louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00268658: Clinical Use of Andante SmartStep System in Gait Rehabilitation
Official title: Clinical Use of Andante SmartStep System in Gait Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Femoral Neck Fractures
Keywords: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Arthroscopy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.

Detailed description: To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.

Eligibility criteria: Inclusion Criteria:

* Rehabilitation after operation
* Patient is allowed full weight bearing
* Patient is motivated and able to communicate and understands orders
* Patient is able to walk 10 meters
* Patient filled out agreement and consent form

Exclusion Criteria:

* Activity limitation due to medical disorder, medications, or emotional status.
* Pain markedly obstructs gait ability
* Documented peripheral neuropathy
* Functional limitation prior to the current condition
* Premorbid, ongoing major depression or psychosis
* Multiple/pathological fractures
* Serious early complications
* Terminally ill patients
* Pregnant women
* Participation in current or recent (within 60 days prior to surgery) clinical trial

Primary outcomes:
measure: load bearing over the affected lower limb
measure: quality/symmetry of gait
measure: level of ambulation and physical independence
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Daniel Plotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933958: Regorafenib Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumors
Keywords: Regorafenib
Gastrointestinal stromal tumors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are treated with Regorafenib/STIVARGA and meet the product label

Brief summary: The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice

Detailed description: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for gastrointestinal stromal tumors progressed after cancer chemotherapy.

A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Eligibility criteria: Inclusion Criteria:

* Patients who are treated with Regorafenib/ STIVARGA and meet the product label.

Exclusion Criteria:

* Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.

Primary outcomes:
measure: Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
timeFrame: Up to 6 months
measure: Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
timeFrame: Up to 6 months
measure: Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
timeFrame: up to 6 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: Up to 3 years
measure: time to treatment failure (TTF)
timeFrame: Up to 3 years
measure: tumour response
timeFrame: Up to 3 years
measure: Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.
Clinical trial NCT05176158: Dexketoprofen Dosage According to Chronotherapy
Official title: Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Trismus
Pain
Inflammatory Response
Keywords: Third
Dexketroprofen
Randomized
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2022-01-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.

The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock

Detailed description: A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.

Eligibility criteria: Inclusion Criteria:

* Bilateral impacted lower third molar

Exclusion Criteria:

* NSAID allergic
* Contraindication of surgery

Primary outcomes:
measure: Post operatory pain
timeFrame: From the day of the surgical procedure to the seventh-day
Secondary outcomes:
measure: Swelling
timeFrame: Baseline and post operatory (day 1, day 3, day 7)
Other outcomes:
measure: Trismus
timeFrame: Baseline and post operatory (day 1, day 3 and day 7)
measure: Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha
timeFrame: Baseline, day 3 and day 7
Locations:
city: Madrid
country: Spain
facility: UCM
Study officials:
References:
Clinical trial NCT01243658: "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Official title: "The Effects of Oxytocin on Patients With Borderline Personality Disorder"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Oxytocin on Borderline Personality Disorder
Borderline Personality Disorder
Keywords: Oxytocin
BPD
Borderline
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).

Secondary objectives :

Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.


Eligibility criteria: Inclusion Criteria:

* Gender: Both, male and female
* Minimum Age: 18 Years
* Maximum Age: 50 Years
* Borderline personality disorder or major depression (clinical control group)
* Mini Mental Status Test \> 27 (capacity to consent)

Exclusion Criteria:

* chronic or acute somatic health problems
* Schizophrenia
* Bipolar affective disorder
* pregnancy
* breast feeding
* neurological disorder
* allergy to antidegradants

Primary outcomes:
measure: BPD Symptoms
timeFrame: BPD Symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universität-Freiburg
state: Baden-Würtemberg
Study officials:
affiliation: Institut für Psychologie der Univeristät Freiburg
name: Markus Heinrichs, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04951258: Multicomponent Exercise in People With Dementia
Official title: Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.


Eligibility criteria: Inclusion Criteria:

* Age: 60-80 y/o
* Mini-Mental State Examination: 10-26
* Clinical Dementia Rating: 1-2
* Walk at least 6 meters independently (with or without walking aids)

Exclusion Criteria:

* Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)
* Physical or psychological comorbidities that affect performance during assessment or intervention
* Already participating in other physical training in the last 1 month

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: Change from baseline at 9 week
measure: Chinese version of Verbal learning test
timeFrame: Change from baseline at 9 week
measure: Chinese version of Stroop color and word test
timeFrame: Change from baseline at 9 week
measure: Digit span test
timeFrame: Change from baseline at 9 week
measure: Trail making test - Chinese version
timeFrame: Change from baseline at 9 week
Secondary outcomes:
measure: Barthel index
timeFrame: Change from baseline at 9 week
measure: Instrumental activities of daily living (IADL) scale
timeFrame: Change from baseline at 9 week
measure: Chinese version of Quality of Life in Alzheimer Disease Scale
timeFrame: Change from baseline at 9 week
measure: Time up and go test
timeFrame: Change from baseline at 9 week
measure: 30-second chair stand test
timeFrame: Change from baseline at 9 week
measure: 6-minute walk test
timeFrame: Change from baseline at 9 week
measure: Berg Balance Scale
timeFrame: Change from baseline at 9 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02810158: Mass Spectral Fingerprinting in Obstructive Sleep Apnoea
Official title: Diagnosis of Obstructive Sleep Apnoea by Selective Secondary Electrospray Ionization - Mass Spectrometry (SESIMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnoea (OSA)
Exhaled Breath
Mass Spectrometry
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2016-06-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical suspicion of OSA

Brief summary: To answer the question whether a previously detected breath profile in patients suffering from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA using mass spectrometry (validation study).


Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of obstructive sleep apnoea syndrome (based on clinical symptoms such as increased daytime sleepiness; Epworth Sleepiness Score (ESS) \> 10).
* Age between 18 and 85 years at study entry.

Exclusion Criteria:

* None

Primary outcomes:
measure: OSA-specific mass spectrometric pattern of VOCs in the exhaled breath
timeFrame: one hour, single measurement, no follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nowak N, Engler A, Thiel S, Stoberl AS, Sinues P, Zenobi R, Kohler M. Validation of breath biomarkers for obstructive sleep apnea. Sleep Med. 2021 Sep;85:75-86. doi: 10.1016/j.sleep.2021.06.040. Epub 2021 Jul 3.
Clinical trial NCT07003958: The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth
Official title: Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth: Splint Mouth Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fissure Sealant
Keywords: deproteinization agents
sodium hypochlorite
hypochlorous acid
fissure sealent
Primary Teeth
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 4-6 who do not have any systemic problems
* Have a score of 3 and 4 on the Frankl Behavior Scale
* Do not have a habit of clenching and/or grinding their teeth
* Have lower second primary molars without caries
* Have an indication for fissure sealant application

Exclusion Criteria:

* Teeth with fissure sealants
* Teeth with developmental defects such as hypoplasia
* Teeth with approximal or incipient caries lesions on one or both mandibular second primary molars

Primary outcomes:
measure: Modified Simonsen Criteria
timeFrame: Following the sealant application, controls will be made at 3,6, 12 and 24 months
Secondary outcomes:
measure: Edge Integrity Evaluation Criteria
timeFrame: Following the sealant application, controls will be made at 3,6, 12 and 24 months.
Other outcomes:
measure: Marginal Coloration Evaluation Criteria
timeFrame: Following the sealant application, checks will be made at3, 6, 12 and 24 months
measure: Anatomical Form Evaluation Criteria
timeFrame: Following the sealant application, checks will be made at 3,6, 12 and 24 months
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University, Tokat, 60030
Study officials:
References:
citation: Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.
citation: Simonsen RJ. Retention and effectiveness of dental sealant after 15 years. J Am Dent Assoc. 1991 Oct;122(10):34-42. doi: 10.14219/jada.archive.1991.0289.
Clinical trial NCT06805058: Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Care Acceptor, Health
Pain, Postoperative
Anxiety Postoperative
Surgery
Keywords: comedy therapy
pain
anxiety
surgery
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pre-testpost- test control group experimental model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery.

The hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery.

H1-1: Comedy therapy has an effect on pain levels in patients after Uretero-Renoscopy surgery.

H2-0: Comedy therapy has no effect on anxiety levels in patients after Uretero-Renoscopy surgery.

H2-1: Comedy therapy has an effect on anxiety levels in patients after Uretero-Renoscopy surgery.

Detailed description: Intervention Group

After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.

Control Group

After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Not having any visual or auditory problems,
* Not having any communication problems,
* Not having any psychiatric problems.

Exclusion Criteria:

* Not accepting to participate in the study or wanting to leave,
* Having had complications during the perioperative process.

Primary outcomes:
measure: pain level
timeFrame: It will take approximately 5 minutes
measure: anxiety level
timeFrame: It will take approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Study Principal Investigator Bitlis Eren University
name: Şerafettin OKUTAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02771158: Midodrine During Recovery From Septic Shock
Official title: A Randomized Controlled Trial of Midodrine During Recovery Phase From Septic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypotension
Shock, Septic
Sepsis
Keywords: critical care
shock, septic
sepsis
hypotension
midodrine
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether midodrine administration decreases duration of intravenous vasopressors and intensive care unit length of stay for patients in septic shock.


Eligibility criteria: Inclusion Criteria:

* admitted to intensive care unit
* diagnosis of septic shock on intravenous vasopressors
* stable/decreasing doses of intravenous vasopressors
* stable/improving organ function

Exclusion Criteria:

* allergy to midodrine
* multiple intravenous vasopressors
* increasing intravenous vasopressor requirements
* worsening organ dysfunction
* severe bradycardia

Primary outcomes:
measure: duration of intravenous vasopressors
timeFrame: from enrollment until discontinuation of intravenous vasopressors, expected to be 3-5 days
Secondary outcomes:
measure: intensive care unit length of stay
timeFrame: from enrollment until eligible for discharge from intensive care unit, expected to be 4-7 days
measure: re-institution of intravenous vasopressor
timeFrame: from enrollment until hospital discharge, expected to be up to 30 days
measure: hospital length of stay
timeFrame: from enrollment until hospital discharge, expected to be up to 30 days
measure: mortality
timeFrame: from enrollment until hospital discharge, expected to be up to 30 days
measure: midodrine side effects requiring discontinuation
timeFrame: from enrollment until hospital discharge, expected to be up to 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.