louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02053454: A Study of the Safety, Tolerability and Pharmacokinetics of ALN-TTR02 in Japanese Healthy Volunteers
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Japanese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Transthyretin (TTR)-Mediated Amyloidosis
Keywords: RNAi therapeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese adult males and females aged 20 to 65 years, inclusive (The subject was born in Japan and has lived outside of Japan for \<10 years, and subject's biological parents and grandparents are fully Japanese and were born in Japan);
* Subjects who are healthy as determined by clinical assessments;
* Females subjects must be of non-childbearing potential;
* Males with partners of child-bearing potential, must agree to use appropriate contraception.

Exclusion Criteria:

* Subjects with a history of serious mental illness;
* Subjects who have a clinically relevant medical or surgical history;
* Subjects with a positive screen for alcohol or drugs of abuse;
* Subjects with safety laboratory test results deemed clinically significant;
* Subjects with known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;
* Subjects who have received an investigational agent within the 3 months prior to study entry.

Primary outcomes:
measure: The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation
timeFrame: Up to 28 days
Secondary outcomes:
measure: Pharmacodynamics (PD) of ALN-TTR02 (serum concentrations of Transthyretin, Vitamin A, and Retinol Binding Protein)
timeFrame: Up to 90 days
measure: Observed maximum concentration (Cmax) of ALN-TTR02
timeFrame: Up to 90 days
measure: Time of observed maximum concentration (tmax) of ALN-TTR02
timeFrame: Up to 90 days
measure: Area under the plasma concentration versus time curve (AUC) of ALN-TTR02
timeFrame: Up to 90 days
measure: Terminal elimination half-life (t1/2) of ALN-TTR02
timeFrame: Up to 90 days
measure: Systemic clearance (CL) of ALN-TTR02
timeFrame: Up to 90 days
measure: Volume of distribution (V) of ALN-TTR02
timeFrame: Up to 90 days
measure: Renal clearance (CLR) of ALN-TTR02
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Jared Gollob, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04963933: A Medical Device to Treat Brain Aneurysms
Official title: Treatment of Ruptured and Unruptured Wide-Neck Aneurysms With Nautilus™ Device Assisted Occlusion (TORNADO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Aneurysm
Lead sponsor: EndoStream Medical
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 30
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: An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms.

The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

Detailed description: Patients will be treated with the Nautilus, then will be followed up for up to 6 months.

Eligibility criteria: Inclusion Criteria:

\* Patients who present with intracranial aneurysm

Exclusion Criteria:

\* Unstable neurological deficit

Primary outcomes:
measure: Serious Adverse Events
timeFrame: 3-6 months
measure: Probable benefit
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: St. Ivan Rilski University hospital
city: Riga
country: Latvia
facility: Paula Stradina university hospital
Study officials:
References:
Clinical trial NCT03653533: Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
Official title: Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type I Diabetes
Lead sponsor: ARAIR Assistance
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.

Detailed description: The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.

There are several phases:

* phase 1: insulin pump without captor (12 weeks)
* phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)
* phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)
* phase 4: insulin pump without captor (4 weeks)

Eligibility criteria: Inclusion Criteria:

* type I diabetic patients undr basal/prandial diet
* treated by insuline
* with no insuline pump during at least 3 months
* with HbA1C dosed during the 3 months before inclusion

Exclusion Criteria:

* minor patients
* pregnant woman
* already participating to another studies

Primary outcomes:
measure: Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Pole Sante Sud Le Mans
Study officials:
References:
Clinical trial NCT02850133: Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury
Official title: Effect of Aerobic Exercise Training on the Blood Biochemical Factors and Peripheral Hemodynamics in Person With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2016-07-29
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Background:

Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI.

Method:

Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.

Detailed description: The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.

Eligibility criteria: Inclusion Criteria:

* age \>20 years, male sex, and onset of injury more than one year

Exclusion Criteria:

* known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers

Primary outcomes:
measure: serum myokines
timeFrame: 12-16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05228054: Treatment of Hemorrhoid With 1940nm Laser Procedure
Official title: Treatment of Hemorrhoid With 1940nm Laser Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Keywords: hemorrhoids, laser, sclerotherapy
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2022-02-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with hemorrhoids 2-3st will be randomized in two groups
Primary purpose: TREATMENT

Brief summary: Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol

Detailed description: Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.

Follow up for one year. Primary end point - recurrence of hemorrhoids desease.

Eligibility criteria: Inclusion Criteria:

hemorrhoids 2-3st

Exclusion Criteria:

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Primary outcomes:
measure: Reccurence rate
timeFrame: 12 months
Secondary outcomes:
measure: Pain intensity
timeFrame: 7 days
measure: QoL
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT01248754: Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study
Official title: A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer (High-grace Glioma)
Keywords: Neurosurgery
Neuronavigation
Positron emission tomography
FDOPA
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 20
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: The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.


Eligibility criteria: Inclusion Criteria:

* Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma
* Karnofsky Performance status (KPS) ≥ 70
* Age ≥18 years
* Subject is able to understand and consent to study
* Glomerular filtration rate (GFR) ≥ 45 ml/minute

Exclusion Criteria:

* Indication for urgent craniotomy to relieve mass effect
* Only stereotactic biopsy indicated because tumour is located in eloquent brain.
* The enhancement on the T1 MRI sequence involves or abuts the basal ganglia
* Previous intracranial malignancy or any invasive malignancy unless free of disease \> 5 years
* Prior cranial irradiation
* Contra-indications to systemic radiation exposure: pregnancy or breast feeding
* Subject exceeds the weight limit of the PET scanner bed (204.5 kg)
* Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease
* Allergies or other contraindication to CT contrast or MRI contrast

Primary outcomes:
measure: The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.
timeFrame: Less than 72 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Alan Nichol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646654: Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia
Official title: Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interscalene Block
Erector Spinae Plane Block
Arthroscopy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the effectiveness of ESPB versus ISB in anesthesia for shoulder arthroscopy

Detailed description: Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids. Among the various types of regional anesthetic techniques, the interscalene brachial plexus block (ISB) is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

the interscalene brachial plexus block (ISB) regional anesthesia offers many advantages over general anesthesia for both arthroscopic and open surgeries of the shoulder it provides excellent intraoperative anesthesia and muscle relaxation' as well as analgesia that continues into the postoperative period

Eligibility criteria: Inclusion Criteria:

* Patients with Body Mass Index \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* scheduled for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* Allergy to all opioid medications
* Diagnostic shoulder arthroscopic procedures
* Patients with chronic opioids
* Patients who converted to general anesthesia use and coagulopathy

Primary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: 30 minutes
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours postoperative
measure: Rescue analgesia in the form of IV meperidine (0.5 mg/kg) boluses if NRS >3. Time to the 1st rescue analgesic request will be recorded
timeFrame: 24 hours postoperative
measure: Total amount of rescue analgesic
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Islam Morsy
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04181554: Postural Stability, Pelvic Floor Dysfunction, Respiratory Muscle Strength in Post-partum Women With Diastasis Recti
Official title: The Effect of Diastasis Recti on Postural Stability, Pelvic Floor Dysfunction and Respiratory Muscle Strength in Post-partum Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastasis Recti
Post-partum
Postural Stability
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The post-partum women with diastasis recti abdominis will be enrolled to the study.

Brief summary: The aim of this study is to determine the effect of inter-rectus distance on postural stability, pelvic floor dysfunction and respiratory muscle strength in women with diastasis recti abdominis.

Detailed description: Diastasis of recti abdominis muscles (DRAM) is defined as a separation of the two rectus abdominis muscles along the linea alba. Increased volume in the abdominal cavity, hormonal changes during pregnancy, neurodevelopmental differences, or abdominal wall laxity may caused. It is very common during pregnancy and may continue for eight weeks in postnatal period. The loss of abdominal wall stability and weakened pelvic floor muscles may occur with DRAM. The abdominal wall is one of the key point for body posture, trunk and pelvic stability. However, in our best knowledge, there is no study in the literature that evaluates women with and without DRA in terms of components related to postural control systems.

Eligibility criteria: Inclusion Criteria:

* Post- partum women (min 8 weeks - max 5 years)

Exclusion Criteria:

* Having a neurological, orthopedical or any other condition which affect postural stability.

Primary outcomes:
measure: Limits of stability test score
timeFrame: 5 minutes
measure: Sensory integration test score
timeFrame: 6 minutes
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 5 minutes
measure: Abdominal Muscle Endurance
timeFrame: 3 minutes
measure: Pelvic floor dysfunction
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Hilal Denizoglu Kulli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107233: Using Electronic Medical Record Data to Improve HIV Primary Care
Official title: Using Electronic Medical Record Data to Improve HIV Primary Care: an Audit and Feedback Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Health Care
HIV/AIDS
Electronic Health Records
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting.

Detailed description: This cluster randomized control trial will use electronic medical record (EMR) data from the St. Michael's Hospital Academic Family Health Team to examine whether the quality of HIV care provided to patients can be improved through an audit and feedback (A\&F) intervention. Our objective is to examine whether A\&F targeting family physicians caring for people living with HIV/AIDS (PHLA) using EMR data can improve laboratory monitoring, engagement in primary care and the uptake of preventive interventions.

Eligibility criteria: Inclusion Criteria:

* Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.

Exclusion Criteria:

* None

Primary outcomes:
measure: Up to date viral load
timeFrame: Within six months
Secondary outcomes:
measure: Clinic visit
timeFrame: Within the last 6 months
measure: Up-to-date cancer screenings
timeFrame: 1-3 years
measure: Vaccinations
timeFrame: Since 2013
measure: Screening for diabetes
timeFrame: Within 1 year
measure: Screening for hypercholesterolemia
timeFrame: Within 1 year
measure: Screening for osteoporosis
timeFrame: Within 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Andrew Pinto, MSc MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06455033: Manual Diaphragm Release on Stepping Reaction Time in Chronic Obstructive Pulmonary Disease
Official title: Effect of Manual Diaphragm Release Technique on Stepping Reaction Time and Balance in Patients with Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Respiratory Disease
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Finding the effect of diaphragm release exercises on stepping reaction time and balance in patients with chronic obstructive pulmonary disease patients.

Detailed description: Sixty patients with Chronic Obstructive Pulmonary Disease (COPD) will be randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be 55 years and above with history of COPD. The Ex group will attend 4 sessions/week of Manual Diaphragm Release Technique Combined with Deep Breathing (10:15-min) for 8 weeks, the CON will attend 4 sessions/week of Deep Breathing (10:15-min) for 8 weeks. The stepping reaction time will be assessed by the choice stepping reaction time (CSRT). The Balance will be determined using a Time up and Go test (TUG) an d Berg balance scale (BBS). All the outcomes will be examined at baseline, and 8 weeks of the intervention.

Eligibility criteria: Inclusion Criteria:

* All participants with a history of COPD
* Adults ranging from 55- 70 years old of both genders.
* Medically stable

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m2)
* History of Pneumonia
* Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm.
* History of Myocardial infarction and/or cardiothoracic surgery
* orthopedics, or neurological that may interfere the intervention.
* Visual impairments, vestibular disorders, and postural hypotension.
* Dementia that interferes with the ability to follow instructions.

Primary outcomes:
measure: stepping reaction time
timeFrame: up to 8 weeks
measure: Balance
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kz Hospital
Study officials:
affiliation: National institute for Gerontology
name: Mohammed S Saif, Ph.D
role: STUDY_DIRECTOR
References: