louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00628589: Staccato Loxapine in Agitated Patients With Schizophrenia
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients With Schizophrenia and Acute Agitation
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Detailed description: This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Eligibility criteria: Inclusion Criteria:

* Male and female adult patients with schizophrenia and acute agitation

Exclusion Criteria:

* Agitation caused primarily by acute intoxication
* History of drug or alcohol dependence
* Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

Primary outcomes:
measure: Change in PANSS-EC From Baseline
timeFrame: Baseline and 2 hours
Secondary outcomes:
measure: Clinical Global Impression-Improvement (CGI-I) Score
timeFrame: Baseline and 2 hours
measure: CGI-I Responders
timeFrame: Baseline and 2 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
Study officials:
affiliation: Alexza Pharmaceuticals, Inc.
name: Robert S Fishman, MD
role: STUDY_DIRECTOR
References:
citation: Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.
citation: Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.
Clinical trial NCT06711289: Predicting If the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck
Official title: Prediction of Hypotension After Spinal Anesthesia by Doppler Measurement of the Corrected Carotid Flow Time and the Peak Velocity Variation Within the Common Carotid Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia-induced Hypotension
Keywords: Spinal anesthesia-induced hypotension
Carotid Doppler ultrasound
Common carotid artery
Corrected carotid flow time
Peak velocity variation
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 44
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 scheduled for elective surgery under spinal anesthesia.

Brief summary: After a spinal injection, blood pressure might drop for a short time, similar to what happens with general anesthesia. This drop can be different for each person. An anesthesiologist will use medicine to bring the blood pressure back to normal. If this drop could be predicted in advance, it would help the anesthesiologist treat it faster, making the procedure even safer and preventing side effects like dizziness or nausea.


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
* Who fasted for 6 hours or more

Exclusion Criteria:

* Age \<18 years old
* No informed consent for study participation
* Contra-indication for spinal anesthesia
* Emergency surgery
* Known poor left or right ventricular function / heart failure
* Moderate to severe valvular disease
* Atrial fibrillation
* Pacemaker rhythm
* Carotid artery stenosis \> 50%
* History of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
* History of cerebral trauma
* Pregnancy
* Neck complaints
* Morbid obesity (BMI \> 40 kg/m2)

Primary outcomes:
measure: Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.
timeFrame: Prior to surgery.
Secondary outcomes:
measure: Correlation between carotid parameters and blood pressure.
timeFrame: Trough study completion, an average of 30 minutes.
Other outcomes:
measure: Intra-observer and inter-observer reproducibility of carotid Doppler parameters.
timeFrame: Prior to surgery.
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis
name: Arthur Bouwman, Professor
role: STUDY_DIRECTOR
References:
citation: J. van Houte. The corrected carotid artery flow time and carotid peak velocity variation do not predict spinal anesthesia-induced hypotension: A prospective observational study. JCA Advances. 2024; 1: 1-8.
Clinical trial NCT05911789: Online Adaptive Radiation Therapy for Rectal Cancer
Official title: A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer
adaptive radiation therapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-06-22
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: In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old;
2. Diagnose with rectal cancer;
3. T3-T4 or N+, and no distant metastasis
4. Neoadjuvant chemoradiotherapy intended;
5. Surgery is expected after neoadjuvant therapy;
6. ECOG score 0-2, expected to lie in the treatment bed for at least half an hour;

Exclusion Criteria:

1. With contraindications to rectal MRI;
2. Received surgery, radiotherapy or chemotherapy for rectal cancer;
3. History of pelvic radiotherapy.

Primary outcomes:
measure: Acute toxicities(CTCA
timeFrame: 3 months for the start of treatment
measure: Response rate after surgery
timeFrame: 3 monsh after treatment
Secondary outcomes:
measure: Chronic toxicity
timeFrame: 2 years after treatment
measure: Dose coverage of target volume (assessed by planing target volume V100%)
timeFrame: Through study completion, an average of five month
measure: Margins for clinical target volume(CTV) and gross tumor volume (GTV)
timeFrame: Through study completion, an average of five month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04035889: Melatonin for Sleep in MS
Official title: A Randomized, Crossover Pilot Trial of Melatonin for Sleep Disturbance in Adults With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Sleep
Melatonin
Sleep disturbance
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Many people with MS report sleep disturbances. However, objective data on sleep quality in MS, such as those obtained using actigraphy, remain scant, as do data about optimal therapeutic management. Melatonin is frequently used to improve sleep parameters, both in healthy and neurological populations. Altered melatonin regulation and signaling has been implicated in MS, through observations including (1) MS risk associated with shift work, (2) contribution of melatonin to seasonal risk of MS relapses, and (3) possible reduction of endogenous melatonin levels from exogenous corticosteroid administration.

To the best of our knowledge, no studies have evaluated melatonin vs. placebo as a low-cost, low-risk agent to treat sleep disturbance in MS. To test this, we are conducting a randomized controlled pilot trial.


Eligibility criteria: Inclusion Criteria:

* Adults aged 20-70 with a diagnosis of MS by 2010 McDonald Criteria or CIS (clinically isolated syndrome), who report sleep disturbance as measured by a score \>=5 on the Pittsburgh Sleep Quality Index, or more specific insomnia symptoms (a score of \>14 on the Insomnia Severity Index) over the past month.
* Participants must be able to read and write English

Exclusion Criteria:

* Individuals with nocturnal asthma, use of melatonin or another sleep agent in the past 2 weeks, women attempting conception, relapse or steroids or infusible disease modifying therapies (DMTs) in prior month.
* Non-English speaking individuals
* Individuals with hypertension, impaired liver function, or seizure disorder
* Individuals with untreated depression, as determined by a score greater than or equal to 8 points on the HADS (Hospital Anxiety and Depression Scale)

Primary outcomes:
measure: Sleep time
timeFrame: 4 weeks
measure: Sleep quality
timeFrame: 4 weeks
Secondary outcomes:
measure: Sleep efficiency
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060109: Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System
Official title: Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Head injury
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2017-02-23
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected head injury subjects over the age of 18 who present to the HCF or ED within 12 hours from the time of head injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.

Brief summary: The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.


Eligibility criteria: Inclusion Criteria:

* The Subject is at least 18 years of age at screening.
* The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
* The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
* The venous blood sample is collected no later than 12 hours from the time of head injury.
* The Subject is competent and willing to undergo the Informed Consent process

Exclusion Criteria:

* Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
* Time of suspected head injury cannot be determined.
* Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
* Blood transfusion after head injury, and prior to study blood draw
* Blood donation within 1 week of study enrollment.
* The subject is a female who is pregnant or lactating.
* The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation

Primary outcomes:
measure: Measurement of biomarkers
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: The Hague
country: Netherlands
facility: Haaglanden MC Westeinde
Study officials:
References:
Clinical trial NCT00159809: Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction
Official title: A Multi-Center, Flexible Dose Study With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Evaluate The Impact Of Treatment With Sildenafil Citrate On The Symptoms Of Depression And Quality Of Life (Qol) Of Male Patients With Erectile Dysfunction (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-09-12
Enrollment: 140
Sex: MALE
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 will measure the impact of treatment with Viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS), including minor depressive symptoms but excluding any form of psychotic disorder.


Eligibility criteria: Inclusion Criteria:

* Men above age of majority with ED (SHIM score less than 21)
* Beck Depression Inventory II score between 14 and 28

Exclusion Criteria:

* Subjects with symptoms of mania or major depressive disorders as demonstrated by the Mini International Neuropsychiatric Interview (MINI)
* Subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months

Primary outcomes:
measure: Describe the effect of treatment with sildenafil on the depressive symptoms in subjects with ED as measured by the BDI II at the end of the double-blind phase
Secondary outcomes:
measure: Measure QoL improvement; Describe treatment effect on social motivation & behavior; Describe relationship between depression severity and ED; Describe effectiveness of sildenafil; Describe correlation between the SEX FX and the IIEF; Validate the PREFA
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03390309: Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
Official title: Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms

Detailed description: This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.

Eligibility criteria: Inclusion Criteria:

* Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
* Infant is between 30-180 days of age.
* Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

* Complementary food was added for infants or parents are willing to add complementary food during study.
* Suffer from infection/illness.
* Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Infant has visible bloody stools (detected before enrollment) prior to enrollment.
* Participation in another study.

Primary outcomes:
measure: Change of total symptom score of infant feeding & stool pattern questionnaire.
timeFrame: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01342809: Follow up by General Practitioner After Self-poisoning
Official title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal and Self-injurious Behaviour
Keywords: Depression
Hopelessness
Suicidal ideation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Lovisenberg Diakonale Hospital
name: Diakonhjemmet Hospital
First posted: 2011-04-27
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.

Detailed description: Patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. The intervention is close follow up by general practitioner six months. Both groups will receive treatment as usual.

Eligibility criteria: Inclusion Criteria:

* Self Poisoning (according to the WHO definition)
* Ability to fill out questionnaire

Exclusion Criteria:

* Hospitalization into psychiatric ward
* Unknown address or ID
* Not registered with General Practitioner
* If institutionalized or in jail.

Primary outcomes:
measure: Suicidal behaviour
timeFrame: 3 and 6 months
measure: Suicidal behaviour
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Treatment
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Effect of Systematic Follow-Up by General Practitioners after Deliberate Self-Poisoning: A Randomised Controlled Trial. PLoS One. 2015 Dec 2;10(12):e0143934. doi: 10.1371/journal.pone.0143934. eCollection 2015.
citation: Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Structured follow-up by general practitioners after deliberate self-poisoning: a randomised controlled trial. BMC Psychiatry. 2015 Oct 14;15:245. doi: 10.1186/s12888-015-0635-2.
Clinical trial NCT01561209: Low Doses Amitriptyline & Chronic Neck Pain
Official title: Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neck Pain
Keywords: amitryptiline
Chronic pain
Neck pain
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.

Detailed description: Patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-Amitriptyline 5 mg for 2 months 2- placebo for 2 months. Co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to Visual Analog Scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (Bergen insomnia scale, neck pain disability score, neck pain diary \& anxiety and depression score). Patients are followed at 2 months and outcome measures are assessed.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain (since more than 3 months, and more than 15 days/month)
* Normal neurologic exam
* X-ray = normal or loss of lordosis

Exclusion Criteria:

* Neurologic signs or symptoms
* Past history of neck surgery
* MRI = abnormal findings except for loss of lordosis
* Past cervical trauma
* severe depression
* drug abuse
* pregnancy
* Follow-up not possible
* cardiac rhythms problems
* Glaucoma
* Urinary tract obstruction or prostatism

Primary outcomes:
measure: Change in Visual analog scale (VAS)
timeFrame: 0 and 2 months after treatment
Secondary outcomes:
measure: Change in Bergen insomnia score
timeFrame: 0, 2 months
measure: Change in Neck pain disability score
timeFrame: 0, 2 months
measure: side effects
timeFrame: Up to 12 weeks after treatment
measure: Percentage of satisfaction
timeFrame: 2 months after treatment
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 and 2 months after treatment
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de france Hospital
Study officials:
affiliation: St Joseph University, Beirut, Lebanon
name: Joseph Maarrawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: