louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05604729: The Effect on Envelope of Motion in Asymptomatic Bruxers
Official title: The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Wear
Bruxism
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
First posted: 2022-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded
Primary purpose: TREATMENT

Brief summary: Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

Detailed description: Research subjects will be allocated to placebo or botulinum neurotoxin intervention. A control group will not receive any intervention. The intervention will be administered at three separate sessions with 12 weeks in between. Prior to intervention, and 6 months after last intervention the jaw-neck envelope of motion will be studied using 3D optoelectronic recording systems.

Eligibility criteria: Inclusion Criteria:

• Tooth wear into dentin.

Exclusion Criteria:

* No temporomandibular pathology.
* No drugs affecting the central nervous system.
* No conditions affecting muscles or central nervous system.

Primary outcomes:
measure: Change of range of motion
timeFrame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
measure: Change of envelope of motion
timeFrame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
measure: Change of length in chewing cycles
timeFrame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Secondary outcomes:
measure: Change of muscle thickness
timeFrame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
measure: Change of maximal voluntary bite force
timeFrame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
measure: Tooth wear, change of hard tissue mass
timeFrame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Mattias Pettersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02336529: Nerveblocks for Persistent Pain After Breast Cancer Surgery
Official title: Tenderpoint and Ultrasound Guided Nerveblocks for Persistent Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain
Neuropathic Pain
Breast Cancer
Keywords: postoperative
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Persistent pain after breast cancer surgery (PPBCS) affects 25-60% of breast cancer survivors and nerve damage has been implicated as the cause of this neuropathic pain condition. Local anaesthetic blockade of tenderpoints and the intercostobrachial nerve (ICBN) could provide clues to pathophysiological mechanisms as well as aiding diagnosis and treatment of PPBCS but has never been attempted. The aims of this study is to examine clinical effect of ultrasound guided blockades of the ICBN and tenderpoints of pain.


Eligibility criteria: Inclusion Criteria:

* At least 1 year after surgery for breast cancer
* Women aged 18 or over
* Suffering from persistent pain in the breast, side of chest, axilla or arm (NRS 4 or over)

Exclusion Criteria:

* Previous cosmetic surgery
* bilateral cancer
* pregnant or lactating
* other disease in the nervous system
* in treatment for psychiatric disease
* unable to understand Danish
* unable to give informed concent

Primary outcomes:
measure: Summed pain intensity
timeFrame: At least 1 year after surgery
Secondary outcomes:
measure: Pain at rest, pain during movement and pressure pain
timeFrame: At least 1 year after surgery
measure: Pain related reduction of physical function
timeFrame: At least 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Nelun Wijayasinghe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, University of Copenhagen
name: Kenneth G Andersen, MD, PhD
role: STUDY_CHAIR
References:
citation: Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.
Clinical trial NCT06178029: Effectiveness of Acupuncture Treatment Applied in Addition to the Rehabilitation Program in Multiple Sclerosis Patients
Official title: Effectiveness of Acupuncture Treatment Applied in Addition to the Rehabilitation Program in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Acupuncture
Gait
Fatigue
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effect of acupuncture treatment combinated with conventional rehabilitation methods on gait, fatigue, quality of life and bladder functions in patients with multiple sclerosis

Detailed description: After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into two groups in a conventional rehabilitation and acupuncture combined with conventional rehabilitation

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with MS according to McDonald criteria
* EDSS score between 1-6
* The patient is clinically stable
* Having not had a new MS attack in the last 3 months
* Being cognitively suitable to participate in the study

Exclusion Criteria:

* Being clinically unstable
* Inability to cognitively participate in tests
* Having received acupuncture treatment in the last 6 months

Primary outcomes:
measure: Timed 25 Foot Walk Test Score
timeFrame: Baseline, after 1 month and 3 month changes
Secondary outcomes:
measure: Neurogenic Bladder Symptom Scoring
timeFrame: Baseline, after 1 month and 3 month changes
measure: Incontinence Quality of Life Questionnaire
timeFrame: Baseline, after 1 month and 3 month changes
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: Baseline, after 1 month and 3 month changes
measure: Fatigue Severity Scale
timeFrame: Baseline, after 1 month and 3 month changes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Bilkent-Cankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Zeynep İNCE KESKİN, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Müyesser ARAS, Professor Doctor
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital Bilkent
name: Semra MUNGAN, Associate Professor
role: STUDY_CHAIR
References:
citation: Criado MB, Santos MJ, Machado J, Goncalves AM, Greten HJ. Effects of Acupuncture on Gait of Patients with Multiple Sclerosis. J Altern Complement Med. 2017 Nov;23(11):852-857. doi: 10.1089/acm.2016.0355. Epub 2017 Apr 14.
Clinical trial NCT06861829: A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood
Official title: The Effect of Food on the Single-dose Pharmacokinetics of BI 3731579 Administered Orally in Healthy Male Subjects (an Open Label, Two-period, Two-sequence Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial investigates whether food influences the amount of BI 3731579 in the blood.


Eligibility criteria: Inclusion criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 4 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 4 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT02076529: Phamacokinetic and Pharmacodynamic Study of Ramosetron in Chemotherapy Induced Nasea and Vomiting
Official title: A Study About Pharmacokinetic and Pharmacodynamics of Ramosetron in Chemotherapy Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: chemotherapy induced nausea vomiting
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 51
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: SUPPORTIVE_CARE

Brief summary: This study is designted to know optimal dose of Ramosteron to control for chemotherapy induced nasea and vomoting (CINV)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using Rhodes Index.

Detailed description: Nausea and vomiting is a common adverse event during chemotherapy treatment. Even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. Serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. However, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. Therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and Rhodes Index as a suggogate marker for CINV.

Eligibility criteria: Inclusion Criteria:

* Patients who recevied moderate emetogenic chemotherapy
* Age between 18-75
* ECOG PS 0-2
* Adequate organ fuction including bone marrow, liver and kidney

Exclusion Criteria:

* Gastrointestinal obstruction or carcinomatosis peritonei
* CNS metastasis or disability in CNS
* Intractable medical illness
* Pregnancy or inadequate contraception

Primary outcomes:
measure: Pharmacokinetic profile of Ramosetron according to 3 level of dose
timeFrame: 10min to 48 hours post-dose
Secondary outcomes:
measure: Rhodes Index
timeFrame: 1 hour to seven days post-dose
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanamdo
Study officials:
affiliation: CNUHH
name: Sang-Hee Cho, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754429: The Effect of Losartan Versus Amlodipine-based Therapy in Ischemic Stroke (0954-338)(COMPLETED)
Official title: The Effect of Losartan Versus Amlodipine-based Antihypertensive Therapy on Atherosclerotic Inflammatory Markers and Cerebrovascular Regulation in Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2008-09-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in Ischemic stroke patients.


Eligibility criteria: Inclusion Criteria:

* Patient With Tia Or Ischemic Stroke (Event Has Occurred More Thaan 4 Weeks But Less Than 24 Weeks, And Modified Rankin'S Scale, Mrs\<=3) With Mild To Moderate Hypertension
* Patient Has No Other Active Medical Problem, Which Might Of Itself Or By This Treatment Significantly Affect The Patient's Blood Pressure
* The Blood Level Of Hscrp\>0.2 Ng/Dl By Two Measurements Performed Respectively One-Week Apart

Exclusion Criteria:

* Patients With Cardiac Arrhythmia
* Diabetes Mellitus
* Patient With Other Active Inflammatory Diseases Such As Rheumatoid Disease, Fever And Systemic Infection Which Will Confound The Level Of Serum CRP
* Patients With Known Intolerance, Contraindication Or Hypersensitivity To Losartan, Amlodipine and Hydrochlorothiazide
* Patient With Myocardial Infarction Within The Recent Three Months
* Anatomy Abnormality Which Results In Poor Bilateral Temporal Acoustic Windows Which Prevent TCD Procedure
* Patient Who Requires Continuous Medication With Alpha Blocking Agents
* Concurrent Usage Of Acei
* Poor Mental Function Or Any Other Reason To Expect Difficulty In Meeting The Requirements Of The Study
* Concurrent Treatment With Other Lipid-Lowering Drug
* Childbearing Potential Women Not Undergoing Adequate Contraceptive Control

Primary outcomes:
measure: MCAFV and TCD for measuring cerebral autoregulatory indices at week 0, week 6, week 18 and week 30.
timeFrame: At week 0, week 6, week 18 and week 30.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00729729: Pharmacokinetic Study for PCA Derivate Formulations
Official title: Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Comparative
bioavailability
of PCA
formulations
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-08-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who have completed the informed consent process culminating with written informed consent by the subject.
* Males
* Age 18-45 years
* Abstinence from alcohol for 1 week prior to the study
* Non smoking
* BMI \> 19 and \< 30
* No history or evidence of significant

  * cardiovascular,
  * hepatic,
  * renal,
  * hematopoietic,
  * gastrointestinal disease,
  * endocrine,
  * metabolic,
  * psychiatric
  * psychological disorders
* Normal physical examination
* Within +/- 10% of normal values in laboratory examinations

Exclusion Criteria:

* Subjects who suffer from a current medical condition.
* Subjects who smoke.
* Subjects who drink \> 20 grams of alcohol per day.
* Subjects who take prescription medication.
* Subjects with an abnormality in screening blood tests
* Known sensitivity to any ingredients in the study drug

Primary outcomes:
measure: PCA derivate blood levels
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00721929: Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Official title: Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Gland Disease
Keywords: adrenal glands, adrenal masses
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 16
Sex: ALL
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 determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.


Eligibility criteria: Inclusion Criteria:

* Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type.

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are lactating.
* A patient who is claustrophobic and would require sedation to complete the MRI exam.

Primary outcomes:
measure: Diagnosis of either benign or malignant adrenal mass on pathology
timeFrame: 0-6 months
Secondary outcomes:
measure: stability of growth of mass on follow up imaging
timeFrame: 3-24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT06825429: Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
Official title: Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neoplastic Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre, uncontrolled interventional feasibility study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.

Detailed description: The intervention will consist of EFG sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the Rehabilitation Day Hospital.

Each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. The exercises proposed to the group with ECOG 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, V2, 07/10/2024). The groups will consist of a minimum of five patients and a maximum of ten. Patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. Patients will be assessed at baseline (T0), at the end of the intervention (T1,12 weeks) and 6 months after the start of the intervention (T2).

Eligibility criteria: Inclusion Criteria:

* neoplastic tumor
* age\>= 18
* prognosis\> 12 months
* ECOG \<=2
* Walking with/ without aids
* clinically stable
* signed informed consent
* Patients with bone metastases with ECOG from 0-1 suitable results

Exclusion Criteria:

* sensory deficits who cannot perform physical exercise
* cognitive impairment that compromises collaboration and questionnaire filling
* patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent

Primary outcomes:
measure: adherence to the group exercise programme
timeFrame: through study completion, an average of 2 years
measure: Frequency
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: QoL
timeFrame: through study completion, an average of 2 years
measure: tolerance to effort
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Besa Kopliku, MD
role: PRINCIPAL_INVESTIGATOR
References: