louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04399694: Identification and Characterization of Novel Non-Coding Variants That Contribute to Genetic Disorders
Official title: Identification and Characterization of Novel Coding, Splicing and Non-Coding Variants That Contribute to Genetic Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Genetic Disease
Inborn Errors of Metabolism
Glycogen Storage Disease
Lysosomal Storage Diseases
Storage Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed genetic disease and inconclusive genetic results and their unaffected family members

Brief summary: The goal of this study is to identify and characterize novel non-coding and splicing variants that may contribute to genetic disorders. We will particularly focus on patients with a diagnosed genetic disorder that has inconclusive genetic findings.

Detailed description: To perform this study, we will use patient DNA and RNA that is isolated from blood samples. DNA will be sequenced (targeted capture and/or whole genome DNA sequencing (WGS)) to identify any non-coding single nucleotide variants (SNVs), smaller insertions/deletions (indels), or larger structural variants (SVs). RNA will be sequenced (RNA-seq) to identify genes that are expressed in a differential and/or allele-specific manner, which may indicate a functional non-coding or splicing variant. We will test the function of non-coding variants using high-throughput reporter assays and CRISPR based methodologies.

Eligibility criteria: Inclusion criteria:

Subjects will have one or more of the following:

* Patients (probands) diagnosed with a genetic disease
* Patients (probands) with inconclusive genetic results
* Patients (probands) that have identical coding and/or splicing variants, but display highly diverse phenotypes
* Unaffected family members of probands

Exclusion Criteria: There are no exclusion criteria for this study.

Primary outcomes:
measure: Number of missing pathogenic protein coding variants
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke
name: Priya Kishnani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke
name: Greg Crawford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04172194: Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas
Official title: Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatocellular carcinoma

Brief summary: Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm.

Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").


Eligibility criteria: Inclusion Criteria:

- hepatocellular carcinoma pouved by pathology,

Exclusion Criteria:

- metastases

Primary outcomes:
measure: overall survival
timeFrame: 30 minutes
Secondary outcomes:
measure: relapse free survival
timeFrame: 30 minutes
measure: tolerance
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
Study officials:
References:
Clinical trial NCT01056094: Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Official title: Effects of Lutein Supplementation on Oxidative Stress and Inflammation in Healthy Nonsmokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Oxidative Stress in Healthy Subjects
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
First posted: 2010-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lutein is one of oxygenated carotenoids. Over the past few years, there has been increased interest in evaluating the effect of lutein for optimizing immune functions. A large number of epidemiological studies support the notion that a high intake of lutein is associated with a reduced risk of coronary heart disease and certain types of cancer. The biological mechanisms for the protective effects of this carotenoid, including powerful modulation of functions and antioxidant properties, are only partially known. Although several nutrients and phytochemicals have been shown to modulate immune functions in humans, few studies have investigated the role of lutein consumption. No information is available as to whether lutein supplementation could be protective against oxidative stress. Therefore, the objective of the present study was to examine the effect of consuming different doses of lutein on oxidative stress in healthy subjects.

Detailed description: Participants with a history of smoking, alcohol consumption, body mass index (BMI)≥30kg/m2, allergies, ocular diseases and participants taking vitamins or other food supplements containing lutein were excluded from the study.

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects aged in the range of 20 to 80

Exclusion Criteria:

* Participants with a history of smoking
* Alcohol consumption
* Body mass index (BMI)≥30kg/m2
* Allergies
* Ocular diseases or recent infections(within the last year) and participants taking vitamins or other food supplements containing lutein the previous 2 months.

Primary outcomes:
measure: Biomarkers of lipid, protein and DNA oxidative damage, marker of antioxidant capacity and antioxidant enzyme activities(GPx,SOD and CAT)in healthy subjects.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: Xi'an Jiaotong University College of Medicine
state: Shaanxi
Study officials:
References:
Clinical trial NCT01941394: Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
Official title: Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Graft-versus-host Disease
Relapse
Keywords: GVHD
Relapse
Overall Survival
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2013-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.

Detailed description: Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

Eligibility criteria: Inclusion Criteria:

* allogenic BMT from related or unrelated donor

Exclusion Criteria:

* Severe infection
* Relapse
* admission to ICU
* refusal of research
* patients with graft failure

Primary outcomes:
measure: GVHD
timeFrame: Every 30 day for 1 year after BMT
Secondary outcomes:
measure: Overall survival
timeFrame: Every 30 day for 1 year after BMT
measure: Relapse-free survival
timeFrame: Every 30 day for 1 year after BMT
measure: Infection rate
timeFrame: Every 30 day for 1 year after BMT
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: BMT department
Study officials:
affiliation: National Research Center for Hematology
name: Elena Parovichnikova, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.
Clinical trial NCT00858494: Homeopathic Cold Medicine for Children
Official title: Homeopathic Cold Medicine for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection
Keywords: upper respiratory tract infection
children
homeopathic
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Standard Homeopathic Company
First posted: 2009-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. It is postulated that children will have relief of symptoms after receiving a dose of the cold remedy


Eligibility criteria: Inclusion Criteria:

* Children 24-59 months old
* Cold/cough symptoms of \<7 days duration
* Diagnosed with upper respiratory tract infection by physician or nurse practitioner
* Parent who speaks and reads English

Exclusion Criteria:

* Use of chronic medication other than multivitamins
* History of asthma
* Medication other than acetaminophen or ibuprofen
* Use of homeopathic remedy within preceding 30 days
* Only 1 participant per family

Primary outcomes:
measure: Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.
timeFrame: up to 10 days from index visit
Secondary outcomes:
measure: Parental Report of an Adverse Event After a Dose of Study Medication
timeFrame: data collected after doses occurring up to 10 days after index visit
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center-Roosevelt Pediatric Care Center
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00629694: Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Official title: Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otitis Media With Effusion
Keywords: adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
Lead sponsor: Aghia Sophia Children's Hospital of Athens
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 52
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far


Eligibility criteria: Inclusion Criteria:

* children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age

Exclusion Criteria:

* other health problems especially related with the condition eg cleft palate

Primary outcomes:
measure: OM-6
timeFrame: one year post operative
Secondary outcomes:
measure: tympanogram type B
timeFrame: one year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
Study officials:
affiliation: Aghia Sophia Children's Hospital of Athens
name: Ioannis M Vlastos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04307394: Development of a Video-based Intervention for Suicide Prevention
Official title: Development of an Adjunctive Video-Based Suicide Prevention Intervention Immediately Following Psychiatric Hospitalization: Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Psychiatric Hospitalization
Keywords: video intervention
treatment development
open trial
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.


Eligibility criteria: Inclusion Criteria:

* current psychiatric hospitalization for suicidal thoughts and behaviors
* 18 years or older
* ability to speak and read English
* plan to continue outpatient treatment
* access to means for viewing videos (computer, tablet, smartphone)

Exclusion Criteria:

* current psychotic symptoms

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month
Secondary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Lisa Uebelacker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012994: Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery
Official title: Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included patients who were preoperatively diagnosed as requiring elective thoracic cardiac surgery under general anesthesia.

Brief summary: Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet the entry and discharge standards. The patient 's medical record data were divided into study group and control group according to the use of gastrodin during operation. The perioperative data and prognostic outcomes in the patient 's medical records were collected and analyzed. The degree of myocardial injury and postoperative clinical outcomes were compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patients aged≥18 years, regardless of gender;
* Patients undergoing elective cardiac surgery under general anesthesia;
* ASA grade 1 \~ 3.

Exclusion Criteria:

* Suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);
* Moderate to severe malnutrition, moderate to severe anemia;
* Persistent infection;
* Severe preoperative underlying diseases (such as severe liver and kidney dysfunction)

Primary outcomes:
measure: The degree of myocardial injury
timeFrame: The myocardial tissue was collected during the operation. About 2 hours on average
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00125294: Sublingual Methadone for the Management of Cancer Breakthrough Pain
Official title: Evaluation of a Dose Titration Protocol for Sublingual Methadone Hydrochloride for the Management of Cancer-related Breakthrough Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Pain
Keywords: cancer pain
breakthrough pain
methadone
dose titration
sublingual route of administration
Cancer related pain
currently taking narcotics
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
First posted: 2005-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Detailed description: This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Experiences episodes of breakthrough pain which respond to opioid therapy
* Controlled baseline pain
* Cognitive status sufficient for accurate completion of assessment form
* Willing to provide written informed consent
* Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion Criteria:

* Currently or has received methadone during the previous week
* Recent history of substance abuse
* Severe respiratory impairment or other contraindications to opioids
* Recently received therapies that had the potential to alter pain intensity or response to analgesics
* Symptomatic anemia

Primary outcomes:
measure: Determine optimal dose titration
measure: Determine assessment protocol
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alberta Cancerboard
name: Neil Hagen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04972994: Laparoscopic Colectomies In Management of Colonic Cancers
Official title: Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Colectomy
Cancer Colon
Intracorporeal Anastomosis
Keywords: laparoscopic
intracorporeal
extracorporeal
anastomosis
hemicolectomies
, colonic cance
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: right and left hemicolectomies in colonic cancers
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .

Detailed description: This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.

In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.

Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program

Eligibility criteria: Inclusion Criteria:

* Patients had to present histologically confirmed cancer( right and left) colon.
* All grades of cancer will be included.
* Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.

Exclusion Criteria:

* Locally advanced disease with invasion of adjacent important organs.
* Acute bowel obstruction or perforation from cancer.
* Pregnant ladies.
* Rectal cancer and transverse colon cancer.

Primary outcomes:
measure: intraoperative time of surgery
timeFrame: intraoperative time of surgery
measure: post operative hospital stay
timeFrame: up to 1 year
measure: Post operative leakage
timeFrame: 1 year
measure: early recurrence of the cancer
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Sohag University
name: Omar AS Al tabary, Professor
role: STUDY_DIRECTOR
References: