louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00882973: Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Subjects who aged 18 years or older
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
4. Subjects with no other malignancy diagnosed within past five years except for:

   * Cured non-melanoma skin cancer
   * Cured cervical intraepithelial neoplasia (CIN)
   * Cured In-situ cervical cancer (CIS)
5. Subjects who are ECOG performance status of ≤ 1

Primary outcomes:
measure: The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
timeFrame: 1 year
measure: The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
timeFrame: 1 year
Secondary outcomes:
measure: Objective response rate (complete response (CR) + partial response (PR))
timeFrame: 1 year
measure: Time to tumor progression
timeFrame: 1 year
measure: Progression free survival
timeFrame: 1 year
measure: Safety profiles
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03420573: Clinical Profile of Parkinson's Disease in Patients With Hepatitis C Infection
Official title: Clinical Profile of Parkinson's Disease in Patients With Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease patients with hepatitis C infection

Brief summary: There is association between Hepatitis C and Parkinson's Disease as shown from previous studies. The clinical profile and natural history is not fully studied yet. We aim at studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C infection.


Eligibility criteria: Inclusion Criteria:

* Patient with history of Parkinson's Disease and Hepatitis C infection.

Exclusion Criteria:

* Advanced liver cirrhosis.
* Patients with hepatic failure.
* Symptoms of Parkinson's plus syndrome.

Primary outcomes:
measure: Score of UPDRS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of Kasr Alainy Movement Disorders Unit KAMDU
name: Shaimaa I. El-Jaafary, MD
role: STUDY_DIRECTOR
References:
citation: Pakpoor J, Noyce A, Goldacre R, Selkihova M, Mullin S, Schrag A, Lees A, Goldacre M. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Apr 25;88(17):1630-1633. doi: 10.1212/WNL.0000000000003848. Epub 2017 Mar 29.
citation: Kim JM, Jang ES, Ok K, Oh ES, Kim KJ, Jeon B, Jo HJ, Ki M, Jeong SH. Association between hepatitis C virus infection and Parkinson's disease. Mov Disord. 2016 Oct;31(10):1584-1585. doi: 10.1002/mds.26755. No abstract available.
citation: Golabi P, Otgonsuren M, Sayiner M, Arsalla A, Gogoll T, Younossi ZM. The Prevalence of Parkinson Disease Among Patients With Hepatitis C Infection. Ann Hepatol. 2017 May-Jun;16(3):342-348. doi: 10.5604/16652681.1235476.
Clinical trial NCT00004773: Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rett Syndrome
Keywords: Rett syndrome
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Baylor College of Medicine
First posted: 2000-02-25
Enrollment: 95
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and QRS morphology/duration, across clinical stages in patients with Rett syndrome.

II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess arrhythmias, heart rate variability, and autonomic nervous system function in these patients using 24-hour Holter monitoring.

IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and polygraph monitoring in patients who have more than 1 clinical seizure every 5 days.

V. Characterize these events with respect to clinical manifestations, EEG correlates, and other physiologic data.

VI. Determine the frequency of seizures vs. events without electrographic correlates in these patients.

VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures and/or an epileptic syndrome.

Detailed description: PROTOCOL OUTLINE: Patients receive an electrocardiogram at baseline and every 6 months for 3 years. Clinical stage II patients undergo 24-hour Holter monitoring on the same schedule; age-matched controls are tested once.

A group of patients with more than 1 seizure or possible seizure every 5 days undergo 5-day continuous electroencephalogram/polygraphic/video monitoring, with respiratory effort assessment, end tidal carbon dioxide and oxygen saturation levels, and a seizure log.

Eligibility criteria: * Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria
* Age-matched girls without neurologic or cardiac problems entered as controls

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Daniel G. Glaze
role: STUDY_CHAIR
References:
citation: Glaze DG. Commentary: the challenge of Rett syndrome. Neuropediatrics. 1995 Apr;26(2):78-80. doi: 10.1055/s-2007-979728. No abstract available.
citation: Glaze DG, Schultz RJ. Rett Syndrome: Meeting the Challenge of This Gender-Specific Neurodevelopmental Disorder. Medscape Womens Health. 1997 Jan;2(1):3.
citation: Sekul EA, Moak JP, Schultz RJ, Glaze DG, Dunn JK, Percy AK. Electrocardiographic findings in Rett syndrome: an explanation for sudden death? J Pediatr. 1994 Jul;125(1):80-2. doi: 10.1016/s0022-3476(94)70128-8.
Clinical trial NCT05609773: Comparing Intubation Rates in the Delivery Room by Interface
Official title: Comparing Intubation Rates in the Delivery Room by Interface
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventilator Lung; Newborn
Lead sponsor: University of Illinois College of Medicine at Peoria
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Illinois
name: OSF Healthcare System
First posted: 2022-11-08
Enrollment: 42
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All resuscitated infants \< 30 weeks' gestation born at OSF SFMC.

Brief summary: Although the majority of premature neonates \< 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.


Eligibility criteria: Inclusion Criteria:

All resuscitated infants \< 30 weeks' gestation born at OSF SFMC

Exclusion Criteria:

Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status

Primary outcomes:
measure: Comparing Intubation Rates in the Delivery Room by Interface
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: University of Illinois College of Medicince
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Ashley Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143273: Dose Response Study of Lasofoxifene in Postmenopausal Women With Osteoporosis - Japanese Asian Dose Evaluation
Official title: Dose Response Study Of Lasofoxifene In Postmenopausal Women With Osteoporosis (Placebo-Controlled, Multicenter, Double-Blind, Comparative Study) - Japanese Asian Dose Evaluation: JADE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Ligand Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 497
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish the optimal dose of lasofoxifene that is fully effective in increasing the BMD in postmenopausal Asian women.


Eligibility criteria: Inclusion Criteria:

* postmenopausal Asian women with osteoporosis defined by low BMD

Exclusion Criteria:

* Metabolic bone disease, use of other osteoporosis drugs or drugs interering with normal bone metabolism

Primary outcomes:
measure: Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
timeFrame: 12 months
Secondary outcomes:
measure: Hip BMD, bone markers, lipids and new radiographic vertebral fractures at 1 year
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kagoshima-shi
country: Japan
facility: Pfizer Investigational Site
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Pfizer Investigational Site
state: Kagoshima
city: Miyazaki-shi
country: Japan
facility: Pfizer Investigational Site
state: Miyazaki
city: Fuchu
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kiyose
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Yonago-shi
country: Japan
facility: Pfizer Investigational Site
state: Tottori
city: Kangnam-ku
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Sonpagu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Youngdeungpo-gu
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Seoul
city: Changhua City 500
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyun 333
country: Taiwan
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02912273: Optimizing Fall-risk Prediction in Older Adults With Cancer
Official title: Optimizing Fall-risk Prediction in Older Adults With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Geriatric assessment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 227
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults receiving systemic therapy at Siteman Cancer Center

Brief summary: To establish the optimal strategy of fall-risk assessment to predict falls in older adults receiving cancer therapy.


Eligibility criteria: Inclusion Criteria:

* Age ≥65
* Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents or hormonal agents (e.g. anti-estrogen or anti-androgen) OR will begin systemic therapy within the next 4 weeks.
* Estimated life expectancy \>1 year
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Unable to read and understand English

Primary outcomes:
measure: Number of falls
timeFrame: Up to 6 months
Secondary outcomes:
measure: Time to fall event
timeFrame: Up to 6 months
measure: Overall survival
timeFrame: Up to 6 months
measure: Number of falls that were considered injurious falls
timeFrame: Up to 6 months
measure: Fear of falling as Measured by the Falls Efficacy Scale-International
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Katherine Clifton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03694873: Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia
Official title: Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Perineal Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women

Detailed description: Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics

Eligibility criteria: Inclusion Criteria:

* Age:18-35 years
* Obese women with BMI ≥ 30.
* completed full 37-weeks gestation.
* spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
* Singleton alive fetus.

Exclusion Criteria:

* known allergy to investigated drugs(tramadol or celecoxib).
* regular use of analgesic drugs before or during pregnancy.
* any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease.
* instrumental vaginal delivery.
* 3rd or 4th degree perineal tear.
* severe postpartum haemorrhage (\>1,500 ml).
* complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy).
* epidural nor combined spinal-epidural analgesia in labour
* a history of peptic ulcer,asthma,thrombocytopaenia.

Primary outcomes:
measure: perineal pain
timeFrame: 1 hour after repair of episiotomy
Secondary outcomes:
measure: perineal pain
timeFrame: 1 hours after repair of episiotomy
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951573: Evaluation of a New Daily Disposable Multifocal Contact Lens Design
Official title: Delefilcon A Multifocal Plus Power Lens Design Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Hyperopia
Refractive Error
Keywords: contact lenses
multifocal
daily disposable
silicone hydrogel
presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).


Eligibility criteria: Inclusion Criteria:

* Subjects with normal eyes who are not using any ocular medication.
* Must sign the Informed Consent document.
* Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
* Manifest cylinder less than or equal to 0.75D.
* Best corrected distance VA greater than or equal to 20/25 in each eye.
* Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
* Presbyopic with a spectacle addition (ADD) \>0.50D and \<2.75D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
* Any use of systemic or ocular medications for which CL wear could be contraindicated.
* History of herpetic keratitis.
* History of refractive surgery or irregular cornea.
* A clinically significant dry eye that precludes CL wear.
* Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
* Monocular (only 1 eye with functional vision).
* History of intolerance or hypersensitivity to any component of the test articles.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
timeFrame: Dispense (Day 1), Hour 9
Secondary outcomes:
measure: HC/HI Binocular VA at Distance
timeFrame: Dispense (Day 1), Hour 9
measure: Over-refraction (OR) Monocular at Distance
timeFrame: Dispense (Day 1), Hour 9
Other outcomes:
Locations:
Study officials:
affiliation: CIBA VISION GmbH
name: Joachim Nick, Dipl. Ing.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03342573: Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris
Official title: Cosentyx (Secukinumab) for the Treatment of Adult Onset Pityriasis Rubra Pilaris: A Single Arm, Open-label Exploratory Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PITYRIASIS RUBRA PILARIS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cosentyx (Secukinumab) for the treatment of adult onset pityriasis rubra pilaris
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the potential effectiveness of Cosentyx in the treatment of adult-onset Pityriasis Rubra Pilaris or PRP.


Eligibility criteria: Inclusion Criteria

Informed subject consent will be obtained from those patients meeting the following inclusion criteria:

* Male and female patients 18 years or older.
* Clinical and/or histopathological diagnosis of PRP
* Candidate for systemic therapy (PASI ≥ 10)
* Body surface area of involvement ≥ 10%
* Good general health as confirmed by medical history
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion Criteria

Patients are to be excluded based on the following criteria:

* Vulnerable study population
* Pregnant or nursing women
* Women planning a pregnancy within the study period
* Human immunodeficiency virus (HIV) positivity
* Known history of adverse reaction to Cosentyx
* Known history of hepatitis B, hepatitis C, or tuberculosis
* Personal or family history of inflammatory bowel disease

Primary outcomes:
measure: PASI-75
timeFrame: 28 weeks
Secondary outcomes:
measure: PASI-90
timeFrame: 28 weeks
measure: DLQI
timeFrame: 28 weeks
measure: PGA
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jason C Sluzevich
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boudreaux BW, Pincelli TP, Bhullar PK, Patel MH, Brumfiel CM, Li X, Heckman MG, Pittelkow MR, Mangold AR, Sluzevich JC. Secukinumab for the treatment of adult-onset pityriasis rubra pilaris: a single-arm clinical trial with transcriptomic analysis. Br J Dermatol. 2022 Nov;187(5):650-658. doi: 10.1111/bjd.21708. Epub 2022 Jul 15.