louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06904287: Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines
Official title: Evaluating the Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines in the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Magnesium
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 100
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 research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.

Detailed description: The purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. Participants will be patients presenting to the Emergency Department with primary diagnosis of migraine.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or older
* Able to provide informed consent
* English speaking
* Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics

Exclusion Criteria:

* Pregnancy defined as a positive urine HCG
* Allergy or sensitivity to study drug
* Stated history of renal insufficiency
* Documented history of myasthenia gravis
* Consumption of study drug within 48 hours prior to enrollment
* Previously enrolled in this trial during a different patient encounter

Primary outcomes:
measure: Mean change in pain - baseline to 30 minutes
timeFrame: Baseline to 30 minutes after initiation of infusion
Secondary outcomes:
measure: Mean change in pain - baseline to 45 minutes and baseline to 60 minutes
timeFrame: Baseline to 45 minutes and 60 minutes after initiation of infusion
measure: Number of adverse events
timeFrame: Infusion through hour 2
measure: Emergency Department length of stay
timeFrame: Hour 24
measure: Number of patients that require rescue medications
timeFrame: Infusion through hour 2
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center Emergency Department
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ryan McKillip, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122587: Non-Invasive Brain Stimulation and Substance Use
Official title: Non-Invasive Brain Stimulation and Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: tACS
Brain Stimulation
Transcranial Alternating Current Stimulation
Substance Use
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The will investigate the feasibility and effectiveness and initial efficacy of non-invasive transcranial alternating current stimulation (tACS) on distress tolerance and inhibitory control among treatment seeking substance users.

Detailed description: Disruptions in inhibitory control (IC) and distress tolerance (DT) are implicated in the development and maintenance of substance use disorders. Findings suggest that differential DLPFC engagement during affective and cognitive processing, and in particular, distress tolerance, in substance use disorder may be malleable, providing a promising intervention. Modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions such as the DLPFC may provide an avenue to improve distress tolerance and inhibitory control in SUD. Transcranial alternating current stimulation (tACS) may be a particularly promising approach as it is a safe and non-invasive method of electric stimulation that has the potential to effectively modulate neural network and circuit dynamics, more closely aligning with a network-based conceptualization of affective and cognitive processesThis study will test the effects of tACS on distress tolerance and inhibitory control among treatment-seeking adults with substance use disorder.

Eligibility criteria: Inclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Substance Use Disorder
* Current smoker
* Abstinent from all substances (except nicotine) for at least the past 2 weeks

Exclusion Criteria:

* Current use of antiepileptic drugs and/or benzodiazepines
* Less than 6 months since an electroconvulsive therapy (ECT) session
* Current DSM-V Psychotic Disorder
* Pregnancy and/or nursing
* Ongoing or history of traumatic brain injury (TBI), reoccurring seizures, stroke, or brain tumors
* Medical or neurological illness
* Brain devices and/or implants

Primary outcomes:
measure: Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)
timeFrame: From Session 1 to Session 2, up to 6 days
measure: Change in Inhibitory Control (Mean D-prime on the Go/No-Go)
timeFrame: From Session 1 to Session 2, up to 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Southlight Healthcare
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacey B Daughters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02099487: Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma
Official title: Hypofractionated Imrt (Vmat-Ra) With Temozolomide For Elderly Patients, Unsuitable For Surgery With Newly Diagnosed High Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Keywords: HGG
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Detailed description: Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 70 years
* Karnosky performance status (KPS) ≤60
* Histologically confirmed HGG after tumor biopsy

  * GBM
  * Anaplastic Astrocytoma
  * Anaplastic Oligoastrocytoma
  * Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q
* Estimated survival ≥ 3 months.
* Normal liver, Kidney and bone marrow function
* Written informed consent

Exclusion criteria:

* Prior radiation therapy
* Other primary cancer

Exclusion Criteria:

-

Primary outcomes:
measure: PFS
timeFrame: one year
Secondary outcomes:
measure: OS
timeFrame: one year
Other outcomes:
measure: Toxicity
timeFrame: one year
measure: QoL
timeFrame: one year
Locations:
city: Milan
country: Italy
facility: ICH Humanitas Cancer Center
state: Lombardia
Study officials:
affiliation: Humanitas Cancer Center
name: Piera Navarria, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00018187: Combinations of Pharmacologic Smoking Cessation Treatments
Official title: Combinations of Pharmacologic Smoking Cessation Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Keywords: smoking cessation
bupropion
mecamylamine
nicotine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of a combination of the drugs bupropion and mecamylamine along with a nicotine patch as a therapy for smoking cessation.


Eligibility criteria: Subjects must be a smoker between 20 and 40 years old, have smoked at least 20 cigarettes per day for at least 2 years, wish to stop smoking and be in good general health

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
name: Neil Hartman, M.D.
References:
Clinical trial NCT04543487: Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Official title: The Effect of Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Pregnancy
Vaginal Delivery
Keywords: therapeutic touch
labour pain
anxiety
childbirth attitude
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.

Methods: The sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes Questionnaire.


Eligibility criteria: Inclusion Criteria:

* Having a first pregnancy
* Not having a high-risk pregnancy
* Having no health problems with the baby or herself
* Having a single foetus
* Being about to have a vaginal delivery
* Not receiving infertility treatment
* Not having a chronic physical or psychiatric diagnosis
* Agreeing to participate in the research

Exclusion criterion

-Multiparity

Primary outcomes:
measure: Scale
timeFrame: 6 months
measure: Inventory
timeFrame: 6 months
measure: Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sukran Ertekin Pinar
Study officials:
References:
Clinical trial NCT01310387: Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)
Official title: A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Lung cancer
Cancer pain
Opioid
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2011-03-08
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is:

* A single-center, randomized, prospective controlled trial.
* To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain.
* 204 patients will be recruited.

Detailed description: * The recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (NRS)
* Active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain.
* The percent of pain intensity difference (%PID)

  * PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

Eligibility criteria: Inclusion Criteria:

* Outpatients with lung cancer.
* The patients with uncontrolled lung cancer pain - more than and equal NRS 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication.
* Over 20 year-old male or female.
* The patients can be able to received telephone counseling by investigator's decision.

Exclusion Criteria:

* Drug or alcohol abusers.
* Child-bearing women or pregnant women.
* The patients with moderate to severe psychiatric problems.
* The patients who have hypersensitivity to opioids.

Primary outcomes:
measure: The percent of pain intensity difference
timeFrame: visit 3 (6 to 8 weeks)
Secondary outcomes:
measure: Patients' satisfaction score about pain management
timeFrame: visit 3 (6 to 8 weeks)
measure: Eastern Cooperative Oncology Group (ECOG) Performance score
timeFrame: visit 3 (6 to 8 weeks)
measure: Assessment of Korean Brief Pain Inventory score
timeFrame: visit 3 (6 to 8 weeks)
measure: Investigator's global assessment score
timeFrame: visit 3 (6 to 8 weeks)
Other outcomes:
Locations:
city: Jeonnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00185887: Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Official title: Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Distress
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation


Eligibility criteria: Inclusion Criteria::

* nonreassuring fetal heart rate tracing Exclusion Criteria:- maternal cardiac disease, placental abruption, intrauterine growth restriction, prior cesarean section

Primary outcomes:
measure: resolution of abnormal fetal heart tracing
timeFrame: Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery.
Secondary outcomes:
measure: cesarean section rate
timeFrame: Data analysis
measure: operative vaginal delivery rate
timeFrame: Data analysis
measure: neonatal outcomes
timeFrame: time of delivery to time of discharge
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176587: Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery
Official title: Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery (SPOC Study (Suivi Parcours Obésité en Chirurgie))
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bariatric Surgery Candidate
Lead sponsor: Elsan
Sponsor class: OTHER
Collaborators: name: Cemka-Eval
First posted: 2022-01-04
Enrollment: 0
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: Adult patients undergoing bariatric surgery

Brief summary: Study design :

Prospective, longitudinal, observational (non-interventional), multicenter, comparative medico-economic study - RIPH2, with direct matching to SNDS data (National Health Data System)

Main objective :

To evaluate the effectiveness of a multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for the Integrated group (SPOC)

  * Patient, male or female, at least 18 years old;
  * Patient undergoing bariatric surgery after the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  * Patient informed and not objecting to this research;
  * Subject affiliated to or benefiting from a social security program.
* Inclusion criteria for the control group

  * Patient, male or female, at least 18 years old;
  * Patient undergoing bariatric surgery before the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  * Patient informed and not objecting to this research;
  * Subject affiliated to or benefiting from a social security program.

Exclusion Criteria:

* • Protected patient : adult under tutorship, curatorship or other legal protection, deprived of his freedom by judiciary or administrative decision;

  * Patient hospitalised without consent

Primary outcomes:
measure: Bariatric revision surgery at 5 years follow-up
timeFrame: 5 years after the first surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ELSAN
Study officials:
References:
Clinical trial NCT04403087: Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications
Official title: Additive Effect of Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications; an Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 132
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: Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Detailed description: Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events.

The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination.

Exclusion Criteria:

* Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics,
* Subjects who underwent stomach resection
* Subjects less than 18 years of age

Primary outcomes:
measure: Overall compliance of eradication medication
timeFrame: 2 weeks after prescription of eradication medication
Secondary outcomes:
measure: Adverse events related to eradication medication
timeFrame: 2 weeks and 6 weeks after prescription of eradication medication
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart hospital
state: Gangwon
Study officials:
affiliation: Hallym University
name: Chang Seok Bang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02948387: Preventing Infections in Orthopaedic Patients
Official title: Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Open Fracture
Lead sponsor: Triple O Research Institute PA
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2016-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are at least 18 years of age with Type II or III open fractures

Brief summary: Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.

Detailed description: 1. Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
2. Identify the incidence of acute kidney injury.
3. Identify the type and number of associated infections
4. Identify the antibiotic resistance profile noted
5. Identify any secondary infections at sites other than the fracture site

Eligibility criteria: Inclusion Criteria:

* Male or Female \>= 18 years old
* Patients are diagnosed with a Type II or III open fracture

Exclusion Criteria:

* Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
* pregnancy
* did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
* receiving ongoing inpatient care

Primary outcomes:
measure: Rate of fracture site infections
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of acute renal injury
timeFrame: 30 days
measure: type of bacteria infection
timeFrame: 30 days
measure: resistance trend in patients with infections
timeFrame: 30 days
measure: number of secondary infections at site other than fracture sites
timeFrame: 30 days
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
Study officials:
affiliation: Triple O Research Institute PA
name: Olayemi Osiyemi, MD
role: PRINCIPAL_INVESTIGATOR
References: