louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00792779: Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Official title: Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemolysis
Keywords: Morbid obesity
General anaesthesia
Propofol
Sevoflurane
Lead sponsor: Centro Medico Campinas
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.


Eligibility criteria: Inclusion Criteria:

* patients between BMI 40-50 kg/m2

Exclusion Criteria:

* patients with BMI under 40 kg/m2 and over 50 kg/m2
* alcohol users
* illicit-drug users
* patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers
* patients transfused either recently, during the intra-operative period or within 10 hours post-operative
* patients previously known to be hypersensitive to any drug that is used during the study
* patients with any psychiatric disorder or dementia

Primary outcomes:
measure: Count erythrocytes
timeFrame: After 10 hours post-surgery
Secondary outcomes:
measure: Bilirubins(direct and indirect)
timeFrame: After 10 hours post-surgery
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Fundação Centro Médico de Campinas
state: São Paulo
Study officials:
affiliation: Fundação Centro Médico de Campinas
name: Ricardo F Simoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsuchiya M, Asada A, Kasahara E, Sato EF, Shindo M, Inoue M. Antioxidant protection of propofol and its recycling in erythrocyte membranes. Am J Respir Crit Care Med. 2002 Jan 1;165(1):54-60. doi: 10.1164/ajrccm.165.1.2010134.
Clinical trial NCT06131879: Laser Versus Physiotherapy in Management of Bruxism in Children: RCS
Official title: Evaluation of Laser Acupuncture Versus Modified Physical Therapy Intervention in Management of Bruxism in Children, Study Protocol for a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism
Keywords: bruxism
laser
children
Physiotherapy
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double arm controlled study
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are:

* Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy?
* Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism

Detailed description: The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria \[ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training.

Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.

Eligibility criteria: Inclusion Criteria:

1. Six to twelve years children
2. Medically free
3. Normal occlusion
4. No or low caries experience
5. Clinical dental wear
6. Clenching or grinding reported by the parents

Exclusion Criteria:

1. Children with any physical or psychological disease.
2. Children received any previous treatment for bruxism.
3. Children with tempro-mandibular joint disorders

Primary outcomes:
measure: Tempro-mandibular joint pain
timeFrame: 2 months
Secondary outcomes:
measure: Activity of temporalis and masseter muscles
timeFrame: 2 months
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: National Research Centre
state: Giza
Study officials:
affiliation: National Research Centre, Egypt
name: Mohamed F Rashed, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377779: Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions
Official title: Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asherman Syndrome
Keywords: Oxiplex/AP gel
Prevention of Asherman's syndrome
Intra uterine adhesions
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-06-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.

Detailed description: Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years
* Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

Exclusion Criteria:

* Signs of infection upon admission
* Ongoing pregnancy

Primary outcomes:
measure: safety of intrauterine application of Intercoat
timeFrame: 18 months
Secondary outcomes:
measure: efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception
timeFrame: 14 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofe MC
Study officials:
affiliation: Asaf Harofe MC
name: Moty Pansky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685279: Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children
Official title: Testing the Efficacy of the Nurtured Heart Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group.

Detailed description: The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods.

Eligibility criteria: Inclusion Criteria:

* Parent or guardian of a child diagnosed with ADHD or suspected of ADHD
* Child must be 6 - 8 years of age
* Access to a computer with Internet

Exclusion Criteria:

* Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism

Primary outcomes:
measure: Inattention
timeFrame: Six-week change from pre-intervention inattention to post-intervention inattention.
measure: Hyperactivity/Impulsivity
timeFrame: Six-week change from pre-intervention hyperactivity/impulsivity to post-intervention hyperactivity/impulsivity.
Secondary outcomes:
measure: Parental Stress
timeFrame: Six-week change from pre-intervention parental stress to post-intervention parental stress.
measure: Parenting Competency
timeFrame: Six-week change from pre-intervention parenting competency to post-intervention parenting competency.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT02386579: Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy, Neurogenic
Diabetes Complications
Diabetes Mellitus
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes patients with and without acute charcot foot

Brief summary: The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow.

Patients will be compared with healthy diabetic controls.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist

Exclusion Criteria:

* Osteoporosis
* Anti-osteoporotic treatment
* Lower extremity amputation
* Lower extremity infection

Primary outcomes:
measure: RANKL
timeFrame: 10 min between measurements
Secondary outcomes:
measure: osteocalcin
timeFrame: 10 min between measurements
measure: CTX-I
timeFrame: 10 min between measurements
measure: sRAGE
timeFrame: 10 min between measurements
measure: P1NP
timeFrame: 10 min between measurements
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04645979: A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico
Official title: The Perception of Celestamine Treatment in Mexico: a Retrospective Assessment of Consumer Perception of Prior Celestamine Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis.

Brief summary: Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It causes inflammation inside the nose, resulting in symptoms similar to the common cold. Allergic rhinitis is also known as hay fever.

In this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. These participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. During the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.


Eligibility criteria: Inclusion Criteria:

* Participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis
* Participants allowing to use the data for research and marketing purposes as well as talking to authorities
* Participants allowing us to use the pseudo-randomized individual data for further data analysis
* Able to read and understand the language of the online questionnaire

Exclusion Criteria:

- None

Primary outcomes:
measure: Experience with betamethasone plus loratadine via an online questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Mexico
facility: Many locations
Study officials:
References:
Clinical trial NCT00886379: Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Official title: Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin d Deficiency
Keywords: vitamin d
children
Mongolia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 597
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.


Eligibility criteria: Inclusion Criteria:

* Children in 3rd and 4th grade from selected Mongolian schools.
* School selection will consider:

  * socioeconomic position;
  * geographic location;
  * school size;
  * current lunch or supplementation program; and
  * the interest and willingness to participate of the school's administration and faculty.

Exclusion Criteria:

* Allergy to milk or wheat products.

Primary outcomes:
measure: Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
timeFrame: Blood was analyzed at day 0 and day 49
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Janet Rich-Edwards, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28.
citation: Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22.
Clinical trial NCT06056479: Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy
Official title: Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal Nephrectomy: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request.

Detailed description: General anaesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anaesthesia will be maintained with mechanical ventilation with isoflurane with O2 \\ Air mixture.

During anaesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics.

All patients will receive 1g intravenous paracetamol and 4mg ondansetron 8mg dexamethasone.

Eligibility criteria: Inclusion Criteria:

- Eligible patients will be older than 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy

Exclusion Criteria:

* Patients who are:
* Unable to cooperate.
* Patients who have allergy to any of the study drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy
* Patients with coagulation disorders or on anticoagulation therapy

Primary outcomes:
measure: Time for first rescue analgesia
timeFrame: day 0
Secondary outcomes:
measure: VAS score
timeFrame: 24 hours
measure: rescue analgesics
timeFrame: 24hous
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775879: Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
Official title: Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: Général anesthesia
Gynecology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence.


Eligibility criteria: Inclusion Criteria:

* programmed gynecological surgery
* ASA 1 or 2

Exclusion Criteria:

* arterial hypertension
* gastro-oesophageal reflux
* pregnancy
* diabetes
* obesity
* asthma
* tobacco

Primary outcomes:
measure: Incidence of spike wave
timeFrame: during anaesthesia induction with sevoflurane
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Benjamin JULLIAC, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068379: Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation
Official title: Randomized Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation for Retinopexy in Scleral Buckle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhegmatogenous Retinal Detachment
Keywords: rhegmatogenous retinal detachment
cryopexy
photocoagulation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Detailed description: The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Eligibility criteria: Inclusion Criteria:

* Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days

Exclusion Criteria:

* No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.

Primary outcomes:
measure: The primary outcome was one week reattachment rate
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lira RP, Takasaka I, Arieta CE, Nascimento MA, Caldato R, Panetta H. Cryotherapy vs laser photocoagulation in scleral buckle surgery: A randomized clinical trial. Arch Ophthalmol. 2010 Dec;128(12):1519-22. doi: 10.1001/archophthalmol.2010.271.