louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01566786: Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
Official title: Randomised, Double-Blind, Placebo-Controlled, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Intracerebral Haemorrhage
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).


Eligibility criteria: Inclusion Criteria:

* Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset
* Signed informed consent form, or in countries where waiver of informed consent is allowed by IRB/IEC, a completed waiver form

Exclusion Criteria:

* Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT
* Patients with secondary ICH related to infarction, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM) or severe trauma
* Surgical haematoma evacuation planned or performed within 24 hours of onset

Primary outcomes:
measure: Change in ICH volume as measured by CT head scans
Secondary outcomes:
measure: Occurrence of adverse events
measure: Occurrence of serious adverse events
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Copenhagen
country: Denmark
facility: Novo Nordisk Investigational Site
city: Jyväskylä
country: Finland
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Girona
country: Spain
facility: Novo Nordisk Investigational Site
city: Taiwan
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Newcastle
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Europe/AustralAsia NovoSeven ICH Trial Investigators. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005 Jan;36(1):74-9. doi: 10.1161/01.STR.0000149628.80251.b8. Epub 2004 Nov 29.
Clinical trial NCT04927286: Implementing Learning 2 BREATHE in Campus Connections
Official title: Implementing Learning 2 BREATHE in Campus Connections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Keywords: adolescents
mindfulness
ecological momentary assessment
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 103
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to investigate a mindfulness-based intervention's feasibility/acceptability and effectiveness for improving eating behaviors and depression symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based mentoring program for being "at-risk for not reaching their full potential" (e.g., Department of Human Services involvement, behavioral/emotion problems). As a part of this study, we will also characterize the real-time relationships among life stressors, untrained state mindfulness, and emotion regulation difficulties in adolescents' daily lives and determine to what extent an MBI helps adolescents to maintain mindfulness and emotion regulation in moments when they experience a stressor.


Eligibility criteria: Inclusion Criteria:

* Mentees (adolescents) participating in campus connections who are 9-18y and English speaking

Exclusion Criteria:

* Mentees (adolescents) that are not participating in campus connections

Primary outcomes:
measure: Reward-based Eating Behaviors
timeFrame: Through study completion, an average of 6 months
measure: Internalizing and Externalizing Symptoms
timeFrame: Through study completion, an average of 6 months
measure: Mindfulness
timeFrame: Through study completion, an average of 6 months
measure: Emotion Regulation
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State Univeristy
state: Colorado
Study officials:
References:
Clinical trial NCT01471886: Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Official title: Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 83
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: The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

Detailed description: * double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
* Experiment duration: 04 days.
* 03 visits (days 0, 2 and 4).
* Efficacy will be evaluated for back pain relief based on visual analog scale.
* Adverse events evaluation.

Eligibility criteria: Inclusion Criteria:

* Consent of the patient or legal guardian.
* Men or women aged between 18 and 65.
* Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm)

Exclusion Criteria:

* fracture confirmed by X-ray
* Diagnosis of infection, fever,
* Pregnancy, lactation;
* Diagnosis of fibromyalgia;
* Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory

Primary outcomes:
measure: Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).
timeFrame: 4 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: day 4
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IOT - Instituto de Ortopedia e Traumatologia
state: SP
Study officials:
affiliation: Instituto do Coracao
name: Pérola Plaper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plapler PG, Scheinberg MA, Ecclissato Cda C, Bocchi de Oliveira MF, Amazonas RB. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain. Drug Des Devel Ther. 2016 Jun 17;10:1987-93. doi: 10.2147/DDDT.S97756. eCollection 2016.
Clinical trial NCT03887286: Focused Cardiac Ultrasound
Official title: Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Dysfunction
Pericardial Effusion
Valvular Disease
Septal Defect
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
* Willing and able to provide informed consent or assent.
* In clinically stable condition as assessed by the principal investigator..
* With adequate echocardiographic windows.

Exclusion Criteria:

* Patients with poor echocardiographic windows.
* Patients who refuse informed consent.
* Pregnant women.
* Prisoners.
* Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.

Primary outcomes:
measure: Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Mary Sokoloski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376086: Segmental Epidural Block for Feeding Jeujunostomy in Cancer Patients
Official title: Segmental Epidural Block for Feeding Jejunostomy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy

Detailed description: Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy

Eligibility criteria: Inclusion Criteria:

* patients scheduled for surgical feeding jejunostomy more than 18 years old

Exclusion Criteria:

* patien refusal Coagulation defect Abnormal kidney or liver functions Local infection at site of block Bone metastases

Primary outcomes:
measure: Analgesic requirements
timeFrame: first 24 hours
measure: Haemodynamics
timeFrame: periooperative time
Secondary outcomes:
measure: VAS score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Lecturer
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168986: The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Official title: The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neck Pain
Keywords: neck pain
manual therapy
exercise
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.


Eligibility criteria: Inclusion Criteria:

* currently experiencing neck pain which does not extend below the elbow
* pain at least 4/10 over the past 24 hours
* appropriate for conservative management of neck pain
* english speaking

Exclusion Criteria:

* surgery to the neck within the past 6 months
* systemic problem know to affect sensation
* other chronic pain condition other than neck pain
* neck pain as the result of trauma such as whiplash
* neck pain as the result of a fracture

Primary outcomes:
measure: 2 Week Change in Pain Score on a Numeric Rating Scale
timeFrame: 2 weeks
measure: 2 Week Change in Disability on the Neck Disability Index
timeFrame: 2 weeks
measure: Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
timeFrame: Immediate within session change pre to post intervention
Secondary outcomes:
measure: Change From Baseline in Neck Extension Range of Motion at 2 Weeks
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joel E Bialosky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098786: Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine
Official title: Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swine-Origin Influenza A H1N1 Virus
Keywords: Influenza A
H1N1 subtype
Vaccine
Adjuvant
Cell culture
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-05
Enrollment: 556
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy Japanese

Exclusion Criteria:

1. The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
2. The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.

   The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
3. The person shows obvious fever.
4. The person obviously suffers from serious acute disease.
5. The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
6. The person is otherwise in an inappropriate state to receive preventive vaccination.

Primary outcomes:
measure: Evaluate clinical symptoms according to the subject background after vaccination
timeFrame: 28 days
Secondary outcomes:
measure: The kinds, degrees, durations and onset ratios of adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
state: Kumamoto
Study officials:
References:
Clinical trial NCT02043886: Acarbose, Postprandial Hypotension and Type 2 Diabetes
Official title: The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Postprandial Hypotension
Keywords: Type 2 Diabetes, Postprandial Hypotension, Acarbose
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2014-01-23
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.

The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.

Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.

This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.


Eligibility criteria: Inclusion Criteria:

* age 65 year and older
* Type 2 diabetes

Exclusion Criteria:

* less than 65 years of age

Primary outcomes:
measure: Heart rate
timeFrame: continuously during Meal Test; about 4 hours
measure: Blood pressure
timeFrame: Continuously during Meal Tests (approximately 4 hours)
measure: Middle cerebral artery velocity
timeFrame: continuously during Meal Tests (approximately 4 hours)
measure: Serum glucose
timeFrame: Every 15 minutes during Meal Tests
measure: Serum insulin
timeFrame: Every 15 minutes during Meal Tests (approximately 4 hours)
measure: Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)
timeFrame: Every 15 minutes during Meal Tests (approximately 4 hours)
measure: Catecholamines
timeFrame: Continuously during Meal Test (approximately 4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: VITALiTY Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kenneth M Madden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195286: Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.
Official title: Study of the Safety and Efficacy of Piperacillin/Tazobactam in the Treatment of Patients With Complicated Urinary Infections.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Infections
Keywords: Urinary Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at internal medicine units

Brief summary: The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with Piperacillin-tazobactam.

Exclusion Criteria:

* Patients known, or thought to be hypersensitivity to beta-lactams
* Patients with an uncomplicated urinary tract infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antequera (Málaga)
country: Spain
city: Avila
country: Spain
city: Barcelona
country: Spain
city: Berga (Barcelona)
country: Spain
city: Caceres
country: Spain
city: Castellón
country: Spain
city: Ciudad Real
country: Spain
city: Cuenca
country: Spain
city: Cádiz
country: Spain
city: Ferrol
country: Spain
city: Granada
country: Spain
city: Jaen
country: Spain
city: Las Palmas
country: Spain
city: Lorca (Murcia)
country: Spain
city: Lugo
country: Spain
city: Lérida
country: Spain
city: Madrid
country: Spain
city: Osuna (Sevilla)
country: Spain
city: Palma Mallorca
country: Spain
city: Pamplona
country: Spain
city: Pontevedra
country: Spain
city: Terrasa
country: Spain
city: Torrelavega
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Vitoria
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02147886: Study To Assess Safety, Tolerability and Efficacy of Intravenous Cabaletta in Patients With Machado-Joseph Disease
Official title: A Single-Center, Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study, to Assess Safety, Tolerability and Efficacy of Intravenous Cabaletta® in Patients With Machado-Joseph Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Machado-Joseph Disease / Spinocerebellar Ataxia 3
Keywords: Bioblast, Randomized, parallel-group, and dose-controlled
Lead sponsor: Bioblast Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 15
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: * This is an exploratory, randomized, parallel-group, dose escalation and dose-controlled study without a placebo arm.
* Eligible patients will be randomized in a 1:1 ratio (double-blind) to receive Cabaletta in 2 doses, once weekly for 22 weeks (total of 24 weeks of treatment).


Eligibility criteria: Inclusion Criteria:

1. Men and women, 18 - 75 years
2. Clinically diagnosed as Machado-Joseph disease/Spinocerebellar ataxia 3 confirmed by genetic testing
3. With disease stage 2 or less
4. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
5. Body Mass Index (BMI) ≤32 kg/m2.
6. Ability to ambulate with or without assistance

Exclusion Criteria:

1. Diabetes mellitus type 1 or 2
2. Other major diseases
3. Uncontrolled heart disease, chronic heart failure (CHF).
4. Other neurological diseases.
5. Ataxia derived from any other cause than genetically-confirmed spinocerebellar ataxia
6. Presence of psychosis, bipolar disorder, untreated depression
7. History of malignancy (except non-invasive skin malignancy).

Primary outcomes:
measure: Adverse events
timeFrame: 28 weeks
measure: Physical examination
timeFrame: 28 weeks
measure: Vital signs
timeFrame: 28weeks
measure: 12-lead ECG
timeFrame: 28weeks
measure: Safety laboratory tests
timeFrame: 28weeks
Secondary outcomes:
measure: Disease markers
timeFrame: 27 weeks
Other outcomes:
measure: Biochemical marker
timeFrame: 27 weeks
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center Kfar Saba Israel
name: Carlos Gordon, Prof.
role: PRINCIPAL_INVESTIGATOR
References: