louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00186147: Bone Marrow Grafting for Leukemia and Lymphoma
Official title: Bone Marrow Grafting for Leukemia and Lymphoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Leukemia
Lymphoma
Hematologic Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2005-09-16
Enrollment: 9999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hematopoietic cell transplant recipients and donors who agree to participate

Brief summary: The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.

Detailed description: The purpose of this study is to acquire critical tissue and biological samples that can be evaluated to elucidate underlying mechanisms of disease control, transplant related complications and overall outcomes

Eligibility criteria: Inclusion Criteria:- All hematopoietic cell transplant recipients and donors who agree to participate

Exclusion Criteria:- Subject does not agree to participate

Primary outcomes:
measure: Identify and characterize proteins and genes that may contribute to the development and progression of cancer.
timeFrame: blood sample is collected prior transplant, periodically during the first three months and then indefinately at follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Miklos
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Robert S Negrin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257047: Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effect of red yeast rice on subclinical atherosclerosis in patients with rheumatoid arthritis


Eligibility criteria: Inclusion Criteria:

* patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010
* aged from 18 to 75 years
* without conflict to the written, informed consent signed prior to the enrollment
* no severe hepatic or renal disorders
* no known carotid artery stenosis
* no coagulation disorders
* no hypertension

Exclusion Criteria:

* being in pregnancy, lactation period or under a pregnancy plan
* being allergic to the test drug
* not compatible for the trial medication
* without full legal capacity

Primary outcomes:
measure: Changes from baseline in Carotid intima-media thickness at 24 weeks
timeFrame: At 0 week, 12 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References:
Clinical trial NCT03433547: Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
Official title: A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
High Myopia
Macular Detachment
Keywords: macular buckling
full-thickness macular hole
macular detachment
internal limiting membrane peeling
high myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.

Detailed description: A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on full-thickness macular hole associated with macular detachment in eyes with high myopia.

Eligibility criteria: Inclusion Criteria:

* axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
* full-thickness macular hole
* macular retinal detachment
* evidence of posterior staphyloma on clinical examination

Exclusion Criteria:

* macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
* a history of vitrectomy or scleral buckling
* intraocular active hemorrhage or inflammation
* any media opacity which precluded imaging or clinical evaluation of the macula

Primary outcomes:
measure: Retinal re-attachment rate
timeFrame: 1 month
Secondary outcomes:
measure: Macular hole status
timeFrame: 3 month
measure: Post-operative best corrected visual acuity
timeFrame: 3 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lin Lu, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4.
citation: Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Clinical trial NCT00992147: Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
Official title: A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depressed Scar
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.


Eligibility criteria: Inclusion Criteria:

* older than 19 years
* depressed scar less than volume of 5 ml
* negative for urine beta-HCG for women of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* failure to meet inclusion criteria
* any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* allergy to bovine-derived materials
* Diagnosis of cancer, AIDS, HBV or HCV.
* Patient has a lot of hairs or a tattoo on depressed site
* Insufficient adipose tissue for manufacturing of ANTG-adip
* Patient has depressed scar caused by a malignant tumor
* Patient whom investigator consider is not suitable in this study

Primary outcomes:
measure: Efficacy: recovery rate(%)
timeFrame: week 12
measure: Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Secondary outcomes:
measure: Recovery rate (%)
timeFrame: day 7, 14, 21, 28 days and week 8
measure: A digital photograph
timeFrame: day 1, 3, 7, 14, 21, 28, week 8 and week 12
measure: Patient satisfaction
timeFrame: week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Gab-sung Oh, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697147: Zika and Neurodevelopment Among Infants in Grenada
Official title: Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zika Virus Infection
Neurocognitive Deficit
Development, Child
Neurodevelopmental Abnormality
Lead sponsor: Windward Islands Research and Education Foundation
Sponsor class: OTHER
Collaborators: name: St. George's University
name: Stanford University
name: National Institutes of Health (NIH)
First posted: 2021-01-06
Enrollment: 148
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.

Detailed description: The intervention group received up to twelve 1-hour weekly visits by trained and experienced Grenadian parent and infant relationship specialists who provided home-based interventions as part of the Saving Brains Grenada project.

The environmental enrichment intervention is a brain-based program that teaches parents about brain development in young infants and skills for building a strong social-emotional connection that stimulates brain development and maximizes neurocognitive function. A detailed intervention manual was developed and used as a guide for the intervention specialists. Neurocognitive outcomes in the intervention and control group were assessed pre and post intervention by a separate and blinded assessment team.

Eligibility criteria: Inclusion Criteria:

* Must be actively enrolled in the pre-existing Zika Cohort Study
* Infant must be alive and living with a parent/guardian at the time of recruitment
* Infant must be between 24-27 months at the time of recruitment

Exclusion Criteria:

* Any infants older than 27 months
* Persons not enrolled in the pre-existing Zika Cohort Study

Primary outcomes:
measure: The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA)
timeFrame: 22-30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint George's
country: Grenada
facility: Windward Islands Research and Education Foundation (WINDREF)
Study officials:
affiliation: Windward Islands Research and Education Foundation
name: Randall Waechter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waechter R, Burgen KS, Punch B, Evans R, Blackmon K, Noel T, Fernandes M, Landon B. Improving neurodevelopment in Zika-exposed children: A randomized controlled trial. PLoS Negl Trop Dis. 2022 Mar 8;16(3):e0010263. doi: 10.1371/journal.pntd.0010263. eCollection 2022 Mar.
Clinical trial NCT01756547: Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
Official title: Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nephrocalcinosis
Keywords: Nephrocalcinosis
Extreme premature
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-12-27
Enrollment: 74
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Premature infants of both sexes born at the Hospital Clinic of Barcelona.
2. Corrected gestational age below 32 weeks and lower birth weight 1500gr.
3. Survivors at 7 days old.
4. Clinically stable, in the opinion of the investigator, at the time of inclusion.
5. That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails

Exclusion Criteria:

1. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
2. Chronic renal failure (serum creatinine\> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis \<0.5 mL / kg / hour after the first day of life)
3. Treatment with furosemide or dexamethasone
4. Addison's disease.
5. Persistent severe metabolic alkalosis.
6. Impossibility of oral feeding.

Primary outcomes:
measure: incidence of nephrocalcinosis in extremely preterm infants
timeFrame: 38-40 weeks of corrected gestational age
Secondary outcomes:
measure: Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks
timeFrame: 38-40 weeks of corrected gestational age
measure: To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value
timeFrame: 38-40 weeks of corrected gestational age
measure: Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.
timeFrame: 38-40 weeks of corrected gestational age
measure: To determine the incidence of adverse events and serious adverse events related to study treatment.
timeFrame: 38-40 weeks of corrected gestational age
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Francisco Botet Mussons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02011347: Ketamine and Closed-Loop Anesthesia System
Official title: Influence of Ketamine on a Closed-Loop Anesthesia System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 67
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 objective is to evaluate the sparing effect of ketamine on the dose of propofol.


Eligibility criteria: Inclusion Criteria:

* patients with an American Society of Anesthesiology score 1, 2 or 3
* scheduled for a surgical procedure lasting more than 2 hours under general anesthesia

Exclusion Criteria:

* pregnancy
* chronic pain
* simultaneous general and loco-regional anesthesia
* contra-indication to to nonsteroidal anti-inflammatory drug
* contra-indication to Ketamine
* contra-indication to propofol, to remifentanil, to morphine
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker

Primary outcomes:
measure: administered dose of propofol during maintenance of anesthesia
timeFrame: day 1
Secondary outcomes:
measure: bispectral index measurement
timeFrame: 1 day
measure: administered dose of propofol during induction of anesthesia
timeFrame: day 1
measure: administered doses of remifentanil during induction and maintenance of anesthesia
timeFrame: day 1
measure: delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
timeFrame: day 1
measure: hemodynamic abnormalities requiring treatment
timeFrame: day 1
measure: % of time with a bispectral index between 40 and 60
timeFrame: day 1
measure: postoperative morphine requirement
timeFrame: day 1
measure: incidence of postoperative nausea and vomiting
timeFrame: day 1
measure: White and Song score
timeFrame: day 1
measure: % of patients with an explicit memorisation of the intraoperative period
timeFrame: second postoperative day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts de Seine
city: Fontaine les Dijon
country: France
facility: Clinique Fontaine les Dijons
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05133947: Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN
Official title: A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nervous System Diseases
Lead sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-70 years old CIPN Patients and healthy subjects.

Brief summary: This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.

Detailed description: This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects. After the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. Subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.

Eligibility criteria: Inclusion Criteria:

Received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; Persistent peripheral neuropathy of the lower extremities;

CIPN Severity:

The presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling.

Examination of the lower extremities showed needling loss of both legs; Neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; NRS rating ≥ 4.

Exclusion Criteria:

Pregnant or lactating women. Presence of any neuropathy other than CIPN. According to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors.

The presence of non-CIPN pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.

Primary outcomes:
measure: IENFD
timeFrame: 2021.10~2022.6
Secondary outcomes:
Other outcomes:
Locations:
city: Jilin
country: China
facility: Bethune First Hospital Of Jilin University
Study officials:
affiliation: China
name: Xiaojiao Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06008847: Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study
Official title: Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bowel Cancer
Keywords: bowel
cancer
AI
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2023-08-24
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female, aged 18 and over

Brief summary: The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

Detailed description: Participants will be continuing to follow their standard care pathway, and there are no additional requirements of the participants other than providing consent for their pseudonymised capsule video and data to be used to test the AI system.

The participant's final diagnosis will only be determined by the clinician's standard analysis pathway and not influenced by the AI enabled analysis pathway. All data is de-identified before a video is created and re-identified only once the standard final report is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed data is minimised.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or over
* Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care

Exclusion Criteria:

* Patients unable to provide consent to take part in the study

Primary outcomes:
measure: Sensitivity and specificity of polyp detection in AI enabled CCE reporting
timeFrame: 11 months
measure: Time taken to read video by clinicians and AI tool
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
Study officials:
References: