louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03269435: Greater Occipital Nerve Block Versus Metoclopramide
Official title: A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 99
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: We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.


Eligibility criteria: Inclusion Criteria:

Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.

Exclusion Criteria:

Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Primary outcomes:
measure: 0-10 Pain Score
timeFrame: one hour
Secondary outcomes:
measure: Sustained Headache Relief
timeFrame: 48 hours
measure: Sustained Headache Freedom
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT03612635: Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications
Official title: Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Implantable Electronic Device Complications
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 2811
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).

Brief summary: The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.

Detailed description: Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.

Exclusion Criteria:

* patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.

Primary outcomes:
measure: All-cause Death (dead/alive status assessment during follow-up)
timeFrame: An average of 48 months
Secondary outcomes:
measure: Occurrence of hospitalizations related to cardiac implantable electronic device complications
timeFrame: An average of 48 months
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: "Card. G. Panico" Hospital
state: Lecce
city: Ancona
country: Italy
facility: Federico Guerra
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Genova
country: Italy
facility: Mattia Laffi
city: Napoli
country: Italy
facility: Monaldi Hospital
city: Novara
country: Italy
facility: AOU "Maggiore della Carità"
Study officials:
References:
Clinical trial NCT03148535: Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
Official title: Clinical Psychopharmacology Division Institute of Mental Health, Peking University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: the Use of Antidepressants in Patients With Bipolar Depression
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The bipolar depression patients of 18-55 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological, neurobiological and genetic data was collected. After the completion of the baseline assessment and examination, the patients were given lithium carbonate or lithium carbonate combined with SSRI antidepressant treatment. Clinical evaluation was performed at 2 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions, and monitoring of serum lithium concentration. The patients further receive the fMRI scans after treatment for 8 weeks. Through above work, this study aimed to provide some guidance for the use of antidepressants in patients with bipolar depression.


Eligibility criteria: Inclusion Criteria:

* age 18-55 years old, bipolar depression

Exclusion Criteria:

* other mental illness, serious somatic illnesses, MRI contradictions.

Primary outcomes:
measure: HRSD reduction ratio
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of mental health, Peking University
state: Beijing
city: Shijiazhuang
country: China
facility: The first hospital of Hebei Province University
state: Hebei
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Dalian
country: China
facility: Dalian No.7 People's Hospital
state: Liaoning
Study officials:
References:
Clinical trial NCT06090435: Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women
Official title: Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Imagery
Action Observation
Therapeutic Exercise
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both motor imagery and action observation training, either alone or in combination with physical practice, have been shown to improve some clinical variables of interest such as strength and motor control. However, this has not yet been investigated in the pelvic floor musculature.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age and asymptomatic women.

Exclusion Criteria:

* This study will exclude those who presented a respiratory pathology, cardiac, systematic, or metabolic disease, history of recent surgery, vertebral fracture, or osteoarticular disorders of the spine area.

Primary outcomes:
measure: maximal pelvic floor muscle strength (measured in grams and with the phenix device)
timeFrame: pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
measure: Algometry for assessing pressure pain thresholds (Pain sensitivity)
timeFrame: pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
measure: Motor control of the lumbopelvic area assessed with a biofeedback device.
timeFrame: pre-intervention (T0), at one week after the intervention (T1) and at two weeks after starting the intervention (post-intervention (T2)).
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ferran Cuenca Martínez
Study officials:
References:
Clinical trial NCT01173835: Incentive-based Intervention for Smoking Cessation and Prevention in High Schools
Official title: Incentive-based Intervention for Smoking Cessation and Prevention in High Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Prevention and Cessation
Keywords: Adolescent tobacco use
Tobacco Free and Win
Incentive-based intervention
Contingency Management
Smoking Prevention
Smoking cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-02
Enrollment: 1651
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial.

The study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.


Eligibility criteria: Inclusion Criteria:

* high school student at school that is invited to participate

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: The number of students who join the tobacco free program
timeFrame: at the end of each academic year
Secondary outcomes:
measure: Change in tobacco use rates and attitudes following the intervention exposure
timeFrame: at the end of each academic year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC, Substance Abuse Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741635: The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Official title: The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.

A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.

The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* AHI ≥ 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal pillows mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks
timeFrame: 12 hours
Secondary outcomes:
measure: Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask
timeFrame: 12 hours
measure: Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask
timeFrame: 12 hours
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare Ltd
state: East Tamaki
Study officials:
affiliation: Sponsor Employee
name: Bhavi Ogra, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563535: Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Artery Disease
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 105
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 aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* critical limb ischemia (Rutherford class 4-6)
* angiographic stenosis\>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion Criteria:

* need for major amputation known before intervention
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent

Primary outcomes:
measure: Late Lumen Loss (LLL) in the target lesion documented by angiography
timeFrame: 6 months
Secondary outcomes:
measure: Number of events of angiographic occlusive restenosis
timeFrame: 6 months
measure: Number of events of target lesion revascularization (TLR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
Clinical trial NCT01362335: Nexfin®-Monitoring System
Official title: Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, that are having a routine surgical procedure.

Brief summary: In many surgical procedures, anaesthesiological care is provided according to the best scientific and clinical information available. However, since hemodynamic monitoring until recently did not allow for beat-to-beat information of the haemodynamical changes, many fast-changing events may have been unnoticed or have not been investigated as precisely as is possible today. Moreover, in several surgical procedures - like eye surgery - the invasiveness of the classical haemodynamical monitoring devices was of such a degree that until now, in these circumstances these vital parameters were not investigated yet.

Therefore, the availability of this new device, which allows for noninvasive beat-to-beat assessment of these haemodynamical parameters gives a unique opportunity to investigate our anaesthesiological management and to elucidate whether improvements are desirable and possible.

The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger. It simultaneously uses continuous pressure readings and light-absorption spectrometry to determine valuable haemodynamical information. Data is recorded and available for subsequent offline analysis.


Eligibility criteria: Inclusion Criteria:

* Patients that are accepted for surgery

Exclusion Criteria:

* Patients unable or unwilling to provide consent.

Primary outcomes:
measure: haemodynamical changes after several surgical and anaesthesiological interventions.
timeFrame: 30 minutes - 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Alain F Kalmar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vos JJ, Poterman M, Mooyaart EA, Weening M, Struys MM, Scheeren TW, Kalmar AF. Comparison of continuous non-invasive finger arterial pressure monitoring with conventional intermittent automated arm arterial pressure measurement in patients under general anaesthesia. Br J Anaesth. 2014 Jul;113(1):67-74. doi: 10.1093/bja/aeu091. Epub 2014 Apr 15.
Clinical trial NCT00198835: Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India
Official title: Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underweight
Stunting
Wasting
Anemia
Keywords: malnutrition
anemia
infants
children
India
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2005-09-20
Enrollment: 17000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.


Eligibility criteria: Inclusion Criteria:

* Mothers with a child 0-23 months of age
* Children 0-23 months of age
* Currently pregnant women
* Resides in the program or control area

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of underweight among children 0-23 months
measure: Prevalence of stunting among children 0-23 months
measure: Prevalence of wasting among children 0-23 months
measure: Prevalence of anemia among children 12-23 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: King George Medical University
state: Uttar Pradesh
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Michele L Dreyfuss, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. An integrated nutrition and health program package on IYCN improves breastfeeding but not complementary feeding and nutritional status in rural northern India: A quasi-experimental randomized longitudinal study. PLoS One. 2017 Sep 20;12(9):e0185030. doi: 10.1371/journal.pone.0185030. eCollection 2017.
citation: Singh V, Ahmed S, Dreyfuss ML, Kiran U, Chaudhery DN, Srivastava VK, Ahuja RC, Baqui AH, Darmstadt GL, Santosham M, West KP Jr. Non-governmental organization facilitation of a community-based nutrition and health program: Effect on program exposure and associated infant feeding practices in rural India. PLoS One. 2017 Sep 14;12(9):e0183316. doi: 10.1371/journal.pone.0183316. eCollection 2017.
Clinical trial NCT01251835: Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
Official title: A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Keywords: Sitaxsentan
Rifampin
Drug Interaction
Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or women of non-child bearing potential.
* Subjects between the ages of 21 and 55 years, inclusive.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Has hepatic dysfunction.
* Has history of excessive alcohol and tobacco use.

Primary outcomes:
measure: Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
timeFrame: 24 hours
measure: Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: