louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06185270: Effects of Preoperative Frailty on Postoperative Recovery
Official title: Effects of Preoperative Frailty Assessed by Short Physical Performance Battery (SPPB) on Short-term Postoperative Recovery Among Gastric Cancer Patients Undergoing Minimally Invasive Distal Gastrectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Frailty
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 139
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery

Brief summary: This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.

Detailed description: As the elderly population increases, the evaluation and management of preoperative frailty is becoming important. In patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. This study aims to evaluate frailty using an automated device performing SPPB (Andantefit) and find out how frailty affects postoperative recovery.

Eligibility criteria: Inclusion Criteria:

* Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery

Exclusion Criteria:

* Patients who have a difficulty in communication
* Patients who have a major medical or mental disease that can affect treatment outcome
* Patients unsuitable for this clinical trail on the opinion of researcher

Primary outcomes:
measure: Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
timeFrame: on postoperative day 3
Secondary outcomes:
measure: Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
timeFrame: on postoperative day 1
measure: Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)
timeFrame: on postoperative day 2
Other outcomes:
measure: Postoperative QoR-15K score
timeFrame: postoperative day 1, 2, 3
measure: Pain score at rest / during ambulation
timeFrame: postoperative day 1, 2, 3
measure: Ambulation distance
timeFrame: postoperative day 1, 2, 3
measure: First gas out time
timeFrame: up to 1 week after surgery
measure: Postoperative complication
timeFrame: up to 1 month after surgery
measure: Hospital length of stay
timeFrame: at the day of discharge (up to 1 month after admission)
Locations:
Study officials:
References:
Clinical trial NCT02854670: A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Vestibulodynia
Keywords: capsaicin
pain improvement
provoked vulvodynia
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.


Eligibility criteria: Inclusion Criteria:

* Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
* Pain ≥ 4 on Visual Analogic Scale (VAS)
* Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A
* If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment)
* Negative screening test results
* Menopause, surgically sterilized women or women using effective contraceptive method
* Good understanding and predictable adherence to the protocol
* Beneficiary/affiliated to French social security/social healthcare
* Signed Informed Consent Form

Exclusion Criteria:

* Predictable poor adherence
* Pregnant or breastfeeding women
* Diabetes mellitus type 1 or type 2
* Major mental disorders
* Underlying etiology such as chronic vulvar disease
* Initial vulvar erythema
* Vulnerable subjects (particularly adults under guardianship)
* Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses

Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback)

Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form

Primary outcomes:
measure: Pain assessment with Visual Analogic Scale (using a q-tip)
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Fabien Pelletier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205970: Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
Official title: Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: TENS
Dysmenorrhea
analgesia
interactive
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.

Detailed description: The denouement will be the intensity of pain from visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Primary dysmenorrhoea
* Moderate to severe pain

Exclusion Criteria:

* Secondary dysmenorrhea
* Users of intrauterine device
* Cognitive impairment
* Failure to appear for treatment
* Pacemaker use
* Illicit drug use
* Epilepsy
* Skin problems
* Use of pain medication before the application of TENS

Primary outcomes:
measure: measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
timeFrame: participants will be monitored for 24 hours
Secondary outcomes:
measure: duration of analgesia after application
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Fundação de Educação e Cultura de Santa Fé do Sul
name: Fábio M. Camilo, teacher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957970: Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Official title: Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of Hip
Keywords: Stress shielding
Bone mineral density
stemless femoral component
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 120
Sex: ALL
Standard ages: CHILD
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 if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.

Detailed description: Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

* Neurologic disorders affecting motor function of lower extremity
* foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.

Primary outcomes:
measure: Bone mineral density of surrounding proximal femur according to Gruen zones
timeFrame: At least 2years after surgery
Secondary outcomes:
measure: Harris hip score
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Korean Joint replacement Center
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
citation: Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.
citation: Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.
citation: Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.
citation: Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.
Clinical trial NCT00015470: Diagnostic Evaluation of Patients With Neuromuscular Disease
Official title: Diagnostic Evaluation of Patients With Neuromuscular Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Disease
Keywords: Myopathy
Dystrophy
Neuropathy
Muscle Weakness
Muscle Cramps and Pains
Neuromuscular Disorders
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-04-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

Detailed description: The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

Eligibility criteria: * INCLUSION CRITERIA:

Research patients will be studied under this protocol if they fulfill the following criteria:

Have an identifiable neuromuscular disorder that may be suitable for a specific current or future protocol;

Present a diagnostic puzzle in spite of the previously performed diagnostic work-up;

Have unusual manifestation of a more usual neuromuscular disease;

Have a disorder useful for teaching purposes.

Patients should be referred by a physician who will continue their care after our evaluation. A report of the patients' visit and tests, along with suggestions or recommendations will be sent to each referring physician. There is a wide spectrum of neuromuscular diseases to be studied, among them are: peripheral neuropathies, myopathies, dystrophies, myasthenia, stiff person syndrome, muscle cramps, myotonias, motor neuron diseases, post-polio syndrome, and certain demyelinating disorders affecting both the central and the peripheral nervous system.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT06957470: TCI vs. Manuel TIVA in Septorhinoplasty Surgeries
Official title: Comparison of the Effects in Target-controlled and Manually Controlled Total Intravenous Anesthesia on Postoperative Recovery and Patient Quality of Recovery in Septorhinoplasty Surgeries
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anesthesia
Keywords: septorhinoplasty
TIVA (total intravenous anesthesia)
TCI (target controlled infusion)
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia

Brief summary: Septorhinoplasty is a surgical technique that can be used to correct various nasal deformities.Total intravenous anesthesia (TIVA) is a frequently preferred method as an anesthesia technique in septorhinoplasty surgeries.It has been reported that TIVA reduces the incidence of postoperative nausea and vomiting, is more successful in acute postoperative pain control compared to inhalational anesthesia, provides more stable hemodynamics, provides quicker awakening after anesthesia, is more effective in preventing recovery agitation and cough, and is effective in controlled hypotension.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia will be included in the study.

Exclusion Criteria:

Patients who do not agree to participate in the study Patients under 18 and over 65 Patients with ASA score III and above Clinical diagnosis of neuropsychiatric disorders Those with a history of chronic NSAID, tranquilizer, opioid or sleeping pill use Clinical diagnosis of Serious cardiac diseases Clinical diagnosis of central-autonomic nervous system disease Clinical diagnosis of Coagulopathy Those with soybean oil allergy and a history of allergy to any study drug BMI \>30 kg m2, pregnancy breastfeeding patients

Primary outcomes:
measure: postoperative recovery
timeFrame: at postoperative 6 hours and 24 hours
measure: agitation during emergence
timeFrame: Postoperative 0 and 15. Minutes at the recovery room
Secondary outcomes:
measure: surgeon satisfaction
timeFrame: at the end of surgery
measure: postoperative pain
timeFrame: at the end of the surgery
measure: nausea and vomiting
timeFrame: Postoperative 0 hours at recovery room
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguladk Bulent ecevit University
state: Kozlu
city: Zonguldak
country: Turkey
facility: Bulent Ecevit University
Study officials:
References:
Clinical trial NCT02081170: The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,
Large Size Macular Hole (Diameter > 600 Microns) or
Recurred or Failed Macular Hole From Previous Surgery
or Chronic Macular Hole (Symptom Duration > 6 Months)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.


Eligibility criteria: Inclusion Criteria:

* Macular hole with any of following condition

  * High myopia (spherical equivalent ≤ -6.0 Diopters)
  * Large size macular hole (Diameter \> 600 microns)
  * Recurred or failed macular hole from previous surgery
  * Chronic macular hole (symptom duration \> 6 months)

Exclusion Criteria:

* Systemic infection
* Hematologic disease
* Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration

Primary outcomes:
measure: macular hole closure
timeFrame: 6 months
Secondary outcomes:
measure: best-corrected visual acuity
timeFrame: 6 months
measure: metamorphopsia score
timeFrame: 6 months
measure: safety outcome
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03530670: Effect of Premedication Type on Preoperative Anxiety in Children
Official title: The Effect of Three Different Interventions on Preoperative Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preoperative Anxiety
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-05-21
Enrollment: 138
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
Primary purpose: OTHER

Brief summary: Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy

Detailed description: Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated' animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU , playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety by m-YPAS in the holding area, in the operating room and while induction of anesthesia.

Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU at arrive and every 10 minutes.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Chronic diseases
* Development disability
* Prematurity
* Neurological diseases
* Psychoactive medication use
* Hearing/visual impairment
* History of surgery

Primary outcomes:
measure: Change in preoperative anxiety
timeFrame: Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction.
Secondary outcomes:
measure: Emergence agitation
timeFrame: Postoperative every 10 minutes from entrance to the recovery room until discharge. If there is not a problem, patients are watched 20 minutes in our hospital's recovery room.
measure: Mask acceptance score while mask induction
timeFrame: At anesthesia induction
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: DiskapiYBERH
Study officials:
References:
citation: Sakizci Uyar B, Polat R, Bolat M, Donmez A. Which is good for pre-operative anxiety? Midazolam, video games or teaching with cartoons: A randomised trial. Eur J Anaesthesiol. 2021 Jul 1;38(7):744-750. doi: 10.1097/EJA.0000000000001384.
Clinical trial NCT06373770: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
Official title: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum

Detailed description: "This study named effects of ayres sensory integration therapy versus conservative treatment in autism spectrum is a randomized clinical trail study.There is no evidence-based intervention protocol to treat sensory integration dysfunction in autism spectrum. This study may help finding best therapeutic treatment approach for sensory integration dysfunction results in repetitive behavior and impairments in functionality in autism spectrum.This study helps

* To evaluate best intervention plan for sensory integration dysfunction, Ayres sensory integration therapy versus conservative treatment in autism spectrum.
* To determine how many patients will be having what type of sensory integration dysfunction that come with autism spectrum leading to certain level of functional restrictions in Activity of Daily Livings (ADLs).
* Which type of sensory integration dysfunction having greater functional impairment and need to be focused more for intervention?
* To make better individualized rehabilitation treatment plan being an Occupational Therapist."

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of autism age range from 2 year to 8 years.
* All patients will be assed using sensory profile by Winnie Dunn.
* All the patients fulfilling the above-mentioned inclusion criteria will be assessed and evaluated by occupational therapist for sensory integration dysfunction.

Exclusion Criteria:

* All other patients not having diagnosed as autism spectrum criteria are excluded.
* All patients with sensory processing disorder assessed by using sensory profile.

Primary outcomes:
measure: sensory profile by winnie dunn
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: RICCER Institute
state: Punjab
Study officials:
References: