louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05782413: Effect of Mechanical Vestibular Stimulation On Hand Function In Hemiparetic Children
Official title: Effect of Mechanical Vestibular Stimulation On Hand Function In Children With Hemiparetic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study will be directed to determine the effect of mechanical vestibular stimulation on fine motor skills and pinch strength in children with hemiparesis. Hemiplegic cerebral palsy causes problems with contraction, sensation, and muscular strength in the upper limbs, and its effective use of muscles for reaching, grasping, releasing, and manipulating objects is often compromised


Eligibility criteria: Inclusion Criteria:

* Children will be included in the study if they fulfil the following criteria:

  1. Diagnosed with hemiparetic cerebral palsy.
  2. Age ranged from 4 to 6 years.
  3. Children with spasticity grades ranged from 1 to 1+ according to Modified Ashworth Scale
  4. Both genders will be included.
  5. The child will be able to follow verbal commands and instructions.

Exclusion Criteria:

* Children will be excluded from the study if:

  1. Any congenital or developmental disorders in addition to hemiplegia cerebral palsy.
  2. Current hospitalization for urgent medical reasons.
  3. Severe mental retardation.
  4. Children having visual or auditory defects.
  5. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to the wrist and hand.

Primary outcomes:
measure: fine motor skills
timeFrame: 3 month
measure: pinch strength
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Physical Therapy
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT04956913: Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients
Official title: Macintosh Versus Macgrath for Laryngoscopy in COVID 19 Hypoxemic ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: Tracheal intubation
mechanical ventilation
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU covid 19 patients requiring tracheal intubation

Brief summary: In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

Detailed description: In this comparative prospective study, we aim to compare the classic Macintosh laryngoscope and the Mac Grath videolaryncoscope in ICU covid 19 patients recruiting intubation and invasive mechanical ventilation.

All hypoxemic COVID19 patients requiring intubation were enrolled in this trial.

all patients had a preoxygenation with non invasive ventilation with 100% oxygen.

patients meeting inclusion criteria were randomized in 2 groups: MacGrath and Macintosh.

we collected anthropometric and intubation data among all patients, and the 2 groups were compared regarding the time for intubation, the need of alternative techniques to intubate and the impact on the oxygenation by recording the lowest SPO2.

Eligibility criteria: Inclusion Criteria:

* All COVID 19 hypoxemic patients requiring tracheal intubation

Exclusion Criteria:

* hypoxemic cardiac arrest before intubation

Primary outcomes:
measure: Time for tracheal intubation
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05119413: Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma
Official title: Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-11-15
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: Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.


Eligibility criteria: Inclusion Criteria:

* SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

Exclusion Criteria:

1. Pregnant woman
2. Other pigmentary disorder affecting the face
3. Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion

Primary outcomes:
measure: The melasma's type
timeFrame: at 12 weeks
Secondary outcomes:
measure: the Quality of life of patient
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Thierry Passeron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06501313: PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Official title: PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Heart Failure, Systolic
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Laser Light Medical Innovations Ltd.
First posted: 2024-07-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, double-blind, randomized
Primary purpose: TREATMENT

Brief summary: The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.


Eligibility criteria: Inclusion Criteria:

Advanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form

Exclusion Criteria:

Non-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial

Primary outcomes:
measure: Echocardiographic response
timeFrame: 12 months
Secondary outcomes:
measure: Other echocardiographic response
timeFrame: 12 months
measure: Biomarker changes
timeFrame: 12 months
measure: Symptomes
timeFrame: 12 months
measure: Qulaity of Life
timeFrame: 12 months
measure: All-cause mortality or HF hospitalisation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04864613: The Importance of ENDING-S Score in the Diagnosis of Palliative Patients in the Intensive Care Unit
Official title: The Importance of ENDING-S Score in the Diagnosis of Palliative Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Critical Care
Length of Stay
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care patients

Brief summary: In our study, we aim to predict palliative care patients earlier, to reduce hospitalization periods and to prevent intensive care unit occupation by palliative care patients.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years will be included in the study. Patients staying longer than 48 hours intensive care will be included in the study.

Exclusion Criteria:

* Patients younger than 18 years. Patients staying less than 48 hours

Primary outcomes:
measure: Recognition of palliative care unit patients before intensive care discharge
timeFrame: Fourth day of intensive care follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Ankara City Hospital
Study officials:
affiliation: Ministry of Health Ankara City Hospital
name: Işıl Özkoçak Turan, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03361813: Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy
Official title: Comparative Study Between Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Space Infiltration With Bupivacaine During Elective Tonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound as a technique is safe, readily available, quick and portable allowing more accuracy of different regional blocks and local infiltration. It allows imaging of the mouth, oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration. The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and surgeon satisfaction(intra-operative reactionary bleeding).

Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.


Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status I-II with no airway complications or systemic diseases or known psychological diseases. Reason for their surgery was recurrent or chronic tonsillitis.

Exclusion Criteria:

* Infection at the site of injection, peritonsillar abscess or cellulites.

Primary outcomes:
measure: Surgical field (intra-operative reactionary bleeding and/or muscle tear)
timeFrame: time of surgery
measure: Surgeon satisfaction
timeFrame: time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University Hospital
Study officials:
References:
Clinical trial NCT03754413: Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
Official title: A Multicenter Randomized, Evaluator-Blinded, "No Treatment" Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mid Face Volume Loss
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 236
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

Detailed description: This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.

Eligibility criteria: Inclusion Criteria:

1. Male or female 20 to 75 years of age
2. Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale

Exclusion Criteria:

1. Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
2. Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.

Primary outcomes:
measure: Total Facial Volume Scale(FVS) improvement rate at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52
timeFrame: Weeks 4, 12, 36, and 52
measure: Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hopsital
Study officials:
References:
Clinical trial NCT02485613: Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis
Official title: Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyloidosis
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.

Brief summary: Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Detailed description: This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Eligibility criteria: Inclusion Criteria:

* Female or male patients aged between 18 to 80 years
* Renal or other type biopsy was used to diagnose AL amyloidosis
* Understand and voluntarily sign an informed consent form
* ECOG score 0-3 points
* Adequate residual organ function

Exclusion Criteria:

* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Grade 3 sensory or grade 1 painful peripheral neuropathy
* Known hypersensitivity to bortezomib, boron or mannitol
* Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
* Clinically overt multiple myeloma
* Pregnant or nursing women.

Primary outcomes:
measure: Hematologic response rate
timeFrame: 3 months
Secondary outcomes:
measure: organ response rate
timeFrame: 12 months
measure: Overall survival
timeFrame: From date of the start of treatment to date of death,up to 3 months
measure: Progression free survival
timeFrame: From date of the start of treatment to date of disease progression,up to 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04145713: Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
Official title: Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment: a Randomized, Multicentric, Blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asphyxia Neonatorum
Morbidity;Newborn
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 120
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, blinded, multicentre
Primary purpose: PREVENTION

Brief summary: The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.

It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age.

After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags.

Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors.

Participant files will be stored for a period of 10 years after completion of the study.

All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.


Eligibility criteria: Inclusion Criteria:

* o Newborns with gestational age \>/= 35 weeks and birth weight \>/= 1800 grams

  o Intrapartum asphyxia defined according at least one of the following:
* APGAR index at 10 minutes \</=5;
* Resuscitation with endotracheal tube or mask IPPV for more then 10 minutes;
* pH \</= 7 or excess of base \>/= 12 mmol/l on arterial blood gas (ABG) analysis within the first 60 minutes of life

  * Moderate/severe Hypoxic-ischemic encephalopathy assessed between 30 and 60 minutes of life according to Sarnat \& Sarnat definition
  * Hypothermic treatment. According to the Italian national guidelines on Perinatal Asphyxia and Therapeutic Hypothermia, the hypothermic therapy will be started in the first six hours of life and will last 72 hours.

Exclusion Criteria:

* Inability to obtain the informed consent from both parents
* Congenital major malformations or syndromes o Surgical diseases

Primary outcomes:
measure: Morbidity
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Nicola Laforgia
state: BA
Study officials:
References:
Clinical trial NCT03804736: Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection
Official title: Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clostridium Difficile Infection
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 21
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection

Detailed description: Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection.

From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

-

Primary outcomes:
measure: decrease in the number of evacuations
timeFrame: up to two days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: