louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04923100: Therapeutic Effect of New Biologics in Crohn's Disease
Official title: Therapeutic Effect of New Biologics in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Treatment Side Effects
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics

Brief summary: New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.


Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.

Exclusion Criteria:

* loss of follow-up, incomplete clinical data, without confirmed diagnosis

Primary outcomes:
measure: endoscopic remission
timeFrame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Secondary outcomes:
measure: clinical remission
timeFrame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
measure: clinical response
timeFrame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
measure: endoscopic response
timeFrame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
citation: Yao JY, Zhang M, Wang W, Peng X, Zhao JZ, Liu T, Li ZW, Sun HT, Hu P, Zhi M. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study. BMC Gastroenterol. 2021 Oct 18;21(1):380. doi: 10.1186/s12876-021-01946-8.
Clinical trial NCT05803200: A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy
Official title: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure During Pregnancy
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 7
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end of pregnancy and their infants included in the MarketScan Research Database during the period 2014-2020.

Brief summary: The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.

Detailed description: This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.

This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort:

• HyQvia

This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US.

The overall time for data collection in this study will be approximately 7 years.

Eligibility criteria: Inclusion criteria • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.

Exclusion criteria

• NA

Primary outcomes:
measure: Number of Participants with Major Congenital Malformations in the Infant
timeFrame: Up to 7 years
measure: Number of Participants with Spontaneous Abortion
timeFrame: Up to 7 years
measure: Number of Participants with Stillbirth
timeFrame: Up to 7 years
measure: Number of Participants with Preterm Birth
timeFrame: Up to 7 years
measure: Number of Participants Being Small for Gestational Age (SGA)
timeFrame: Up to 7 years
measure: Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)
timeFrame: Up to 7 years
measure: Number of Participants With Any Major Clinical Diagnosis or Procedures
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00904800: AZD0837 Extended Release (ER) Japan Study
Official title: A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.


Eligibility criteria: Inclusion Criteria:

* Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion Criteria:

* Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
* Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
* Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Primary outcomes:
measure: To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
timeFrame: All assessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.
timeFrame: Blood samples will be taken before and after study drug administration.
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Research Site
Study officials:
affiliation: CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan
name: Hiroyuki Fukase, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236300: In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
Official title: In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cysts
Keywords: Pancreatic cysts
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Mauna Kea Technologies
name: Institut Paoli-Calmettes
name: Technical University of Munich
name: Yale University
name: University of California, Irvine
name: Mayo Clinic
name: University of Washington
name: Cedars-Sinai Medical Center
First posted: 2010-11-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)

Detailed description: The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
* Patients aged 18 years or older,
* Patients is under surgical consideration for management of the cyst
* Patients have provided written informed consent for the study

Exclusion Criteria:

* Allergy to fluorescein
* Pregnancy or breast-feeding

Primary outcomes:
measure: Sensitivity
timeFrame: October 2011
measure: Specificity
timeFrame: October 2011
measure: PPV (Positive Predictive Value)
timeFrame: October 2011
measure: NPV (Negative Predictive Value)
timeFrame: October 2011
Secondary outcomes:
measure: Overall Complication Rate
timeFrame: August 2011
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Irving Waxman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04847700: Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
Official title: Minimally Invasive Vestibular Neurectomy Versus Tenotomy of the Stapedius and Tensor Tympani Muscles in the Management of Patients With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ménière
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The distinctive symptoms of Meniere's disease (MD) include recurrent vertigo spells, fluctuating hearing loss, aural fullness and tinnitus. Conservative treatment in MD comprises lifestyle modifications, such as low-sodium diet, avoidance of caffeine, alcohol and stress, in addition to medication such as diuretics and betahistine. When conservative treatment fails, surgical management is attempted. Surgical interventions comprise transtympanic steroids or gentamicin, endolymphatic sac surgery (ES), ventilation tube placement, vestibular neurectomy, and labyrinthectomy. Recently, Loader et al. have presented encouraging results of the effectiveness of tenotomy of the stapedius and tensor tympani muscles (TSTM) in the management of patients with definite MD. Also, satisfactory results were obtained with endoscopic assisted minimally invasive vestibular neurectomy (MIVN). The aim of this study is to compare the clinical outcomes of MD patients who were submitted to either MIVN or TSTM in our department.


Eligibility criteria: Inclusion Criteria:

* unilateral definite Meniere's disease.

Exclusion Criteria:

* other peripheral or central vestibular disorders, bilateral MD and neurologic disorders.
* Previous history of chronic otitis media or middle ear surgery.

Primary outcomes:
measure: dizziness handicap inventory (DHI)
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
state: ElDakahlia
Study officials:
References:
Clinical trial NCT05127200: Cervical Neuromodulation and Nociceptive Processing
Official title: Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Keywords: tsDCS
non-invasive neuromodulation
healthy volunteers
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Several studies have demonstrated that direct currents delivered through the skin at the level of the lumbar spinal cord can influence spinal cord function. In human volunteers, anodal lumbar transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known.

Detailed description: The investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and lumbar tsDCS. This study will be a double-blinded, sham-controlled, cross-over trial. Each participant will undergo two experimental sessions (anodal cervical tsDCS and sham lumbar tsDCS vs. sham cervical tsDCS and anodal lumbar tsDCS), separated by at least one week.

Eligibility criteria: Inclusion Criteria:

- Healthy young adults

Exclusion Criteria:

* Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
* Use of any medication (except contraception)

Primary outcomes:
measure: Change in contact-heat evoked potentials amplitude
timeFrame: Change from Baseline, at 15-minutes after the end of stimulation
Secondary outcomes:
measure: Change in intensity of perception to contact-heat nociceptive stimuli
timeFrame: Change from Baseline, at 15-minutes after the end of stimulation
measure: Change in temporal summation of pain
timeFrame: Change from Baseline, at 15-minutes after the end of stimulation
measure: Change in intensity of perception to mechanical pinprick nociceptive stimuli
timeFrame: Change from Baseline, at 15-minutes after the end of stimulation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: NOCIONS lab
Study officials:
affiliation: Université Catholique de Louvain
name: André Mouraux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lenoir C, Jankovski A, Mouraux A. Anodal Transcutaneous Spinal Direct Current Stimulation (tsDCS) Selectively Inhibits the Synaptic Efficacy of Nociceptive Transmission at Spinal Cord Level. Neuroscience. 2018 Nov 21;393:150-163. doi: 10.1016/j.neuroscience.2018.10.007. Epub 2018 Oct 12.
Clinical trial NCT02163200: Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
Official title: Changes of Pressure on Soft Tissue Before and After Total Hip Replacement to Prevent Bedsores
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Transient Arthropathy of Hip
Keywords: Bedsores
pressure
hip
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient 60 y.o. or more both sexs, schedule for total hip replacement, without previous bedsore

Brief summary: Patients candidates for total hip replacement are, generally elderlies and have hip pain, we will check if the pressure to the soft tissue changes before and after operation using a tapet with pressure sensors sending the information to specific software.

Detailed description: one hundred Patients 60 years old and more will be considered for this study, both sexs, that have schedule for elective unilateral total hip replacement and have not bedsores previously.

All the data will be collected by FSA software, classified in an excel table. A crossover study will be performed and analyzed by a paired test.

Eligibility criteria: Inclusion Criteria: 60 y/o/ and more

* Both sexes
* Schedule for total hip replacement

Exclusion Criteria:

* Patient with previous bedsore
* Patients under 60 y.0.
* Previous CVA

Primary outcomes:
measure: Changes in soft tissue pressure
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuta MC
name: Sergio G Susmallian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01055600: Milk-only Lactation Study for Patients on Eltrombopag
Official title: A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Thrombocytopaenia
Keywords: eltrombopag
pharmacokinetics
PROMACTA
lactation
milk-only study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their infant. Information will be collected in a diary. Breast milk samples will be collected before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate the eltrombopag concentrations in the breast milk. Mothers will also be given the option to have a pharmacokinetic (PK) blood sample collected from the infant.


Eligibility criteria: Inclusion Criteria:

* Mother is registered with the PROMACTA Pregnancy Registry and meets all the enrollment criteria defined in the PROMACTA Pregnancy Registry study (113327).
* Mother is continuing to take eltrombopag.
* Mother has received 7 consecutive eltrombopag doses prior to the milk sample collection.
* Infant is 4 weeks to 26 weeks of age at the time of milk sampling.
* Exclusively breastfeeding mother-infant pair; either via breast or with expressed milk from the mother.
* Mother is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

* Infant was born with complications that could impact ability to participate in this study.
* Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply).
* Infants who are supplemented with formula or are consuming solid foods.
* Unwillingness or inability of mother to follow the procedures outlined in the protocol.
* Mother is mentally or legally incapacitated

Primary outcomes:
measure: Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag
timeFrame: 24 hours
Secondary outcomes:
measure: AEs in infant reported during the 24 hour breast milk collection period
timeFrame: 24 hours
measure: Plasma eltrombopag concentrations from infant, as data permit (optional)
timeFrame: 1 sample within 2 days
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00643500: Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Official title: Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Partial
Keywords: Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 342
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

* to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
* to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.


Eligibility criteria: Inclusion Criteria:

* Male and female older than 16 years;
* Epilepsy with partial onset seizures, with or without secondary generalization;
* At least one concomitant marketed anti-epileptic drug

Exclusion Criteria:

* Safety reasons

Primary outcomes:
measure: Adverse event rates, seizure counts and quality of life.
timeFrame: 16 week treatment period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01037400: Biochemical Approach to Measuring Surgical Trauma
Official title: Further Development of a Biochemical Approach to Measuring Surgical Trauma to Musculoskeletal Tissues
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Total Knee Replacement
Keywords: Knee Replacement
Arthroplasty
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty men and women ages 18-75 undergoing unilateral (n = 20) or bilateral (n = 20) knee replacement surgery with no musculoskeletal injury requiring medical attention in the past 3 months or producing pain in the previous 2 weeks and no inflammatory disease other than osteoarthritis.

Brief summary: This study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. The sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. Specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).


Eligibility criteria: Inclusion Criteria

* Age 18 to 75
* No musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level.
* No musculoskeletal injury producing pain in the previous 2 weeks.
* No inflammatory disease other than osteoarthritis)
* No exercise with weights in the 2 weeks before surgery.

Primary outcomes:
measure: Sensitivity and Specificity of biomarkers in response to tissue injury
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
References: