louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00418769: Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers
Official title: A Randomized, Open Label, Two-arm, Three Period Crossover Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: nilotinib
bioavailability
tablet
capsule
PK
healthy, subject(s),
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bioavailability study comparing two new nilotinib tablet formulations to an established nilotinib capsule formulation in healthy volunteers


Eligibility criteria: Inclusion

1. Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects
2. Body weight must be ≥50 kg and \<100 kg, with a body mass index (BMI) \>18 but \<33.
3. Laboratory parameter values must fall within the normal range

Exclusion

1. Female who is pregnant or breast feeding.
2. Contraindication to receiving nilotinib.
3. Smokers or user of tobacco products
4. A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: bioavailability of nilotinib
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03507569: Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Official title: A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-04-25
Enrollment: 6
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the Investigator.
* Males and women of non-childbearing potential (WONCBP)

Exclusion Criteria:

* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections
* Clinically significant abnormal finding from the MRI performed after the initial screening examination
* Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
* Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

Primary outcomes:
measure: Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
timeFrame: Baseline up to 48 hours (hrs)
measure: Plasma Concentrations of RO7017773
timeFrame: Baseline up to 48 hrs
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From treatment initiation until 14 days after the last dose of study treatment.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research; Central Middlesex Hospital
Study officials:
References:
Clinical trial NCT01248169: Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy
Official title: Impedance Cardiographic Assessment of Gravidas With Severe Hypertension (ICASH)to Assess Impact of Standard Therapy on Hemodynamic Parameters - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia)
Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe)
Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous or parous patients with severe hypertension, a singleton gestation, gestational age greater than 20 weeks along who are admitted to the Wiser Hospital for Women and Infants at the University of Mississippi Medical Center.

Brief summary: The utilization of external cardiohemodynamic patient assessment, applying non-invasive stick-on contact patches to the mother's neck on either side and chest wall on either side, enables the practitioner to have information about the patient's cardiac function and vascular status beyond simply blood pressure and pulse. This information, once collected, should open the practitioner's eyes to better assess the patient's disease status and her response to therapy. We will use this information to compare the effectiveness of the two standard medications used for treatment of maternal high blood pressure.

Detailed description: Pregnant patients with severe acute hypertension due either to superimposed preeclampsia, severe preeclampsia or severe gestational hypertension will be randomized to receive either of two antihypertensive agents (hydralazine or labetalol). Just before drug administration and immediately thereafter impedance cardiography of the patient will be undertaken and the results analyzed relative to the cardiac profile and the drug administered to reduce the severe hypertension.

Eligibility criteria: Inclusion Criteria:

* Nulliparous or parous patients with severe hypertension
* Singleton gestation
* Gestational age greater than 20 weeks

Exclusion Criteria:

* Multiple gestation
* Gestational age less than 20 weeks

Primary outcomes:
measure: Usefulness of Impedance Cardiography (ICG) in pregnant women with hypertension
timeFrame: 36
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Wiser Hospital for Women and Infants at the University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: SOM-Obstetrics & Gynecology
name: James N Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02853669: Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement
Official title: Adductor Canal Block Versus Lumbar Plexus Block for Post Operative Pain Management After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adductor canal block (ACB), Saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. Also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (\*).On the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. Likewise, the great variation of the knee nerve supply.

This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.

This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

Detailed description: This prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (ACB) versus ultrasound-guided lumbar plexus block (LPB) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy.

This study hypothesizes that ACB, compared with LPB, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Age more than 25 and less than 80 were included

Exclusion Criteria:

* Patients with known allergy to the medications to be given
* ASA III, IV
* Age less than 25 or more than 80
* Dementia
* Deafness
* Psychological disease
* Difficult to communicate
* Cannot lay flat
* INR more than 1.5
* Low platelets (less than 100000/ml3) or with significant coagulopathy

Primary outcomes:
measure: pain
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Anesthesia department, faculty of medicine ,Cairo university
name: Hassan Ali, LECTURER
role: STUDY_DIRECTOR
References:
Clinical trial NCT04313569: Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function
Official title: Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function: Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Chronic
Keywords: Degenerative meniscal tear
arthroscopic partial meniscectomy
conservative treatment
medial meniscal tear
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arthroscopic meniscectomy
Primary purpose: TREATMENT

Brief summary: The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated conservatively, thirty patients were treated arthroscopically.


Eligibility criteria: Inclusion Criteria:

1. Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
2. Grade 3 degenerative tear of medial meniscus approved on MRI.

Exclusion Criteria:

1. Meniscal tear due to trauma.
2. Any rheumatologic knee disease.
3. MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
4. Former surgery of knee and lower limb fractures in the last year.
5. Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
6. Lateral meniscus tear.

Primary outcomes:
measure: Lysholm Knee Scoring Scale
timeFrame: All patients were reviewed and evaluated one year, by Lysholm score
measure: Visual analogue score
timeFrame: All patients were reviewed and evaluated one year, by Visual Analogue score scales
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Sherwan Hamawandi
Study officials:
References:
Clinical trial NCT04651569: An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer
Official title: A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma Recurrent
Lead sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 26
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with relapsed/ refractory osteosarcom

Brief summary: A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma


Eligibility criteria: Inclusion Criteria:

* Diagnosis of high risk relapsed/ refractory osteosarcoma
* Aged \<= 40 years at the beginning of treatment
* at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
* disease evaluation according to RECIST criteria v.1.1

Exclusion Criteria:

* none

Primary outcomes:
measure: Progression Free Survival
timeFrame: Evaluated during the first 4 months at the end of treatment
measure: growth modulation index - GMI
timeFrame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
measure: toxicity according to CTCAE v.5.0
timeFrame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Milan
country: Italy
facility: IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria
city: Roma
country: Italy
facility: Regina Elena National Cancer Institute IRCCS
city: Torino
country: Italy
facility: OIRM - AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Celeste Cagnazzo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03151369: Visual Pain Score and Perfusion Index in Postoperative Patients
Official title: The Relationship Between Visual Pain Score and Perfusion Index in Postoperative Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perfusion
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The relationship between visual pain score and perfusion index in postoperative patients.

Detailed description: The patients' operated with general anesthesia and who had visual pain score(VAS) above 3 will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of morphine will be made. When the VAS score is below 3, the perfusion index will be measured again.Thus, the changes between vas and perfusion index will be measured.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent surgery with general anesthesia

Exclusion Criteria:

* Patients with caesarean section, pregnancy story and chronic pain

Primary outcomes:
measure: Perfusion index Perfusion index
timeFrame: two times in one day
Secondary outcomes:
measure: visual analog scale
timeFrame: two times in one day
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Assistant professor
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05230069: Emergency Call for Heart Attack and Stroke (ECHAS) - ECHAS One Study
Official title: Assessment of a Prehospital Mobile App and Sensor Triage System to Detect Neurologic and Cardiac Emergencies: The ECHAS Assessment Study (ECHAS- One)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Attack and Stroke
Keywords: Triage
Smartphone
Lead sponsor: Emergency Call for Heart Attack and Stroke (ECHAS)
Sponsor class: INDUSTRY
Collaborators: name: University of Saskatchewan
First posted: 2022-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients who activated emergency system for symptoms of possible heart attack or stroke.

Brief summary: ECHAS One will test the use of a smartphone app to assist patients to decide if it is necessary to call for emergency care with symptoms that could represent a heart attack or stroke.

Detailed description: The ECHAS One Study will be conducted in 200 patients who have already called for emergency care for a heart or stroke, and have been evaluated. The endpoint of the study will be a decision if the initial call was an appropriate call for emergency care. The sensitivity of the app for detecting appropriate calls will be assessed.

Eligibility criteria: Inclusion Criteria:

* Presented to ED via emergency medical services (EMS) for "Stroke alert" symptoms, including:

Slurred speech Asymmetric weakness or numbness Balance problems Vision changes Headache

And/or "MI alert" symptoms including:

Chest discomfort Chest pressure or pain Palpitations Shortness of breath Lightheadedness or presyncope Syncope Age ≥ 18 years Able to provide informed consent

Exclusion Criteria:

* Non-English speaking
* Moderate or greater dementia
* Severe visual impairment
* Inability to use smartphone (for physical, cognitive, or other reasons)
* Unable to consent for study

Primary outcomes:
measure: Appropriate Emergency Activation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CEO, ECHAS, LLC
name: James E Muller
role: STUDY_DIRECTOR
References:
Clinical trial NCT00893269: The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Official title: The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Marijuana Dependence
Keywords: marijuana
cannabis
dependence
withdrawal
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Institute on Drug Abuse (NIDA)
First posted: 2009-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.


Eligibility criteria: Inclusion Criteria:

* current use of marijuana
* able to give informed consent

Exclusion Criteria:

* dependence on drug other than marijuana
* current sleep disorder
* pregnant, breast feeding, or planning to become pregnant within the next 3 months
* currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
* use of cannabis under the guidance of a physician for a medical disorder
* unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
* allergy to study medication

Primary outcomes:
measure: Marijuana Withdrawal
timeFrame: Every day during study participation
Secondary outcomes:
measure: Objective Sleep Assessment
timeFrame: Every day during study participation
measure: Cognitive Performance
timeFrame: Every day during study participation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ryan Vandrey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.
citation: Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.
Clinical trial NCT05924269: Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)
Official title: Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Keywords: Neuronal Guidance Protein
Acute Kidney Injury
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery followed by postoperative surveillance in the intensive care unit

Brief summary: Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery
* written consent

Exclusion Criteria:

* no written consent possible
* Polytrauma, severe burns
* Immunosuppression
* Pregnancy
* Diagnosis of Hepatitis B, Hepatitis C, and/or HIV
* Sepsis
* Pre-existing kidney damage

Primary outcomes:
measure: AKI
timeFrame: 1-7 days
Secondary outcomes:
measure: NGP
timeFrame: 1-7 days
Other outcomes:
Locations:
Study officials:
affiliation: University Clinic of Tuebingen
name: Andreas Körner, MD
role: PRINCIPAL_INVESTIGATOR
References: