louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02314351: Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Official title: Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Keywords: migraine disorders
migraine with aura
migraine without aura
pain management
emergency department
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 148
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: Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.


Eligibility criteria: Inclusion Criteria:

* Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
* The patients older than 18 years
* Patients who agree to participate to the study by reading and signing the informed consent document

Exclusion Criteria:

* The patients younger than 18 years
* Pregnants
* Patients taking any analgesic drugs last 2 hours
* Documented or declared allergy to metoclopramide
* Patients who are hemodynamically unstable
* Patients who do not agree to participate to the study

Primary outcomes:
measure: The difference between pain scores for both drugs
timeFrame: 15th and 30th minutes
Secondary outcomes:
measure: Nausea and vomiting
timeFrame: 30th minute
measure: Adverse reactions
timeFrame: 30th minute
measure: Need for rescue analgesic
timeFrame: 30th minute
measure: Change in the headache intensity
timeFrame: Between 24th and 72th hours
measure: Duplicative presentation to the emergency department
timeFrame: Between 24th and 72th hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University, Faculty of Medicine
Study officials:
affiliation: Kocaeli University, Faculty of Medicine
name: Nurettin Özgür Doğan, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06094751: An ACT Website for College Students With Insomnia
Official title: Online ACT Guide for Sub-clinical and Clinical Insomnia Among College Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
college student
university student
online
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 80
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: College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why this study will investigate the efficacy and feasibility of an online ACT intervention for insomnia among college students. Specifically, Is an online ACT for college students effective in treating insomnia? And, is an online ACT for college students feasible and acceptable in treating insomnia? Participants will be randomized into one of two conditions: waitlist or online ACT guide. Participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. enrolled in a 2- or 4-year college (includes graduate students)
3. fluent in English
4. have access to the internet
5. meets diagnosis for at least acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
6. searching/wanting in treatment
7. currently residing in the US

Exclusion Criteria:

1. diagnosed with another sleep disorder that is not insomnia
2. currently attending therapy for an emotional disorder (anxiety or depression) or insomnia
3. prescribed medications to treat insomnia or another sleep-inducing medication

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
References:
Clinical trial NCT01820351: Assessment of Thigh Muscle After a Stretching Program
Official title: BICEPS FEMORIS AND VASTUS LATERALIS MUSCLE ARCHITECTURE AFTER A CHRONIC STRETCHING PROGRAM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assessment of Muscle Architecture and Tendon After Chronic Stretching Program
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2013-03-28
Sex: MALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to establish, through ultrasound, measurements of the thigh muscles (Biceps Femoris and Vastus Lateralis)and the chronic effects of a static stretching program on the muscle-tendon unit these muscles.


Eligibility criteria: Inclusion Criteria:

* physically active male volunteers
* soldiers of the Army School of Physical Education of Rio de Janeiro, Brazil
* young men

Exclusion Criteria:

* any musculoskeletal disorder in the lower limbs
* neurological or cardiovascular disease experienced previous to or reported during the study.

Primary outcomes:
measure: Assessment of Thigh Muscle After a Stretching Program
timeFrame: after 8 weeks that static stretching protocol was applied
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: School of Physical Education of Rio de Janeiro
Study officials:
References:
Clinical trial NCT04888351: Immediate Breast Reconstruction's Increasing
Official title: Mastectomy and Breast Cancer : Follow-up of IBR's Rate and Study of Complications as Compared to Delayed Reconstructions Between 2016 and 2020 in Lyon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Reconstruction
Breast Cancer
Keywords: Immediate Breast Reconstruction (IBR)
Mastectomy
Breast cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients aged 18 or more, who have had a mastectomy for breast cancer in Croix-Rousse's hospital in Lyon, between 1st of January 2016 and 31st of December 2020

Brief summary: Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France. However, IGR (Insitut Gustave Roussey) in Paris just wrote a new protocole wich allows more IBR by including more patients.

This study aims to compare complications in 2 groups: mastectomies followed by IBR and mastectomies without IBR. The second goal will try to estimate the proportion of eligible's patients to IBR, and to analyse their surgicals and oncologicals risk factors


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Breast cancer
* Mastectomy
* Hopital de la Croix-Rousse
* January 2016 and January 2020

Exclusion Criteria:

* Prophylactic mastectomy
* Male gender

Primary outcomes:
measure: Global complications's rates in 2 groups (percentage)
timeFrame: During first year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
References:
Clinical trial NCT00304551: A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
Official title: A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cirrhosis
Chronic Hepatitis C
Keywords: CHC with compensated LC
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-03-20
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.

Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.

Exclusion Criteria:

* Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
* Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter)
* Anemia (less than 12 g hemoglobin per deciliter )
* Hepatitis B co-infection; decompensated liver disease.
* Organ transplant
* Creatinine clearance less than 50 milliliters per minute
* Poorly controlled psychiatric disease
* Poorly controlled diabetes
* Malignant neoplastic disease
* Severe cardiac or chronic pulmonary disease
* Immunologically mediated disease
* Retinopathy

Primary outcomes:
measure: Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
timeFrame: week 24 from the end of treatment
Secondary outcomes:
measure: Biochemical response (normalization of serum alanine aminotransferase activity)
timeFrame: at the end of treatment and week 24 form the end of treatment
measure: Virological response (HCV-RNA < 50 IU per milliliter)
timeFrame: at the end of treatment and week 24 form the end of treatment
Other outcomes:
Locations:
city: Chugoku
country: Japan
facility: Chugoku
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyusyu
country: Japan
facility: Kyusyu Region
city: Shikoku
country: Japan
facility: Shikoku Region
city: Tohoku
country: Japan
facility: Tohoku Region
city: Tokai
country: Japan
facility: Tokai Region
Study officials:
affiliation: Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
name: Takehiko Aoshima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02632851: Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
Official title: Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis
Cough
Sputum, Cellular Atypia
Dyspnoea
Keywords: inhalation
isotonic saline
NaCl solution 0.9 %
Ectoin
bronchitis
respiratory tract infection
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 135
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care or ENT units study the therapeutic process in this obvservational trial in total of 120 patients suffering on respiratory tract infection and/or acute bronchitis

Brief summary: This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution

Detailed description: The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea

Eligibility criteria: Inclusion Criteria:

* according to instruction for use

Exclusion Criteria:

* according to instruction for use

Primary outcomes:
measure: Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
timeFrame: day 7
Secondary outcomes:
measure: Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)
timeFrame: day 14
measure: patients´ evaluation of tolerability (4 point scale)
timeFrame: day7
measure: physicians´ evaluation of tolerability (4 point scale)
timeFrame: day 7
measure: patients´ evaluation of efficacy (five point IMOS scale)
timeFrame: day 7
measure: physicians´ evaluation of efficacy (five point IMOS scale)
timeFrame: day 7
measure: Change in number and type of adverse events
timeFrame: day 7
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Facharzt für HNO, Allergologie
Study officials:
affiliation: University of Cologne
name: R Mösges, Prof Dr
role: STUDY_CHAIR
References:
citation: Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Curr Med Res Opin. 2013 Oct;29(10):1383-90. doi: 10.1185/03007995.2013.832183. Epub 2013 Aug 23.
Clinical trial NCT05535751: Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections
Official title: Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Keywords: Bacteremia
Cefepime
carbapenems
AmpC β-lactamase
enterobacteriaceae bloodstream infections
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia

Brief summary: Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years of age)
* managed within a study center for high-grade cephalosporinase-producing bacteremia
* Not objecting to the reuse of their health data for scientific research purposes.

Exclusion Criteria:

* Patient who has expressed opposition to the reuse of their data for scientific research purposes.
* Resistance to Cefepime or carbapenems
* Multiple bacteremia
* Treatment with a molecule other than Cefepime or carbapenem.

Primary outcomes:
measure: Hospital mortality
timeFrame: 30 days after infection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des maladies infectieuses et tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04023851: Mobile Application of Seizure Diary (Brain4U) in Epilepsy Care
Official title: Mobile Application of Seizure Diary (Brain4U) in Epilepsy for the Better Patient Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Seizure diary
Mobile application
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 119
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are 2 groups of study population in this study:

Adolescent patients with epilepsy and Parents with epilepsy children.

1. Adolescent patient

   * Participant between the ages of 15-18
   * Participants who are taking antiepileptic drug for seizure control
2. Parents with epilepsy children

   * Participants who have child with epilepsy (ages of 1-15)
   * Participants' child who are taking antiepileptic drug for seizure control

Brief summary: The study is intended to evaluate the impact of mobile application on management and knowledge acquisition in patients with epilepsy.

Detailed description: Investigators assess the general and personal knowledge of epilepsy, compliance of antiepileptic drugs (AED), and self efficacy scale. Participants be asked to use the mobile application (Brain4U) and record seizure type, frequency of seizures, aggravating factors, and adverse events related to antiepileptic drugs for 2 month period.

Eligibility criteria: Inclusion Criteria:

* Participants must be between the ages of 1-99.
* Participants must attend Seoul National University Bundang Hospital Pediatric Neurology Outpatient Clinic.
* Participants under age 18 must have an adult guardian give informed consent.
* Participants must have a functioning smartphone (iOS or Android) which can download the and perform Brain4U application.
* Participants must be able to use mobile application skillfully.

Exclusion Criteria:

* Person who does not have smartphone nor restricted to use mobile application can not participate this study.
* Person with intellectual disability or unable to use mobile application can not participate this study.

Primary outcomes:
measure: Evaluation of knowledge acquisition in epilepsy
timeFrame: 2 months
Secondary outcomes:
measure: AED compliance
timeFrame: 2 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hunmin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01188551: Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
Official title: Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Otitis Media
Keywords: myringotomy
pressure equalization tubes
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.


Eligibility criteria: Inclusion Criteria:

* functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
* patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

* history of allergy to either dexmedetomidine or fentanyl
* concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.

Primary outcomes:
measure: FLACC Behavioral Pain Assessment Scale Scores
timeFrame: 30 mins. post-op
Secondary outcomes:
measure: Recovery From General Anesthesia
timeFrame: 30 mins. post-op
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. doi: 10.1097/01.PCC.0000257100.31779.41.
citation: Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
Clinical trial NCT00658151: Ultrasound Diagnosis of Antibiotic Associated Diarrhea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic-Associated Diarrhea
Keywords: focus
study
evaluate
sonographic
findings
colon
patients
developed
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 100
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: Patients in internal and geriatrics departments who developed diarrhea in a period of 72 hours since the beginning of admission and received antibiotics.

Brief summary: The hypothesis is that there are unique sonographic characteristics of antibiotic-associated diarrhea. We will compare the ultrasound findings in patients who received antibiotics and developed diarrhea to toxin analysis for clostridium difficile in stool in order to find differences in the sonographic findings in the positive and negative cases.


Eligibility criteria: Inclusion Criteria:

* admitted patients who developed diarrhea in 72 hours since the beginning of admission
* patients age above 18 years.
* patients received antibiotics during admission

Exclusion Criteria:

* other reasons of diarrhea
* drugs induced diarrhea
* length of time since the beginning of diarrhea is shorter than 72 hours.
* patients had diarrhea during the first day of admission

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
References: