louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00829127: AZD8075 Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: daily
Secondary outcomes:
measure: characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK
timeFrame: daily
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles, Uppsala, Sweden
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06000527: Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")
Official title: Juvenile Recurrent Respiratory Papillomatosis: Establishment of a French National Cohort (PRR : National Cohort " REPA ")
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Juvenile Recurrent Respiratory Papillomatosis
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with juvenile PRR in France

Brief summary: Recurrent respiratory papillomatosis (RRP) is a rare disease. However, it is the most common benign laryngeal tumor in children. To date, no epidemiological data are available in France. The aim of this study is to establish the epidemiology of juvenile PPR.

Detailed description: Recurrent respiratory papillomatosis (RRP) is characterized by the recurrent proliferation of multiple polypoid squamous tumors in the respiratory tract, linked to HPV infection. RRP is a rare disease. However, it is the most common benign laryngeal tumor in children.

There are currently no French national epidemiological data on this disease. The data collected by the reference centers will enable us to gain a better understanding of this pathology in terms of epidemiology, risk factors, genetic susceptibility and clinical manifestations, as well as to significantly study the efficacy of the various existing therapies and preventive measures, in order to establish a clear, standardized and optimal guideline.

Eligibility criteria: Inclusion Criteria:

* Patients with juvenile PRR (disease onset before age 18)
* Followed in the :

  * The MALO CRMR
  * One of the MALO network's CCMRs
  * One of the main correspondent centers

Exclusion Criteria:

* Patients objecting to the collection of their personal data
* Parents of minor patients objecting to the collection of their child's personal data

Primary outcomes:
measure: Epidemiology of juvenile RRP in France by clinical information
timeFrame: 10 years
measure: Epidemiology of juvenile PRR in France according to vaccine and adjuvant therapeutic information
timeFrame: 10 years
measure: Epidemiology of juvenile PRR in France by paraclinical information
timeFrame: 10 years
Secondary outcomes:
measure: Define standardized management of juvenile RRP
timeFrame: 10 years
measure: Therapeutic management of RRP
timeFrame: 10 years
measure: Prevention of RRP
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: hôpital Necker Enfants malades
Study officials:
References:
Clinical trial NCT04245527: Use of Infrared Photomodulation for Hormonal Balance (Joovvin' for Hormonal Health)
Official title: Joovvin' for Hormonal Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Testosterone Deficiency
Estrogen Deficiency
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Joovv
First posted: 2020-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Enrolled individuals will receive a Joovv solo for the 8 week study.
Primary purpose: PREVENTION

Brief summary: 8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.


Eligibility criteria: Inclusion Criteria:

* United States resident

Exclusion Criteria:

* current Joovv or other photomodulation therapy user
* under medical supervision for medically treatable illness
* significant travel during study period
* use of birth control

Primary outcomes:
measure: Testosterone Change
timeFrame: baseline to week 8
measure: change of thyroid-stimulating hormone (TSH)
timeFrame: baseline to week 8
measure: Self report general wellness
timeFrame: baseline to week 8
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Virtual Study: https://p.proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT06725927: Vaccination Against Influenza Pre-discharge in Heart Failure
Official title: Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Heart Failure
Keywords: heart failure
influenza
vaccination
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In patients with heart failure (HF), influenza vaccination should be considered to prevent HF hospitalizations. However, vaccination rates among patients with HF are low, in part because of subjective but common concerns about whether patients with such severe disease should be vaccinated. In this randomized, open-label study, we will investigate whether influenza vaccination before discharge in patients stabilized after cardiac decompensation is safe and improves outcomes over a 6-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* informed consent to participate in the study
* hospitalization (unplanned) due to exacerbation (decompensation) of heart failure
* planned discharge within the next 48 hours due to completion of hospital treatment
* no current (2024/25 season) influenza vaccination.

Exclusion Criteria:

* severe post-vaccination reaction during influenza vaccination in any previous influenza season
* hypersensitivity to any of the components of the vaccine planned to be administered
* discharge to another hospital for continued treatment or discharge to a nursing home
* antibiotic therapy among the drugs recommended for taking after hospitalization.

Primary outcomes:
measure: Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wroclaw Medical University
name: Jan Biegus, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03469427: Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
Official title: Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Facial Nerve Paralysis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 15
Sex: ALL
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 of different age groups presented with facial nerve paralysis due to temporal bone trauma

Brief summary: Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures.

The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.

Detailed description: Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes.

Surgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery.

High-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography.

There are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography.

Eligibility criteria: Inclusion Criteria:

* All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex.

Exclusion Criteria:

* Pregnant women.
* Unfit patients for surgery.
* Patients refuse surgical intervention.

Primary outcomes:
measure: Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
Clinical trial NCT02240927: Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves
Official title: Comparison of Different Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Heart; Complications, Valve, Prosthesis
Keywords: Anticoagulation
Prosthetic Heart Valves
Pregnancy
Warfarin
Thrombosis
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-09-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Detailed description: Four different anticoagulant treatment regimens for pregnant patients with prosthetic heart valves have been described. In the first arm warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day which is monitored by weekly anti-Xa levels (between 0.7-1.2) during the first trimester and followed by only warfarin after first trimester. In the second arm, if the patient's warfarin consumption is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester combined with enoxaparine in 1mg/kg dose twice a day; adjusted by measurements of anti-Xa levels (between 0.5-1) weekly until the end of 12th week of pregnancy . In the third arm warfarin dose is decreased to 4 mg during the first trimester combined with enoxaparine given in a similar manner. If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy in the 4th arm. All patients are followed by serial transesophageal echocardiography performed at 0,3,6 and 9. months of pregnancy. Informed consent is taken from all patients. After delivery the babies are examined by a experinced pediatrician and pediatric cardiologist for any congenital anomalies.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients with prosthetic heart valves

Exclusion Criteria:

Primary outcomes:
measure: Successful pregnancy
timeFrame: 12 month
measure: Maternal Complications
timeFrame: Participants will be followed during pregnancy and postpartum period, an expected average of 12 months
measure: Fetal Complications
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kosuyolu Kartal Heart Training and Research Hospital
Study officials:
affiliation: Kosuyolu Kartal Heart Training and Research Hospital
name: Mehmet Ozkan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02762227: The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
Official title: The Role of Different Imaging Methods in the Diagnosis of Gallbladder Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyp of Gallbladder
Keywords: CEUS
CT
gallbladder cholesterol polyps
adenoma
gallbladder cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective cohort study is designed to investigate and to compare the diagnostic performance of contrast-enhanced ultrasonography (CEUS) and multidetector computed tomography (CT) for gallbladder cholesterol polyps, adenoma and gallbladder cancer.

Detailed description: In this study, investigators aimed to investigate the diagnostic performance of CEUS and high resolution CT (HRCT) for the preoperative differential diagnostic accuracies of gallbladder polypoid lesions.

Eligibility criteria: Inclusion Criteria:

* All patients with a gallbladder polypoid lesion visited our department, diagnosed by conventional transabdominal US.

Exclusion Criteria:

* Gallbladder polyp with a diameter less than 10 mm.
* Lesions highly suspected to be cancer due to visible metastasis.
* Allergy to contrast agents and cannot received CT or CEUS examination.
* Women in pregnancy or lactation.

Primary outcomes:
measure: Pathological diagnosis of gallbladder polyps （Cholesterol / Adenoma / Others）
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
affiliation: Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: JIAN WANG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218827: Topical Steroid Treatment For Dry Eye
Official title: Evaluation of Steroidal Treatment For Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: Dry Eye
Inflammatory reaction
steroids
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms. epidemiologic studies estimate that as many as 15% of the population over 60 years suffer from dry eye. the disease can be treated both topically through several drugs or through mechanical closure of the lacrimal drainage system. in the past decade a few studies demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the inflammatory process that occurs in it. this treatment rises goblet cell counts but in the meantime elevates the intra ocular pressure and elevates the risk for infections. steroids that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry eye disease. we with to subjectively and objectively evaluate an FDA approved topical steroidal drug in the treatment of dry eye.

Detailed description: 30 patients 21 year or older, from both sexes with no previous eyelid or corneal surgeries, refered to our outpatient clinics will be recruited and evaluated.

the initial examination will include schirmer1 test, Tear break up time test, a full ophthalmologic evaluation and a dry eye questionaire.

after signing a concent form patient will be treated with Loteprednol Etabonate four times a ady for a month, then a second examination will take place. after that and according to necessity patients will be treated with Loteprednol Etabonate two times daily for another month and return for a follow up examination. intraocular pressure will be evaluated in each follow up visit as well as dry eye symptoms, schirmer 1 test and tear break up time test.

Eligibility criteria: Inclusion Criteria:

* referral for ophthalmic examination due to dry eye symptoms
* ability to sign a concent form

Exclusion Criteria:

* former corneal, eyelid or lacrimal gland operations
* former orbital chemotherapy or irradiation treatment

Primary outcomes:
measure: clinical improvement in dry eye measurements
timeFrame: two months
Secondary outcomes:
measure: symptomatic improvement
timeFrame: two months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Meir Medical Center
name: Shay Ofir, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06476327: Robot-Assisted Gait Training With Self-Observation in Stroke Rehabilitation
Official title: The Effects of Robot-Assisted Gait Training Concurrent With Self-Observation Training on Balance, Gait, Cognitive Function in Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
gait
cognitive function
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of robot-assisted gait training Concurrent with self-observation training on balance, gait, and cognitive function in stroke participants. The main question it aims to answer is:

Does robot-assisted gait training combined with self-observation improve balance abilities in stroke participants?

Participants will be

Group 1 Perform robot-assisted gait training combined with self-observation five times a week for four weeks.

Group 2 Perform robot-assisted gait training five times a week for four weeks.

All groups perform for 30 minutes per session.


Eligibility criteria: Inclusion Criteria:

* Participants who have had a stroke for more than 6 months but less than 1 year
* Functional Ambulation Category (FAC) ≥ 2
* Able to walk 10 meters independently with or without an assistive device
* Participants eligible for application of the robot (ANGEL LEGS M20, Anger Robotics)

Exclusion Criteria:

* Inability to wear the robot due to open wounds or skin conditions
* Severe cognitive impairment (MMSE-K \< 10) or significant difficulty in communication due to language disorders
* Spasticity of the paralyzed limb with a Modified Ashworth Scale (MAS) ≥ 2
* High risk of fractures, such as osteoporosis
* Severe cardiovascular or pulmonary diseases
* Neurological disorders affecting gait function, such as Parkinson's disease or multiple sclerosis

Primary outcomes:
measure: Balance ability
timeFrame: from enrollment to the end of treatment at 4 weeks
measure: Gait ability
timeFrame: from enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Cognitive ability
timeFrame: from enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chungdam hospital
state: Gangnam-gu
Study officials:
References: