louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03408236: Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
Official title: Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crow's Feet Lines
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of Botulax® in treatment of crow's feet line

Detailed description: 1. Allocation: Randomized
2. Masking: Double Blind

Eligibility criteria: Inclusion Criteria:

* Male or female of at least 19 to 65 years old
* Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Subject with hypersensitivity to the investigational products or their components
* Female subject who are pregnant or lactating
* Subject who are unable to communicate or follow the instructions
* Subject who are not eligible for this study based on the judgment of an investigator

Primary outcomes:
measure: Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel
Study officials:
References:
citation: Yoo KH, Park SJ, Han HS, Won CH, Lee YW, Kim BJ. Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1587-1594. doi: 10.1111/jdv.17217. Epub 2021 Apr 12.
Clinical trial NCT02401399: Preoperative Diet Before Sleeve Gastrectomy
Official title: Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Detailed description: Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Eligibility criteria: Inclusion Criteria:

* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

* gastroesophageal reflux
* patients with uncontrolled psychiatric disorders
* active infections or malignancies
* other concomitant pathology considered as a contraindication for bariatric surgery

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: C reactive protein
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Elche
name: Jaime Ruiz Tovar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Tovar J, Zubiaga L, Diez M, Murcia A, Boix E, Munoz JL, Llavero C; OBELCHE group. Preoperative Regular Diet of 900 kcal/day vs Balanced Energy High-Protein Formula vs Immunonutrition Formula: Effect on Preoperative Weight Loss and Postoperative Pain, Complications and Analytical Acute Phase Reactants After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jun;26(6):1221-7. doi: 10.1007/s11695-015-1880-7.
Clinical trial NCT04058899: Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
Official title: Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Emergence Delirium
Keywords: dexmedetomidine
emergence agitation
adenotonsillectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into 2 groups ,dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to compare the effect of IV infusion 0.5 µg/kg dexmedetomidine and IV 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.

Detailed description: Consent will be obtained from legal guardian of children,patients will be randomized according to computer randomization to one of two groups, dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.

Eligibility criteria: Inclusion Criteria:

* Children of (American Society of Anesthesiologist)ASA physical status grade I or II.
* Aged 2-5 years
* Undergoing elective adenotonsillectomy.

Exclusion Criteria:

* History of hypersensitivity to the studied drug.
* Refusal of the legal guardian to participate in the study.
* Severely agitated child at induction of anesthesia
* Occurrence of postoperative bleeding at(Post Anesthesia Care Unit) PACU

Primary outcomes:
measure: postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia
timeFrame: stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks
Secondary outcomes:
measure: sedation in early postopertive time during child stay in postanesthesia care unit
timeFrame: stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04890899: Splenic Surgery for Hydatid Spleen in Single Institutional Experience
Official title: Splenic Preserving Surgery in Hydatid Spleen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spleen; Cyst, Hydatid (Manifestation)
Keywords: Spleen
Hydatid cyst
Surgery
Preserving surgery
Lead sponsor: Jabir Ibn Hayyan Medical University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: from 5- 40 years (mean 23.6 years).

Brief summary: Splenic-preserving surgery in hydatid spleen: Single intuitional experience

Detailed description: Background:

Although hydatid disease affects many organs in the human body, splenic hydatid represents about 0.8-4% of all human echinococcosis cases. Until recently, splenectomy was the recommended surgical procedure for splenic hydatid. Since 1980 there has been an increasing tendency to use conservative option to deal with such pathology.

Aim of the study:

To evaluate our experience in open splenic-preserving surgery for splenic hydatid in a single institutional study.

Patient and methods:

A retrospective study. Ten patients with splenic hydatid were operated upon from August 2013 to January 2018 in our medical centre. Spleen has affected alone in 7 cases, liver and spleen were affected in 3 cases, and one of them had intraperitoneal cyst affection in addition. The diagnosis confirmed mainly by ultrasonography. In some cases, it computed tomography CT scan, and magnetic resonance imaging MRI were needed. Chest X-ray had taken for all patients to exclude pulmonary hydatid. The open surgical procedure used. Isolation of the field, aspiration of cystic fluid and injection of 1% cetrimide solution, re-aspiration, endocystectomy, suturing of cystic edges over intracystic tube drain. All surgery did under cover of albendazole pre and postoperative 15mg/kg/day.

Results:

No significant intraoperative and postoperative complications. No reoperation was needed. Hospital stays 3-5 days. No recurrence after (1-3) year follow-up. However, three patients missed follow-up after two years.

Conclusion:

Our experience in splenic hydatid encourages us to use splenic-preserving surgery whenever possible instead of splenectomy.

Eligibility criteria: Inclusion Criteria:

Single hydatid spleen Primary spleen hydatid

-

Exclusion Criteria:

* Multiple splenic hydatid Rupture hydatid spleen

Primary outcomes:
measure: splenic sparing surgery for hydatid spleen
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01887899: Influence of tDCS on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Official title: Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia of Type Alzheimer
Keywords: cortical plasticity
transcranial direct current stimulation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with dementia of the Alzheimer type (DAT) leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).


Eligibility criteria: Inclusion Criteria:

* Right-handed according to the Oldfield Händigkeits inventory (lateralization index\> 70) (1971)
* Cognitive impairment, which corresponds to a mild to moderate DAT
* No treatment with AChE inhibitors, or existing stable treatment with AChE inhibitors for over 3 months
* No motor impairments relevant to everyday life
* Age 50 to 80 years
* Existing Insurance certificate
* Existing informed consent

Exclusion criteria:

* Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
* Epilepsy, epileptic seizure in medical history
* Cognitive deficit (MMSE \<20)
* Depressive episode (Beck Depression Inventory (BDI)\> 12)
* intake of centrally active drugs \<3 months, particularly acetylcholinesterase inhibitors
* Pregnancy
* Pacemaker (contraindication for MRI)
* Other metal parts in the body (contraindication for MRI)

Primary outcomes:
measure: the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
timeFrame: 1 week
Secondary outcomes:
measure: tDCS effects on central cholinergic activity in patients with DAT
timeFrame: 1 week
measure: tDCS effects on learning
timeFrame: 1 week
measure: MR elastography
timeFrame: 1 week
measure: genetic polymorphism, ApoE4
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Study officials:
References:
Clinical trial NCT04457999: Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
Official title: Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease


Eligibility criteria: Inclusion Criteria:

* Patients older than 21, who will get catarct surgeyr
* Patients whose visual acuity anticipated better than 20/25 after surgery
* Patients with informed consent
* Patients with meibomian gland dysfunction

Exclusion Criteria:

* ocular injury, active injection
* uncontrolled systemic disease
* Contact lens wear within 1 month
* Allergic to fluorescein sodium or topical anesthetics
* ocular surgery or trauma within 6 months
* disorder of lid anatomy
* other reason for decreased vision other than cataract
* anticipated visual acuity less than 20/25
* Patients less than 20 years.

Primary outcomes:
measure: improvement of dry eye symptom
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00785499: Milk Components and Metabolic Syndrome
Official title: The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: obesity
metabolic syndrome
milk components
casein
whey
children
adolescent
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 193
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Milk contains a vast number of bioactive components that have been suggested to have a positive impact on human health, of special interest is the effects related to metabolic syndrome and obesity but the effect of the individual milk components is not clear. This study examine whether it is beneficial for overweight and obese children to increase the intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.

The participants will be randomized to receive skim milk, whey milk drink, casein milk drink or mineral water for 3 mo. They will be examined at baseline, end of intervention and followed up 3 month later.


Eligibility criteria: Inclusion Criteria:

* 12 years to 15 years old
* iso BMI larger than 25
* habitual milk intake less than 250 ml/day
* non-smoker
* healthy at the time of inclusion

Exclusion Criteria:

* chronic illnesses
* intake of antibiotic 1 mo before start of intervention

Primary outcomes:
measure: body composition and markers for metabolic syndrome (e.g.fasting insulin, glucose, lipid profile, CRP, PAI-1, tPA)
timeFrame: at baseline, after intervention and body composition 3 mo after end of intervention
Secondary outcomes:
measure: diet
timeFrame: baseline and end of intervention
measure: pulse wave velocity,
timeFrame: baseline and end of intervention
measure: blood pressure, metabolomics, IFG-I, IGFBP-3, appetite regulatory hormones,immune parameters, bone turn over parameters, composition of microbiota, vitamin D, physical activity
timeFrame: baseline and end of intervention
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
References:
citation: Andersen LB, Arnberg K, Trolle E, Michaelsen KF, Bro R, Pipper CB, Molgaard C. The effects of water and dairy drinks on dietary patterns in overweight adolescents. Int J Food Sci Nutr. 2016;67(3):314-24. doi: 10.3109/09637486.2016.1150435. Epub 2016 Feb 22.
citation: Arnberg K, Molgaard C, Michaelsen KF, Jensen SM, Trolle E, Larnkjaer A. Skim milk, whey, and casein increase body weight and whey and casein increase the plasma C-peptide concentration in overweight adolescents. J Nutr. 2012 Dec;142(12):2083-90. doi: 10.3945/jn.112.161208. Epub 2012 Oct 17.
citation: Arnberg K, Larnkjaer A, Michaelsen KF, Molgaard C. Central adiposity and protein intake are associated with arterial stiffness in overweight children. J Nutr. 2012 May;142(5):878-85. doi: 10.3945/jn.111.150672. Epub 2012 Mar 21.
Clinical trial NCT02028299: Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
Official title: Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
Pulmonary Vascular Resistance
Right Heart Catheterization
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 38
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: An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.


Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital

Exclusion Criteria:

* Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren

Primary outcomes:
measure: Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical Faculty Associates, Inc.
name: Brian Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058499: Mindfulness Based Stress Reduction in COPD
Official title: Mindfulness Based Stress Reduction in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the efficacy of a Mindfulness Based Stress Reduction program in COPD on quality of life, dyspnea, daily physical activity and mindfulness during daily life.


Eligibility criteria: Inclusion criteria:

* clinical diagnosis of COPD
* clinically significant dyspnea, as determined by a score of \>=2 on the Medical Research Council of Dyspnea Score questionnaire (0-4).

Exclusion criteria:

* patients with a high likelihood of not completing the program (active chemical dependency)
* patients with an inability fo provide good data or to follow commands (neurologic or psychiatric condition).
* poor motivation or lack of interest in program

Primary outcomes:
measure: We hypothesize that the perception of well being will increase after participants go through the MBSR program for COPD.
timeFrame: Baseline and at eight weeks
Secondary outcomes:
measure: Participants in the MBSR for COPD will have an increase in their physical activity level.
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03328299: Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block
Official title: Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.


Eligibility criteria: Inclusion Criteria:

* 24 ASA I-II
* patients (age 18-60 years
* weight 50-89 kg

Exclusion Criteria:

* a known allergy to the study drugs
* significant cardiac
* respiratory, renal or hepatic diseases
* bleeding diathesis

Primary outcomes:
measure: measure dexmedetomidine level into systemic circulation after local administration
timeFrame: up to 6 hours
Secondary outcomes:
measure: total dose of IV PCA morphine consumption in the first 24 h postoperative
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer instIitute
Study officials:
References:
citation: El Sherif FA, Abdel-Ghaffar H, Othman A, Mohamed S, Omran M, Shouman S, Hassan N, Allam A, Hassan S. Pharmacokinetics and Pharmacodynamics of Dexmedetomidine Administered as an Adjunct to Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgery. J Pain Res. 2022 Jan 4;15:1-12. doi: 10.2147/JPR.S335806. eCollection 2022.