients without nocturnal pain, and 30 healthy subjects were included in the study. The demographic characteristics and body mass indexes of the patients were recorded. The visual analogue scale was used to determine pain severity. The American Shoulder and Elbow Surgeons Scale Assessment, Short Form-36 and Beck Depression Inventory were used to determine patients' shoulder function, general quality of life and depression levels, respectively. The peak systolic velocity and resistive index of anterior circumflex humeral artery was assessed with power doppler ultrasonography.The peak systolic velocity and resistive index of anterior circumflex humeral artery values of the affected and unaffected sides were compared.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years diagnosed with rotator cuff tendinopathy

Exclusion Criteria:

* Severe limitation and pain in head and neck movements
* Loss of strength
* Sensation and reflexes loss in the upper extremity
* Limitation in passive shoulder movements on physical examination
* Systemic rheumatic disease
* Diabetes mellitus
* Malignant disease
* Active infection
* Intraarticular injection
* Trauma
* Dementia
* History of surgery
* Bilateral should pain
* Psychiatric discomfort
* Smoking history
* Antiinflammatory drugs or received physical therapy within the last 3 months
* Beck depression score of higher than 13.

Primary outcomes:
measure: Anterior circumflex humeral artery peak systolic velocity
timeFrame: 1 week
measure: Anterior circumflex humeral artery resistive index
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Suleyman Demirel University
name: Çiğdem Aydoğan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00226707: Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis
Official title: A 6-Week Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Pimecrolimus Cream 1% in Patients With Mild-to-Moderate Chronic Hand Dermatitis Followed by a 6-Week Open-Label Phase to Assess the Safety of Pimecrolimus Cream 1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hand Dermatitis
Keywords: Chronic hand dermatitis, pimecrolimus, dermatitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is associated with adverse effects. This study will assess the efficacy and safety of pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.


Eligibility criteria: Inclusion Criteria:

* - Patients who are outpatients at baseline (Day 1)
* Patients must be 18 years of age or above
* Patients must have chronic hand dermatitis based upon clinical diagnosis with mild to moderate dermatitis of the target hand at baseline, as defined by an Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
* Patients must have been informed of the study procedures and medication and have given their written informed consent

Exclusion Criteria:

* - Women who are pregnant or who are breast-feeding.
* Patients who have received systemic corticosteroids (i.e., oral, intravenous, intra-articular, rectal, intramuscular) within one month prior to first application of study medication.
* Patients who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on hand dermatitis within at least one month prior to first application of study medication.
* Patients who have received pimecrolimus cream 1% or tacrolimus ointment 0.1% or 0.03% within 14 days prior to first application of study medication.
* Patients who were treated with topical therapy (e.g., tar, topical corticosteroids, Burrows solution soaks) known or suspected to have an effect on hand dermatitis within 7 days prior to first application of trial medication.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.
Secondary outcomes:
measure: IGA of the non-target hand
measure: Itching/burning assessment for the target and non-target hand
measure: Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit
measure: Work productivity and activity impairment questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References:
Clinical trial NCT05932407: A Database Survey of Comparison The Risk of Haemorrhage Between Vortioxetine Tablet Treatment and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment in Participants With Depression
Official title: Post-marketing Database Survey: A Cohort Study of Comparison the Risk of Haemorrhage (Serious Intracranial Haemorrhage Such as Cerebral Haemorrhage and Subarachnoid Haemorrhage) Between Vortioxetine Tablets and SSRIs In Patients With Depression Using JMDC Claims Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 147777
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a retrospective database study in Japan to evaluate the relative risk of serious intracranial hemorrhage requiring hospitalization between Vortioxetine tablet treatment and selective serotonin reuptake inhibitor (SSRI) treatment for patients with depression. This survey will conduct in use of medical database called JMDC claims database.


Eligibility criteria: Inclusion Criteria:

1. Has diagnosis of depression and prescription of Vortioxetine tablet or SSRI within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Participants can be observed for the past 6 months (180 days) (Look back period) from the day before the Index Date.
3. Had not prescription of Vortioxetine tablet or SSRI in the Look back period.

Exclusion Criteria:

1. Has diagnosis of intracranial hemorrhage during the look back period.
2. Has been taken Vortioxetine tablet in combination with SSRI on the index date.

Primary outcomes:
measure: Number of Participants Who Experienced of Intracranial Hemorrhage in Total Follow-up Period
timeFrame: 360 Days
measure: Incidence Rate of Intracranial Hemorrhage
timeFrame: 360 Days
Secondary outcomes:
measure: Number of Participants Who Experienced of Intracranial Hemorrhage From Baseline at Each Timepoint in Total Follow-up Period
timeFrame: 60, 120, 180, 240, 300, and 360 Days
measure: Incidence Rate of Intracranial Hemorrhage Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
timeFrame: 360 Days
measure: Incidence Rate of Serious Bleeding Requiring Hospitalization
timeFrame: 360 Days
measure: Incidence Rate of Serious Bleeding Requiring Hospitalization Categorized by Individual SSRI Drug for Intracranial Hemorrhage Treatment in SSRI Treatment Group
timeFrame: 360 Days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Takeda Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02558907: Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology
Official title: Comparison of MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) in Cognitive Assessment in Geriatric Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatrics
Cancer
Keywords: geriatrics
cancer
MMS test
MoCA test
cognitive evaluation
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 66
Sex: ALL
Minimum age (years): 71
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged patients with 1st line treatment of their cancer will be received an examination oncogériatric

Brief summary: Compare neurocognitive testing MMSE (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) to candidates aged patients with 1st line treatment of their cancer will be received an examination oncogériatric


Eligibility criteria: Inclusion Criteria:

* Patient old over 70 years
* Patient with cancer (solid tumor or hematological) for which a 1st line treatment is planned
* Patient candidate an oncogeriatric assessment
* Patient agreeing to participate in the study
* French language
* Lack of subsequent neurological sequelae with cognitive impact stroke, dementia or progressive psychiatric disorder
* Patient having a life expectancy ≥ 6 months

Exclusion Criteria:

* Primitive cancer of the central nervous system or brain metastasis
* Patients unable to meet the cognitive tests
* Refusal to participate
* Realization of a MMSE or MoCA test in the last 6 months

Primary outcomes:
measure: proportion of patients with cognitive disorders identified by the MoCA or the MMSE prior to treatment
timeFrame: before their first treatment for the cancer, at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
affiliation: Centre François Baclesse - CAEN
name: Heidi LAVIEC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05546307: Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials
Official title: Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relaxation
Somatosensory Evoked Potentials
Patient Experience
Keywords: Relaxation
Somatosensory Evoked Potentials
Patient experience
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 242
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: OTHER

Brief summary: Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.

The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.

The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience


Eligibility criteria: Inclusion Criteria:

* Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
* Patients between 18 to 70 years old.
* Patients able to understand the instructions of the relaxation session and the examination.
* Patient providing informed consent exclusion criteria

Exclusion Criteria:

* No availability of a technician trained in relaxation
* Patient's refusal to participate in the protocol

Primary outcomes:
measure: Variation of average rate of automatized artifacts rejection between both groups
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
References:
Clinical trial NCT04801407: Comparative Study inTreatment of Trigeminal Neuralgia
Official title: Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: trigeminal neuralgia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective case -series hospital based study
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters.

Detailed description: This is prospective case -series hospital based study, will be conducted on 40 patients with trigeminal neuralgia treated either by percutaneous radiofrequency trigeminal rhizotomy or microvascular decompression at Sohag University Hospitals, between march 2021 and June 2022 and we will divide the the patients into two groups ,one group will be treated with percutaneous radiofrequency trigeminal rhizotomy and the other group will be treated with microvascular decompression and we will asses the results with the Barrow Neurological Institute Pain Intensity Score .

Eligibility criteria: Inclusion Criteria:

* Failed medical treatment more than 6 months

Exclusion Criteria:

* Coagulation disorder or hemorrhagic disease;
* Mental illness and inability to cooperate;

Primary outcomes:
measure: Barrow Neurological Institute Pain Intensity Score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mohamed Abdelsamee Ahmed
state: Sohag City
Study officials:
References:
Clinical trial NCT03728907: A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
Official title: A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Keywords: hearing aid
self-fitting
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2018-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated-measures crossover design
Primary purpose: TREATMENT

Brief summary: Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.


Eligibility criteria: Inclusion Criteria:

* bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
* English speaking

Exclusion Criteria:

* Score less than 21 on the MoCa (Montreal Cognitive Assessment)
* Evidence of conductive or retrocochlear pathology

Primary outcomes:
measure: Real-ear aided output
timeFrame: two weeks
Secondary outcomes:
measure: Device Oriented Scale of Improvement (DOSO)
timeFrame: two weeks
measure: Computerized Assisted Speech Perception Assessment (CASPA)
timeFrame: two weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03748407: Determination of Baseline Thyroid Status Values in French Adult Population
Official title: Determination of Baseline Thyroid Status Values
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to establish reference values in the general population from a Beckman Coulter DxI chemiluminescence assay.

Indeed, the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease.

This supplier has recently optimized its dosing kit according to the 3rd international standard of the WHO (IRB 81/565) for the TSH (Thyroid Stimulating Hormon).

It is necessary to carry out a study of the distribution of the values of this TSH within our metropolitan population. The current data proposed by the supplier come from a study of a North American population.

investigators propose to define usual values for thyroid status markers (TSH, FT4 \[free thyroxine\], FT3 \[free triiodothyroxine\]) from healthy EFS (French Blood Establishment) donors who meet the standard exclusion criteria for this type of study.


Eligibility criteria: Inclusion Criteria:

* Donors (18-70 years old) volunteers at EFS

Exclusion Criteria:

* pregnancy,
* known antecedents of thyroid diseases (goiter, nodule, hypo or hyperthyroidism),
* current antithyroid treatment (neomercazole \[Thyrozol(r)\], levothyroxyn LT4 \[levothyrox(r)\], ...),
* cardiac treatment with amiodarone (cordarone(r)),
* injection of iodinated contrast medium less than 1 month old

Primary outcomes:
measure: Determination of the usual values of TSH
timeFrame: baseline
measure: Determination of the usual values of FT4
timeFrame: baseline
measure: Determination of the usual values of FT3
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04559607: TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
Official title: TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 188
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 purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.

Detailed description: This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of HCC confirmed by radiology, histology, or cytology

  -≥18 years
* China liver cancer staging: Ib-IIIa
* Child-Pugh score ≤6 point
* Previous TACE treatment(≤2 times) is permitted
* Adequate organ and marrow function

Exclusion Criteria:

* Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated \>5 years prior to enrolment with no recurrence
* Participants who have severe allergy to iodine, and unable to receive TACE
* Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
* Participants who had congenital or acquired immune deficiency, such as HIV infection
* Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
* Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism

Primary outcomes:
measure: Progression-free survival (PFS) by investigator
timeFrame: Up to ~2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~4 years
measure: PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Up to ~2 years
measure: Time to untreatable (unTACEable) progression (TTUP) by investigator
timeFrame: Up to ~2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: