louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04666701: Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Escócia Association in the Treatment of Acute Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 0
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: The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants, aged 18 years and older, with renal colic admitted in the emergency service, or those who underwent an extracorporeal lithotripsy procedure to eliminate kidney stones.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
* Participants weighing less than 50 kg;
* Participants with suspected other causes of acute abdominal pain;
* Participants with a known history of peptic ulcer, gastrointestinal bleeding, perforation or inflammatory bowel disease;
* Participants with hypovolemia or dehydration;
* Renal failure, defined by the estimated glomerular filtration rate \[eGFR\] \<60 mL / min / 1.73 m2;
* Participants with a known medical history of cerebrovascular bleeding, hemorrhagic diathesis (hemophilia), blood clotting disorders; postoperative of coronary artery bypass graft surgery, or using anticoagulants, including low heparin dose (2500-5000 units every 12 hours);
* Participants in the postoperative period with a high risk of bleeding or incomplete homeostasis;
* Participants with cardiovascular disease, chronic heart failure or with increased risk of cardiovascular events are at the discretion of the investigator, in order to include the participant;
* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
* Participants using pentoxifylline, probenecid or lithium salts;
* Participants with megacolon and / or paralytic or obstructive ileus;
* Participants with glaucoma and myasthenia gravis;
* Participants on treatment with MAO inhibitors, or participants who have been treated with these drugs within 14 days;
* Participants on epilepsy not adequately controlled treatment.

Primary outcomes:
measure: Change from baseline in pain intensity
timeFrame: 0-1 hour
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00644501: Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
Official title: Open Label Study to Evaluate Long Term Treatment Effect of DiaPep277® in Patients Who Have Completed Studies 461* (Phase II) or 901** (Pase III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
beta cells
immunomodulation
immunointervention
Lead sponsor: Andromeda Biotech Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.


Eligibility criteria: Inclusion Criteria:

* A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
* Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.

Exclusion Criteria:

* The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
* The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.

Primary outcomes:
measure: Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion.
timeFrame: every 6 months up to 24 months from T0
Secondary outcomes:
measure: improved metabolic control and the insulin dose required to maintain it.
timeFrame: every 3 months up to 24 months from T0
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Centre
city: Jerusalem
country: Israel
facility: Diabetic Unit, Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Centre
Study officials:
affiliation: Hadassah Medical Organization
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03525301: Short Course Radiation Therapy in Palliative Treatment of Brain Metastases
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Metastases
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Symptomatic brain metastases
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 108
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: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

Detailed description: Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic brain metastases from solid tumors
* age \> 18 years
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme
timeFrame: 3 months
Secondary outcomes:
measure: Acute toxicity in the two treatment groups
timeFrame: 3 months
measure: Late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702701: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Official title: Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Eosinophilic Esophagitis
Dysphagia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare response to treatment of Eosinophilic Esophagitis with montelukast vs standard therapy fluticasone. Investigators hypothesize that montelukast is equally effective in treating symptoms and histology of EoE when compared to fluticasone. The study will be conducted at multiple sites with Medical College of Wisconsin as the coordinating site. After identification and recruitment all patients will be randomized (provider blinded) to one of two medications: montelukast 10mg po qday vs fluticasone 440mcg po bid. Patients will also complete a pretreatment, 6 week therapy and 12 week therapy questionaire. They will then undergo a repeat endoscopy to evaluate endoscopic and histologic response.

Detailed description: Eosinophilic esophagitis is an allergic condition of the esophagus with an incidence that is on the rise, and has limited treatment options. Current gold standard of treatment is with topical steroids (swallowed fluticasone). There is preliminary data that oral montelukast may prove to be effective in inducing and maintaining symptomatic along with histologic remission of this disease. Investigators will be comparing the effectiveness of singulair to swallowed fluticasone in inducing and maintaining histologic and symptomatic remission of eosinophilic esophagitis.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of EoE on biopsy
* with \>15 eos per HPF
* ages \>18
* Both male and Female.
* Not pregnant

Exclusion Criteria:

* pregnancy
* patients receiving ongoing medical therapy for EoE
* patients who underwent dilation in the last 12 weeks with improvement in symptoms
* LA grade B or worse erosive esophagitis.
* age \< 18
* nursing mothers
* use of prohibited concomitant medications : budesonide-oral compounded liquid, fluticasone or montelukast.

Primary outcomes:
measure: Improvement in Dysphagia symptom score
timeFrame: 3 month
Secondary outcomes:
measure: Improvement in esophageal histology counts of eosinophils/hpf
timeFrame: 3 month
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: GI Associates
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Walter Hogan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Nikhil Shastri, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02114801: Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Official title: Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy;
Dental Plaque
Keywords: Cerebral Palsy;
Toothbrushing;
Dental Plaque
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to determine the effectiveness of brushing with an electric toothbrush switched on and switched off in comparison to manual brushing for the removal of dental plaque in children aged four to 16 years with cerebral palsy.

Detailed description: Advances in the design and type of movement of electric toothbrushes can determine the increase in effectiveness in the control of biofilm by caregivers and patients.There is a paucity of studies evaluating the effectiveness of the electric toothbrush compared to manual toothbrush specifically in patients with cerebral palsy.Only one study used the electric toothbrush in patients with cerebral palsy and demonstrated superiority of the electric toothbrush over the manual. However, the study investigated the effect of various cleaning strategies on symptoms of gingival inflammation, not specifically focusing on the comparison of the efficiency of removal of biofilm from the manual toothbrush and electric toothbrush. The primary objective of this study was to evaluate the effectiveness of the electric brush on and off the removal of dental plaque in subjects with cerebral palsy compared to manual toothbrush. The secondary objective was to characterize the study as socioeconomic population.

Eligibility criteria: Inclusion Criteria:

* medical diagnosis of cerebral palsy

Exclusion Criteria:

* who did not complete the cycle three brushings

Primary outcomes:
measure: Removal of dental plaque
timeFrame: after brushing three minutes duration
Secondary outcomes:
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Universidade Federal dos Vales do Jequitinhonha e Mucuri
state: Minas Gerais
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Nayara Kelly Lyrio Ferraz, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05381701: Effects of Different Flow Anesthesia on Atelectasis
Official title: Evaluation Of Peroperative Atelectasis In Minimal, Low And Medium Flow Anesthesia By Lung Ultrasound Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis; Due to Anesthesia
General Anesthesia
Low- Flow Anesthesia
Minimal Flow Anesthesia
Keywords: Lung Ultrasound Score
Minimal Flow Anesthesia
Atelectasis
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA I-II septoplasty and rhinoplasty patients aged 18-65 years

Brief summary: Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score.


Eligibility criteria: Inclusion Criteria:

* operation time 2-5 hours
* elective septoplasty and rhinoplasty
* ASA I-II

Exclusion Criteria:

* morbid obesity
* malignant hyperthermia
* opioid sensitivity
* alcohol or drug addiction
* congestive heart failure
* chronic obstructive pulmonary disease
* coronary artery disease
* anemia
* liver and kidney diseases
* pregnancy
* breast-feeding
* history of allergy to drugs used

Primary outcomes:
measure: assessment of lung ultrasound score
timeFrame: Change from Baseline and 30 minute after emergence
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Faculty of Medicine
state: Kozlu
Study officials:
References:
Clinical trial NCT02766101: Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
Official title: Can a Physical Activity Program Implemented at a Therapeutic School Promote Emotional Regulation and School Success in Socially and Emotionally Vulnerable Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Attention Deficit and Disruptive Behavior Disorders
Anxiety Disorders
Mood Disorders
Conduct Disorder
Oppositional Defiant Disorder
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Judge Baker Children's Center
First posted: 2016-05-09
Enrollment: 103
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.


Eligibility criteria: Inclusion Criteria:

* Attending the Manville School at the time of study initiation

Exclusion Criteria:

* Medical exemption from physical education classes
* Parental opt out from physical education classes

Primary outcomes:
measure: Change in Minutes and Number of Disciplinary Time Out of Class Events (classroom functioning)
timeFrame: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
measure: Change in Conners Abbreviated Teacher Rating Scale score (behavioral dysregulation: impulsivity/emotional lability)
timeFrame: Assessed Daily for 14 weeks (7 weeks in intervention arm and 7 weeks in control arm)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Judge Baker Children's Center, Manville School
state: Massachusetts
Study officials:
References:
citation: Davison K, Bowling A, Garcia J, Wood B, Hermesch R, Prince J, Hayes A, Kow R, Newlan S, Slavet J. A cybercycling intervention to improve behavioral regulation and classroom functioning among children with behavioral health disorders: Pragmatic randomized trial design for Manville Moves. Contemp Clin Trials. 2016 Jul;49:40-6. doi: 10.1016/j.cct.2016.05.008. Epub 2016 May 31.
Clinical trial NCT06461767: Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months
Official title: Repetitive Transcranial Magnetic Stimulation in Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the patient will divide into 4 groups first group will receive stimulation over the left motor cortex second group will receive stimulation over left dorsolateral prefrontal cortex third group will receive stimulation over both left motor cortex and left dorsolateral prefrontal cortex fourth group will receive sham stimulation
Primary purpose: TREATMENT

Brief summary: Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine


Eligibility criteria: Inclusion criteria:

* A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
* Patients are regular on follow up visits.

Exclusion criteria:

* Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
* patients on prophylactic medications for chronic migraine.
* pregnancy.
* cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
* Patients refused to give informed consent.
* History of seizures.

Primary outcomes:
measure: improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test
timeFrame: one month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag faculty of medicine
name: Tarek Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333567: Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: arthroscopic knee surgery
cyclooxygenase-2 inhibitors
lumiracoxib
COX189
Ambulatory arthroscopic knee surgery
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 110
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: This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery


Eligibility criteria: Inclusion Criteria:

* Patients who need scheduled minor ambulatory arthroscopic knee surgery.

Exclusion Criteria:

* Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pain Intensity (PI) in the target knee after movement at the 2 h time-point
Secondary outcomes:
measure: PI at 1, 2, 3, 4 and 24 h time-points while at rest
measure: PI at 1, 3, 4 and 24 h time-points after movement
measure: Time to first rescue medication intake
measure: Patient's global evaluation of response to study medication
measure: Safety and tolerability profile
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis Pharma AG
role: STUDY_DIRECTOR
References: