louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00529425: Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture
Official title: Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fracture
Keywords: Femoral neck fracture
Hip fracture
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.


Eligibility criteria: Inclusion Criteria:

* Femoral neck fracture
* Fracture due to low energy trauma
* Ability to understand danish and give informed consent
* Ability to walk before trauma
* Indication for osteosynthesis
* ≥ 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points
* Informed consent

Exclusion Criteria:

* Drug or medical abuse
* Drug intolerance
* Pathological fractures
* Inflammatory arthritis
* Patient included in the study with the contralateral hip

Primary outcomes:
measure: Consumption of opioids
Secondary outcomes:
measure: Pain
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital, DK-5000 Odense C, Denmark
name: Soren Overgaard, Professor, MD, DmSc
role: STUDY_CHAIR
affiliation: Odense University Hospital, DK-5000 Odense C, Denmark
name: Rune Dueholm Bech, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bech RD, Lauritsen J, Ovesen O, Emmeluth C, Lindholm P, Overgaard S. Local anaesthetic wound infiltration after internal fixation of femoral neck fractures: a randomized, double-blind clinical trial in 33 patients. Hip Int. 2011 Mar-Apr;21(2):251-9. doi: 10.5301/HIP.2011.6513. Epub 2011 Apr 5.
Clinical trial NCT02483325: Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
Official title: Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematological Diseases
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
First posted: 2015-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine the efficiency of a myéloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.


Eligibility criteria: Inclusion Criteria :

* Informed consent signed,
* Patient affiliated to a social security system or benefiting from such a system,
* Related HLA identical donor or unrelated HLA identical donor :

all patients aged \> 55 years with hematological malignancy and deemed eligible for an allogeneic transplant from a geno-identical donor and pheno-identical 10/10

- the basic pathology should be considered "chemo-sensitive" complete or partial remission (CR, PR) or stable disease

Exclusion Criteria :

* Pregnant or lactating woman or without contraception (for child bearing potential women)
* Patient deprived of liberty or under supervision of a guardian
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
* Usual contra-indications for allogenic transplant
* Aged \< 55 years
* History of allogenic transplant
* Concomitant neoplastic disease
* Evolutive psychiatric disease
* HIV seropositivity or C hepatitis under treatment
* Women of childbearing age or man, in the absence of effective contraception during treatment and up to 12 months after treatment discontinuation

Primary outcomes:
measure: rates progression free survival 2 years
timeFrame: Time to progression or death
Secondary outcomes:
measure: Plasmatic concentration of Busulfan
timeFrame: Time from inclusion until Day -1 before allogenic transplantation
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
References:
Clinical trial NCT05373225: Shockwave Phonophoresis on Calcaneal Spur Patients
Official title: Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal Spur Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calcaneal Spur
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Self
First posted: 2022-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patients and also might improve the quality of life in a fast and efficient way.


Eligibility criteria: Inclusion Criteria:

* Heel pain with a calcaneal spur.
* Calcaneal spur in a lateral calcaneal x-ray.
* Patient's age ranged from 30 to 65 years.
* Patients with a calcaneal spur.
* Patients with intact sensory perception.
* At least 6 weeks from last corticosteroid injection; 4 weeks from the last local anaesthetic injection, iontophoresis, ultrasound, and electrotherapy

Exclusion Criteria:

* History of fracture or surgery of the heel or ankle.
* Presence of inflammatory joint disease.
* Marked osteoporotic patient.
* Presence of ankylosing spondylitis or other inflammatory joint diseases.
* Heart pacemaker use.
* Patient on anticoagulant and coagulation disease.
* Skin wound or ulcers.

Primary outcomes:
measure: calcaneal spur length by X-ray (mm)
timeFrame: three months
measure: calcaneal spur width by X-ray (mm)
timeFrame: three months
Secondary outcomes:
measure: FPX 50 wagner Pressure pain threshold (PPT)
timeFrame: three months
measure: Activity of daily living: by Foot and Ankle Ability Measure scale
timeFrame: three months
measure: visual analogue scale.
timeFrame: three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References:
Clinical trial NCT02318225: Misoprostol Prior to Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain
Official title: Cervical Priming With Misoprostol Before Diagnostic Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain. A Randomized Double Blinded Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Keywords: Misoprostol
Office hysteroscopy
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Detailed description: Cervical ripening with misoprostol to minimize the pain experienced during office hysteroscopy has been proposed by several authors.

The use of misoprostol is usually associated with undesired side effects and therefore any beneficial effect of misoprostol on reducing pain should be weighed against its undesired side effects (nausea, vomiting, diarrhea, fever, shivering, pain) and coasts. Till now , no studies have yet determined whether misoprostol should be used routinely or for the subgroup of patients at higher risk for cervical stenosis.

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one vaginal delivery who have an indication for office hysteroscopy.

Exclusion Criteria:

* Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean section or cervical surgery

Primary outcomes:
measure: Intensity of pain
timeFrame: procedure
Secondary outcomes:
measure: Operative time
timeFrame: procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics and Gynecology Department,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, M.D,PhD
role: STUDY_CHAIR
References:
citation: Cicinelli E, Rossi AC, Marinaccio M, Matteo M, Saliani N, Tinelli R. Predictive factors for pain experienced at office fluid minihysteroscopy. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):485-8. doi: 10.1016/j.jmig.2007.03.008.
Clinical trial NCT04049825: A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
Official title: A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Trial to Evaluate the Safety of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.


Eligibility criteria: Inclusion Criteria:

* Patients with a definite diagnosis of Diffuse large B-cell lymphoma(DLBCL)
* Patients who have received at least initial standard treatment
* Patients with measurable lesions (based on International Working Group \[IWG\] 2014 criteria)
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

\<Only for dose-expansion stage\>

* Patients who are pathologically diagnosed as CD20 positive lymphoma
* Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease

Exclusion Criteria:

* Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation
* Patients who were refractory to initial standard treatment
* Patients who have a history of bendamustine administration and are intolerant to bendamustine
* Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma
* Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL)

\<Only for dose-expansion stage\>

- Patients who have a history of rituximab administration and are intolerant to rituximab

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 23days
measure: Incidence of Adverse events(AEs)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014))
timeFrame: Last dose of study drug (up to 3 years)
Other outcomes:
Locations:
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Nobuhito Sanada
role: STUDY_DIRECTOR
References:
Clinical trial NCT00721825: Study of NeuroAid In Enhancing Recovery After Stroke
Official title: A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Cerebral Infarction
Keywords: Stroke
Cerebral infarct
Rehabilitation
Double blind Randomized
Placebo controlled
Traditional Chinese Medicine
Neuroaid
Lead sponsor: Moleac Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.


Eligibility criteria: Inclusion Criteria:

* Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
* Presents within 1 month after stroke onset
* Presents with motor power of from grade 1 - 4/5 in at least one limb
* Has a pre-stroke modified Rankin score ≤ 1.
* Age between 21 and 80 years old
* Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal)
* Subject or legally acceptable representative is willing and able to provide written informed consent
* Subject and carer are willing and able to comply with investigational drug administration schedule.

Exclusion Criteria:

* Subject has received thrombolysis
* Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
* Subject has definite indication for full-dose or long-term anticoagulation therapy
* Subject has other significant non-ischemic brain lesion which could affect function disability
* Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine \>200 μmol/L, if known), cirrhosis, severe dementia or psychosis
* Subject has a history of previous stroke/s
* Subject has participated in another clinical trial within the last three months
* Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions
* Subject has dense hemiplegia (grade 0 motor power)
* Subject has haemoglobin level of \<10mg/dl on admission
* Subject has a history of craniotomy or seizures

Primary outcomes:
measure: Fugl-Meyer assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional Independence Measure (FIM) scale
timeFrame: 4 weeks and 8 weeks
measure: Fugl-Meyer subscores
timeFrame: 4 weeks and 8 weeks
measure: NIHSS and NIHSS subscores
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Rehabilitation department
Study officials:
affiliation: Tan Tock Seng Hospital
name: Keng He Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164525: Validation of the Thai Version CPOT and BPS in Postoperative ICU Patients
Official title: Validation of the Thai Version Critical Care Pain Observation Tool and Behavioral Pain Scale in Postoperative Mechanically Ventilated ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult ICU Patients
Keywords: Thai version
validated
Critical Care Pain Observation Tool
Behavioral Pain Scale
adult ICU patients
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 27
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: Postoperative Mechanically Ventilated Adult ICU Patients

Brief summary: The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Detailed description: The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Eligibility criteria: Inclusion Criteria:

* aged ≥18 years
* be able to communicate in Thai
* intubated during postoperative period.

Exclusion Criteria:

* quadriplegia
* patients with limb or facial injuries
* patients receiving neuromuscular blockers
* patients with limb mobility adversely affected by stroke
* patients with epidural catheter used for postoperative pain control

Primary outcomes:
measure: construct validity
timeFrame: before and after analgesic given during 24 hours postoperative period
Secondary outcomes:
measure: content validity, concurrent validity, inter-rater reliability, and practicality
timeFrame: 24 hours after operation
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT06514625: Sleep Quality in Carpal Tunnel Syndrome, Splinting and Kinesiotaping
Official title: Effect of Splinting and Kinesiotaping Treatments on Functional Status, Sleep Quality and Median Nerve Cross-sectional Area in Carpal Tunnel Syndrome: a Single Blind Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effect of conservative treatments on sleep quality in carpal tunnel syndrome is unclear.

Comparing the effect of splinting and kinesiotaping in carpal tunnel syndrome on functional status, pain, grip strength, nerve cross-sectional area and sleep quality.

Participants were divided into 3 groups. One group received night splint and nerve tendon gliding exercises, one group received kinesiotaping and nerve tendon gliding exercises, and one group received only nerve tendon gliding exercises. Participants were evaluated by a blinded investigator at baseline and at 3 months by Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire, Pittsburgh Sleep Quality Index (PSQI), Jamar hand dynamometer and ultrasonography.


Eligibility criteria: Inclusion Criteria

* Being diagnosed with mild and moderate carpal tunnel syndrome with nerve conduction velocity study
* To be between the ages of 18-65

Exclusion Criteria:

* Inflammatory disease (rheumatoid arthritis, tendinitis, etc.),
* Osteoarthritis in the hand/wrist,
* Musculoskeletal conditions (hand, elbow, wrist),
* Thyroid disease
* Chronic kidney failure
* Carpal tunnel syndrome surgery,
* History of surgery and/or trauma to the upper extremity and neck.
* Pregnancy or diabetes-related carpal tunnel syndrome,
* Receiving any treatment for carpal tunnel syndrome (splint therapy, electrophysical agents, exercise, local corticosteroid injection) up to 3 months prior to the tests.

Primary outcomes:
measure: sleep quality
timeFrame: at baseline and third month
measure: median nerve cross-sectional area
timeFrame: at baseline and third month
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Research and Training Hospital
state: Selçuklu
Study officials:
References:
Clinical trial NCT01607125: Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study Investigating the Effects of [Vortioxetine] Lu AA21004 on Cognition and BOLD fMRI Signals in Subjects Remitted From Depression and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2012-05-28
Enrollment: 96
Sex: ALL
Minimum age (years): 25
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 study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.


Eligibility criteria: Inclusion Criteria:

All subjects must have:

* a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7

Subjects remitted from depression must:

* be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs)
* have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE
* report present subjective cognitive dysfunction
* not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit

Control group subjects must:

* have no history of MDEs
* have no history of MDEs in a biological parent or other first degree relative as reported by the subject
* not report present subjective cognitive dysfunction
* never have been treated with antidepressants or psychotherapy

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory)
timeFrame: Day 1 to Day 13
measure: Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory
timeFrame: Day 1 to Day 13
Secondary outcomes:
measure: Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing
timeFrame: Day 1 to Day 13
Other outcomes:
Locations:
city: Headington
country: United Kingdom
facility: GB001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: