louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00402259: Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Official title: A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Hemorrhage
Keywords: acute non-variceal upper gastrointestinal bleeding
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 440
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 purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-65 years.
* GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
* One endoscopically confirmed bleeding peptic ulcer or erosive gastritis

Exclusion Criteria:

* GI bleeding caused by Esophageal varices
* Mallory Weiss syndrome
* Zollinger-Ellison syndrome
* Suspicion of gastric malignancy at baseline endoscopy
* Post-Billroth-resection
* Unknown source of GI bleeding · 2.Unstable vital signs

Primary outcomes:
measure: Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
Secondary outcomes:
measure: Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
measure: Time to absence of clinically significant upper GI bleeding
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Research site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Beijing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tore Lind, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00771459: Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo
Official title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Local infiltration analgesia
postoperative pain
ropivacaine
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-10-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.


Eligibility criteria: Inclusion Criteria:

* patients eligible for major spine surgery
* must speak and understand Danish
* must be able to give oral and written consent

Exclusion Criteria:

* alcohol or medicine abuse
* treatment with opioids \> 100 mg daily
* allergy to local anesthetics
* severe obesity

Primary outcomes:
measure: Postoperative Pain
timeFrame: 0-48 h postoperatively
Secondary outcomes:
measure: Analgesia consumption
timeFrame: 0-48 h postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
Clinical trial NCT06400459: IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease
Official title: Phase 1/2a, Proof-of-Concept, Multicenter, Parallel, Vehicle-Controlled, Double-Masked, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of IVW-1001 Ophthalmic Eyelid Wipe in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Lead sponsor: IVIEW Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-masked
Primary purpose: TREATMENT

Brief summary: Double-masked, dose-response, trial of IVW-1001 in subjects with dry eye disease.

Detailed description: This is a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipes in subjects with DED. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle). Subjects will participate in a 7-day, run-in period followed by a 28-daydosing period.

Eligibility criteria: Inclusion Criteria:

1. Subjects of any gender at least 18 years of age at the Screening Visit
2. Able to voluntarily provide written informed consent to participate in the study
3. Able and willing to comply with all study procedures and restrictions, follow study instructions, and complete required study visits
4. Diagnosis of Dry Eye Disease (DED)

Exclusion Criteria:

1. Corneal fluorescein staining score of 4 using the NEI grading system
2. Intraocular pressure ≥23 mmHg
3. History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention
4. Subjects with ocular inflammatory conditions (eg, conjunctivitis, keratitis, severe anterior blepharitis, etc.) not related to DED

Primary outcomes:
measure: Schirmer's
timeFrame: 29 Days
Secondary outcomes:
measure: Visual acuity
timeFrame: 29 Days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
Study officials:
affiliation: IVIEW Therapeutics Inc.
name: Bo Liang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01086059: OTIS Humira Pregnancy Registry
Official title: Humira (Adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Rheumatoid Arthritis
Keywords: Autoimmune diseases
adalimumab
pregnancy
birth defects
TNF
Tumor necrosis factor
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Organization of Teratology Information Specialists
name: Abbott
First posted: 2010-03-12
Enrollment: 944
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who reside in the United States, Canada or Puerto Rico.

Brief summary: The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant

Primary outcomes:
measure: Major malformations
timeFrame: Throughout pregnancy and up to 1 year of life
Secondary outcomes:
measure: Minor malformations
timeFrame: At dysmorphological exam
measure: Pregnancy outcome
timeFrame: Throughout pregnancy
measure: Infant follow-up
timeFrame: Throughout pregnancy and up to 1 year of life
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Kenneth L Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chambers CD, Johnson DL, Xu R, Luo Y, Lopez-Jimenez J, Adam MP, Braddock SR, Robinson LK, Vaux K, Lyons Jones K; OTIS Collaborative Research Group. Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study. PLoS One. 2019 Oct 18;14(10):e0223603. doi: 10.1371/journal.pone.0223603. eCollection 2019.
Clinical trial NCT04926259: Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
Official title: Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neurodegenerative Disorders
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.

Detailed description: In this study, 18F-T807 (AV1451) molecular probe PET/CT was used to monitor the regional distribution and the degree of deposition in patients with neurodegenerative diseases, and compared with clinical symptoms to evaluate its value in the early differential diagnosis of neurodegenerative diseases.

Eligibility criteria: Inclusion Criteria:

* Patients or their families complain of significant memory impairment;
* Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
* Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
* Signed written consent.

Exclusion Criteria:

* Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
* Pregnancy or lactation.

Primary outcomes:
measure: standardized uptake value ratio (SUVR)
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Aβ42 in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: t-tau in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: p-tau in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: NfL in CSF
timeFrame: Within 2 hours prior to tracer injection
measure: NfL in the blood
timeFrame: Within 2 hours prior to tracer injection
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT02001259: Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
Official title: Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: post-operative pain control
total knee arthroplasty
epidural steroid injection
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA

Detailed description: Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA

Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
* 50-85 years old
* ASA class 1-3

Exclusion Criteria:

* unable to perform epidural anaesthesia
* history of drug allergies: lidocaine, steroid
* renal impairment (CrCl \<30 mL/min)
* liver impairment
* cognitive function disorders
* displacement of epidural catheter

Primary outcomes:
measure: post-operative pain
timeFrame: 3 months
Secondary outcomes:
measure: functional knee score
timeFrame: 3 months
Other outcomes:
measure: complication of epidural triamcinolone
timeFrame: 2 weeks
measure: range of motion of the knee
timeFrame: 3 months
Locations:
city: Khlong Luang
country: Thailand
facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university
state: Pathumthani
Study officials:
affiliation: orthopaedic department
name: Supakit Kanitnate, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858059: A Randomized Controlled Trial of the Efficacy of the Lighthouse Parenting Programme in Addressing Parenting Difficulties in China
Official title: A Randomized Controlled Trial of the Efficacy of the Lighthouse Parenting Effectiveness Enhancement Programme in Addressing Parenting Difficulties
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parenting Intervention
Keywords: Parenting Intervention
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 56
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted in three phases: assessments, group intervention and individual intervention. All participants will engage in the full program over a period of five weeks, divided into ten sessions. The 5 group interventions will occur once a week for 1.5 hours. During this time, the psychotherapist will disseminate psychological knowledge and skills pertinent to parenting, after which the group members will engage in practice exercises and discourse. Subsequently, one individual session will be conducted each week for one hour. The test group (Group A) will be assessed once at recruitment and after the last individual session. The control group (Group B) will undergo the same intervention as the test group after the test group completes the intervention and posttest, and will be assessed one additional time for pre-intervention status.


Eligibility criteria: Inclusion Criteria:

* Parents with children aged 2-14 years who exhibited parenting that were identified as being problematic (Parenting Stress Indicator PSI ≥ 86 (critical high level)).

Exclusion Criteria:

* Parents in the family with either parent and child who have a serious medical condition (e.g., cancer, heart disease, etc.), an acute psychotic episode, or difficulty engaging in group interventions may be excluded from participation.

Primary outcomes:
measure: Parenting stress
timeFrame: From enrollment to the end of treatment at 5 weeks
Secondary outcomes:
measure: Parental mentalising
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: Quality of the parent-child relationship
timeFrame: From enrollment to the end of treatment at 5 weeks
measure: parenting efficacy
timeFrame: From enrollment to the end of treatment at 5 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Volkert J, Georg A, Hauschild S, Herpertz SC, Neukel C, Byrne G, Taubner S. [Strengthening Attachment Competencies in Parents with Mental Illness: Adaptation and Pilot Testing of the Mentalization-Based Lighthouse Parenting Program]. Prax Kinderpsychol Kinderpsychiatr. 2019 Jan;68(1):27-42. doi: 10.13109/prkk.2019.68.1.27. German.
Clinical trial NCT02308059: Ultrasonographic Evaluation of Diabetic Neuropathy
Official title: Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in a University Hospital

Brief summary: The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.

Detailed description: Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale \[VAS\]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
* probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.

Exclusion Criteria

* type 1 diabetes mellitus
* hypothyroidism
* LANSS pain scale scores \< 12
* body mass index (BMI) \> 35
* current pregnancy
* histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.

Primary outcomes:
measure: Pain scores on the visual analog scale
timeFrame: 3 years
Secondary outcomes:
measure: Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Çukurova University, Faculty of Medicine
name: Bayram Kelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01752270: the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
Official title: The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.


Eligibility criteria: Inclusion Criteria:

* diagnosed polycystic ovary syndrome patients according to Rotterdam criteria
* with hyperandrogenism and/or clinical hyperandrogenic manifestations
* no other oral contraceptives treatment for at least 3 months before this experiment
* no any other assisted reproductive therapy
* accompanied with fallopian tube and/or male factors
* normal hepato-/nephro- function

Exclusion Criteria:

* oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
* smoking, drunk
* exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.

Primary outcomes:
measure: fertilization rate
timeFrame: up to 2years
Secondary outcomes:
measure: implantation rate
timeFrame: up to 2years
Other outcomes:
measure: clinical pregnancy rate
timeFrame: up to 2years
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yatsen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yatsen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04438070: COVID Screening Strategies in Homeless Shelters
Official title: COVID Screening Strategies in Homeless Shelters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Timothy O'Shea
name: Marek Smieja
name: Lawrence Mbuagbaw
First posted: 2020-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized multi-center trial
Primary purpose: SCREENING

Brief summary: Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18
* Able to provide oral consent
* Able to perform a self-collected swab if in the relevant intervention arm

Exclusion Criteria:

-

Primary outcomes:
measure: COVID-19 Detection Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of outbreaks
timeFrame: 8 weeks
measure: Enrollment over time
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Various Homeless Shelters
state: Ontario
Study officials:
References:
citation: O'Shea T, Mbuagbaw L, Mokashi V, Bulir D, Gilchrist J, Smieja N, Chong S, Marttala S, Vera V, Cvetkovic A, Smieja M. Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 23;21(1):941. doi: 10.1186/s13063-020-04890-2.