louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06032585: TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population
Official title: TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population: an Evaluation in the Form of a Retrospective Cohort Study With a Long Follow-up Time
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinsonism
Tremor
Dementia
Keywords: Transcranial ultrasound
Substantia nigra
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosted patients with parkinsonism between 2013-2017 at our centre

Brief summary: Popular science summary of the project The purpose of the study is to investigate in a Swedish population how well the investigators' previous ultrasound findings match the final diagnosis (PD, APS or ET) after a particularly long follow-up time, which greatly increases the certainty that the diagnosis does not change more and is thus correct. Furthermore, the investigators want to study whether the initial ultrasound findings have changed during the control interval and whether measurement results regarding the diameter in one of the fluid-filled rooms in the brain (third ventricle) can be correlated with the development of cognitive impairment or dementia later in the course of the disease. For this, this study have got ethical permission to go into the patients' medical records and to call a subgroup back to the clinic to be able to do a new examination and a memory test.


Eligibility criteria: Inclusion Criteria:

* Patients with parkinsonism or essential tremor who came into contact with our clinic before 2017
* Satisfactory transcranial bone window
* Previous TU (clinical indication)

Exclusion Criteria:

* No transcranial bone window

Primary outcomes:
measure: Correlation
timeFrame: over 7-10 yrs
Secondary outcomes:
measure: Correlation
timeFrame: 7-10 (retrospective)
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne Univ Hospital
state: Skåne
Study officials:
References:
Clinical trial NCT06013085: Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
Official title: Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Behavioral Therapy
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.

Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.

Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.

Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.


Eligibility criteria: Inclusion Criteria:

* nurses with post COVID-19 condition

Exclusion Criteria:

* history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Primary outcomes:
measure: insomnia severity
timeFrame: 20 weeks
measure: sleep quality
timeFrame: 20 weeks
measure: sleep efficiency
timeFrame: 20 weeks
Secondary outcomes:
measure: anxiety
timeFrame: 20weeks
measure: depression
timeFrame: 20weeks
measure: health-related quality of life
timeFrame: 20weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01817985: A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Official title: A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C (HCV) Infection
Moderate Hepatic Impairment
Severe Hepatic Impairment
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic (\> 6 months), hepatic impairment.
* In the opinion of the Investigator, be in good health.

Exclusion Criteria:

* Severe hepatic encephalopathy.
* Prior placement of a portosystemic shunt.
* Hepatorenal or hepatopulmonary syndrome.
* Suspicion of hepatocellular carcinoma.

Primary outcomes:
measure: Pharmacokinetic parameters of GS-5816
timeFrame: Up to one year
Secondary outcomes:
measure: Incidences of adverse events and laboratory abnormalities
timeFrame: Up to one year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: San Juan
country: Puerto Rico
facility: Investigational Site
Study officials:
affiliation: Gilead Sciences
name: Diana Brainard, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03826485: Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Pranlukast hydrate
Lead sponsor: SamA Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is Safety, Pharmacokinetic Study of PRIC

Detailed description: 1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup

Eligibility criteria: Inclusion Criteria:

* 19 to 45 years old healthy male subject at the screening
* Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study

Exclusion Criteria:

* Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
* Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions

Primary outcomes:
measure: Area Under the Curve (AUC) to last time point (t)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
measure: Maximum concentration of drug (Cmax)
timeFrame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References:
Clinical trial NCT03808285: Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
Official title: Denosumab Related Osteonecrossi of the Jaw : : an Emergent and Potentially Complex Bone and Joint Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Osteomyelitis
Adverse Drug Event
Keywords: bone and joint infection
osteomyelitis
mandibular
denosumab
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 13
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: patients having a mandibular osteomylelitis due to DENOSUMAB betwwen 01/01/2013 and 31/12/2018 and managed at the Lyon Bone and joint infection refence Center

Brief summary: The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.


Eligibility criteria: Inclusion Criteria:

* patients having a mandibular osteomylelitis due to DENOSUMAB

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of mandibular osteomyelitis
timeFrame: Entire description can be made at the outcome which is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: Duration of antibiotics
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: management of mandibular osteomyelitis by medical team
timeFrame: all data are available at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: TRISTAN FERRY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01052285: The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair
Official title: The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia
Keywords: Transversus abdominis plane block
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* groin hernia repair
* written consent
* ASA 1-3
* BMI 18-35

Exclusion Criteria:

* unable to communicate in Danish
* relevant drug allergy
* pain medication in the last 24 hours
* pregnancy
* alcohol or/and drug abuse
* daily opioid intake
* infection at injection site

Primary outcomes:
measure: Pain scores by coughing between TAP block group and placebo group
timeFrame: 0,2,4,6,8,19 and 24 hours postoperative
Secondary outcomes:
measure: Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.
timeFrame: 0,2,4,6,8,19 and 24 hours postoperative
measure: Total opioid consumption
timeFrame: 0-24 hours postoperative
measure: Postoperative nausea and vomiting
timeFrame: 0,2,4,6,8,19,24 hours postoperative
measure: Sedation
timeFrame: 0,2,4,6,8,19,24 hours postoperative
measure: Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo
timeFrame: 0,2,4,6,8,19,24 hours postoperative
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Anaesthesiology, Glostrup university hospital
Study officials:
affiliation: Glostrup University Hospital
name: Pernille L Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.
Clinical trial NCT00442585: S(+)-Ibuprofen Effects on Asprin Treated Volunteers
Official title: Double Blind, Randomised, Parallel Group, Placebo Controlled Clinical Trial of S(+)-Ibuprofen Effects on TxB2 Concentrations and Platelet Aggregation in Aspirin-treated Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Lead sponsor: Gebro Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy caucasian volunteer
* Must be able to swallow tablets

Exclusion Criteria:

* Underlying diseases
* Ulcus pepticum in history
* Abuse of alcoholic beverages (40g/d)
* Hypersensitivity to investigational medicinal products

Primary outcomes:
measure: Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days
Secondary outcomes:
measure: percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
measure: prostacyclin metabolite
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Division of Clinical Pharmacokinetics, Medical Univerisity of Vienna
name: Christian Joukhadar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cryer B, Berlin RG, Cooper SA, Hsu C, Wason S. Double-blind, randomized, parallel, placebo-controlled study of ibuprofen effects on thromboxane B2 concentrations in aspirin-treated healthy adult volunteers. Clin Ther. 2005 Feb;27(2):185-91. doi: 10.1016/j.clinthera.2005.01.011.
Clinical trial NCT01300585: MRI Evaluation of the Breast Areolar Margin and Paryenchyma
Official title: MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast
Cancer
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. MRI results will be examined to identify the pattern of breast gland attachment to the overlying skin. This will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.


Eligibility criteria: Inclusion Criteria:

* Have one of the following indications for MRI study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from MRI.
* No prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants.
* Capable of fitting into the MRI machine.
* Permission to contact and consent the patient to participate from the investigator(s)
* Provide written informed consent and Authorization for Use/Disclosure of PHI

Exclusion Criteria:

* Have a contraindication to MRI study.
* Prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants \[Patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration\]
* Inability to fit into the MRI machine.
* Psychological factors that may interfere with successful completion of the study
* Refusal to provide written informed consent and/or Authorization for Use/Disclosure of PHI

Primary outcomes:
measure: Patterns of Breast Gland Attachment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
Study officials:
affiliation: Piedmont Hospital
name: Heather Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00549185: Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
Official title: An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Non-Hodgkin
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
* ECOG performance status 0 to 2

Exclusion Criteria:

* Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
* Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
* Previous radioimmunotherapy within 12 weeks
* Known intolerance to infused protein products or maytansinoids
* Poor kidney, liver and bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Pregnant or breast-feeding women
* Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of Dose Limiting Toxicity(ies) at each tested dose level
timeFrame: Study period
Secondary outcomes:
measure: Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response
timeFrame: Study period
measure: Incidence of Adverse Events
timeFrame: Study period
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02594085: An Exploratory Study Investigating Adhesive Reaction to Output
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to investigate the impact that faecal output has on adhesives.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than 3 months
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter (≤) 35mm

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal area
5. Convex user
6. Participate in other interventional clinical investigations

Primary outcomes:
measure: Remaining adherent area of the adhesive
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Medical Director
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References: