louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04689581: Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery
Official title: Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Analgesia
Keywords: Regional anaesthesia
Erector spinae plane block
PECs blocks
Breast cancer surgery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.

Detailed description: After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) I-II patients
* 18-70 aged patients
* patients who scheuled elective breast cancer surgery

Exclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) III-IV patients
* patients with coagulopathy
* patients with infection at the injection site

Primary outcomes:
measure: Morphin consumption
timeFrame: during postoperative 24 hour
measure: numerical rating scale (NRS)
timeFrame: during postoperative 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Sevim Cesur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06144281: Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease
Official title: Study of Home-Embedded Palliative Care for Hemodialysis- (and Peritoneal-) Dependent End-Stage Renal Disease (SHEPHERD 2.0)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: palliative
ESRD
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Home palliative care needs are often under-recognized in patients with End-Stage Renal Disease (ESRD). This pilot study is designed to evaluate the effectiveness of referrals to home palliative care services in improving patient outcomes compared with usual care among patients with ESRD admitted to a Penn hospital. Evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients


Eligibility criteria: Inclusion Criteria:

* Be an adult (18 years of age or older) hospitalized at a Penn study hospital
* AND digital signature of ESRD (N18.6) within the last 12 months
* AND resides in the five-county area surrounding Philadelphia which is served by Penn Palliative Care Nurse Practitioner program
* AND have one or more of the following markers of potentially unmet needs: (i) existing home care eligibility or referral for home care (but not already receiving PC); (ii) non-ambulatory status determined via nursing assessment; (iii) severe protein-calorie malnutrition; (iv) 2 or more hospitalizations within the prior year

Exclusion Criteria:

* Patients with functional kidney transplants
* Patients discharged to skilled nursing facilities and LTC facilities

Primary outcomes:
measure: Acute Encounters
timeFrame: Baseline - 180 days
Secondary outcomes:
measure: Hospital-Free Days
timeFrame: Baseline - 180 days
measure: Home Palliative Care Visits
timeFrame: Baseline - 180 days
measure: Time to Home Palliative Care Visit
timeFrame: Baseline - 180 days
measure: Mortality
timeFrame: Baseline - 180 days
measure: Hospice Enrollment
timeFrame: Baseline - 180 days
measure: Health-Related Quality of Life
timeFrame: 1- and 3-months
measure: Symptom Burden
timeFrame: 1- and 3-months
measure: Quality of Care
timeFrame: 1- and 3-months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00892281: ORCA - Oracea® for Rosacea: A Community-based Assessment
Official title: A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 1421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18 and older
* Subjects with diagnosis of rosacea (IGA of 2 to 4)

Exclusion Criteria:

* Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
* Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
* Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
* Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
* Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded

Primary outcomes:
measure: Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
timeFrame: Baaseline to Week 12
measure: Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Lexington
country: United States
facility: REGISTRAT® - MAP1, Inc. (CRO)
state: Kentucky
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02657681: Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Official title: Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyskinesia, Medication-Induced
Parkinson's Disease
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Hospital Nacional de Parapléjicos de Toledo
name: Hospital San Carlos, Madrid
First posted: 2016-01-18
Enrollment: 50
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: TREATMENT

Brief summary: This is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tSMS) of the motor cortex improves levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will receive real tSMS treatment, the other half will receive sham treatment (placebo).


Eligibility criteria: Inclusion Criteria:

* advanced idiopathic Parkinson's disease (Brain Bank criteria)
* optimal clinical response to dopaminergic medication (\>30% UPDRS-III improvement)
* presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb

Exclusion Criteria:

* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
* other main neuropsychiatric co-morbidity

Primary outcomes:
measure: Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one day after the end of treatment.
timeFrame: One day after the end of treatment compared to baseline
Secondary outcomes:
measure: Change from baseline of the maximal dyskinesia severity within 90min after levodopa intake, as measured by objective evaluation with the Unified Dyskinesia Rating Scale (UDysRS) one week after the end of treatment.
timeFrame: One week after the end of treatment compared to baseline
measure: Dyskinesia severity evaluated for each body segment
timeFrame: Baseline, one day and one week after the end of treatment
measure: Subjective evaluation of the treatment, as measured by the patient global impression of change (PGIC)
timeFrame: One day and one week after the end of treatment
measure: Change from baseline in motor symptoms, as measured by the MDS-UDPRS III scale
timeFrame: Baseline, one day and one week after the end of treatment
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: CINAC, Hospital Universitario Puerta del Sur
state: Madrid
Study officials:
affiliation: CINAC, Hospital Universitario HM Puerta del Sur
name: Guglielmo Foffani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06750081: Cross-Training and Locomotor Abilities in Cerebral Palsy
Official title: Effect of Cross-Training on Locomotor Abilities in Children with Spastic Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Spastic Hemiparesis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.

Detailed description: Thirty children with spastic unilateral cerebral palsy were recruited from different rehabilitation centers. They were assigned randomly into two groups. Children in the control group (A) were engaged in a selected physical therapy program while those in the experimental group (B) received cross-training program followed by application of the same selected physical therapy program received by group (A). The treatment programs were conducted five times per week for six successive weeks. Measurements obtained included active ankle dorsiflexion range of motion (AROM), and the speed of walking obtained by 10-meter walking test. These measures were recorded two times: pre- and post-treatment.

Eligibility criteria: Inclusion Criteria:

* Spasticity grade 1 to 1+, according to the Modified Ashworth Scale.
* Can stand and walk autonomously.
* Able to follow verbal commands and instructions.

Exclusion Criteria:

* Fixed musculoskeletal deformities
* significant cognitive disorders
* significant perceptual disorders
* significant auditory disorders
* significant visual disorders

Primary outcomes:
measure: active ankle dorsiflexion range of motion (AROM)
timeFrame: Baseline and at the end - through study completion, an average of 1 year
measure: 10-meter walking test
timeFrame: Baseline and at the end - through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
Study officials:
References:
citation: Peterson MD, Lukasik L, Muth T, Esposito P, Haapala H, Gordon PM, IglayReger H, Hurvitz EA. Recumbent cross-training is a feasible and safe mode of physical activity for significantly motor-impaired adults with cerebral palsy. Arch Phys Med Rehabil. 2013 Feb;94(2):401-7. doi: 10.1016/j.apmr.2012.09.027. Epub 2012 Oct 10.
Clinical trial NCT01439581: Utility of Interface Pressure Mapping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcers
Bedsores
Keywords: patients
susceptible to
hospital
acquired pressure
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Wellsense USA Inc.
First posted: 2011-09-23
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Primary purpose: PREVENTION

Brief summary: To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* 18 years and older,
* care giver trained on mapping system

Exclusion Criteria:

* Less than 18 years,
* pregnant women,
* weight greater 550 lbs, and subjects requiring a specialty mattress

Primary outcomes:
measure: Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
timeFrame: Time admitted in the Medical Intensive Care Unit
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT05918081: The Relationship of Aerobic Capacity With Agility, Core Muscle Endurance and Peripheral Muscle Strength in Adolescent Basketball Players
Official title: The Relationship of Aerobic Capacity With Agility, Core Muscle Endurance and Peripheral Muscle Strength in Adolescent Basketball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Physical Therapy
Keywords: Basketball
Aerobic Capacity
Agility
Core Muscle Endurance
Peripheral Muscle Strength
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 30
Sex: MALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent Male Basketball Players

Brief summary: The aim of this study is to investigate the relationship of aerobic capacity with agility, core muscle endurance and peripheral muscle strength in adolescent basketball players.

Detailed description: A basketball player must have good physical condition to contribute to the team. In this physical condition, especially cardiorespiratory endurance (aerobic and anaerobic capacity), agility, muscle endurance and strength are important for basketball.

Revealing the interaction of aerobic capacity, which is critical for basketball, with other physical fitness components such as agility, core muscle endurance and peripheral muscle strength may shed light on the shaping of basketball players' exercise programs.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 10-19
* Male gender
* Interested in basketball sport for at least one year

Exclusion Criteria:

* Refusing to participate in the study
* Having any disability (orthopedic, cardiovascular, etc.) that would prevent participation in the study

Primary outcomes:
measure: Aerobic capacity
timeFrame: One Month
Secondary outcomes:
measure: Agility
timeFrame: One Month
measure: Core Muscle Endurance
timeFrame: One Month
measure: Peripheral Muscle Strength
timeFrame: One Month
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Eyüp Basket Akademi
state: Eyüp
Study officials:
affiliation: Bezmialem Vakif University
name: Selva Otsay, BPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Semiramis Özyılmaz, PhD
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Gökhan C Törpü, BPT
role: STUDY_CHAIR
References:
citation: Mancha-Triguero D, Garcia-Rubio J, Antunez A, Ibanez SJ. Physical and Physiological Profiles of Aerobic and Anaerobic Capacities in Young Basketball Players. Int J Environ Res Public Health. 2020 Feb 21;17(4):1409. doi: 10.3390/ijerph17041409.
citation: McInnes SE, Carlson JS, Jones CJ, McKenna MJ. The physiological load imposed on basketball players during competition. J Sports Sci. 1995 Oct;13(5):387-97. doi: 10.1080/02640419508732254.
Clinical trial NCT04858581: Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
Official title: Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019.

In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%).

An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19.

Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.

Detailed description: The scientific and medical world is mobilizing to accelerate the production of knowledge on this virus, on the disease it causes as well as the means of curing and preventing it. But no one yet knows how much it can cause immunological changes in the body. For some specialists, this virus is even much more than a viral infection and causes a general disruption of the immune system.

Faced with the COVID-19 pandemic, healthcare workers are a particularly exposed.

The main objective of this research is to assess the presence of symptoms attributed to COVID-19 at least 6 months after infection confirmed by RT-PCR test of healthcare workers.

Eligibility criteria: Inclusion Criteria:

* Healthcare workers over 18 years of age
* Healthcare workers who had a diagnosis confirmed by a nasopharyngeal RT-PCR test with SARS-CoV-2
* Healthcare workers with signed consent

Exclusion Criteria:

* Protected healthcare workers
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Description of symptoms attributed to COVID-19 at 6 months.
timeFrame: 6 months after COVID-19 infection
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital privé d'Antony
Study officials:
affiliation: Hôpital privé d'Antony
name: Jean-Charles Gagnard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04346381: Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor
Official title: An Open-label, Multi-center，Phase II Study of Camrelizumab Combined With Famitinib in the Treatment of Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.


Eligibility criteria: Inclusion Criteria:

1. Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
2. Willing to provide tumor tissue for PD-L1 biomarker analysis.
3. At least one measurable lesion according to RECIST 1.1.
4. ECOG performance status of 0 to 1.
5. Life expectancy of more than 12 weeks.
6. Signing the informed consent forms.
7. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

1. Subjects with untreated central nervous system (CNS) metastases.
2. Subjects with an active, known or suspected autoimmune disease.
3. Subjects with clinically significant cardiovascular and cerebrovascular diseases.
4. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
5. Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
6. Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
7. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

Primary outcomes:
measure: Response Rate
timeFrame: Up to 18 months
Secondary outcomes:
measure: PFS
timeFrame: Up to 18 months
measure: DOR
timeFrame: Up to 18months
measure: DCR
timeFrame: Up to 18months
measure: TTR
timeFrame: Up to 18 months
measure: OS
timeFrame: Up to 18 months
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
timeFrame: Up to 18 months
measure: Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
timeFrame: Up to 18 months
measure: Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
timeFrame: Up to 18 months
measure: Serum concentration of camrelizumab
timeFrame: Up to 18 months
measure: Plasma concentration of famitinib
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
Study officials:
References: