louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05303675: The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery
Official title: The Effect of Education, Lymphedema Risk Scoring, and Progressive Upper Extremity Exercises on Strengthening the Self-care Skills of Women Who Have Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer Lymphedema
Keywords: breast cancer
lymphedema
risk scoring
exercise
self-care
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female gender,
* Between 18-65 years old
* BMI ≤30 kg/m2
* Axillary lymph node dissection (removal of at least 2 lymph nodes),
* No history of cancer other than breast cancer,
* Does not have any chronic disease (such as diabetes mellitus, hypertension, chronic obstructive pulmonary disease) that prevents exercise
* No previous diagnosis of lymphedema,
* Not pregnant or breastfeeding during the study,
* Individuals who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Total (simple) mastectomy,
* History of bilateral lymph node dissection,
* Lymphedema (difference \>2 cm with an intact extremity)
* Individuals who do not agree to participate in the study will not be included in the study.

Primary outcomes:
measure: arm circumference measurement
timeFrame: 1st month
measure: arm circumference measurement
timeFrame: 2nd month
measure: arm circumference measurement
timeFrame: 3nd month
measure: lymphedema symptom
timeFrame: 1rd month
measure: lymphedema symptom
timeFrame: 2rd month
measure: lymphedema symptom
timeFrame: 3rd month
measure: self-care
timeFrame: 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Erciyes University
state: Melikgazi
Study officials:
References:
Clinical trial NCT06114459: Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization
Official title: Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization Following Shoulder Arthroplasty Surgery: A Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A double-blinded, controlled study was conducted at one county hospital in Sweden. Patients were randomly assigned, skin samples were collected at four times; baseline, preoperative, after intervention and after 48 hours. Bacterial colonization were assessed.

Detailed description: METHOD Study design

This was a double blinded, controlled, block-randomized intervention study with random allocation to Chlorhexidine- group or Sodium Chloride- group.

Sample and setting Participants was recruited at one county hospital in the southeast of Sweden from august 2019 to mars 2023. Consecutive sampling of adult patients over 18 years of age scheduled for primary elective shoulder arthroplasty surgery was approached for participation.

Intervention According to a predetermined schedule, the surgery site was either disinfected with 5 mg chlorhexidine in 70% ethanol or cleaned with sterile sodium chloride, Skin samples Skin swabs were collected on four occasions: 1. Baseline, 2. After skin disinfection, 3. Post-intervention, and 4. After 48 hours. All samples in the study were collected utilizing the eSwab system with flocked swabs Two swabs were collected on each occasion. The Pencil Eraser Swab (PES)- technique was employed (26). Swabs were gently rubbed in an oscillating motion, moving downward, and then replicating the same motion upward, repeated 15 times. For sample 1 and 2, one swab on each side of the intended incision site was collected. For samples 3 and 4, swabs were taken from each sides of the incision, positioned 1 cm away from the sutures or staples, with one swab collected on each side

Eligibility criteria: Inclusion Criteria: Adult patients over 18 years, scheduled for primary elective shoulder arthroplasty surgery.

Exclusion Criteria: Exclusion criteria were previous allergic reaction or perceived adverse effects of chlorhexidine, prolonged treatment with cortisone (\>5 mg), antibiotic treatment within 14 days prior to scheduled surgery, skin disease or ongoing skin infection.

-

Primary outcomes:
measure: Bacterial colonization
timeFrame: At 48 hours after shoulder surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Ryhov Hospital
state: Småland
Study officials:
References:
Clinical trial NCT01690559: Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Ciprofloxacin
sepsis
infection
pneumonia
peritonitis
cholecystitis
cholangitis
anthrax
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 704
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received Ciproxan iv administration without dilution in the daily practice among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Brief summary: This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.


Eligibility criteria: Inclusion Criteria:

* - The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax
* The patients treated with this drug without dilution due to strict restriction of fluid intake.
* In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects..

Exclusion Criteria:

* Patients who are contraindicated based on the product label.

Primary outcomes:
measure: Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs)
timeFrame: After 8 days
measure: Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion
timeFrame: After 8 days
Secondary outcomes:
measure: ADR incidence rates classified by patient's background factors
timeFrame: After 8 days
measure: Efficacy rate calculated with Response and Minor Response considered as responder
timeFrame: After 8 days
measure: Efficacy rates classified by patient's background factors
timeFrame: After 8 days
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03073759: Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy
Official title: Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal direct transcranial cortical stimulation (dTCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions.

Detailed description: This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal transcranial direct current stimulation (tDCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions. In one of the sessions, decided randomly, the stimulation will be applied on the right side and in the second session it will be on the left.

The tDCS portion of the experiment will begins with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA). One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.

Eligibility criteria: Inclusion Criteria:

* Peripheral Neuropathy
* Walking independently but with problems with balance

Exclusion Criteria:

* Prominent weakness at the ankle
* Not able to walk independently
* History of Seizure
* Cardiac Pacemaker
* Metal implants in the head
* Increased intracranial pressure
* Pregnancy

Primary outcomes:
measure: Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes
timeFrame: At 10 and 20 minutes
measure: Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe
timeFrame: At 10 and 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohammad Khoshnoodi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271359: EMDR vs. PC For Motor Vehicle Accident Trauma
Official title: EMDR vs. PC For Motor Vehicle Accident Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Psychological
Motor Vehicle Accident
Lead sponsor: Trauma Institute & Child Trauma Institute
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.


Eligibility criteria: Inclusion Criteria:

* adult reporting distress related to motor vehicle accident-related trauma
* English-speaking

Exclusion Criteria:

* already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method
* any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)
* any indication of instability during interactions prior to the therapy session
* an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder

Primary outcomes:
measure: Change in SUDS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in PRS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
measure: Change in PDS following treatment
timeFrame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northampton
country: United States
facility: Trauma Institute & Child Trauma Institute
state: Massachusetts
Study officials:
affiliation: Trauma Institute & Child Trauma Institute
name: Ricky Greenwald
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066659: Balance Performance and Corticomotor Inhibition in PD
Official title: Relationship Between Balance Performance and Corticomotor Inhibition in Individuals With Parkinsons' Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with Parkinson's disease

Brief summary: Postural instability is one of the motor features of Parkinson's disease (PD). Most patients will develop balance dysfunction, and they may get worse with disease progression. According to previous studies, people with PD had abnormal changes in corticomotor excitability, especially disinhibition in the primary motor cortex (M1). Some evidence had shown that the cortical function in the M1 is crucial for the pathophysiology of the underlying motor symptoms in PD. Furthermore, neurostimulation over the M1 could modulate the corticomotor excitability in individuals with PD, and then improve their motor and also balance performance. However, whether the impaired corticomotor inhibition relates to balance dysfunction in people with PD is still unknown. In this study, the purpose is to investigate the possible relationship between corticomotor inhibition and balance performance in individuals with PD. However, the postural position during TMS measurement may affect the corticomotor excitability. To further establish the above-mentioned relationship, the secondary purpose is to explore and confirm whether the postural position will influence the correlation.


Eligibility criteria: Inclusion Criteria:

* the Hoehn and Yahr stage between 1 and 3
* age 40 to 80 years
* a stable treatment of anti-PD medications

Exclusion Criteria:

* any contraindications of TMS
* any injury histories or disorders affecting balance
* any neurosurgery experience
* neurologic conditions other than PD
* the Mini-mental State Examination (MMSE) score \< 24

Primary outcomes:
measure: Intracortical inhibition
timeFrame: 20 minutes
measure: Corticospinal inhibition
timeFrame: 20 minutes
measure: Static balance
timeFrame: 3 minutes
measure: Dynamic balance
timeFrame: 5 minutes
measure: Functional balance
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT04719559: Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy
Official title: Combined Use of Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid; Wound
Steroid Acne
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study was conducted to assess the effects of LADD combined with a fractional ablative carbon dioxide laser and a topical steroid for the treatment of post-thyroidectomy hypertrophic scars.

Detailed description: Thyroidectomy results in unsightly scarring at the anterior neck of the patient. A clinical study was conducted to assess the effectiveness of five courses, applied every 4 weeks, of laser-assisted drug delivery (LADD) combining a fractional ablative carbon dioxide laser and topical 0.05% clobetasol propionate to the treatment of post-thyroidectomy hypertrophic scars in patients. Assessments of the scars by the patient themselves according to the patient and observer scar assessment scale.

Eligibility criteria: Inclusion Criteria:

* Patients had presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

Exclusion Criteria:

* Systemic chronic disease or a history of autoimmune disease or human immunodeficiency virus infections.

Primary outcomes:
measure: Self-assessment by patients before treatment
timeFrame: before first treatment
measure: Self-assessment by patients after treatment
timeFrame: 1 year after the first treatment
measure: Doctor evaluations using the POSAS scoring range of 1-10
timeFrame: 1 year after the first treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02183259: Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers
Official title: Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.


Eligibility criteria: Inclusion Criteria:

* healthy male subjects
* age: \>= 20 and \<= 35 years
* weight: \>= 50 to \<= 80 kg and within +/- 20 % of standard weight
* blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
* pulse rate: 45 to 80 beat/min
* volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up

Exclusion Criteria:

* history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
* history of drug allergy
* history of drug dependency, alcohol dependency, etc.
* use of other trial drug within 6 months before study drug administration
* use of any drugs within 7 days before study drug administration

Primary outcomes:
measure: Area under the plasma drug concentration-time curve from time zero to infinity
timeFrame: up to 16 hours after drug administration
measure: maximum drug plasma concentration (Cmax)
timeFrame: up to 16 hours after drug administration
measure: time to achieve maximum drug plasma concentration (tmax)
timeFrame: up to 16 hours after drug administration
measure: elimination half-life (t1/2)
timeFrame: up to 16 hours after drug administration
measure: mean residence time (MRT)
timeFrame: up to 16 hours after drug administration
measure: total clearance (CL)
timeFrame: up to 16 hours after drug administration
Secondary outcomes:
measure: number of adverse events
timeFrame: up to day 22
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05747859: Voice Telerehabilitation
Official title: Voice Telerehabilitation for Patients Affected by Iatrogenic Unilateral Vocal Fold Paralysis: From Necessity to Opportunity in the COVID-19 Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vocal Fold Palsy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 subjects affected by permanent iatrogenic UVFP

Brief summary: The aim of the study was to determine functional results of telerehabilitation (TR) in subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. A multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.


Eligibility criteria: Inclusion Criteria:

* age between 18-75 years
* onset of UVFP less than 1 month before
* internet access
* availability and ability to use a computer with an internal or external webcam.

Exclusion Criteria:

* previous history of laryngeal pulmonary or gastric surgery
* current or previous pulmonary diseases
* hearing loss, neurological or motor deficits
* reading difficulties
* dysphagia
* unavailability of a computer and a webcam.

Primary outcomes:
measure: analysis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, Rome
name: Giorgia Mari, SLP MSC
role: PRINCIPAL_INVESTIGATOR
References: