louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00773240: A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment
Official title: A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grass Pollen Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis


Eligibility criteria: Inclusion Criteria:

* Positive skin prick test to Phleum pratense
* Positive IgE to Phleum pratense
* signed informed consent
* A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion Criteria:

* No uncontrolled asthma in the past 12 months
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension

Primary outcomes:
measure: Pharmacodynamics - Immunological assessments
timeFrame: Pre- and post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: ALK-Abello A/S, Bøge alle 6-8
Study officials:
affiliation: ALK-Abelló A/S
name: Kim Simonsen, MD
role: STUDY_DIRECTOR
References:
citation: Reich K, Gessner C, Kroker A, Schwab JA, Pohl W, Villesen H, Wustenberg E, Emminger W. Immunologic effects and tolerability profile of in-season initiation of a standardized-quality grass allergy immunotherapy tablet: a phase III, multicenter, randomized, double-blind, placebo-controlled trial in adults with grass pollen-induced rhinoconjunctivitis. Clin Ther. 2011 Jul;33(7):828-40. doi: 10.1016/j.clinthera.2011.06.006. Epub 2011 Jul 7.
Clinical trial NCT01125540: The Role of Daily Disposable Contact Lenses in Ocular Allergy
Official title: The Role of Daily Disposable Contact Lenses in Ocular Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grass Pollen Ocular Allergy
Keywords: Allergic conjunctivitis
Lead sponsor: Aston University
Sponsor class: OTHER
Collaborators: name: National Pollen and Aerobiology Unit, Worcester
First posted: 2010-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens wear when they are having symptoms. However, modern soft contact lenses which are disposed of daily offer the potential to protect and lubricate the ocular surface. This study examines this possible effect.


Eligibility criteria: Inclusion Criteria:

* contact lens wearer
* proven allergy to grass pollen

Exclusion Criteria:

* eye disease
* ocular medication
* allergy medication
* asthma

Primary outcomes:
measure: Symptoms
timeFrame: 4 hours
measure: Signs
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Aston University
state: West Midlands
Study officials:
References:
citation: Wolffsohn JS, Emberlin JC. Role of contact lenses in relieving ocular allergy. Cont Lens Anterior Eye. 2011 Aug;34(4):169-72. doi: 10.1016/j.clae.2011.03.004. Epub 2011 May 6.
Clinical trial NCT01568840: Global Postural Reeducation and Segmental Exercises in Patients With Scapular Dyskinesis and Cervicalgia
Official title: Effectiveness of Global Postural Reeducation and Segmental Exercises on Function, Pain, and Quality of Life of Patients With Scapular Dyskinesis and Cervicalgia: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scapular Dyskinesis
Cervicalgia
Keywords: Physical Therapy Modalities
Posture
Muscle Stretching Exercises
Dyskinesias
Neck pain
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 30
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: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.

Detailed description: Purpose: To assess the effectiveness of global postural reeducation relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.

Methods: Participants with scapular dyskinesis and cervicalgia (n = 30) aged 18 to 65 years were randomly assigned to one of two groups: Global Postural Reeducation and Segmental Exercises(stretching and strengthening). Upper extremity was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Function of the neck was estimated using the Neck Disability Index (NDI). Pain severity was measured using a Visual Analogical Scale. Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-12. Assessments were conducted at baseline and after 10 weekly sessions (60 minutes each). Significance level was established at 5%.

Eligibility criteria: Inclusion Criteria:

* Scapular Dyskinesis as per the SICK Scapula Rating Scale
* Chronic Cervicalgia (pain for at least three months)

Exclusion Criteria:

* Cervical Stenosis
* Myelopathy
* Prolapsed Inter-Vertebral Disk (as confirmed by magnetic resonance imaging),
* Winged Scapula due to lesions of the long thoracic nerve or spinal accessory nerve, (as documented by electromyography)

Primary outcomes:
measure: Function of the upper extremity
timeFrame: 10 weeks
Secondary outcomes:
measure: Pain severity
timeFrame: 10 weeks
measure: Health-related quality of life (HRQoL)
timeFrame: 10 weeks
measure: Function of the neck
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT01917240: Sequential vs. Monophasic Media Impact Trial (SuMMIT)
Official title: Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Monophasic
Sequential
Media
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of two FDA approved culture media on potential of human embryos resulting from IVF (sequential \& monophasic media). Half of each patient's embryos will be randomly assigned to grow in monophasic media \& the other half in sequential media. All embryos will undergo Comprehensive Chromosome Screening (CCS) \& the best euploid embryo from each group will be transferred resulting in a double embryo transfer (DET). If there are only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or frozen).


Eligibility criteria: Inclusion Criteria:

* Patient undergoing IVF/CCS (no PGD banking)
* Patient meets ASRM guidelines for Double Embryo Transfer (DET)
* Donor Sperm OK
* AMH ≥ 1.2
* FSH ≤ 12
* BAFC ≥12
* Max 1 prior failed IVF cycle for patients 35-45 years old
* Patient \<35 years old MUST have 1 prior failed IVF cycle

Exclusion Criteria:

* Chronic endometrial insufficiency
* Use of oocyte donor or gestational carriers
* Medical contraindications to Double Embryo Transfer (DET)
* Male Factor (\<100,000 sperm or surgical sperm)
* Communicating hydrosalpinx (on HSG)
* Single gene disorders or sex selection

Primary outcomes:
measure: Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T. Scott, M.D., HCLD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Werner MD, Hong KH, Franasiak JM, Forman EJ, Reda CV, Molinaro TA, Upham KM, Scott RT Jr. Sequential versus Monophasic Media Impact Trial (SuMMIT): a paired randomized controlled trial comparing a sequential media system to a monophasic medium. Fertil Steril. 2016 May;105(5):1215-1221. doi: 10.1016/j.fertnstert.2016.01.005. Epub 2016 Jan 27.
Clinical trial NCT01549340: Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)
Official title: Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perennial Allergic Rhinitis
Seasonal Allergic Rhinitis
Keywords: Rhinitis
Allergen immunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 8790
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were managed by physicians in a large allergy practice, recommended for AIT between 2005 and 2011 and identified by their electronic health records.

Brief summary: The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of participants that persist with their AIT throughout the recommended course.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AR with or without allergic conjunctivitis (AC)
* Documented provider-to-patient or parent discussion of AIT as a treatment option

Exclusion Criteria:

* Participants receiving AIT as an AR treatment without documented provider-to-patient or parent discussion of AIT as a treatment option
* Participants receiving immunotherapy for insect sensitivities only
* AIT started before 2005

Primary outcomes:
measure: Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops
timeFrame: Up to 5 years
measure: Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment
timeFrame: At 5 years
measure: Duration of Treatment With SCIT or SLIT
timeFrame: Up to 5 years
measure: Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course
timeFrame: Up to 5 years
Secondary outcomes:
measure: Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT
timeFrame: Up to 5 years
measure: Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Anolik R, Schwartz AM, Sajjan S, Allen-Ramey F. Patient initiation and persistence with allergen immunotherapy. Ann Allergy Asthma Immunol. 2014 Jul;113(1):101-7. doi: 10.1016/j.anai.2014.04.008. Epub 2014 May 9.
Clinical trial NCT03072940: Brain Imaging in the Idiopathic REM Sleep Behavior Disorder (ALICE)
Official title: 3 T Multimodal MRI in Idiopathic RBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: REM Sleep Behavior Disorder
Healthy
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
Collaborators: name: NRJ Foundation - Institute of France
name: National Research Agency, France
First posted: 2017-03-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

- idiopathic RBD (criteria of the international classification of sleep disorders-3)

For healthy controls : no neurologic or psychiatric disorder

Exclusion Criteria:

* Contraindication to MRI
* Do not speak French

Primary outcomes:
measure: Signal in the subcoeruleus/coeruleus complex
timeFrame: 24h
Secondary outcomes:
measure: Substantia nigra quantity
timeFrame: 24h
measure: Quality of Sleep
timeFrame: 24h
measure: Cognition
timeFrame: 24h
measure: Olfactory function
timeFrame: 24h
measure: Color vision
timeFrame: 24h
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie Salpetriere hospital
Study officials:
References:
citation: Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.
Clinical trial NCT02996240: Breast, Omega 3 Free Fatty Acid, Ph 0
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastcancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the impact of dietary omega 3 free fatty acids breast cancer patients.

Detailed description: Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* ECOG ≤2
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
* Consented for tissue collection on CTRC repository 07-32

Exclusion Criteria:

* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days
* History of medical noncompliance
* Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days

Primary outcomes:
measure: Change in serum colony stimulating factor at surgery
timeFrame: 30 days
measure: Change in circulating levels of pro-inflammatory cytokines.
timeFrame: 30 days
measure: Change in circulating levels of eicosanoids.
timeFrame: 30 days
measure: Change in circulating levels of metabolics.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CTRC at University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: Principal Investigator
name: Virginia G Kaklamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697840: Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
Official title: Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Positive titres for anti HBs antibody.
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous administration of any other vaccine(s).
* Administration of any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At month 7
measure: Occurrence and intensity of solicited local and general symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence of unsolicited adverse events
timeFrame: 30-days after vaccination
measure: Incidence of serious adverse events
timeFrame: Throughout the study period
measure: Anti-Hbs antibody concentrations
timeFrame: Months 1, 6 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02955667: The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Official title: The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Cervical Precancer
Keywords: invivo microscopy
colposcopy
cervical precancer and cancer
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.


Eligibility criteria: Inclusion Criteria:

1. cervical cytologic test result is HSIL
2. persistent infection with high-risk HPV
3. cervical pathological diagnosis is LSIL or HSIL

Exclusion Criteria:

1. acute infection of lower genital tract
2. the wound in lower genital tract
3. active bleeding in lower genital tract

Primary outcomes:
measure: diagnostic accuracy rate
timeFrame: 1 day (time of the examination)
Secondary outcomes:
measure: image accordance rate
timeFrame: 1 day (time of the examination)
Other outcomes:
Locations:
Study officials:
References: