louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05609565: Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy
Official title: Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: - Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I-II.
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Patient's refusal.
* Known coagulopathy.
* Known peripheral neuropathy or neurological deficits.
* Known allergy to study drugs.

Primary outcomes:
measure: The duration of motor block (minutes)
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT02246465: A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars
Official title: An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertrophic Scar
Keywords: Hypertrophic scar
Cicatrix
Scar prevention
Scar revision
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2014-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.


Eligibility criteria: Inclusion Criteria:

* Adults, 21-55 years of age
* General good health
* Previous surgery or injury resulting in a hypertrophic scar

Exclusion Criteria:

* Scars on the face or front of neck may not be included in the trial
* Use of tobacco or nicotine-containing products
* Pregnant or lactating

Primary outcomes:
measure: Reducing the recurrence of hypertrophic scar after scar revision surgery
timeFrame: 9 months
Secondary outcomes:
measure: Safety evaluation of RXI-109
timeFrame: 9 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Lake Worth
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Saint Louis
country: United States
state: Missouri
city: Huntersville
country: United States
state: North Carolina
city: San Pedro Sula
country: Honduras
Study officials:
affiliation: RXi Pharmaceuticals
name: Pamela Pavco, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05989165: Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
Official title: Effectiveness of Combination Therapy of Microneedling and Minoxidil in Androgenetic Alopecia of Indonesian Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of Indonesian men. The main questions it aims to answer are:

* Is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?
* Is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy?

Participants will be divided into 2 groups. The first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. Researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.


Eligibility criteria: Inclusion Criteria:

* Male
* Indonesian
* Age 18-59 years
* Diagnosis of androgenetic alopecia
* Hamilton-Norwood type III-IV

Exclusion Criteria:

* Use of minoxidil or finasteride topical 1 month prior
* Use of minoxidil or finasteride oral 1 month prior
* Skin infection in the treatment area
* Cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior
* History of keloid

Primary outcomes:
measure: Density of hair
timeFrame: 12 weeks
measure: Diameter of hair
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangungkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of medicine, University of Indonesia
name: Kara Adistri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhurat R, Sukesh M, Avhad G, Dandale A, Pal A, Pund P. A randomized evaluator blinded study of effect of microneedling in androgenetic alopecia: a pilot study. Int J Trichology. 2013 Jan;5(1):6-11. doi: 10.4103/0974-7753.114700.
citation: Kumar MK, Inamadar AC, Palit A. A Randomized Controlled, Single-Observer Blinded Study to Determine the Efficacy of Topical Minoxidil plus Microneedling versus Topical Minoxidil Alone in the Treatment of Androgenetic Alopecia. J Cutan Aesthet Surg. 2018 Oct-Dec;11(4):211-216. doi: 10.4103/JCAS.JCAS_130_17.
Clinical trial NCT06485765: DASH Diet, Quality of Life and Cardiac Parameters of Patients With Acute Coronary Syndrome
Official title: The Effect of the DASH (Dietary Approaches to Stop Hypertension) Diet on Quality of Life and Cardiac Parameters in Patients Acute Coronary Syndrome With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Hypertension
Keywords: acute coronary syndrome
hypertension
DASH diet
quality of life
cardiac parameters
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This clinical trial is a single-group, pre-post design. In this model, quality of life and cardiac parameters were assessed before and after individualised DASH diet.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome.

The main questions it aims to answer are:

1. DASH diet improve quality of life?
2. DASH diet improve cardiac parameters?

The researchers assessed the results of 12 weeks of the DASH diet.

Patients will apply the DASH diet prepared individually by the researchers for 12 weeks.

Detailed description: The study period was 12 weeks. Patients' food consumption (3 day), anthropometric measurements, blood pressure measurements, physical activity levels, biochemical and cardiac parameters, adherence to DASH eating plan and the MacNew Heart Health-Related Quality of Life Scale were recorded at the beginning of the study and at the end of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* diagnosed with acute coronary syndrome within the last month
* with a measured blood pressure above 140/90 mmHg or using antihypertensive drugs
* not obese (body mass index \< 30)
* not diagnosed with a disease requiring a different medical nutrition therapy (chronic renal failure, diabetes, cancer, etc.)
* volunteered to participate in the study

Exclusion Criteria:

* Acute coronary syndrome diagnosed more than 1 month ago
* obese (body mass index \> 30 )
* without hypertension
* receiving different medical nutrition therapy

Primary outcomes:
measure: Quality of Life (MacNew Heart Disease Health-Related Quality of Life Scale)
timeFrame: 12 week
measure: Ejection Fraction (%)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylul University
state: Bandırma
Study officials:
References:
Clinical trial NCT03549065: Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention
Official title: Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Addiction
Keywords: Brain stimulation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. Its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. Brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rTMS) and trans-cranial direct current stimulation (tDCS) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. There is some evidence that rTMS applied to the left prefrontal cortex results in significantly lowered craving. To date, no studies have investigated the effects of a course of either rTMS or tDCS treatment on opioid craving, brain function, and relapse prevention in opioid addicts. Individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. The present study aims to examine the effects of a course of daily prefrontal rTMS and tDCS on brain function, desire and craving and help to relapse prevention in abstinence phase.

Detailed description: The investigators plan to compare and contrast TMS and tDCS alone or in combination to treat opioid abuse. We will use a 4 cell randomised parallel controlled trial, consisting of active or sham TMS, and active or sham tDCS \[a-tDCS, a-TMS; s-tDCS, a-TMS; a-tDCS, s-TMS; s-tDCS, s-TMS). The investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. Moreover, The investigators hypothesise that COMBINING the two active treatments will be synergistic and will produce the largest reductions in craving and use.

Eligibility criteria: Inclusion Criteria:

* 40 treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study.

Exclusion criteria includes:

* history of seizures,
* receiving any medications known to lower seizure threshold,
* pregnancy,
* metal implants above the waist,
* brain lesions or tumors,
* a history of negative reactions to TMS, and
* a positive opioid urine screen (except methadone and suboxone

Primary outcomes:
measure: Change in craving and opioid relapse Using Opioid Cue panel
timeFrame: Day 1, 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01730820: Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output
Official title: Influence of Preload Dependence on the Effect of Phenylephrine on Cardiac Output
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General anesthesia.Orotracheal intubation and mechanical ventilation Advanced Hemodynamic Monitoring intraoperative ( arterial pressure catheter, esophageal Doppler)

Brief summary: The perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. Phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control.

Several questions on phenylephrine global and regional hemodynamics effects remain unresolved.

The investigators assume that Phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. The investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal Doppler.

The aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.


Eligibility criteria: Inclusion Criteria:

* Hypotension (SBP \<90 mm Hg and / or MAP \<60 mm Hg)
* Injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient.

Exclusion Criteria:

* Minor or major patient under guardianship
* Esophageal Diseases
* supra ventricular rhythm trouble
* Severe valvular
* Shunt intracardiac
* Vt \<7ml/kg theoretical weight
* heart rate / respiratory rate \<3.6
* Clinical hypepression of intra-abdominal
* Compliance \<30 mL/cmH2O
* pulmonary hypertension, Right ventricular failure
* Spontaneous Ventilation
* Thorax open
* VG severe dysfunction (LVEF \<40%)
* Prior Injection of ephedrine prior

Primary outcomes:
measure: cardiac output
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
state: Basse Normandie
Study officials:
affiliation: University Hospital, Caen
name: Olivier REBET, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rebet O, Andremont O, Gerard JL, Fellahi JL, Hanouz JL, Fischer MO. Preload dependency determines the effects of phenylephrine on cardiac output in anaesthetised patients: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):638-44. doi: 10.1097/EJA.0000000000000470.
Clinical trial NCT00533520: Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Official title: Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Degeneration
Choroidal Neovascularization
Lead sponsor: Tennessee Retina
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-09-21
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Detailed description: Phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. An additional purpose is to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.

Eligibility criteria: Inclusion Criteria:

* Treatment naive macular degeneration patients with choroidal neovascularization
* \>50 years old
* Visual acuity 20/40 to 20/320

Exclusion Criteria:

* Pregnancy
* Previous history of thromboembolic event including myocardial infarction or stroke

Primary outcomes:
measure: Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection
timeFrame: 24 months
Secondary outcomes:
measure: Injection interval: mean time and number of injections
timeFrame: 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Retina, P.C.
state: Tennessee
Study officials:
affiliation: Tennessee Retina, P.C,.
name: Brandon G Busbee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06244420: Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis
Official title: Malignant Myoepithelioma of Bone and Soft Tissues: Diagnostic Imaging and Histology in Relation to Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoepithelioma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 33
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with soft tissue and bone MC

Brief summary: The purpose of the study is to assess whether there is a correlation between imaging and histology with prognosis in patients with soft tissue and bone MC from the archives of the Rizzoli Orthopaedic Institute all the patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021


Eligibility criteria: Inclusion Criteria:

* Male and female patients treated at Rizzoli Orthopaedic Institute between 01 Jan 1998 and 31 Dec 2021
* Age ≥ 2 years old
* Diagnosis of soft tissue or bone malignant myoepithelioma (MC-SB)
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met

Primary outcomes:
measure: Correlation
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Xu B, Katabi N. Myoepithelial Carcinoma. Surg Pathol Clin. 2021 Mar;14(1):67-73. doi: 10.1016/j.path.2020.09.008. Epub 2021 Jan 5.
citation: Thway K, Fisher C. Myoepithelial tumor of soft tissue: histology and genetics of an evolving entity. Adv Anat Pathol. 2014 Nov;21(6):411-9. doi: 10.1097/PAP.0000000000000039.
Clinical trial NCT01068574: Evaluation of the Basic Assessment of Severity of Illness in Children (BASIC) Scale
Official title: Evaluation of the BASIC Scale (Basic Assessment of Severity of Illness in Children): A Simple Triage Tool for Resource-limited Settings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Illness
Keywords: Acute illnesses in children under five
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Partners in Health
name: Thrasher Research Fund
name: Ministry of Health, Rwanda
First posted: 2010-02-15
Enrollment: 2500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged two months to five years presenting to a rural health center in Rwanda.

Brief summary: The purpose of this study is to assess whether the BASIC Scale--a simple, non-invasive clinical triage protocol--predicts severe illness, hospitalization or death among children under age five presenting for acute care in a rural African health center.


Eligibility criteria: Inclusion Criteria:

* Child aged two months to five years presenting routine or urgent care in an ambulatory facility

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Butaro
country: Rwanda
facility: Butaro Health Centre
state: Northern Province
Study officials:
References:
Clinical trial NCT04695574: The Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
Official title: Development, Reliability and Validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Endurance
Lower limb
Performance test
Power
Reliability and Validity
Strength
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial
Primary purpose: OTHER

Brief summary: It becomes important to evaluate closed kinetic chain activity. The aim of this study was to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST).

Detailed description: Closed kinetic chain activities and exercises are used more and more in rehabilitation programs as they take place in daily life as functional movements. Therefore, it becomes important to evaluate closed kinetic chain activity. The aim of this study is to develop and to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST). Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial. To assess the reliability of CKCLEST, intraclass correlation coefficient (ICC), standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman plot will be used. For concurrent validity of CKCLEST will be applied Spearman correlation analysis with Vertical Jump Test, Isokinetic Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test. All analyses were made for both the best score and the average score. This test allows the evaluation of functional lower extremity stability, static/dynamic control of the lower extremity (knee/hip) or trunk, and simultaneous activation of the quadriceps and hamstring muscles / such coactivation.

Eligibility criteria: Inclusion Criteria:

* Individuals who healthy adults,
* Volunteer

Exclusion Criteria:

* Surgery last six months and pain,
* Disability,
* Instability,
* Limited range of motion in knee function,
* Chronic diseases

Primary outcomes:
measure: To determine the concurrent validity of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
timeFrame: 45 minutes
Secondary outcomes:
measure: To determine the the test-retest, intra- and interrater reliability of the Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST)
timeFrame: 4 minutes, 7-14 days apart.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Halime ARIKAN
state: Çankaya
Study officials:
References: