louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00618332: Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?
Official title: Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2008-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.


Eligibility criteria: Inclusion Criteria

1. Males and females between 18 and 60 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin or RAST test to grass, trees and/or ragweed antigen.
4. Symptomatic at time of entry into study.

Exclusion Criteria

1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.
2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
3. Use of any other investigational agent in the last 30 days.
4. Absence of nasal symptoms.
5. Smoking.
6. URI at the time of screening.

Primary outcomes:
measure: Global Assessment
timeFrame: at week 2
Secondary outcomes:
measure: Changes in RQLQ: Overall
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Activity
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Sleep
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Non-Nasal/Eye
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Practical
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Nasal
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Emotional
timeFrame: Baseline and 2 weeks
measure: Changes in RQLQ: Eye
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.
Clinical trial NCT02816632: Feedbacks' Influence on Decision Making Processes
Official title: Feedbacks' Influence on Decision Making Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: functional Magnetic Resonance Imaging
Galvanic Vestibular Stimulation
Feedback Processing
Reward, Social, Vestibular System
Cingulate Cortex
Decision-making
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to identify and probe the neural networks involved in feedback processing. It aims at translating this knowledge to clinical populations in which this network is disrupted or compromised.

It includes two studies: 1) with fMRI in healthy subjects to identify the neural bases of feedback processing on decision making using different types of feedback (neutral, social and monetary) presented either infra- or supra-laminary and 2) probing the role of one structure, the anterior cingulate cortex, using Galvanic Vestibular Stimulation (GVS) in healthy subjects. The interventional part consists in the administration of Galvanic Vestibular Stimulation (GVS), which by means of small intensity currents activates the vestibular organs and subsequently vestibular-related brain areas. GVS will be delivered to healthy participants engaged in behavioural tasks requiring the processing of feedbacks of different nature (e.g. social or monetary feedbacks)


Eligibility criteria: Inclusion Criteria:

* Benefit of social health security
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Anamnesis of neurological of psychiatric illness
* Pregnancy or breastfeeding
* Administrative measures restricting legal rights
* Epilepsy (including familiarity), migraines, chronic headaches
* presence of pacemakers, cochlear implants, surgical clips, or any metallic component fixed in participants' body
* Current treatment with psychotropic drugs
* Alcohol assumption during the last 24 hours
* Sleep deprivation
* Recent participation to other brain stimulation studies (\< 1 week)

Primary outcomes:
measure: Behavioral performance (Accuracy)
timeFrame: up to 4 days
measure: Behavioral performance (Reaction times)
timeFrame: up to 4 days
Secondary outcomes:
measure: Neural activity (BOLD signal measured using fMRI) as a function of the nature of the feedback.
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
Study officials:
affiliation: Unité de Neuro-Ophtalmologie Hôpital Neurologique - HOSPICES CIVILS DE LYON
name: Caroline TILIKETE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02333032: Effects of a Positive Slope Treadmill Training in Individuals After Stroke. (Hemislope)
Official title: Evaluation of Biomechanical and Functional Effects of a Positive Slope Treadmill Training in Individuals After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: randomised controlled study experimental group : training with slope N=15 control group training with no slope N=15
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb.

Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.

Detailed description: comparison between patients having a single session of treadmill training with slope and those having a single session of treadmill training with no slope

Eligibility criteria: Inclusion Criteria:

* Hemiplegic patient
* capacity to walk during 20 minutes without technical assistance

Exclusion Criteria:

* patient with bilateral brain lesions
* previous orthopedic surgery
* pregnant woman

Primary outcomes:
measure: kinematic gait parameters
timeFrame: One year
measure: cinetic gait parameters
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
References:
Clinical trial NCT05321732: The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
Official title: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

Detailed description: The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Peak Plasma Concentration (Cmax,ss) of DWP16001
timeFrame: Before IP administration of Day 1, Day 5, and Day 6
measure: Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001
timeFrame: Before IP administration of Day 1, Day 5, and Day 6
measure: Peak Plasma Concentration (Cmax,ss) of DWC202010
timeFrame: Before IP administration and post-dose up to 24 hours
measure: Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010
timeFrame: Before IP administration and post-dose up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
References:
Clinical trial NCT01105832: Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
Official title: Påskyndar PTH läkningen av Konservativt Behandlade Humerusfrakturer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Humeral Fracture
Keywords: Teriparatide
fracture healing
proximal humeral fractures
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).

Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups.

The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.


Eligibility criteria: Inclusion Criteria:

* proximal humeral fracture
* postmenopausal woman 50 years or older
* non-surgical treatment

Exclusion Criteria:

* dementia or psychiatric disorder
* known malignancy \< 5 years prior to fracture
* calcium above reference value
* signs of liver disease
* creatinine over ref. value
* inflammatory joint disease
* alcohol or drug abuse
* oral corticosteroid medication
* long-term NSAID-treatment (=\> 3 months prior to fracture)

Primary outcomes:
measure: Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment
timeFrame: 7 weeks
Secondary outcomes:
measure: Function
timeFrame: 7 weeks and 3 months
measure: Pain
timeFrame: 7 weeks and 3 months
Other outcomes:
Locations:
city: Motala
country: Sweden
facility: Lasarettet i Motala
city: Norrköping
country: Sweden
facility: Department of Orthopaedics
Study officials:
References:
citation: Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
citation: Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.
citation: Johansson T. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients. Acta Orthop. 2016 Feb;87(1):79-82. doi: 10.3109/17453674.2015.1073050. Epub 2015 Jul 15.
Clinical trial NCT02039232: Safety and Efficacy of the CarboFix Pedicle Screw System
Official title: CarboFix Pedicle Screw System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis
Spinal Stenosis
Spinal Curvatures
Tumor
Lead sponsor: CarboFix Orthopedics Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 46
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 purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years old or older.
2. Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
3. Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
4. Informed consent given by the subject.

Exclusion Criteria:

1. Subject is not eligible for fixation with market-available fixation means.
2. Familial history NF2.
3. Acute traumatic spinal injury with or without neurological signs.
4. Metabolic bone disease.
5. History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
6. History of mental disorder or current psychiatric treatment.
7. Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
8. Immune deficiency disease.
9. Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
10. Scoliosis.
11. Treatment with drugs that may interfere with bone metabolism such as:

    1. Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
    2. Calcitonin within the past 6 months.
    3. Bisphosphonates for 30 days or more within the last 12 months.
    4. Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
    5. Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
    6. Treatment by chemotherapy within the last 12 months.
12. Lack of willingness to make a commitment to return for required follow up visits.
13. Drug and/or alcohol abuse.
14. Morbid obesity.
15. Metal allergies.
16. Recent use of other investigational drugs or devices (within the past 30 days).

Primary outcomes:
measure: Fusion success
timeFrame: 6 months post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera;
country: Israel
facility: Hillel Yafe MC;
city: Herzliya
country: Israel
facility: Herzliya Medical Center
Study officials:
References:
Clinical trial NCT02169232: Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Need of Awake Intubation for Difficult Airways
Keywords: Awake intubation
Videolaryngoscope
Fiberoptic
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.


Eligibility criteria: Inclusion Criteria:

* morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital

Exclusion Criteria:

* moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
* inability to communicate in English or French
* contraindications to the drugs used in the study

Primary outcomes:
measure: The time required for successful intubation
timeFrame: 10 minutes
Secondary outcomes:
measure: Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.
timeFrame: 10 minutes
Other outcomes:
measure: The ease of intubation using a 10 cm visual analogue scale, completed both by the person performing the intubation, and an independent observer.
timeFrame: one hour
measure: Post-operatively the patient's satisfaction
timeFrame: 24 hours
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Albert Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06214832: An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)
Official title: An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine) and the Changes of Symptoms According to the Treatment Effect of Hypertension for Korean Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Prescribed Lodient Tab for Hypertension Treatment

Brief summary: This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.

Detailed description: This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years of age
2. A person diagnosed with hypertension
3. A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab
4. A person who voluntarily agreed in writing to this study

Exclusion Criteria:

1. Pregnant women or nursing mothers
2. Persons subject to prohibition according to the permission of the Lodient Tab
3. Patients who in the judgement of the investigator, were inappropriate to participate in the study

Primary outcomes:
measure: The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline
timeFrame: at 6 months of prescription for Lodient Tab compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul song clinic
Study officials:
affiliation: Seoul song clinic
name: Minseob Song
role: STUDY_CHAIR
References:
Clinical trial NCT02665832: Study of DWJ1351 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-Dose, 2-Way Cross-over Study To Compare the Safety and Pharmacokinetic Characteristics of Combination of Amlodipine, Olmesartan and Rosuvastatin and DWJ1351 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 58
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adult male subjects aged 19 to 50 years
* Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2
* Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
* Subject who provided written informed consent to participate in this study

Exclusion Criteria:

* Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs
* Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease
* Subjects who had a serious clinical illness that can impact fate of drugs absorption
* Subject who shows vital signs with the number of systolic blood pressure of ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg
* Subject who have experienced drug abuse
* Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month)
* Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication

Primary outcomes:
measure: AUC
timeFrame: 0 - 144 hr
measure: Cmax
timeFrame: 0 - 144 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: